PetVivo Hldgs (OTC:PETV) Stock, Quote.Headers.trade-ideas

PetVivo Hldgs

PetVivo Holdings Inc is an emerging biomedical device company. It is focused on the manufacturing, commercialization, and licensing of medical devices and therapeutics for companion animals. The product pipeline includes approximately seventeen products intended to treat animals and people. Its patent protection extends to biomaterials, products, production processes, and methods of use provided by the company's portfolio of several patents. The company has also begun the commercialization of its product Spryng with OsteoCushion technology, a veterinarian-administered, intraarticular injection for the management of lameness and other joint afflictions such as osteoarthritis in dogs and horses.

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The Dow Jones index closed lower by around 0.1% on Wednesday. When insiders purchase or sell shares, it indicates their confidence or concern around the company&#39;s prospects. Investors and traders interested in penny stocks can consider this a factor in their overall investment or trading decision.

IZEA Worldwide And 2 Other Stocks Under $3 Insiders Are Buying

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Infrared Cameras Holdings, Inc. - Common Stock

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Shares of CarMax, Inc. (NYSE: KMX) moved higher during Thursday’s session following better-than-expected quarterly earnings.

Why CarMax Shares Are Trading Higher By Around 8%? Here Are Other Stocks Moving In Thursday&#39;s Mid-Day Session

Pre-Market Outlook

EGIO

MESO

MGAM

PASG

VINO

Shares of  BlackBerry Limited  (NYSE: BB) moved lower in pre-market trading following the release of third-quarter results.

Why BlackBerry Shares Are Trading Lower By Over 5%; Here Are 20 Stocks Moving Premarket

PETVIVO HOLDINGS INC by PetVivo Holdings Inc.

PetVivo Holdings Inc

PetVivo Holdings Inc Warrants (15/04/2026)

WIIM

Maxeon Solar Technologies, Ltd. - Ordinary Shares

MAXN

Maxeon shares are trading lower after the company said it is proceeding with an approved reverse stock split.

BMO Capital analyst Daniel Jester initiates coverage on OneStream (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OS#NASDAQ">OS</a>) with a Outperform rating and announces Price Target of $38.

Price Target

Initiation

Analyst Ratings

BMO Capital Initiates Coverage On OneStream with Outperform Rating, Announces Price Target of $38

General Motors shares are trading lower after Bernstein downgraded the stock from Outperform to Market Perform.

Signing Day Sports shares are trading higher after the company announced that it provided an update regarding its financial position and its plans to acquire Dear Cashmere Group Holding Company, doing business as Swifty Global.

ULTA

Ulta Beauty shares are trading lower after TD Cowen downgraded the stock to Hold.

Baird analyst David Koning maintains Fiserv (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FI#NYSE">FI</a>) with a Outperform and raises the price target from $186 to $200.

Baird Maintains Outperform on Fiserv, Raises Price Target to $200

Wheels Up shares are trading higher after the company announced that approximately 97.2% of lead investor shares will remain subject to a lock-up restriction until September 20, 2025.

Baird analyst Peter Arment maintains Kratos Defense &amp; Security (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KTOS#NASDAQ">KTOS</a>) with a Outperform and raises the price target from $22 to $35.

KTOS

Baird Maintains Outperform on Kratos Defense & Security, Raises Price Target to $35

BDTX

Black Diamond Therapeutics shares are trading higher after the company announced initial Phase 2 data demonstrating encouraging clinical responses and durability of BDTX-1535 in patients with relapsed/refractory epidermal growth factor receptor-mutant non-small cell lung cancer.

In a recent turn of events, the United States has directly cautioned Israel against escalating hostilities with Hezbollah, as the two sides engage in intense cross-border exchanges. The U.S. has urged Israel to seek diplomatic solutions, emphasizing the potential risks of a full-scale land war.
What Happened: On Sunday, Israeli forces and Hezbollah militants clashed in some of the most severe confrontations since Oct. 7, Financial Times <a href="https://www.ft.com/content/2bb03f05-c3d5-4f3f-99e3-56f541f51769">reported</a> on Monday. The escalating violence has raised concerns about the situation spiraling into a full-scale war.
John Kirby, a spokesperson for the U.S. National Security Council, cautioned Israel against escalating the conflict. He stated that there are &#8220;better ways&#8221; to ensure the safety of Israeli citizens than through war or further escalation. President Joe Biden assured that his administration would do everything possible to prevent a wider war.
Despite international calls for de-escalation, Israeli Prime Minister Benjamin Netanyahu has pledged to maintain military pressure on Hezbollah. The situation has become increasingly tense, with the recent hostilities resulting in a significant rise in casualties.
See Also: <a href="https://www.benzinga.com/news/24/09/40970828/data-scientists-election-prediction-kamala-harris-receives-historic-endorsement-from-magazine-elon-m?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Data Scientist&#8217;s Election Prediction, Kamala Harris Receives Historic Endorsement From Magazine, Elon Musk Suggests Warren Buffett Is Preparing For A Harris Win And More: Top Political Update This Week</a>
On Monday, Israeli airstrikes in Lebanon led to 30 deaths and over 300 injuries, as per CNN. This escalation follows a series of events, including Hezbollah&#8217;s rocket attacks on Israel and the detonation of the group&#8217;s communication devices, which Hezbollah blames on Israel. The recent violence has led to fears of a potential full-scale war.
Why It Matters: The recent violence adds to the <a href="https://www.benzinga.com/news/24/09/40924166/hezbollah-hit-in-new-round-of-explosions-across-lebanon-casualties-climb">already tense situation</a> in the region. Just last week, Lebanon experienced a second wave of deadly explosions targeting Hezbollah operatives, following a massive wave of pager explosions that killed 12 people and injured nearly 2,800 more. The second round of explosions killed at least nine people and injured over 300, further exacerbating the situation in Lebanon.
Meanwhile, U.S. Senator Lindsey Graham has called for a new <a href="https://www.benzinga.com/news/24/09/40973072/lindsey-graham-says-either-saudi-arabia-recogonizes-israel-or-tel-aviv-targets-tehran-we-need-game-c">approach to Middle East policy,</a> advocating for either a &#8220;game-changing peace&#8221; or a &#8220;game-changing military strategy.&#8221; Graham suggested that a significant shift in strategy is needed, either through Saudi Arabia recognizing Israel, or Israel taking military action against Iran.
Did You Know?
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<li>Congress Is Making Huge Investments.&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>
Photo by Ilin Sergey on Shutterstock
This story was generated using <a href="https://www.benzinga.com/author/benzinga-neuro">Benzinga Neuro</a> and edited by <a href="https://www.benzinga.com/topic/Pooja-Rajkumari" target="_blank" rel="noreferrer noopener">Pooja Rajkumari</a>

Politics

Global

General

US Warns Israel Against Opening A Full-Blown War Against Hezbollah As Air Strikes Kill 30 In Lebanon

Monday, AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) released high-level results from the TROPION-Breast01 Phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to the investigator&#8217;s choice of chemotherapy.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/datopotamab-deruxtecan-final-overall-survival-results-reported-in-patients-with-metastatic-hr-positive-her2-low-or-negative-breast-cancer-in-tropion-breast01-phase-iii-trial.html" rel="noreferrer noopener">study</a> did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
The study previously met the dual primary endpoint of progression-free survival.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40793946/astrazeneca-ceo-pascal-soriot-updates-on-chinese-compliance-probe-and-lung-cancer-drug-trial-resu" rel="noreferrer noopener">AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results</a>.
An improvement in patient-reported outcomes was also seen.
The safety profile of datopotamab deruxtecan was consistent with that observed in the previous analysis, including lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy, and no new safety concerns were identified.
All-grade interstitial lung disease (ILD) rates remained low, and no new Grade 3 or higher ILD events were observed.
With multiple antibody-drug conjugates (ADCs) approved during the trial, including&nbsp;Enhertu (trastuzumab deruxtecan), subsequent treatment following patients&#8217; disease progression or treatment discontinuation is likely to have affected survival results.
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd ADC discovered by Daiichi Sankyo Ltd&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>) and being jointly developed by AstraZeneca and Daiichi Sankyo.
Earlier this month, AstraZeneca&nbsp;shared detailed results from the TROPION-Lung01 Phase 3 of datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with at least&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40791315/astrazenecas-investigational-cancer-drug-disappoints-in-late-stage-lung-cancer-trial" rel="noreferrer noopener">one prior line of therapy</a>.
In the overall trial population, OS results numerically favored datopotamab deruxtecan compared to docetaxel (12.9 vs. 11.8 months) but did not reach statistical significance.
Friday, the FDA <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html" rel="noreferrer noopener">approved</a> AstraZeneca&#8217;s FluMist as the only self-administered influenza vaccine.&nbsp;
FluMist, a needle-free nasal spray, was approved for self-administration by adults up to 49 years of age or for parent/caregiver administration to individuals 2-17 years of age.
Once available, individuals 18 and older can have FluMist delivered directly to their homes via FluMist Home.
Price Action: AZN stock is down 1.86% at $76.92 during the premarket session at last check Monday.
Read Next:
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<li><a href="https://www.benzinga.com/news/large-cap/24/09/40964870/us-federal-trade-commission-sues-cvs-health-cigna-unitedhealths-pharmacy-benefit-managers-for-infl" target="_blank" rel="noreferrer noopener">US Federal Trade Commission Sues CVS Health, Cigna, UnitedHealth&#8217;s Pharmacy Benefit Managers For Inflating Insulin Prices</a>.</li>
</ul>
Image by Robert Way via Shutterstock

Biotech

Large Cap

Health Care

DSKYF

DSNKY

Latest Trial Setback For AstraZeneca's Dato-DXd, The Drug Fails To Extend Lives Of Pretreated Breast Cancer Patients

Baird analyst Ben Kallo maintains Ameresco (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AMRC#NYSE">AMRC</a>) with a Outperform and raises the price target from $32 to $42.

AMRC

Baird Maintains Outperform on Ameresco, Raises Price Target to $42

BHVN

Biohaven shares are trading higher after the company announced its study of Troriluzole for the treatment of spinocerebellar ataxia in achieved the primary endpoint.

During times of turbulence and uncertainty in the markets, many investors turn to dividend-yielding stocks. These are often companies that have high free cash flows and reward shareholders with a<a href="https://www.benzinga.com/yield-investments"> high dividend payout</a>.
Benzinga readers can review the latest analyst takes on their favorite stocks by visiting <a href="https://www.benzinga.com/analyst-stock-ratings">Analyst Stock Ratings</a> page. Traders can sort through Benzinga's extensive database of analyst ratings, including <a href="https://www.benzinga.com/analyst-ratings/analyst-color/22/09/28888638/exclusive-study-finds-benzinga-analyst-ratings-data-yields-market-beating-strategie">by analyst accuracy</a>.
Below are the ratings of the most accurate analysts for three high-yielding stocks in the industrials sector.
<h3 class="wp-block-heading">ZIM Integrated Shipping Services Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ZIM#NYSE">ZIM</a>)</h3>
<ul>
<li>Dividend Yield: 5.78%</li>
<li>Jefferies analyst Omar Nokta maintained a Buy rating and raised the price target from $22 to $25 on Aug. 20. This analyst has an accuracy rate of 73%.</li>
<li>JP Morgan analyst Samuel Bland maintained a Neutral rating and cut the price target from $9.3 to $9.25 on March 22. This analyst has an accuracy rate of 75%.</li>
<li>Recent News: On Aug. 19, ZIM Integrated Shipping Services reported better-than-expected second-quarter financial results and raised its FY24 guidance.</li>
<li>Benzinga Pro's real-time newsfeed alerted to<a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"> latest ZIM news</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="905" height="845" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073915/image-174.png" alt="" class="wp-image-560853" style="width:669px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073915/image-174.png 905w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073915/image-174-300x280.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073915/image-174-768x717.png 768w" sizes="(max-width: 905px) 100vw, 905px" /></a></figure>
<h3 class="wp-block-heading">Genco Shipping &amp; Trading Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GNK#NYSE">GNK</a>)</h3>
<ul>
<li>Dividend Yield: 7.57%</li>
<li>B. Riley Securities analyst Liam Burke maintained a Buy rating and raised the price target from $27 to $30 on May 10. This analyst has an accuracy rate of 62%</li>
<li>Jefferies analyst Omar Nokta maintained a Buy rating and increased the price target from $26 to $27 on May 9. This analyst has an accuracy rate of 73%.</li>
<li>Recent News: On Sept. 10, Genco Shipping &amp; Trading enhanced Dividend Policy to increase cash distributable to shareholders.</li>
<li>Benzinga Pro&#8217;s charting tool helped identify the<a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"> trend in GNK stock</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="922" height="845" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073956/image-175.png" alt="" class="wp-image-560854" style="width:692px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073956/image-175.png 922w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073956/image-175-300x275.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23073956/image-175-768x704.png 768w" sizes="(max-width: 922px) 100vw, 922px" /></a></figure>
<h3 class="wp-block-heading">Karat Packaging Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KRT#NASDAQ">KRT</a>)</h3>
<ul>
<li>Dividend Yield: 5.32%</li>
<li>Truist Securities analyst Jake Bartlett downgraded the stock from Buy to Hold and cut the price target from $34 to $28 on Aug. 9. This analyst has an accuracy rate of 75%.</li>
<li>Stifel analyst Michael Hoffman reiterated a Buy rating and raised the price target from $30 to $32 on March 15. This analyst has an accuracy rate of 82%.</li>
<li>Recent News: On Aug. 8, Karat Packaging reported worse-than-expected second-quarter financial results.</li>
<li>Benzinga Pro&#8217;s signals feature notified of a potential <a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1">breakout in KRT shares</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent092324&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="888" height="842" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23074037/image-176.png" alt="" class="wp-image-560857" style="width:638px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23074037/image-176.png 888w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23074037/image-176-300x284.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/23074037/image-176-768x728.png 768w" sizes="(max-width: 888px) 100vw, 888px" /></a></figure>
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<iframe loading="lazy" title="How to Find Dividend Stocks: Scan, Analyze, and Capture with Benzinga Pro" width="500" height="281" src="https://www.youtube.com/embed/pVF0O2lsEH4?start=1&#038;feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" referrerpolicy="strict-origin-when-cross-origin" allowfullscreen></iframe>
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</figure>
Read More:<a href="https://www.benzinga.com/markets/24/09/40962695/jim-cramer-viking-has-many-ships-coming-in"> </a>
<ul>
<li><a href="https://www.benzinga.com/markets/24/09/40962695/jim-cramer-viking-has-many-ships-coming-in">Jim Cramer: Viking Has &#8216;Many Ships Coming In&#8217;</a></li>
</ul>

Wall Street's Most Accurate Analysts Spotlight On 3 Industrials Stocks With Over 5% Dividend Yields

Baird analyst Colleen Kusy maintains Apellis Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APLS#NASDAQ">APLS</a>) with a Outperform and lowers the price target from $96 to $92.

APLS

Baird Maintains Outperform on Apellis Pharmaceuticals, Lowers Price Target to $92

Mativ Holdings, Inc. ("Mativ" or the "Company") (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MATV#NYSE">MATV</a>) today announced that it has commenced a private offering that is exempt from registration under the Securities Act of 1933, as amended (the "Securities Act"), subject to market and other conditions, of $400,000,000 in aggregate principal amount of senior notes due 2029 (the "Notes"). The Notes will be senior unsecured obligations of the Company and will be guaranteed by each of the Company's existing and future wholly owned subsidiaries that is a borrower under or that guarantees obligations under its credit agreement or that guarantees certain other indebtedness, subject to certain exceptions. The Company intends to use the net proceeds from the offering (i) to redeem its 6.875% Senior Notes due 2026 ("2026 Notes") and (ii) to repay approximately $43 million aggregate principal amount of outstanding borrowings under the term loan B facility under its credit agreement.
The Notes and the related guarantees will be offered only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and to non-U.S. persons outside the United States in reliance on Regulation S under the Securities Act. The Notes and the related guarantees have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration or an applicable exemption from registration requirements under the Securities Act and any applicable securities laws of any other jurisdiction.

Offerings

MATV

Mativ Holdings To Raie $400M Via Proposed Private Offering of Senior Notes To Repay Debt

Alterity Therapeutics ((ASX: ATH, NASDAQ:<a href="https://www.benzinga.com/stock/ATHE#NASDAQ">ATHE</a>) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that multiple oral and poster presentations will be presented at the International Congress of Parkinson's Disease and Movement Disorders&#xAE; (MDS) taking place September 27 – October 1, 2024 in Philadelphia, PA.
"The MDS Congress promises to be an exceptional medical meeting for Alterity with multiple presentations showcasing our progress this year. Highlights for us include oral presentations on both of our Phase 2 clinical programs including the acceptance of our late-breaking interim data from our ATH434-202 trial in participants with advanced multiple system atrophy (MSA)," commented, David Stamler, M.D., Chief Executive Officer of Alterity Therapeutics.

Alterity Therapeutics Limited - American Depositary Shares

ATHE

Alterity Therapeutics to Present Key Phase 2 Data at Parkinson's Congress

Bowman Consulting Group Ltd. (the Company or Bowman) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BWMN#NASDAQ">BWMN</a>), a national engineering services firm delivering infrastructure design solutions and project management services to customers who own, develop and maintain the built environment, has been contracted by the Illinois Department of Transportation (IDOT) to provide corridor management and design services for a 15.6-mile corridor of I-55.
"We are excited to start working on the highly impactful and innovative I-55 corridor assignment," said Gary Bowman, chairman and CEO of Bowman. "This is one of several awards where we've been anticipating and planning for a final contract and notice to proceed for several months. We had the necessary resources for the assignment in place, so we were able to mobilize quickly and immediately commence work on the project. Our transportation practice has unparalleled experience with the complexities of large-scale infrastructure projects in Illinois, and we appreciate this opportunity to help IDOT improve and modernize one of the most heavily traveled expressways in the state for its constituents."
Corridor management is an innovative approach to transportation system management whereby public agencies and private contractors commit to working together to manage a transportation corridor holistically rather than the more traditional approach of managing individual assets discretely. This contract is one of a few design management corridor contracts to be released from IDOT and is a key component of the state's $45 billion Rebuild Illinois infrastructure investment program strategy.
Under this engagement, Bowman will manage all projects within the highly trafficked stretch of I-55, which connects Chicago to its southwest suburbs, a corridor that transits over 100,000 vehicles daily. Additionally, Bowman will prepare bridge repair plans for 16 bridges within the corridor, as well as develop roadway improvement plans of the expressway. These enhancements have been identified as key to improving safety, reducing congestion and extending the lifespan of Illinois' transportation infrastructure.

Government

Regulations

BWMN

Bowman Consulting Lands Major I-55 Corridor Management Contract with Illinois Department of Transportation (IDOT)

Aileron Therapeutics, Inc. ("Aileron") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALRN#NASDAQ">ALRN</a>), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced the completion of enrollment in Cohort 2 of the ongoing Phase 1b clinical trial of LTI-03 in IPF patients.
&nbsp;
The last patient was enrolled in mid-September, with a total of 24 patients enrolled in the trial. Eligible patients are randomly assigned (3:1) to receive either inhaled LTI-03 or placebo. The primary objective of the trial is to evaluate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints.
"We are pleased to have completed enrollment in the high-dose cohort of our Phase 1b clinical trial and grateful to all participating patients and investigators," said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. "Following the positive trend observed in the low-dose cohort, we are excited to assess the safety, tolerability and biomarkers of 5 mg twice daily of inhaled LTI-03 and expect to report topline data in the near term."
In May 2024, the Company <a href="https://investors.aileronrx.com/news-releases/news-release-details/aileron-therapeutics-announces-positive-data-cohort-1-phase-1b">announced positive data</a> from Cohort 1 evaluating low-dose LTI-03 (2.5 mg BID). Following inhaled administration of low-dose LTI-03 in 12 patients, a positive trend was observed in seven out of eight biomarkers with evidence of reduced expression among multiple profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from three biomarkers that was statistically significant, reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF.
About the Phase 1 Clinical Trial of LTI-03
The Phase 1b clinical trial of LTI-03 is a randomized, double-blind, placebo controlled, multi-center, dose escalation trial in patients recently diagnosed with IPF that have not received prior treatment with anti-fibrotic agents for at least two months (<a href="https://classic.clinicaltrials.gov/ct2/show/NCT05954988">NCT05954988</a>). Eligible patients are randomly assigned (3:1) to receive one of two doses of inhaled LTI-03 or placebo. The primary objective of the trial is to investigate the safety and tolerability of LTI-03 in patients with IPF after treatment for 14 consecutive days, with measurement of multiple protein biomarkers as exploratory endpoints.

ALRN

Aileron Therapeutics Completes Enrollment for Phase 1b IPF Drug Trial, Topline Data Expected Soon

Elevation Oncology, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ELEV#NASDAQ">ELEV</a>), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.
"We are delighted to receive Fast Track designation for EO-3021, which marks an encouraging recognition of the unmet medical need in patients with Claudin 18.2-expressing tumors, as well as the potential for EO-3021 to deliver improved therapeutic outcomes," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "This designation is based on nonclinical and initial clinical data from our ongoing Phase 1 clinical trial. As we announced in August, early results showed a confirmed overall response rate of 42.8% in a Claudin 18.2-enriched subset of gastric and GEJ cancer. In addition, we observed differentiated tolerability, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy/hypoesthesia. We are grateful for the opportunity to potentially expedite the delivery of EO-3021 and look forward to advancing through monotherapy dose expansion and reporting additional data from our ongoing trial in the first half of 2025, and to initiating the combination portion of our study later this year."
Fast Track is a process designed by the FDA to facilitate the development and expedite the review of therapeutic candidates intended to treat serious or life-threatening conditions, for which nonclinical or clinical data demonstrate the potential to address unmet medical needs. Therapeutic candidates that receive FTD may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.

ELEV

Elevation Oncology's EO-3021 Granted FDA Fast Track for Advanced Gastric Cancer Treatment

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PETV Stock Earnings: PetVivo Hldgs Reported Results for Q4 2024

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PetVivo Holdings, Inc. (PETV) Q1 2025 Earnings Call Transcript

PetVivo Holdings GAAP EPS of -$0.11, revenue of $0.12M; reaffirms FY25 outlook

PETVW

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