Tonix Pharmaceuticals Stock (NASDAQ: TNXP)

Tonix Pharmaceuticals Stock (NASDAQ:TNXP), Trade Ideas

Tonix Pharmaceuticals

Tonix Pharmaceuticals Holding Corp is a biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's development portfolio is focused on central nervous system (CNS) disorders. The company's immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease.

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TNXP

Tonix Pharmaceuticals shares are trading lower by 7.2% Monday. The company last week announced the pricing of a $4.4 million registered direct offering.

Tonix Pharmaceuticals Stock (TNXP) Hits A New All-Time Low: What&#39;s Going On?

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XXII

Shares of  Kodiak Sciences Inc.  (NASDAQ: KOD) fell sharply during Thursday’s session after the company reported a wider-than-expected fourth-quarter loss.

Kodiak Sciences posted a quarterly loss of $1.13 per share, compared to market expectations for a loss of 77 cents per share.

Why Kodiak Sciences Shares Are Trading Lower By Around 20%? Here Are Other Stocks Moving In Thursday&#39;s Mid-Day Session

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Tonix Pharmaceuticals shares are trading lower by 22.3% Thursday afternoon. The company announced the pricing of a $4.4 million registered direct offering.

Why Tonix Pharmaceuticals Stock (TNXP) Is Getting Obliterated

Tonix Pharmaceuticals Holding Corp. - Common Stock

Tonix Pharmaceuticals Holding Corp

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WHO's Tedros Adhanom Ghebreyesus Posts On X "In #DRC alone, more than 4500 cases of #mpox and almost 300 deaths have been reported this year. That is triple the number reported at this time last year. The recent surge in cases and deaths among children is of particular concern, along with the re-emergence of Clade One in central Africa...."

Tonix Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) reported quarterly losses of $(0.86) per share which beat the analyst consensus estimate of $(1.55) by 44.52 percent. This is a 75.43 percent increase over losses of $(3.50) per share from the same period last year. The company reported quarterly sales of $3.80 million which missed the analyst consensus estimate of $5.75 million by 33.91 percent.

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Tonix Pharmaceuticals Q4 EPS $(0.86) Beats $(1.55) Estimate, Sales $3.80M Miss $5.75M Estimate

Tonix Pharmaceuticals Holding Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) shares traded lower by 7.2% to $0.17 Monday morning, hitting a new-all time low. The stock is trading lower on downward momentum after the company last week announced the pricing of a $4.4 million registered direct <a href="https://www.benzinga.com/pressreleases/24/03/g37983359/tonix-pharmaceuticals-announces-pricing-of-4-4-million-registered-direct-offering">offering</a>.
Tonix has initiated a securities purchase agreement with existing healthcare-focused institutional investors for the sale of 14,666,666 shares of its common stock and accompanying warrants in a registered direct offering at a combined price of $0.30 per share.
The offering, expected to close around April 1, is anticipated to generate gross proceeds of approximately $4.4 million. The net proceeds will be allocated towards working capital, general corporate purposes, and partial repayment of debt. A.G.P./Alliance Global Partners is the sole placement agent for the offering.
In addition to the offering, the company has agreed to amend certain existing warrants issued in 2023, reducing their exercise price to $0.33 per share and extending their termination dates.
These amendments are contingent upon shareholder approval, and if not obtained within six months of the offering's closing, the warrants will have an exercise price equal to the Nasdaq minimum price.
See Also: <a href="https://www.benzinga.com/markets/asia/24/04/38021682/chinas-march-manufacturing-growth-could-dump-into-global-markets-thus-triggering-deflation-expert-wa">China&#8217;s March Manufacturing Growth Could &#8216;Dump Into Global Markets, Thus Triggering Deflation,&#8217; Expert Warns</a>
<h2 class="wp-block-heading">Should I Sell My TNXP Stock?</h2>
When deciding to hold on to or sell a stock, investors should consider their time horizon, unrealized gains and total return.
Shares of Tonix Pharmaceuticals have decreased by 94.6% in the past year. An investor who bought shares of Tonix Pharmaceuticals at the beginning of the year would take a loss of $0.22 per share if they sold it today. The stock has fallen 48.56% over the past month, meaning an investor who bought shares on Mar. 1 would see a capital loss of $0.18.
Investors may also consider market dynamics. The Relative Strength Index can be used to indicate whether a stock is overbought or oversold. Tonix Pharmaceuticals stock currently has an RSI of 12.61, indicating oversold conditions.
For access to advanced charting and analysis tools and stock data, check out <a href="https://pro.benzinga.com/">Benzinga PRO. Try it for free.</a> 
TNXP has a 52-week high of $3.80 and a 52-week low of $0.17.

Tonix Pharmaceuticals Stock (TNXP) Hits A New All-Time Low: What's Going On?

<h3>Gainers</h3>
<ul>
<li>Avalo Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVTX#NASDAQ">AVTX</a>) shares increased by 364.8% to $22.08 during Friday's regular session. The market value of their outstanding shares is at $17.6 million. </li>
<li>Nexalin Technology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NXL#NASDAQ">NXL</a>) shares moved upwards by 83.33% to $1.43. The company's market cap stands at $10.4 million. </li>
<li>Biodexa Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BDRX#NASDAQ">BDRX</a>) stock moved upwards by 81.6% to $1.56. The company's market cap stands at $6.6 million. </li>
<li>Xilio Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XLO#NASDAQ">XLO</a>) shares moved upwards by 67.44% to $1.07. The company's market cap stands at $29.4 million. </li>
<li>Mesoblast (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MESO#NASDAQ">MESO</a>) shares increased by 44.12% to $5.03. The company's market cap stands at $510.4 million. </li>
<li>Regencell Bioscience (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGC#NASDAQ">RGC</a>) shares increased by 42.65% to $4.95. The company's market cap stands at $64.4 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Tonix Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) stock decreased by 45.4% to $0.18 during Friday's regular session. The company's market cap stands at $10.4 million. </li>
<li>Akanda (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AKAN#NASDAQ">AKAN</a>) shares decreased by 31.81% to $0.11. </li>
<li>Kodiak Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KOD#NASDAQ">KOD</a>) stock decreased by 29.6% to $5.25. The market value of their outstanding shares is at $275.2 million. As per the news, the Q4 earnings report came out yesterday. </li>
<li>ENDRA Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NDRA#NASDAQ">NDRA</a>) shares decreased by 28.84% to $0.58. The company's market cap stands at $6.4 million. The company's, Q4 earnings came out yesterday. </li>
<li>PAVmed (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PAVM#NASDAQ">PAVM</a>) stock declined by 20.15% to $2.18. The market value of their outstanding shares is at $17.5 million. As per the press release, Q4 earnings came out 3 days ago. </li>
<li>Akebia Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AKBA#NASDAQ">AKBA</a>) shares decreased by 18.09% to $1.83. The company's market cap stands at $384.1 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Friday's Intraday Session

Shares of Kodiak Sciences Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kod#NASDAQ">KOD</a>) fell sharply during Thursday&rsquo;s session after the company reported a wider-than-expected fourth-quarter loss.
Kodiak Sciences posted a quarterly loss of $1.13 per share, compared to market expectations for a loss of 77 cents per share.
Kodiak Sciences shares dipped 19.9% to $5.97 on Thursday.
Here are some other stocks moving in today&#39;s mid-day session.
<h3>Gainers</h3>
<ul>
<li>Avalo Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/avtx#NASDAQ">AVTX</a>) shares jumped 430% to $25.35 after the company announced it acquired a Phase 2-ready anti-IL-1&beta; mAb, which it refers to as AVTX-009, through the acquisition of privately held AlmataBio. The company also announced a private placement financing of up to $185 million.</li>
<li>Xilio Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/xlo#NASDAQ">XLO</a>) gained 146% to $1.58 after the company announced an exclusive license agreement with Gilead Sciences for a tumor-activated IL-12 program. The company announced a $11.3 million private placement equity financing.</li>
<li>Biodexa Pharmaceuticals Plc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bdrx#NASDAQ">BDRX</a>) shares climbed 80% to $1.5395. Biodexa&#39;s MTX110 showed promise in extending life expectancy against aggressive brain cancers.</li>
<li>Ontrak, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/otrk#NASDAQ">OTRK</a>) gained 55% to $0.9239.</li>
<li>Binah Capital Group, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bcg#NASDAQ">BCG</a>) gained 48% to $14.05 after dipping more than 20% on Wednesday.</li>
<li>Kidpik Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pik#NASDAQ">PIK</a>) gained 40.7% to $4.5999. Kidpik recently regained compliance with the Nasdaq minimum bid price requirement.</li>
<li>Allego N.V. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/allg#NASDAQ">ALLG</a>) rose 32.8% to $1.7650.</li>
<li>Akanda Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/akan#NASDAQ">AKAN</a>) gained 28% to $0.2053 after the company announced a plan to evaluate opportunities in Bitcoin, Blockchain and AI applications in the cannabis industry.</li>
<li>Destiny Tech100 Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dxyz#NASDAQ">DXYZ</a>) rose 26% to $22.15.</li>
<li>REX American Resources Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/rex#NYSE">REX</a>) gained 23.2% to $54.15 following upbeat earnings.</li>
<li>Nutriband Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ntrb#NASDAQ">NTRB</a>) gained 23% to $4.98. Nutriband recently provided a clinical and regulatory path overview for its AVERSA Fentanyl patch.</li>
<li>Summit Therapeutics Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/smmt#NASDAQ">SMMT</a>) gained 22.8% to $4.6050.</li>
<li>CERo Therapeutics Holdings, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cero#NASDAQ">CERO</a>) gained 22.7% to $2.00.</li>
<li>Hut 8 Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hut#NASDAQ">HUT</a>) gained 20.4% to $11.87. Hut 8 Corp reported revenue of C$60.6 million for the six months ended Dec. 31, 2023.</li>
<li>Matterport, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mttr#NASDAQ">MTTR</a>) rose 16.8% to $2.2802.</li>
<li>RH (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/rh#NYSE">RH</a>) rose 16.2% to $344.99 following the release of quarterly results. RH posted weaker-than-expected results for its fourth quarter, but issued upbeat forecast.</li>
<li>Cazoo Group Ltd (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/czoo#NASDAQ">CZOO</a>) gained 15.5% to $14.52 after jumping over 100% on Wednesday.</li>
<li>Sutro Biopharma, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/stro#NASDAQ">STRO</a>) surged 14.4% to $5.64. Oppenheimer analyst Jay Olson maintained Sutro Biopharma with an Outperform and maintained a $10 price target.</li>
<li>Kintara Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ktra#NASDAQ">KTRA</a>) shares rose 14.1% to $0.1021. Kintara Therapeutics announced expansion of REM-001 clinical study to include patients on pembrolizumab.</li>
<li>Nikola Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nkla#NASDAQ">NKLA</a>) gained 12.7% to $1.0250.</li>
<li>OPKO Health, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/opk#NASDAQ">OPK</a>) climbed 12.1% to $1.1996. Labcorp announced acquisition of select assets of BioReference Health&#39;s Diagnostics Business.</li>
<li>Altimmune, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alt#NASDAQ">ALT</a>) climbed 11.4% to $9.90. Altimmune recently released lean mass preservation data for pemvidutide and worse-than-expected fourth-quarter FY23 earnings.</li>
<li>Marathon Digital Holdings, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mara#NASDAQ">MARA</a>) gained 10.4% to $24.37.</li>
<li>Ginkgo Bioworks Holdings, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/dna#NYSE">DNA</a>) rose 7.1% to $1.1786. Ginkgo Bioworks announced that it has been awarded a contract for up to $6 million from the Defense Advanced Research Projects Agency.</li>
<li>The Est&eacute;e Lauder Companies Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/el#NYSE">EL</a>) gained 5.4% to $152.85 after B of A Securities upgraded the stock from Neutral to Buy and raised its price target from $160 to $170.</li>
</ul>
<h3>Losers</h3>
<ul>
<li>Primech Holdings Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pmec#NASDAQ">PMEC</a>) shares fell 46.7% to $2.07 after the company issued financial updates and corporate highlights for the six months ended Sept. 30, 2023.</li>
<li>Gamida Cell Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gmda#NASDAQ">GMDA</a>) fell 28.1% to $0.0427. Gamida Cell shares dipped over 82% on Wednesday after the company reported fourth-quarter results and disclosed the commencement of a restructuring process.</li>
<li>Data Storage Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dtst#NASDAQ">DTST</a>) dipped 24% to $5.81 following fourth-quarter results.</li>
<li>urban-gro, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ugro#NASDAQ">UGRO</a>) declined 22.9% to $1.3992 after the company reported worse-than-expected fourth-quarter financial results.</li>
<li>Presto Automation Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/prst#NASDAQ">PRST</a>) fell 22% to $0.1493. Presto Automation recently entered securities purchase agreements relating to the issuance and sale of 4.8 million shares</li>
<li>Tonix Pharmaceuticals Holding Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tnxp#NASDAQ">TNXP</a>) dipped 19.6% to $0.2629. Tonix Pharmaceuticals announced pricing of $4.4 million registered direct offering.</li>
<li>MillerKnoll, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mlkn#NASDAQ">MLKN</a>) shares fell 17.2% to $25.28 as the company reported downbeat sales for its third quarter and issued weak guidance for the fourth quarter.</li>
<li>Sezzle Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sezl#NASDAQ">SEZL</a>) fell 16.6% to $77.13.</li>
<li>NuCana plc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ncna#NASDAQ">NCNA</a>) fell 16.3% to $0.2616. NuCana announced a plan to implement 1-for-25 ADS ratio change.</li>
<li>SOBR Safe, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sobr#NASDAQ">SOBR</a>) fell 13.7% to $0.4460 after gaining 12% on Wednesday.</li>
<li>Murano Global Investments Plc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrno#NASDAQ">MRNO</a>) fell 13% to $12.97.</li>
<li>22nd Century Group, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/xxii#NASDAQ">XXII</a>) fell 12.5% to $ 0.1151 as the company posted fourth-quarter results and announced stock split of 1-for-16.</li>
<li>MicroStrategy Incorporated (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mstr#NASDAQ">MSTR</a>) declined 10.9% to $1,710.01.</li>
<li>Hitek Global Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hkit#NASDAQ">HKIT</a>) fell 10.3% to $1.56 after gaining over 22% on Wednesday.</li>
<li>Movella Holdings Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mvla#NASDAQ">MVLA</a>) fell 10.2% to $0.0678 after dipping 20% on Wednesday.</li>
<li>Abits Group Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/abts#NASDAQ">ABTS</a>) fell 10.2% to $0.70.</li>
<li>Reddit, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/rddt#NYSE">RDDT</a>) fell 9.4% to $52.32.</li>
<li>Braze, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/brze#NASDAQ">BRZE</a>) dipped 9.3% to $45.90 after the company issued soft EPS guidance for FY25.</li>
<li>The Chemours Company (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/cc#NYSE">CC</a>) shares dropped 6.2% to $27.09 after the company reported fourth-quarter results. The company also said it identified four material weaknesses amid its internal control over financial reporting.</li>
<li>GCT Semiconductor Holding Inc, (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gcts#NYSE">GCTS</a>) fell 5.1% to $41.77 amid volatility following the company&#39;s recently completed business combination with Concord Acquisition Corp III and NYSE debut.</li>
<li>Carnival Corporation &amp; plc (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ccl#NYSE">CCL</a>) fell 4% to $16.52. Carnival posted a narrower-than-expected loss for its first quarter on Wednesday.</li>
</ul>
&nbsp;
Now Read This: <a href="https://www.benzinga.com/trading-ideas/long-ideas/24/03/37975916/jim-cramer-likes-crown-castle-but-cant-recommend-archer-aviation-it-has-no-earnings-powe"> Jim Cramer Likes Crown Castle, But Can&#39;t Recommend Archer Aviation: It Has &#39;No Earnings Power&#39; </a>

Why Kodiak Sciences Shares Are Trading Lower By Around 20%? Here Are Other Stocks Moving In Thursday's Mid-Day Session

Tonix Pharmaceuticals Holding Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) shares are trading lower by 33.9% to $0.22 Thursday afternoon after the company announced the pricing of a $4.4 million registered direct <a href="https://www.benzinga.com/pressreleases/24/03/g37983359/tonix-pharmaceuticals-announces-pricing-of-4-4-million-registered-direct-offering">offering</a>.
Tonix has initiated a securities purchase agreement with existing healthcare-focused institutional investors for the sale of 14,666,666 shares of its common stock and accompanying warrants in a registered direct offering at a combined price of $0.30 per share. 
The offering, expected to close around April 1, 2024, is anticipated to generate gross proceeds of approximately $4.4 million. The net proceeds will be allocated towards working capital, general corporate purposes, and partial repayment of debt. A.G.P./Alliance Global Partners is the sole placement agent for the offering.
In addition to the offering, the company has agreed to amend certain existing warrants issued in 2023, reducing their exercise price to $0.33 per share and extending their termination dates. 
These amendments are contingent upon shareholder approval, and if not obtained within six months of the offering&#8217;s closing, the warrants will have an exercise price equal to the Nasdaq minimum price.
See Also: <a href="https://www.benzinga.com/general/biotech/24/03/37984877/insurance-coverage-for-weight-loss-drugs-elevance-cvs-health-become-first-to-extend-coverage-to-n">Elevance, CVS Health Are First Medicare Insurers To Cover Novo Nordisk&#8217;s Weight Loss Sensation Wegovy</a>
<h2 class="wp-block-heading">How To Buy TNXP Stock</h2>
By now you're likely curious about how to participate in the market for Tonix Pharmaceuticals &#8211; be it to purchase shares, or even attempt to bet against the company.
Buying shares is typically done through a brokerage account. You can find a list of <a href="https://www.benzinga.com/money/best-stock-trading-platforms">possible trading platforms here.</a> Many will allow you to buy ‘fractional shares,' which allows you to own portions of stock without buying an entire share. For example, some stock, like Berkshire Hathaway, or Amazon.com, can cost thousands of dollars to own just one share. However, if you only want to invest a fraction of that, brokerages will allow you to do so. 
In the the case of Tonix Pharmaceuticals, which is trading at $0.26 as of publishing time, $100 would buy you 384.62 shares of stock.
If you're looking to bet against a company, the process is more complex. You'll need access to an options trading platform, or a broker who will allow you to ‘go short' a share of stock by lending you the shares to sell. The process of shorting a <a href="https://www.benzinga.com/money/how-to-short-a-stock">stock can be found at this resource.</a> Otherwise, if your broker allows you to trade options, you can either buy a put option, or sell a call option at a strike price above where shares are currently trading &#8211; either way it allows you to profit off of the share price decline.
According to data from&nbsp;<a href="https://benzinga.grsm.io/register174">Benzinga Pro</a>, TNXP has a 52-week high of and a 52-week low of

<h3>Gainers</h3>
<ul>
<li>Avalo Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVTX#NASDAQ">AVTX</a>) stock rose 363.1% to $22.0 during Thursday's regular session. The company's market cap stands at $17.6 million. </li>
<li>Xilio Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XLO#NASDAQ">XLO</a>) stock rose 133.95% to $1.5. The company's market cap stands at $41.1 million. </li>
<li>Biodexa Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BDRX#NASDAQ">BDRX</a>) stock increased by 71.82% to $1.48. The market value of their outstanding shares is at $6.2 million. </li>
<li>Mesoblast (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MESO#NASDAQ">MESO</a>) stock increased by 44.41% to $5.04. The company's market cap stands at $511.4 million. </li>
<li>Ontrak (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OTRK#NASDAQ">OTRK</a>) stock increased by 37.66% to $0.82. The company's market cap stands at $22.5 million. </li>
<li>Nexalin Technology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NXL#NASDAQ">NXL</a>) stock moved upwards by 35.85% to $1.06. The company's market cap stands at $7.7 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Tonix Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) shares decreased by 35.8% to $0.21 during Thursday's regular session. The market value of their outstanding shares is at $12.3 million. </li>
<li>Kodiak Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KOD#NASDAQ">KOD</a>) stock fell 18.6% to $6.07. The market value of their outstanding shares is at $318.2 million. As per the press release, Q4 earnings came out today. </li>
<li>NuCana (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NCNA#NASDAQ">NCNA</a>) shares decreased by 15.19% to $0.26. The company's market cap stands at $13.7 million. </li>
<li>Oncology Institute (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TOI#NASDAQ">TOI</a>) shares fell 13.59% to $1.59. The company's market cap stands at $117.2 million. As per the news, the Q4 earnings report came out yesterday. </li>
<li>Vincerx Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VINC#NASDAQ">VINC</a>) stock fell 13.21% to $5.26. The market value of their outstanding shares is at $112.4 million. </li>
<li>ENDRA Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NDRA#NASDAQ">NDRA</a>) stock decreased by 13.13% to $0.71. The market value of their outstanding shares is at $7.8 million. As per the press release, Q4 earnings came out today. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

VINC

12 Health Care Stocks Moving In Thursday's Intraday Session

WIIM

Tonix Pharmaceuticals Holding shares are trading lower after the company announced the pricing of a $4.4 million registered direct offering.

Offerings

Tonix Pharmaceuticals Prices $4.4M Registered Direct Offering Of 14,666,666 Shares And Warrants At $0.30/Share; Warrants Have Exercise Price Of $0.33/Share

TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and eating &nbsp;
Prader Willi syndrome is the most common genetic cause of life-threatening childhood obesity
CHATHAM, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to TNX-2900&#x2A; (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-potentiated formulation of intranasal oxytocin, to treat Prader-Willi syndrome (PWS) in children and adolescents. TNX-2900 was previously granted Orphan Drug designation by the FDA in 2022 for the treatment of PWS and the investigational new drug (IND) application was cleared by the FDA in 2023. The Company may be eligible to receive a transferable Priority Review Voucher if TNX-2900 for PWS is approved for marketing. Recently, vouchers have sold for approximately $100 million.
"The Rare Pediatric Disease Designation is an important regulatory milestone in the development of TNX-2900. With PWS being the most common genetic cause of life-threatening childhood obesity, we are excited that the FDA has recognized this significant unmet need in children and adolescents, particularly for PWS hyperphagia, which currently has no approved treatments1,2," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "As PWS is a genetic disorder associated with abnormalities of the oxytocin system, Tonix believes TNX-2900's unique formulation has the potential to improve intranasal oxytocin's therapeutic action by addressing limitations in efficacy observed at high-dose intranasal oxytocin that is not Mg2+-potentiated3,4."
The FDA defines a rare pediatric disease as a serious or life-threating disease that primarily affects individuals aged from birth to 18 years and affects under 200,000 people in the United States.
About FDA's Rare Pediatric Disease Priority Voucher Program
The FDA's Rare Pediatric Disease Priority Voucher Program is intended to encourage the development of new drugs to treat certain rare pediatric diseases. Under the FDA's Rare Pediatric Disease Designation and Voucher Program, if TNX-2900 is approved for marketing, Tonix may qualify for a priority review voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product. Priority review vouchers may also be sold or transferred to another sponsor. The new sponsor can redeem the voucher to receive priority review for a different product, which reduces the review time of NDAs from 10 months to six months.&nbsp;There is no limit on the number of times a priority review voucher can be transferred. A 2020 U.S. Government Accounting Office analysis5 of the voucher program found that in the ten years since launch of the program in 2009, the price of buying priority review vouchers ranged from $67 million to $350 million. More recently, priority review vouchers were acquired by Novo Nordisk for $110 million in June of 2022, and by Novartis for $100 million from Marinus in July of 2022.6&nbsp;&nbsp; Bluebird Bio sold vouchers for $102 million, $95 million and $103 million in November 2022, January 2023, and October 2023, respectively.7-9 In June of 2023, Novartis bought a priority review voucher from Pharming for $21 million, a price that had been negotiated as part of a purchase agreement when Pharming acquired the asset from Novartis.5

Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation From The FDA For TNX-2900 For The Treatment Of Prader-Willi Syndrome

Four Phase 2 investigator-initiated studies of TNX-1900 (intranasal potentiated oxytocin) are ongoing for pediatric obesity, binge eating disorder, bone health in autism and social anxiety disorder &nbsp;
TNX-2900 (intranasal potentiated oxytocin) is being developed under an IND as a treatment for Prader-Willi Syndrome, an Orphan Disease characterized by excessive eating
TNX-1900 and TNX-2900 may serve as novel neuroendocrine treatments for certain pain, eating and endocrine disorders&nbsp;
CHATHAM, N.J., March 21, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announces a poster presentation at the American Chemistry Society (ACS) Spring 2024 Meeting, held March 17-21, 2024, in New Orleans, Louisiana. A copy of the poster is available under the <a href="https://www.globenewswire.com/Tracker?data=9vS_6CFMb6yG3K5iFmsNaL6Na9Q7_pfW2JNZc7Xa14nS6M6nobwPdkyRT85pk8DDUmILp7K2Ca6IzwXGfGopgzjKVFkLU6wia87Je-mWCSgAFZs5CZb3HW1FBhUDww6oSa0UsYadek5z8q0bJ_ZSnA==">scientific presentations</a> page of the Tonix website at <a href="https://www.globenewswire.com/Tracker?data=moH55LYf0kaOUzMr9soR7gOMFB1khOHE7bO7P7wIuLvZ3YOBYgx73tVTpC9mN8bBgeV1ztFGcgYxThUS8xwxwtfLVWIJj_mKT1VniLL-6tM=">www.tonixpharma.com</a>.
The poster presentation titled, Oxytocin Analogs with Enhanced Craniofacial Antinociceptive Effects in Low Magnesium Formulations, describes the discovery and characterization of novel oxytocin analogues that are candidate treatments for craniofacial pain, excessive eating (including Prader Willi Syndrome), and endocrinological conditions including bone health in autism and insulin resistance.
"Intranasal oxytocin has several potential therapeutic applications," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Preclinical studies have shown that oxytocin, a hypothalamic peptide hormone, simultaneously reduces food intake and increases energy expenditure, leading to weight loss.1-3 Intranasal oxytocin is well-tolerated and in published studies of adults, results in reduced caloric intake, increased fat burning and improved insulin sensitivity.1-3"
Dr. Lederman continued, "There is preclinical evidence that the activity of intranasal oxytocin is dependent on magnesium (Mg++) concentration.4-6&nbsp;Our current intranasal oxytocin formulations of TNX-1900 and TNX-2900 contain Mg++ to augment the activity. We believe the new oxytocin analogues described in the poster have enhanced binding to Mg++ and consequently their activity does not require Mg++ augmentation."
Four Phase 2 investigator-initiated studies of TNX-1900 are currently ongoing; three at the Massachusetts General Hospital (MGH) and one at the University of Washington. The Phase 2 ‘POWER' study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to induce weight loss and improve indicators of cardiometabolic risk in adolescent patients with obesity. The Phase 2 ‘STROBE' study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to reduce binge eating frequency in adults with binge-eating disorder. The Department of Defense (DoD)-funded Phase 2 ‘BOX' study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to improve bone health in children with autism spectrum disorder. In addition, a Phase 2 study at the University of Washington is investigating the potential role of TNX-1900 in enhancing vicarious extinction learning in social anxiety disorder, compared to healthy controls.
About TNX-1900 and TNX-2900
TNX-1900 and TNX-2900 (intranasal potentiated oxytocin) are proprietary formulations of oxytocin. TNX-1900 is in Phase 2 development under investigator-initiated INDs as a candidate for adolescent obesity, binge eating disorder, bone health in autism and social anxiety disorder. TNX-1900 is also planned for development in treating insulin resistance. TNX-2900 is in development as a treatment for Prader Willi Syndrome. TNX-2900 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) and its IND has been cleared. In 2020, TNX-1900 was acquired from Trigemina, Inc. who had licensed the technology underlying the composition and method from Stanford University. TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Tonix's patented intranasal potentiated oxytocin formulation intended for use by adults and adolescents. Tonix's patented potentiated oxytocin formulation is believed to increase specificity for oxytocin receptors relative to vasopressin receptors as well as to enhance the potency of oxytocin. Oxytocin is a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin is believed to be more than 600 million years old and is present in vertebrates including mammals, birds, reptiles, amphibians and fish.7 It was originally approved by the U.S. Food and Drug Administration as Pitocin&#xAE;&#x2A;, an intravenous infusion or intramuscular injection drug, for use in pregnant women to induce labor. An intranasal formulation of oxytocin is marketed in some European countries to assist in the production of breast milk as Syntocinon&#xAE;&#x2A;&#x2A; (oxytocin nasal 40 units/ml). Oxytocin has no recognized addiction potential. Oxytocin, when delivered via the nasal route, concentrates in the trigeminal system1 resulting in binding of oxytocin to receptors on neurons in the trigeminal system. With TNX-1900 and TNX-2900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding8 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models9. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children10. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects. Tonix also has a license with the University of Geneva to use TNX-1900 for the treatment of insulin resistance and related conditions.

Tonix Pharmaceuticals Announces Poster Presentation Describing Discovery Of Novel Next-Generation Oxytocin Analogues At The American Chemistry Society Spring 2024 Meeting

Tonix Pharmaceuticals Announces Selection Of Two Contract Manufacturing Organizations For The Launch And Commercial Manufacture Of Tonmya For Management Of Fibromyalgia; NDA Submission Planned For 2H Of 2024

Zembrace&#xAE; SymTouch&#xAE; and Tosymra&#xAE; will be marketed by Tonix Medicines, Tonix's wholly-owned commercial subsidiary &nbsp;
Commercial capabilities prepare Tonix for the potential launch in 2025 of Tonmya&#x2122; for the management of fibromyalgia, assuming FDA approval
CHATHAM, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it will achieve its goal of transitioning to a fully integrated pharmaceutical company on April 1, 2024. Since the acquisition of Zembrace&#xAE; SymTouch&#xAE; (sumatriptan injection) 3 mg and Tosymra&#xAE; (sumatriptan nasal spray) 10 mg on June 30, 2023, Tonix Pharmaceuticals has been putting in place the personnel, systems and contracts required to support a commercial organization. Both products are indicated for the treatment of acute migraine with or without aura in adults.
"Tonix will become a fully integrated biopharmaceutical company with a mission of developing and marketing innovative, high-value therapeutics," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Tonix will assume responsibility for the distribution, selling and marketing of Zembrace SymTouch and Tosymra, as well as supply chain, regulatory and quality control of the two products."
Dr. Lederman added, "The assumption of commercial activities by Tonix represents an important milestone in the evolution of Tonix as we continue to build and strengthen our commercial organization for the potential launch of Tonmya&#x2122; (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in 2025, assuming approval by the U.S. Food and Drug Administration (FDA)."&nbsp;&nbsp;&nbsp;

Tonix Pharmaceuticals Announces Transition To Fully Integrated Biopharmaceutical Company Expected On April 1, 2024

Tonix Pharmaceuticals Announces Phase 3 RESILIENT Study Of Tonmya Met Its Primary Endpoint Of Daily Pain Reduction And Achieved Statistically Significant Improvements On All Size Key Pre-Speceified Secondary Endpoints

Data support evaluation of the effects of two weeks of TNX-102 SL therapy on severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) and PTSD after civilian motor vehicle collision in upcoming U.S. DoD-Funded Phase 2 investigator-initiated OASIS trial &nbsp;
Nominal improvement in PTSD severity and measures of sleep quality at Week 4 in the HONOR study support development of bedtime TNX-102 SL therapy in the immediate aftermath of trauma
TNX-102 SL (Tonmya&#x2122;) is also in late-stage development for the management of fibromyalgia for which NDA preparation is ongoing

Tonix Pharmaceuticals Announces Publication In Psychiatry Research Showing Activity Of Bedtime TNX-102 SL On PTSD Symptoms And Sleep Quality In Military-Related PTSD At Four Weeks of Therapy

Tonmya is a potential new first-line, centrally acting non-opioid analgesic for the management of fibromyalgia, supported by statistically significant results from two Phase 3 trials &nbsp;
New Drug Application (NDA) submission to the FDA planned for the second half of 2024
CHATHAM, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=LsTqzk5b4mzc8sYGyCa4JIsSy1yv2ZZiU_bMTOw5niaDlbD4EMhSfGthDAGSRw7G2fEuarAv9jpYfxE9Eyv3b5fsS_Q1DhPVxQmhDK8gdFTNxDHezPXyeFjTkF9csiqb">Tonix Pharmaceuticals Holding Corp.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that <a href="https://www.globenewswire.com/Tracker?data=DgGvAG3azmJLL6kOmbzLUUgXiTn5JWFi_AjE3Mlr7GY0ktyYsOUEJuJP2-_7uPx6ZCwEjBanE5tZNcw5mc3eZg==">EVERSANA&#xAE;,</a> a leading provider of commercialization services to the global life sciences industry, has been selected to support the launch strategy and commercial planning of Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in the U.S. Specifically, EVERSANA will work with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market strategy.
"EVERSANA shares our commitment to delivering novel therapeutics to patients in need," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "We are excited to further refine our business strategy for the anticipated launch of Tonmya in 2025. It has been over a decade since patients suffering with fibromyalgia have been provided a new therapeutic option."
"Today's dynamic market requires experts that can help customers navigate the complexities of launch and commercial planning," said Jim Lang, CEO, EVERSANA. "Together, we look forward to bringing a new treatment option to market for the millions of Americans suffering from this chronic disorder."
Tonmya is a centrally acting, non-opioid medication. As previously announced, Tonix's second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.
Tonix plans to submit a New Drug Application to the U.S. Food and Drug Administration in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.
About Tonmya&#x2A; (also known as TNX-102 SL)
Tonmya is a centrally acting, non-opioid, non-addictive, bedtime medication. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, a second positive Phase 3 clinical trial of Tonmya for the management of fibromyalgia. In the study, Tonmya met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first positive Phase 3 trial of Tonmya in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints.
&#x2A;Tonmya&#x2122; is conditionally accepted by the U.S. Food and Drug Administration as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.
About EVERSANA&#xAE;
EVERSANA is a leading independent provider of global services to the life sciences industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 650 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through <a href="https://www.globenewswire.com/Tracker?data=ols7IfZjLc1P3w2tfhqrw16V2Uh_WCRE3_diJ3bsA9MelYuTiWzJ2qjw-4tPy5XvrEqsTyKI18M5DRIF97b7KjVTV21ge8dUMW-zsW4NWtY=">LinkedIn</a>&nbsp;and&nbsp;<a href="https://www.globenewswire.com/Tracker?data=QJ2SX-9pbh-O6AxScymc31-rVZ7uyqqQ17eIuVq7JD1KZ7iqoQxzzookM9TSzbjAmHO2FeQzo3PRj9Y1Hki9Mg==">X</a>.

Tonix Pharmaceuticals Selects EVERSANA To Support Launch Strategy And Commercialization Planning Of Tonmya For The Management Of Fibromyalgia

TNX-1500, a third generation anti-CD40L mAb, was Fc-modified to preserve the activity and bioavailability of first generation mAbs while addressing their thrombosis risk &nbsp;
Sanofi projects its Fc-modified humanized anti-CD40L mAb frexalimab will exceed €5B per year in peak sales1 based on Phase 2 multiple sclerosis data recently published in the New England Journal of Medicine2
Topline results of TNX-1500 Phase 1 trial expected in the third quarter of 2024; clinical stage completed last month
TNX-1500 has multiple potential indications including solid organ and bone marrow transplantation and the treatment of autoimmune diseases: potential ‘pipeline in a product'
CHATHAM, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the results of modeling key human pharmacokinetic (PK) properties for TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)&#x2A; from animal studies. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplantation and for the treatment of autoimmune disorders.
"For more than 30 years, anti-CD40L therapy has shown promise in transplantation and the treatment of autoimmunity, but first-generation humanized mAbs were associated with an increased risk of thrombosis and second-generation agents had poor PK properties or reduced activity," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Preclinical studies in non-human primates have shown that TNX-1500 maintains the activity of first generation mAbs, with reduced risk of thrombotic complications.3-5 Today we are announcing that modeling studies from animal PK data3, predict that a half-life of approximately three weeks for TNX-1500 in humans6,7, which supports monthly dosing. This PK analysis together with TNX-1500's activity and tolerability in animals, suggests that the protein engineering of TNX-1500's Fc region has achieved its design goals."
Dr. Lederman continued, "Recently, positive clinical data have been reported by Sanofi, with its Fc-modified humanized anti-CD40L mAb frexalimab in treating relapsing multiple sclerosis with monthly i.v. or biweekly s.c. dosing regimens.2 Based on its results in multiple sclerosis, Sanofi projects that frexalimab will exceed €5B per year in peak sales1. TNX-1500 was designed to reduce binding to the Fc-receptor for IgG type 2a, or FcγR2a, which has been shown to play a role in the thrombosis associated with first-generation anti-CD40L mAbs, similar to frexalimab. In addition, Eledon Pharmaceuticals is in Phase 2 development for the prevention of rejection of kidney transplants with tegoprubart, a non-covalent dimer antibody with no heavy-light or heavy-heavy interchain disulfide bridges for the prevention of rejection of kidney transplants."8
"Anti-CD40L therapy has multiple possible indications in addition to solid organ and bone marrow transplantation, including autoimmune diseases," Dr. Lederman stated, "We look forward to the results of our Phase 1 PK and pharmacodynamic trial in the third quarter of 2024 and to advancing TNX-1500 as a promising candidate for prevention of organ and bone marrow transplant rejection and for treating autoimmune conditions."
About the Translation of Human Pharmacokinetic Parameters from Animal Data
Results of a single dose PK study in animals were analyzed to predict human PK parameters. The PK study was conducted in six healthy cynomolgus monkeys at 30, 100 and 300 mg/kg and revealed linear PK across those doses, consistent with an antibody with no target mediated drug disposition.6,7 The half-life in cynomolgus monkeys is approximately 14 days. Human half-life prediction for TNX-1500 was based on allometric scaling for mAbs with linear PK.6 Clearance in cynomolgus animals was 6.24 ml/day (26.6% C.V.) and the predicted clearance in humans was 141 mL/day (C.V. 22.9%).6,7 The predicted human half-life for TNX 1500 is 23.8 days (range of 18.3 to 27.6 days) which supports monthly dosing. 6,7
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that binds and blocks the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. A first-in-human Phase 1 trial of TNX-1500 has completed the clinical phase. Topline results are expected in the third quarter of 2024. The primary objective of the Phase 1 trial is to assess the safety, tolerability, PK, and pharmacodynamics of intravenous (i.v.) TNX-1500. Eligible participants enrolled in the Phase 1 trial were distributed across three dosing cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg, respectively) and evaluated regularly over a 120-day period after dosing. The Phase 1 trial is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts.3,4
About anti-CD40L Therapeutics in Development
No anti-CD40L mAb has been approved in any jurisdiction. In addition to TNX-1500, frexalimab and tegoprubart, tn03 fusion protein dazodalibep is being developed by Amgen (formerly Horizon Therapeutics Public Limited Company) for the treatment of Sjögren's Syndrome.9,10 Dapirolizumab pegol, an anti-CD40L pegylated Fab, is being developed by UCB for the treatment of systemic lupus erythematosus.11

Tonix Pharmaceuticals Announces Translation Of Preclinical Pharmacokinetic Parameters Of TNX-1500 Supports Monthly i.v. Dosing In Humans

Dawson James analyst Jason Kolbert initiates coverage on Tonix Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>) with a Buy rating and announces Price Target of $3.

Price Target

Initiation

Analyst Ratings

Dawson James Initiates Coverage On Tonix Pharmaceuticals with Buy Rating, Announces Price Target of $3

Topline results expected in the third quarter of 2024; planning a Phase 2 Trial for prevention of kidney transplant rejection &nbsp;
Anti-CD40L has multiple possible indications in addition to solid organ and bone marrow transplantation including autoimmune diseases: potential pipeline in a product
Sanofi recently published results on their Fc-modified humanized anti-CD40L mAb, frexalimab, for multiple sclerosis in the New England Journal of Medicine1
CHATHAM, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNXP#NASDAQ">TNXP</a>), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the completion of the clinical stage of its Phase 1, single ascending dose escalation trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)&#x2A; in healthy volunteers. TNX-1500 is in development for the prevention of rejection in solid organ and bone marrow transplant and for the treatment of autoimmune disorders.
"Despite advancements in the field of solid organ transplantation, there remains a significant need for new treatments with improved activity and tolerability," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Anti-CD40L modulates T cell function and has the potential to promote tolerance of transplanted organs. We are excited to have completed the clinical stage of this Phase 1 trial of TNX-1500, a third-generation Fc-modified anti-CD40L mAb that has been designed by protein engineering to eliminate the risk of thrombosis associated with first-generation anti-CD40L mAbs. Preclinical studies in non-human primates did not result in any thrombotic complications, suggesting that the protein engineering of TNX-1500's Fc region has achieved its design goals."
Dr. Lederman continued, "Recently, positive clinical data with other CD40L blockers have been reported by Sanofi, with its Fc-modified humanized anti-CD40L mAb frexalimab in treating relapsing multiple sclerosis.2 Eledon Pharmaceuticals is developing tegoprubart, a non-covalent dimer antibody with no heavy-light or heavy-heavy interchain disulfide bridges for the prevention of rejection of kidney transplants3."
Dr. Lederman concluded, "We believe TNX-1500 has the potential to prevent organ transplant rejection and improve graft survival with reduced long-term toxicity burden of current immunosuppressive regimens. In addition, TNX-1500 has the potential to address multiple other indications, including several autoimmune diseases. We look forward to the results of this Phase 1 trial, which are expected in the third quarter of this year, and to continuing the development of TNX-1500 as a promising candidate in an important therapeutic space."
About TNX-1500
TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of allograft and xenograft rejection, for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) and for the treatment of autoimmune diseases. The first-in-human Phase 1 trial of TNX-1500 was initiated in the third quarter of 2023. The primary objective of the Phase 1 trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous (i.v.) TNX-1500. Eligible participants enrolled in the Phase 1 trial were distributed across three dosing cohorts (3 mg/kg, 10 mg/kg, and 30 mg/kg, respectively) and evaluated regularly over a 120-day period after dosing. This first-in-human trial is intended to support dosing in a planned Phase 2 trial in kidney transplant recipients. Two published articles in the American Journal of Transplantation demonstrate TNX-1500 prevents rejection, prolongs survival and preserves graft function as a single agent or in combination with other drugs in non-human primate renal and heart allografts.4,5
&nbsp;

Tonix Pharmaceuticals Completes Clinical Stage Of Phase 1 Trial For TNX-1500 In Healthy Volunteers

Tonix plans to File a Clinical Trial Notification (CTN) in Japan and Investigational New Drug (IND) application in China to support a registration-enabling Asian Phase 3 study without dosage adjustment based on U.S. registrational Phase 3 data &nbsp;
Tonmya's market exclusivity is supported by issued patents in Japan, China, Hong Kong and Taiwan; cyclobenzaprine is a new chemical entity in Japan and China
New Drug Application (NDA) submission to the U.S. FDA for the approval of Tonmya for the management of fibromyalgia planned for second half of 2024

Tonix Pharmaceuticals Announces Results From Clinical Pharmacokinetic Bridging Study Of Tonmya To Support Development And Partnering in Japan and China

Tonix Pharma (TNXP) has provided an announcement. Tonix Pharmaceuticals Holding Corp. has announced its transition to a fully integrated pharmaceut...

Tonix Pharma Announces Full Integration and Future Plans

The latest announcement is out from Tonix Pharma (TNXP). Tonix Pharmaceuticals Holding Corp. is gearing up for the U.S. launch and commercializatio...

Tonix Pharma Readies for Tonmya™ U.S. Launch and Production

Tonix picks CMOs for potential launch of fibromyalgia drug

Tonix Pharma (TNXP) has provided an announcement. At the ACS Spring 2024 Meeting, the Company unveiled groundbreaking research on oxytocin analogs,...

Tonix Pharma Reveals Innovative Oxytocin Research Advancements

<a href="https://investorplace.com">InvestorPlace - Stock Market News, Stock Advice &amp; Trading Tips</a>
Here&rsquo;s the deal with stocks to turn $1,000 into $1 million: if you want to play, you gotta pay. I&rsquo;m not just talking about the price of the securities themselves. Indeed, these lesser-known enterprises are relatively low priced.



No, the cost comes in the fact that extreme speculation such as this involves an inverse relationship. For maximum potential upside, you typically need to absorb the minimal amount of predictability. Let&rsquo;s consider <a href="https://investorplace.com/stock-types/blue-chip-stocks/">blue-chip stocks</a>. Generally, you can be profitable with these securities because they&rsquo;re tied to predictable business models. However, the rewards might not be that grand &ndash; maybe beating inflation but that&rsquo;s about it.



On the flipside, you have high-risk securities. These ideas can potentially give you gargantuan returns; basically beating inflation for the next 100 years. However, you really have no idea whether the underlying business will flourish or will go to zero. And chances are, the latter scenario is likelier than the former.



If you can handle this tough backdrop, maybe these stocks to turn $1,000 into $1 million could be for you. Otherwise, you should consider these <a href="https://investorplace.com/2024/03/trouble-proof-dividend-darlings-7-stocks-that-keep-paying-no-matter-what/">dividend darlings</a> instead.



<h2>Agenus (AGEN)</h2>



<div><img width="300" height="169" src="https://investorplace.com/wp-content/uploads/2022/06/biotechnologyepzm1600-300x169.png" alt="OLK Stock. Modern Medical Research Laboratory: Two Scientists Wearing Face Masks use Microscope, Analyse Sample in Petri Dish, Talk. Advanced Scientific Lab for Medicine, Biotechnology. Blue Color. KZR stock. RSLS stock. Best Biotech Stocks to Buy"><div>Source: Gorodenkoff / Shutterstock.com</div></div>A clinical-stage biotechnology firm, Agenus (NASDAQ:<a href="https://investorplace.com/stock-quotes/agen-stock-quote/">AGEN</a>) discovers and develops immuno-oncology products. Per its public profile, Agenus offers Retrocyte Display, an antibody expression platform for the identification of fully human and humanized monoclonal antibodies. It also offers display technologies. Since the beginning of the year, AGEN lost almost 30% of equity value.



Straight up, Agenus is an extremely risky wager. In the past 52 weeks, AGEN suffered a loss of more than 62%. Further, the company&rsquo;s financials are also noteworthy in a not-so-pleasant way. The average surprise for the past four quarters came out to 37.25% below parity.



Still, analysts believe that for fiscal 2024, the company will post a loss per share of 41 cents on revenue of $191.52 million. Last year, Agenus posted a loss of 69 cents on sales of $156.31 million. If true, AGEN would enjoy a 22.5% top-line growth rate.



Enticingly, covering experts rate AGEN a <a href="https://www.tipranks.com/stocks/agen/forecast">unanimous strong buy</a> with a $6.33 average price target. That implies 1,026% upside potential, making it one of the stocks to turn $1,000 into $1 million.



<h2>Tonix Pharmaceuticals (TNXP)</h2>



<div><img width="300" height="169" src="https://investorplace.com/wp-content/uploads/2022/03/pharmaceuticals_tnxp_1600-300x169.png" alt="medicine research, pharmaceutical background, LJPC stock"><div>Source: Sisacorn / Shutterstock.com</div></div>A biopharmaceutical company, Tonix Pharmaceuticals (NASDAQ:<a href="https://investorplace.com/stock-quotes/tnxp-stock-quote/">TNXP</a>) focuses on developing, discovering, commercializing and licensing therapeutics to treat and prevent human disease and alleviate suffering. Per its <a href="https://finance.yahoo.com/quote/TNXP/profile">public profile</a>, Tonix markets Zembrace SymTouch and Tosymra for the treatment of acute migraine with or without aura in adults. Mainly, its development portfolio focuses on central nervous system disorders.



Financially, TNXP represents one of the riskiest ideas available. Even under the stated context of stocks to turn $1,000 into $1 million, Tonix requires extreme caution. In the trailing one-year period, TNXP incurred a 91% loss. Also, the financials have been all over the map. Last fiscal year, the average quarterly surprise came out to 1.8%.



That said, for the current fiscal year, experts anticipate Tonix to post a loss per share of $3.14 on revenue of $16.77 million. While tiny on an absolute basis, this is a company that posted <a href="https://www.gurufocus.com/stock/TNXP/financials?search=tnxp">no revenue in 2022</a>. On a trailing-12-month (<a href="https://investorplace.com/stock-quotes/ttm-stock-quote/">TTM</a>) basis, it has printed just under $4 million in sales.



Analysts peg shares as a <a href="https://www.tipranks.com/stocks/tnxp/forecast">moderate buy</a> with a $4.50 price target. That implies 1,206% upside potential.



<h2>Biofrontera (BFRI)</h2>



<div><img width="300" height="169" src="https://investorplace.com/wp-content/uploads/2021/12/shutterstock_1397823584-300x169.jpg" alt="BFRI stock: the Biofrontera logo on its website"><div>Source: Pavel Kapysh / Shutterstock</div></div>Another biopharmaceutical firm, Biofrontera (NASDAQ:<a href="https://investorplace.com/stock-quotes/bfri-stock-quote/">BFRI</a>) engages in the commercialization of pharmaceutical products for the treatment of <a href="https://finance.yahoo.com/quote/bfri/profile">dermatological conditions</a>. The company&rsquo;s products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. As with other stocks to turn $1,000 into $1 million, investors should prep for a wild ride.



I&rsquo;m not just saying that for its own sake. Since the start of the year, BFRI stock suffered a loss of more than 55%. In the past 52 weeks, shares hemorrhaged nearly 90% of equity value. Unfortunately, the negativity also extends to the company&rsquo;s earnings performances. Between the first and third quarters last year, the average surprise landed at 41% below breakeven.



That said, in Q4, Biofrontera surprised everyone by posting earnings per share of $1.65. The target was a per-share loss of $1.19. For the current fiscal year, experts believe the company will post a loss per share of $3.24 on revenue of $40.7 million. In 2023, BFRI incurred a loss of $13.02 per share on sales of $34.07 million.



Finally, analysts rate shares a <a href="https://www.tipranks.com/stocks/bfri/forecast#:~:text=BFRI%20Stock%2012%20Months%20Forecast&amp;text=Based%20on%202%20Wall%20Street,the%20last%20price%20of%20%241.23.">moderate buy</a> with a $16 price target, implying 1,180% upside potential.



On the date of publication, Josh Enomoto did not have (either directly or indirectly) any positions in the securities mentioned in this article.&nbsp;The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com&nbsp;<a href="https://investorplace.com/corporate/investorplace-publishing-guidelines/" target="_blank">Publishing Guidelines</a>.
<div>A former senior business analyst for Sony Electronics, Josh Enomoto has helped broker major contracts with Fortune Global 500 companies. Over the past several years, he has delivered unique, critical insights for the investment markets, as well as various other industries including legal, construction management, and healthcare. Tweet him at @EnomotoMedia.</div><h3>More From InvestorPlace</h3>
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The post <a href="https://investorplace.com/2024/03/3-mind-blowing-stocks-that-could-turn-1000-into-1-million/">3 Mind-Blowing Stocks That Could Turn $1,000 Into $1 Million</a> appeared first on <a href="https://investorplace.com">InvestorPlace</a>.

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Tonix Pharma (TNXP) has issued an update. Tonix Pharmaceuticals has received a Rare Pediatric Disease Designation from the FDA for TNX-2900, a prom...

Tonix Pharma Earns FDA Pediatric Designation Amid Risks

Tonix Pharmaceuticals GAAP EPS of -$0.86, revenue of $3.78M

<a href="https://investorplace.com">InvestorPlace - Stock Market News, Stock Advice &amp; Trading Tips</a>
Tonix Pharmaceuticals (NASDAQ:<a href="https://investorplace.com/stock-quotes/tnxp-stock-quote/">TNXP</a>) just reported results for the fourth quarter of 2023.<ul><li>Tonix Pharmaceuticals reported earnings per share of -86 cents. This was above the analyst estimate for EPS of -$1.64.</li><li>The company reported revenue of $3.78 million.</li><li>This was 1.33% worse than the analyst estimate for revenue of $3.83 million.</li></ul><div>InvestorPlace Earnings is a project that leverages data from <a href="https://www.tradesmith.com">TradeSmith</a> to automate coverage of quarterly earnings reports. InvestorPlace Earnings distills key takeaways including earnings per share and revenue, as well as how a company stacks up to analyst estimates. These articles are published without human intervention, allowing us to inform our readers of the latest figures as quickly as possible. To report any concerns or inaccuracies, please contact us at <a href="mailto:editor@investorplace.com">editor@investorplace.com</a>.</div><h3>More From InvestorPlace</h3>
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	The post <a href="https://investorplace.com/earning-results/2024/04/tnxp-stock-earnings-tonix-pharmaceuticals-for-q4-of-2023/">TNXP Stock Earnings: Tonix Pharmaceuticals Beats EPS, Misses Revenue for Q4 2023</a> appeared first on <a href="https://investorplace.com">InvestorPlace</a>.

TNXP Stock Earnings: Tonix Pharmaceuticals Beats EPS, Misses Revenue for Q4 2023

<a href="https://investorplace.com">InvestorPlace - Stock Market News, Stock Advice &amp; Trading Tips</a>
It is not a bad idea to hunt for <a href="https://investorplace.com/industries/healthcare/biotech/">biotech stocks</a> to sell. Such stocks have earned a bad reputation among investors, and for good reason. Most biotech companies fail, as their success often hinges on receiving regulatory approval for their products. It is an extremely high-risk sector to invest in. 



For every promising biotech company that successfully navigates clinical trials and generates multibagger returns, there are 99 others that either fail outright or struggle to deliver any gains at all. These stocks rarely live up to the hype.



However, this tendency for failure also makes biotech companies a prime target if you&rsquo;re looking to short-sell or dump shares. Plenty of biotech firms are burning through cash at an alarming rate while still being years away from potential FDA approval. Going contrarian on these names could help you realize substantial returns in this volatile sector. Let&rsquo;s look at the biotech stocks to sell.



<h2>Tonix Pharmaceuticals (TNXP)</h2>



<div><img width="300" height="169" src="https://investorplace.com/wp-content/uploads/2022/03/pharmaceuticals_tnxp_1600-300x169.png" alt="medicine research, pharmaceutical background, LJPC stock"><div>Source: Sisacorn / Shutterstock.com</div></div>Tonix Pharmaceuticals (NASDAQ:<a href="https://investorplace.com/stock-quotes/tnxp-stock-quote/">TNXP</a>) has been hemorrhaging money for an eternity without any light at the end of the tunnel. Based in Chatham, New Jersey, Tonix is focused on repurposing existing drugs for central nervous system disorders. The company was also chasing a potential COVID-19 vaccine and biodefense projects, but those efforts have fizzled.



The core issue here is simple &mdash; Tonix is an absolute cash incinerator with virtually no revenue to offset the burn rate. In the most recent quarter, the company <a href="https://www.google.com/finance/quote/TNXP:NASDAQ">torched through $27.3 million</a> while only having $25 million left in cash. Do the math, and it&rsquo;s evident this bleeding can&rsquo;t continue any longer.



Analysts see the red ink intensifying going forward, with <a href="https://seekingalpha.com/symbol/TNXP/earnings/estimates">2025 losses projected to swell by 50%</a> compared to 2023 levels. Profitability remains an elusive dream with no line of sight. Unless a miracle product emerges from the pipeline soon, Tonix seems destined for the corporate graveyard through either a bankruptcy filing or perpetual share dilution into oblivion.



<h2>Allakos (ALLK)</h2>



<div><img width="300" height="169" src="https://investorplace.com/wp-content/uploads/2022/01/shutterstock_1392564872-300x169.png" alt="Illustrative Editorial of Allakos (ALLK) Inc website homepage. Allakos Inc logo visible on display screen."><div>Source: Pavel Kapysh/ Shutterstock.com</div></div>Allakos (NASDAQ:<a href="https://investorplace.com/stock-quotes/allk-stock-quote/">ALLK</a>) is another biotech firmly in the &ldquo;Danger Zone.&rdquo; This clinical-stage company is developing treatments that target immunomodulatory receptors, with its lead candidate AK006 being studied for chronic spontaneous urticaria (CSU) and other indications.



Sound promising? Don&rsquo;t be fooled. Allakos has been aggressively diluting shareholders for years to stay afloat with no revenue stream in sight. The $171 million cash balance may seem hefty, but it equates to less than three quarters&rsquo; worth at current burn levels. Any further delays in the clinic could rapidly deplete that buffer.



Some tout Allakos&rsquo; urticaria program as innovative, with blockbuster potential if it is successful. However, by the time this long shot pays off (if it ever does), early investors will likely own just crumbs of the company after endless financing rounds.



<h2>Rapt Therapeutics (RAPT)</h2>



<div><img width="300" height="169" src="https://investorplace.com/wp-content/uploads/2022/02/medicines-therapeutics-300x169.png" alt="Animated image of different medications"><div>Source: Olga Kononok/Shutterstock</div></div>Rapt Therapeutics (NASDAQ:<a href="https://investorplace.com/stock-quotes/rapt-stock-quote/">RAPT</a>) is a clinical-stage biopharma developing oral small molecules for oncology and inflammatory diseases. The lead candidates are RPT193 for inflammation and FLX475 for cancer, but my enthusiasm is muted.



While Rapt boasts a more robust $159 million cash position compared to the prior biotech stocks to sell, the burn is intensifying at an alarming pace. Revenue has effectively dried up, with losses skyrocketing from $53 million in 2020 to <a href="https://www.google.com/finance/quote/RAPT:NASDAQ">$117 million last year</a>. Analysts don&rsquo;t forecast profitability for years, even under rosy drug approval scenarios.



The saving grace? Rapt hasn&rsquo;t overtly abused the share dilution lever&hellip;yet. However, with a roughly 1-2 year cash runway, that could change quickly if the pipeline hits any snags. And in biotech, delays are almost a given.



On the date of publication, Omor Ibne Ehsan did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com&nbsp;<a href="https://investorplace.com/corporate/investorplace-publishing-guidelines/" target="_blank">Publishing Guidelines</a>.
<div>Omor Ibne Ehsan is a writer at InvestorPlace. He is a self-taught investor with a focus on growth and cyclical stocks that have strong fundamentals, value, and long-term potential. He also has an interest in high-risk, high-reward investments such as cryptocurrencies and penny stocks. You can follow him on <a href="https://www.linkedin.com/in/omor-ibne-ehsan-56068022b/">LinkedIn</a>.</div><h3>More From InvestorPlace</h3>
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AGEN

ALLK

BFRI

RAPT

Press Releases

New to The Street Announces TV Episode 560 with its Five Business Guest Interviews, Airs as Sponsored Programming on Bloomberg TV Tonight, Thursday, March 7, 2024, at 9:30 PM PT

Tonix Pharmaceuticals Reports Improvement in "Brain Fog," in Fibromyalgia Patients Treated with Tonmya™ in RESILIENT, an NDA-Enabling Phase 3 Clinical Trial, at the 6th International Congress on Controversies in Fibromyalgia

Health Care

Tonix Pharmaceuticals Announces Presentation at BIO-Europe Spring

Tonix Pharmaceuticals Announces Transition to Fully Integrated Biopharmaceutical Company Expected on April 1, 2024

Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia

Tonix Pharmaceuticals Announces Poster Presentation Describing Discovery of Novel Next-Generation Oxytocin Analogues at the American Chemistry Society (ACS) Spring 2024 Meeting