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Northland Capital Markets analyst Mike Grondahl initiates coverage on Cipher Mining (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CIFR#NASDAQ">CIFR</a>) with a Outperform rating and announces Price Target of $6.

News

Price Target

Initiation

Analyst Ratings

CIFR

Northland Capital Markets Initiates Coverage On Cipher Mining with Outperform Rating, Announces Price Target of $6

Bill Maher, host of Real Time with Bill Maher, has voiced his strong criticism of cryptocurrency, calling it a major threat to the environment due to its <a href="https://www.benzinga.com/markets/cryptocurrency/24/02/36954312/power-hungry-bitcoin-and-other-cryptos-drained-as-much-power-with-mining-as-whole-of-austr">excessive energy consumption</a>.
What Happened: During an <a href="https://x.com/billmaher/status/1838646493118632340">episode</a>, Maher pointed out that the energy usage associated with Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) mining is undoing much of the progress being made in green energy initiatives.
&#8220;All the progress that we&#8217;re making with green energy is being sucked away by crypto,&#8221; Maher remarked, noting that the industry consumes an estimated 8% of the world's electricity. 
Maher highlighted the absurdity of cryptocurrency mining, describing it as &#8220;nonsense of finding a number,&#8221; and drew a stark comparison between crypto&#8217;s energy impact and the environmental cost of traditional fossil fuels.
<figure class="wp-block-image size-full"><a href="https://www.benzinga.com/events/digital-assets/ "><img loading="lazy" decoding="async" width="300" height="250" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/03/29155259/905735A6-57D3-4874-9AA1-75D037842DB3-2.gif" alt="Benzinga Future of Digital Assets conference" class="wp-image-270548" /></a></figure>
Also Read: <a href="https://www.benzinga.com/markets/cryptocurrency/24/09/41014040/from-ceo-to-inmate-caroline-ellison-sentenced-to-24-months-in-ftx-case-what-the-industry-m">From CEO To Inmate: Caroline Ellison Sentenced To 24 Months In FTX Case—What The Industry Must Learn</a>
&#8220;It&#8217;s comparable to putting 15.7 million additional gas-powered cars on the road,&#8221; Maher said, criticizing the environmental burden that crypto imposes.
Maher&#8217;s comments come as the debate around cryptocurrency's carbon footprint intensifies. 
<a href="https://www.benzinga.com/markets/cryptocurrency/24/09/41006505/bitcoin-mining-stock-cipher-mining-is-climbing-today-whats-going-on">Bitcoin mining</a>, in particular, has faced scrutiny for its reliance on energy-intensive proof-of-work protocols, which require vast data centers and computational power to validate transactions.
What&#8217;s Next: As the conversation on crypto's environmental footprint heats up, experts and industry leaders will likely tackle these issues at the upcoming Benzinga <a href="https://www.benzinga.com/events/digital-assets/agenda/">Future of Digital Assets</a> event on Nov. 19.
Read Next: 
<ul>
<li><a href="https://www.benzinga.com/markets/cryptocurrency/24/09/41012993/sec-charges-trusttoken-and-truecoin-with-fraud-and-unregistered-securities-offering-in-sta">SEC Charges TrustToken And TrueCoin With Fraud And Unregistered Securities Offering In Stablecoin Case</a></li>
</ul>
Image: Shutterstock

Coverage of Bitcoin, Etherum, Ripple and all the latest digital currencies.

Cryptocurrency

$BTC

Bill Maher Slams Bitcoin Mining: 'Nonsense Of Finding A Number' Means Green Energy Progress Is Being 'Sucked Away By Crypto'

Biotech

General

WINT

Windtree Therapeutics Reports Topline Results From Phase 2B SEISMiC Extension Study Of Istaroxime In Early Cardiogenic Shock; Istaroxime Significantly Improves Systolic Blood Pressure Over Six Hours And Shows Notable Secondary Endpoint Improvements

– Post-hoc analysis from pivotal Phase 3 REST-ON trial confirmed the efficacy of LUMRYZ in study participants who were and were not using a stable dose of an alerting agent – &nbsp;
– Baseline data underscore that alerting agents alone are often insufficient&nbsp;for excessive daytime sleepiness –
DUBLIN, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVDL#NASDAQ">AVDL</a>), a biopharmaceutical company focused on transforming medicines to transform lives, today announced the publication of results of a post-hoc analysis from the completed pivotal Phase 3 REST-ON clinical trial. Results demonstrated clinically significant improvements from baseline in wakefulness, overall condition, number of weekly cataplexy episodes, and excessive daytime sleepiness in patients taking LUMRYZ (sodium oxybate) compared to those taking placebo, regardless of concomitant use of alerting agents. The paper, titled "Efficacy of Once-Nightly Sodium Oxybate (FT218) on Daytime Symptoms in Individuals With Narcolepsy With or Without Concomitant Alerting Agent Use: A Post Hoc Analysis From the Phase 3 REST-ON Trial," was published online in <a href="https://www.globenewswire.com/Tracker?data=D9x_8rgnhYOtZIShD2JH65LSU2y_BhURrcJc8Z2ub7Mxzilo6nPlz3cU4yXI9e4AE8sP7miFPl8XWuRbw3gB96ivPtAkn94dMyhQ5s8UQojFFP4MGlX1QRKaRuI9f5sddYl8dhNuX2sdGneP37414uH2hMOCPoqbohxB8A-nDLU=">Sleep Medicine</a>.

Avadel Pharmaceuticals plc - American Depositary Shares each representing one Ordinary Share

AVDL

Avadel Pharmaceuticals Announces Publication Of Data In 'Sleep Medicine' Highlighting Efficacy Of LUMRYZ Extended-Release Oral Suspension In Improving Narcolepsy Symptoms Regardless Of Concomitant Use Of An Alerting Agent

Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor &nbsp;
Erasca is also evaluating naporafenib plus trametinib in the ongoing SEACRAFT-2 pivotal Phase 3 trial in NRAS-mutant melanoma where favorable survival was previously demonstrated in pooled analyses
Erasca to host virtual R&amp;D update for investors on Thursday, October 24, 2024, at 8:30 AM ET
SAN DIEGO, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ERAS#NASDAQ">ERAS</a>), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced an oral presentation of preliminary SEACRAFT-1 Phase 1 data for naporafenib plus trametinib (MEKINIST&#xAE;) in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations at the 36th EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics taking place October 23-25 in Barcelona, Spain. Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor.
Erasca plans to host a virtual investor event to provide a research and development (R&amp;D) update on naporafenib and the RAS targeting franchise on Thursday, October 24, 2024, at 8:30 AM ET in conjunction with the 36th ENA Symposium. A live question and answer session will follow the formal presentation. To register for the event, please click <a href="https://www.globenewswire.com/Tracker?data=4mp2ewsOVezFaoAOBTsostdEy2QWJFnWODvsuPIqh0xCqiMWXd4H7oMfMRDvejotpK72CcQRzWPymGDQW5pG-ehklZu2qHjZJrYcrasLwT0=">here.</a>

ERAS

Erasca To Present Preliminary SEACRAFT-1 Phase 1 Data For Naporafenib Plus Trametinib In RAS Q61X Mutant Solid Tumors As Oral Presentation At 36th EORTC-NCI-AACR Symposium

AIMD

Ainos Receives IRB Approval From National Taiwan University Hospital For HIV-Oral Warts Clinical Trial, Showcasing FDA-Designated Orphan Drug VELDONA; Awaits Taiwan FDA Approval To Begin

– Completion of nonclinical safety and toxicity studies, Phase 1 clinical trial design and established Maximum Recommended Starting Dose
– Completion of pre- Clinical Trial Application (CTA) meeting with Health Canada
– Submission of the CTA for the Phase 1 clinical study of Normal Healthy Volunteers and ulcerative colitis patients
– On track towards clinical site initiation and dosing of first patient in Phase 1 human clinical study before year end &nbsp;
Carlsbad,&nbsp;CA, Sept. 25, 2024 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=gPj0tOryZ-1XW_E6RFBEORtv60JdxuEIbv9aJRkFLlwRvmgHOPjp-ojKtMhXtHHVu196onCrTJfCqDvtSXAlvaX_MKdoNecJoT85HqMnBD0=">Palisade Bio, Inc.</a>&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PALI#NASDAQ">PALI</a>) ("Palisade," "Palisade Bio" or the "Company"), a biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases, today provided an update on its progress toward the launch of its Phase 1 human clinical study for PALI-2108 for the treatment of ulcerative colitis (UC).
The Company's lead program, PALI-2108, is a locally activated PDE4 inhibitor prodrug in development for treating patients with moderate to severely active UC. Leveraging advanced machine learning, the Company's research has identified a measurable threshold of elevated PDE4B expression across more than 1,600 patients and 10 studies, identifying over-expressing patients in over 70% of cases. This finding supports the potential for an FDA-approved test that uses PDE4B expression as a reliable marker for patient enrichment. The Company believes this will lead to better UC patient selection, thereby increasing the efficacy of Palisade's PDE4-inhibiting prodrug therapeutic. Additionally, the Company is advancing a second approach featuring six PDE4-related biomarkers, which has demonstrated superior performance compared to benchmark tests and is specifically tailored for PDE4 inhibition, providing a targeted solution to improve therapeutic outcomes. The integration of PCR-based assays aimed at potential FDA approval will ensure precision in patient targeting. These developments underscore the Company's commitment to leading the field of precision medicine for UC, advancing personalized treatment strategies that promise to transform patient care.

PALI

Palisade Bio Provides Update On Progress Toward Launch Of Phase 1 Human Clinical Study For Lead Program, PALI-2108 For The Treatment Of Ulcerative Colitis; On Track Towards Clinical Site Initiation And Dosing Of First Patient In Phase 1 Human Clinical Study Before Year End

Elon Musk on Tuesday said that his rocket manufacturing company SpaceX will launch close to 90% of all mass to orbit by the end of the year, trumping the competition by a huge margin.
What Happened: &#8220;If the rest of the year goes well, SpaceX will launch close to 90% of all mass to orbit. China will be ~6% and rest of world ~4%,&#8221; Musk wrote on social media platform X. 
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
<div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">If the rest of the year goes well, SpaceX will launch close to 90% of all mass to orbit. China will be ~6% and rest of world ~4%.
&mdash; Elon Musk (@elonmusk) <a href="https://twitter.com/elonmusk/status/1838627796530467270?ref_src=twsrc%5Etfw">September 24, 2024</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
The new outlook provided by the billionaire is slightly lower than his previous forecast. In May, Musk said that SpaceX &#8220;<a href="https://www.benzinga.com/news/24/05/38932200/elon-musk-hopeful-of-spacex-launching-over-90-of-earths-payload-to-orbit-in-2024-nothing-stopping-co">might exceed 90%</a> of all Earth payload to orbit&#8221; this year.
The downgrade is possibly due to the <a href="https://www.benzinga.com/news/24/08/40360084/elon-musks-spacex-meets-its-july-launch-numbers-halfway-through-august-with-back-to-back-launch-miss">two-week pause in SpaceX&#8217;s launch operations</a> in July following a mishap that occurred during a Starlink mission launched on July 11. 
In August, a Falcon 9 booster that supported a Starlink mission <a href="https://www.benzinga.com/news/24/08/40618861/faa-grounds-spacexs-falcon-9-after-booster-fails-to-land-upright-polaris-dawn-launch-timeline-hangs">failed to land upright on a droneship </a>at sea upon returning to Earth and exploded. 
Why It Matters: According to a report from analytics firm Bryce Tech, SpaceX launched about 429,125 kgs of spacecraft upmass in Q1, seconded by China's&nbsp;China Aerospace Science and Technology Corporation&nbsp;(CASC)&nbsp;which launched just 29,426 kgs.&nbsp;SpaceX accounted for roughly 87% of all mass to orbit in the quarter. 
SpaceX&nbsp;<a href="https://www.benzinga.com/news/24/07/39612042/elon-musks-spacex-launches-67-missions-in-first-half-of-2024-trailing-own-targets" target="_blank" rel="noreferrer noopener">completed 67 missions</a>&nbsp;using its Falcon launch vehicles as of the end of the second quarter, with its Falcon 9 workhorse alone accounting for 66 launches and Starlink missions accounting for a major chunk of it.&nbsp;&nbsp;
SpaceX is looking to launch 144 times through the end of the year. For the entirety of last year, SpaceX only completed 96 launches, not including two test flights of the company's Starship launch vehicle.
Check out more of Benzinga&#8217;s Future Of Mobility coverage by <a href="https://www.benzinga.com/topic/mobility">following this link.</a>
Read Next:
<ul>
<li><a href="https://www.benzinga.com/news/24/09/40899599/elon-musk-said-spacex-competitors-only-take-up-less-than-we-do-and-they-take-nothing-down-and-they-g">Elon Musk Said SpaceX Competitors Only &#8216;Take Up Less Than We Do, And They Take Nothing Down, And They Get Paid Twice As Much&#8217;</a></li>
</ul>
Photo courtesy: SpaceX

SPACE

Tech

Elon Musk Adjusts Forecast On SpaceX's Share Of All Mass To Orbit: 'If The Rest Of The Year Goes Well...'

Northland Capital Markets analyst Michael Latimore maintains Gorilla Tech Gr (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRRR#NASDAQ">GRRR</a>) with a Outperform and raises the price target from $7 to $9.

GRRR

Northland Capital Markets Maintains Outperform on Gorilla Tech Gr, Raises Price Target to $9

Tactile Systems Technology, Inc. ("Tactile Medical"; the "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TCMD#NASDAQ">TCMD</a>), a medical technology company providing therapies for people with chronic disorders, today announced the publication of a new clinical study in the Journal of Vascular Surgery, Venous and Lymphatic Disorders. This study assessed outcomes associated with use of the Company's Flexitouch advanced pneumatic compression device (APCD) in Veterans with lower extremity lymphedema. Notably, this 52-week study represents the largest peer-reviewed, prospective, clinical trial investigating PCDs and lymphedema ever published in the United States.
The prospective, longitudinal, pragmatic study publication, titled "Longitudinal assessment of health-related quality of life and clinical outcomes with at home advanced pneumatic compression treatment of lower extremity lymphedema", was authored by Padberg et al. and included 179 Veterans across four participating VA medical centers. The primary outcome measures included disease-specific health-related quality of life (QoL) endpoints obtained at baseline and again at each of 12, 24, and 52 weeks. The secondary outcome measures assessed limb circumference, cellulitis events, skin quality, and therapy compliance over the course of 52 weeks. Among the patients included in the study, chronic venous insufficiency was the most common etiology of lymphedema (phlebolymphedema), presenting in approximately 63% of study participants. Further, mild lymphedema was the most common disease stage, presenting in 68% of patients.
The secondary endpoint results demonstrated several statistically significant improvements, baseline to 52 weeks, with reductions in limb girth, cellulitis events, and skin hyperpigmentation. Among these results, the following were observed:
<ul>
<li>Limb girth decreased by 1.4 cm</li>
<li>Cellulitis events decreased from 21.4% to 6.1%</li>
<li>Skin hyperpigmentation decreased from 75% of patients to 40%&nbsp; &nbsp;</li>
</ul>
There were additional improvements also noted in compliance and limb girth reduction which included:
<ul>
<li>92% patient compliance (defined as used for 5 to 7 days per week) with Flexitouch at 8 weeks and 72% patient compliance at 52 weeks</li>
<li>74% patient compliance with compression garments at 52 weeks, compared to 64% at baseline
<ul>
<li>6% limb girth reduction at 12 weeks in patients with moderate (stage 2) and severe (stage 3) lymphedema.</li>
</ul>
</li>
</ul>

TCMD

Tactile Medical Announces Clinical Trial Results In Lymphedema Patients Using Advanced Pneumatic Compression Device Therapy; The Secondary Endpoint Results Demonstrated Statistically Significant Improvements, Baseline To 52 Weeks, With Reductions In Limb Girth, Cellulitis Events, And Skin Hyperpigmentation

WIIM

HRTX

Heron Therapeutics shares are trading higher after the company announced FDA approval of its Prior Approval Supplement application for the ZYNRELEF vial access needle.

Heron Therapeutics Announces FDA Approval Of Co.'s Prior Approval Supplement Application For ZYNRELEF Vial Access Needle

Vice President <a href="https://www.benzinga.com/government/24/09/41019410/long-time-democrat-turned-independent-joe-manchin-withholds-endorsement-for-kamala-harris-this-would">Kamala Harris</a> has moved solidly ahead of Donald Trump, the Republican candidate, in a nationwide poll, while another suggested the two are still running neck-on-neck.
Harris Pulls Ahead: A matchup between Harris and Trump showed 46.6% support for the former among registered voters and 40.48% backing for the latter, the results of the latest Reuters/Ipsos poll conducted on Sept. 21-23 showed. The poll surveyed 1,029 U.S. adults nationwide, which included 871 registered voters. Out of these 785 were considered likely voters. The margin of error is +/- four points.
The vice president has expanded her lead from five points in the previous poll conducted on Sept. 11-12.
Among likely voters, Harris leads Trump by a 50%-46% margin.
The improvement was primarily due to improving voter perception regarding Harris&#8217; ability to shepherd the economy. When registered voters were asked which candidate had the better approach to the &#8220;economy, unemployment and jobs,&#8221; 43% picked Trump and 41% chose Harris. The vice president, though trailing by two points, narrowed her gap vis-a-vis Trump on the front from a three-point deficit in August and an 11-point deficit in late July when she entered the race.
The most recent Reuters/Ipsos poll found that the economy was the number one issue for voters and therefore it doesn&#8217;t come as a surprise that both candidates are vying with each other to feed the electorate with their proposed policy measures.
See Also: <a href="https://www.benzinga.com/news/24/09/40936316/elon-musk-says-warren-buffett-is-positioning-for-kamala-harris-win-with-his-277b-cash-pile-as-pro-tr">Elon Musk Says Warren Buffett Is Positioning For Kamala Harris Win With His $277B Cash Pile As Pro-Trumper John Paulson Warns Of Equity Market Exit</a>
CNN Poll Finds Deadlock: A CNN poll conducted by SSRS from Sept. 19-22 among a random nationwide sample of 2,074 registered voters showed, among likely voters, Harris and Trump were almost on an even keel, with the tally at 48%-47% in favor of the former.
Only &nbsp;2% of likely voters said they haven't yet chosen a candidate to support, and another 12% have chosen one but said they could change their minds.
Harris led Trump by a 45%-41% margin among independent likely voters, although gender-wise analysis showed the former with 58% support among independent woman voters compared to 35% support for the latter in this category. Among independent men voters, the tally was 47% to 40% in favor of Trump.
The former president held sway among white voters (58%-35% lead among white men voters and 50%-47% lead among white women voters). On the other hand, voters under 30 years backed Harris by a 55%-38% margin.
The CNN poll found <a href="https://www.benzinga.com/markets/cryptocurrency/24/09/41012309/trump-blames-democrats-for-food-inflation-but-experts-suggest-blockchain-could-solve-under">likely voters trust Trump over Harris to handle the economy</a> by a 50%-39% margin. He was also favored for handling immigration and foreign policy. Even among those who said Trump's views and policies are too extreme, 15% said they trust him over Harris to handle the economy and the same share said so on immigration.
Harris&#8217; favorability rating rose to the highest level in CNN polling since just before her and President Joe Biden's inauguration in Jan. 2021. She had a net negative two-point favorability rating compared to a worse net negative 12-point favorability rating for Trump. 
Read Next:
<ul>
<li>Check This Out: Lawmakers Made Huge Investments This Year.&nbsp;<a href="https://www.benzinga.com/gov-trades" target="_blank" rel="noreferrer noopener">Get Tips On What They Bought And Sold Ahead Of The 2024 Election With Our Easy-to-Use Tool</a></li>
</ul>
Image via Wikimedia Commons

Politics

Media

Trump Vs. Harris: Vice President's Favorability Hits Record High, But Faces Setback On This Key Election Issue

Boosting Liquidity And Aligning Interests

Stock Split

NVEE

NV5 Announces 4-For-1 Stock Split To Increase Accessibility For Employees And Investors

BNZI

Banzai International shares are trading lower after the company announced a $5 million private placement.

Cidara Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDTX#NASDAQ">CDTX</a>), a biotechnology company using its proprietary Cloudbreak&#xAE;&nbsp;platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced two presentations at OPTIONS XII for the Control of Influenza conference, to be held September 29 through October 2, 2024 in Brisbane, Australia. The presentations, one oral and one poster, will highlight safety and pharmacokinetic (PK) data from clinical studies of CD388, Cidara's influenza drug-Fc conjugate (DFC) candidate.

CDTX

Cidara Therapeutics Announces Two Presentations On Innovative Drug-Fc Conjugate, CD388, At The 2024 OPTIONS XII For The Control Of Influenza Conference

BREA

Brera Holdings shares are trading higher after the company signed a letter of intent to acquire an Italian Serie B football club.

Sports

Brera Holdings Signs Letter Of Intent To Acquire An Italian Serie B Football Club, Financial Details Not Disclosed

In an investor update on Tuesday, Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) released data from Phase 3 trials of rocatinlimab and Uplizna (inebilizumab).
HORIZON Phase 3 trial evaluated rocatinlimab for atopic dermatitis (eczema) in 726 patients.
Amgen <a target="_blank" href="https://investors.amgen.com/static-files/a7119a35-06de-497e-ba75-146404c54d95" rel="noreferrer noopener">reported</a> that rocatinlimab outperformed a placebo regarding the severity and extent of the disease.
<ul>
<li>32.8% of rocatinlimab-treated subjects achieved an EASI-75 response at week 24 vs. 13.7% placebo.</li>
<li>19.3% of rocatinlimab-treated subjects achieved a vIGA-AD 0/1 response at week 24 vs. 6.6% placebo.</li>
<li>16.4% of rocatinlimab-treated subjects achieved a rIGA 0/1 response at week 24 vs. 4.9% placebo.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/08/40229568/amgens-mixed-q2-results-highlight-obesity-drug-potential-analysts-focus-shifts-to-u" rel="noreferrer noopener">Amgen&#8217;s Mixed Q2 Results Highlight Obesity Drug Potential, Analysts Focus Shifts To Upcoming Clinical Readouts</a>.
MINT Phase 3 trial of Uplizna in generalized myasthenia gravis showed a clinically meaningful and statistically significant MG-ADL (Myasthenia Gravis Activities of Daily Living) score, a measure of the severity of myasthenia gravis symptoms.
After two doses of Uplizna, MG-ADL score showed an overall improvement of -4.2, versus -1.9 placebo adjusted.
The trial demonstrated a statistically significant improvement in the Quantitative Myasthenia Gravis (QMG) score, a clinical assessment that measures the severity of myasthenia gravis.
QMG score improvement with Uplizna compared to placebo at week 26 was -4.8 overall improvement compared to -2.5 placebo adjusted.
No new safety signals were identified.
STAT News <a target="_blank" href="https://www.statnews.com/2024/09/24/amgen-success-trials-eczema-rocatinlimab-myasthenia-gravis-uplizna-competition-remains-stiff/" rel="noreferrer noopener">noted</a> that though the trials succeeded, the therapies did not beat existing competitors on the market.
51% of adults <a target="_blank" href="https://www.dupixenthcp.com/atopicdermatitis/efficacy-safety/easi-clinical-trial" rel="noreferrer noopener">treated</a> with Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>)/ Regeneraon Pharmaceuticals Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) Dupixent (dupilumab) achieved EASI-75 vs.&nbsp;15%&nbsp;with placebo at Week 16 in SOLO 1 trial and 44% vs. 12% in SOLO 2 trial.
William Blair noted that rocatinlimab&#8217;s data fell short of expectations, raising concerns about how its clinical profile stacks up in the increasingly competitive atopic dermatitis market, particularly as the broader ROCKET program unfolds.
On the other hand, the Uplizna results for myasthenia gravis exceeded William Blair&#8217;s expectations, indicating a strong market potential for the treatment. Key advantages include its less frequent dosing and potential to reduce steroid use.
The focus will be determining Uplizna&#8217;s position within the myasthenia gravis treatment landscape alongside other options like FcRn, IVIg, complement inhibitors, rituximab, and more. Additionally, the potential for Uplizna&#8217;s CD19-targeting strategy in autoimmune diseases will be closely watched, especially with competitors like Cullinan Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CGEM#NASDAQ">CGEM</a>).
Price Action: AMGN stock is trading lower by 2.09% to $324.04 at the last check on Wednesday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/general/biotech/24/09/41021471/private-equity-firms-circle-sanofis-consumer-health-business-amid-potential-spinoff" target="_blank" rel="noreferrer noopener">Private Equity Firms Circle Sanofi&#8217;s Consumer Health Business Amid Potential Spinoff</a>.</li>
</ul>
Photo via Shutterstock

Analyst Color

Large Cap

Health Care

AMGN

CGEM

REGN

Amgen's Rocatinlimab Data Beats Placebo In Atopic Dermatitis Trial, But Analyst Says Data Raises Concerns Amid Competitive Market

United Homes Group, Inc. (the "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UHG#NASDAQ">UHG</a>), today announced that on October 1, 2024, Michael Nieri, the Company's founder, Chairman, and Chief Executive Officer, will transition to Executive Chairman of the Company. As Executive Chairman, Mr. Nieri will shift his leadership time and energies to focus primarily on the Company's strategic future. Concurrently with the effectiveness of Mr. Nieri's transition to Executive Chairman, Jamie Pirrello, currently a member of the Company's board of directors and a consultant to the Company, was named interim Chief Executive Officer of the Company. The Company's board of directors intends to undertake a search to identify the Company's next permanent CEO and will consider internal and external candidates.
During his tenure with the Company to date, Mr. Nieri has overseen the tremendous growth and transformation of the Company from the founding of Great Southern Homes in 2004 through its transition to becoming a public company in 2023. Mr. Nieri also helmed the Company through its completion of three homebuilder acquisitions since becoming a public company, and the Company's recent designation as 2024's Builder of the Year by Builder Magazine.

Management

United Homes Group Announces Executive Leadership Changes; On October 1, 2024, Michael Nieri, The Company's Founder, Chairman, And CEO, Will Transition To Executive Chairman Of The Company;  Jamie Pirrello, Was Named Interim Chief Executive Officer Of The Company

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