FDA

FDA https://www.benzinga.com/views/taxonomy/term/59 en FULC Stock Crashes After Hours: What Investors Need To Know https://www.benzinga.com/markets/equities/26/06/52929064/fulc-stock-crashes-after-hours-what-investors-need-to-know?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Fulcrum Therapeutics</strong> <a href="https://www.benzinga.com/quote/FULC" target="_blank" class="ticker-link" data-ticker="FULC" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/FULC">FULC</a>)</a> shares are trading sharply lower in after-hours trading on Monday.</p> <p>FULC shares plunged 49.69% to $3.23 in after-hours trading after the company announced it was discontinuing pociredir, its lead experimental drug for sickle cell disease, and launched a strategic review process.</p> <p>Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for rare hematological disorders.</p> <h2 class="wp-block-heading">Program Discontinuation Announcement</h2> <p>The company said it is discontinuing development of pociredir for sickle cell disease following feedback from the <strong>Food and Drug Administration.</strong></p> <p>According to Fulcrum, the FDA raised concerns about the benefit-risk profile of pociredir after observing malignancy risks associated with Tazverik, another drug targeting the PRC2 pathway that was withdrawn from the global market earlier this year. The FDA concluded that therapies targeting the PRC2 complex may carry similar cancer-related risks, leaving ...</p><p><a href=https://www.benzinga.com/markets/equities/26/06/52929064/fulc-stock-crashes-after-hours-what-investors-need-to-know?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=FULC Stock Crashes After Hours: What Investors Need To Know>Full story available on Benzinga.com</a></p> benznews Biotech Equities FULC News Why is it moving? Small Cap FDA Management Markets FULC News Biotech Equities Small Cap FDA Management Markets Benzinga Tue, 02 Jun 2026 05:50:23 +0000 Tanya Rawat 52929064 at https://www.benzinga.com Revolution Medicines' Pancreatic Cancer Pill Doubles Survival, Cuts Death Risk 60% in Trial As Stock Sits Near All-Time Highs https://www.benzinga.com/news/health-care/26/05/52895326/revolution-medicines-pancreatic-cancer-pill-doubles-survival-stock-highs?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Revolution Medicines Inc.</strong> <a href="https://www.benzinga.com/quote/RVMD" target="_blank" class="ticker-link" data-ticker="RVMD" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/RVMD">RVMD</a>)</a>, on Sunday, unveiled breakthrough data showing its experimental pancreatic cancer pill more than doubled median overall survival compared with chemotherapy in a pivotal study.</p> <h2 class="wp-block-heading"><strong>The Survival Benefit</strong></h2> <p>Daraxonrasib reduced the risk of death by 60% versus chemotherapy and more than doubled median overall survival in previously treated patients with metastatic pancreatic cancer harboring KRAS mutations, the company said.</p> <p>The study also met its progression-free survival endpoint, with patients on daraxonrasib experiencing substantially longer disease control than those receiving standard treatment.</p> <p>“These results will change how scientists, clinicians, and patients think about treatment for pancreatic cancer,” <strong>Brian M. Wolpin</strong>, Harvard’s Dana-Farber Cancer Institute and principal investigator for the trial said, adding that the results establish a new standard of care for patients whose disease has already been treated.</p> <div class="bz-read-next-block"<br /> data-variant="card"<br /> ...</div><p><a href=https://www.benzinga.com/news/health-care/26/05/52895326/revolution-medicines-pancreatic-cancer-pill-doubles-survival-stock-highs?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=Revolution Medicines' Pancreatic Cancer Pill Doubles Survival, Cuts Death Risk 60% in Trial As Stock Sits Near All-Time Highs>Full story available on Benzinga.com</a></p> Biotech cancer News Pancreatic Cancer pharmaceuticals RVMD FDA RVMD News Biotech FDA Benzinga Mon, 01 Jun 2026 02:43:12 +0000 radhikanadig@benzinga.com 52895326 at https://www.benzinga.com Pfizer Strikes Up To $10.5 Billion Deal With China's Innovent Biologics To Develop Next-Gen Cancer Therapies https://www.benzinga.com/news/health-care/26/05/52864604/pfizer-strikes-10-5-billion-partnership-with-chinas-innovent-biologics?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Pfizer Inc.</strong> <a class="ticker-link" data-ticker="PFE" data-exchange="NYSE" href="https://www.benzinga.com/quote/PFE" target="_blank" rel="noopener">(NYSE:<a class="ticker" href="https://www.benzinga.com/quote/PFE">PFE</a>)</a> and China’s <strong>Innovent Biologics</strong> have announced a global licensing and collaboration agreement. The deal, valued at up to $10.5 billion, is set to develop 12 early-stage cancer drugs.</p> <p>The agreement comprises an upfront payment of $650 million to Innovent, with potential development, regulatory, and commercial milestone payments reaching up to $9.85 billion. The collaboration encompasses a portfolio of antibody-drug conjugates (ADCs) with novel differentiated payloads and multi-specific antibodies. This includes eight early-stage assets originated by Innovent and four discovery programs proposed by Pfizer.</p> <p>Pfizer will lead the first 12 programs through Phase 1 clinical trials, after which Innovent will take over global development responsibilities. The agreement is divided into three tiers, each outlining distinct terms for co-development, co-commercialization, and licensing rights.</p> <div ...<p><a href=https://www.benzinga.com/news/health-care/26/05/52864604/pfizer-strikes-10-5-billion-partnership-with-chinas-innovent-biologics?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=Pfizer Strikes Up To $10.5 Billion Deal With China's Innovent Biologics To Develop Next-Gen Cancer Therapies>Full story available on Benzinga.com</a></p> Asia AZN China News PFE Health Care FDA AZN US0463531089 PFE US7170811035 News Asia Health Care FDA Benzinga Fri, 29 May 2026 08:12:49 +0000 Namrata Sen 52864604 at https://www.benzinga.com PRF Technologies (PRFX) Shares Surge Over 186% After Hours: Here's What Is Going On https://www.benzinga.com/markets/equities/26/05/52863586/prf-technologies-prfx-shares-surge-over-186-after-hours-heres-what-is-going-on?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>PRF Technologies Ltd. </strong><a class="ticker-link" data-ticker="PRFX" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/PRFX" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/PRFX">PRFX</a>)</a> shares surged 186.22% to $3.92 after the bell on Thursday after the company issued an update on the advancement of its AI-driven renewable energy revenue optimization platform, DeepSolar Predict.</p> <h2 class="wp-block-heading">AI-Driven Revenue Optimization</h2> <p>DeepSolar Predict combines weather intelligence, storage orchestration and real-time market decision support to help renewable operators manage solar, wind and battery storage assets. PRF noted DeepSolar participates in the NVIDIA Connect Program and has filed a patent covering proprietary plant-level micro-climate modeling methods.</p> <p><strong>Dr. Ehud Geller</strong>, Chairman of PRF Technologies, said, “Renewable energy operators are no longer managing only production — they are managing financial exposure in increasingly dynamic power markets.”</p> <p>PRFX is a dual-mandate company focused on pharmaceutical reformulation and ...</p><p><a href=https://www.benzinga.com/markets/equities/26/05/52863586/prf-technologies-prfx-shares-surge-over-186-after-hours-heres-what-is-going-on?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=PRF Technologies (PRFX) Shares Surge Over 186% After Hours: Here's What Is Going On>Full story available on Benzinga.com</a></p> benznews Equities News PRFX Why is it moving? Health Care Movers & Shakers FDA After-Hours Center Markets Tech General PRFX News Equities Health Care Movers & Shakers FDA After-Hours Center Markets Tech General Benzinga Fri, 29 May 2026 05:55:40 +0000 Mohd Haider 52863586 at https://www.benzinga.com EXCLUSIVE: NewcelX Advances Diabetes Therapy Toward Human Trials With FDA Pre-IND Submission https://www.benzinga.com/news/health-care/26/05/52802461/exclusive-newcelx-advances-diabetes-therapy-toward-human-trials-with-fda-pre-ind-submission?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>NewcelX Ltd.</strong> <a href="https://www.benzinga.com/quote/NCEL" target="_blank" class="ticker-link" data-ticker="NCEL" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/NCEL">NCEL</a>)</a>, a regenerative medicine company, on Wednesday announced the submission of a Pre-IND briefing package to the U.S. Food and Drug Administration (FDA) for NCEL-101.</p> <p>NCEL-101 is the company's flagship stem cell-derived islet replacement therapy, designed as a scalable, "off-the-shelf" treatment to restore functional insulin production in patients with Type 1 Diabetes.</p> <p>The submission supports a proposed First-In-Human clinical trial for the company's type 1 diabetes treatment program.</p> <p>"The Pre-IND meeting for NCEL-101 is a pivotal milestone that underscores our commitment towards a potential cure for T1D," said <strong>Ronen Twito</strong>, Executive Chairman and CEO of NewcelX.</p> <h2 class="wp-block-heading">FDA Submission And Trial Plans</h2> <p>NewcelX submitted the Pre-IND package to support a proposed First-In-Human clinical trial evaluating NCEL-101 in combination with <strong>Eledon Pharmaceuticals' ...</strong></p><p><a href=https://www.benzinga.com/news/health-care/26/05/52802461/exclusive-newcelx-advances-diabetes-therapy-toward-human-trials-with-fda-pre-ind-submission?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=EXCLUSIVE: NewcelX Advances Diabetes Therapy Toward Human Trials With FDA Pre-IND Submission>Full story available on Benzinga.com</a></p> ELDN NCEL News why it's moving FDA Market-Moving Exclusives Exclusives Movers ELDN NCEL News FDA Market-Moving Exclusives Exclusives Movers Benzinga Wed, 27 May 2026 11:31:06 +0000 Akanksha Bakshi 52802461 at https://www.benzinga.com Soligenix (SNGX) Stock Soars 72% On ThermoVax Platform Promise Amid Ebola Outbreak Caused By Bundibugyo Virus https://www.benzinga.com/markets/equities/26/05/52798672/soligenix-sngx-stock-soars-thermovax-ebola-bundibugyo-virus?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Soligenix, Inc.</strong> <a class="ticker-link" data-ticker="SNGX" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/SNGX" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/SNGX">SNGX</a>)</a> shares are trending on Wednesday.</p> <p>SNGX shares surged 72.32% to $0.88 in after-hours trading Tuesday following the biotech’s announcement that its ThermoVax platform can rapidly develop a Bundibugyo virus vaccine, addressing a <strong>World Health Organization</strong>-declared <strong>Ebola </strong><a href="https://www.benzinga.com/news/health-care/26/05/52739668/former-cdc-chief-says-ebola-may-become-very-significant-pandemic-warns-it-could-reach-three-more-countries">outbreak emergency</a>.</p> <p>Soligenix made this announcement on Tuesday addressing an urgent outbreak declared a Public Health Emergency of International Concern.</p> <h2 class="wp-block-heading">Critical Vaccine Gap Drives Catalyst</h2> <p>The <a href="https://www.benzinga.com/news/health-care/26/05/52763187/cdc-expands-ebola-screening-to-atlanta-airport-as-congo-outbreak-intensifies">Democratic Republic of Congo outbreak</a> has reported numerous suspected cases and deaths in May. Earlier, WHO Africa regional director warned the <a href="https://www.benzinga.com/news/health-care/26/05/52761718/who-africa-chief-warns-its-a-big-mistake-to-underestimate-ebola-outbreak-as-deadly-virus-spreads">outbreak poses serious cross-border transmission risk</a>, with two confirmed cases already spreading into neighboring Uganda. </p> <p>No approved vaccines exist for Bundibugyo virus, Sudan virus, or Marburg virus, creating immediate demand for rapid vaccine deployment.</p> <p><strong>Christopher J. Schaber</strong>, President and Chief Executive Officer of Soligenix, said, “Our ThermoVax® platform has successfully thermostabilized vaccines for ricin toxin, filoviruses such as Ebola, Sudan ...</p><p><a href=https://www.benzinga.com/markets/equities/26/05/52798672/soligenix-sngx-stock-soars-thermovax-ebola-bundibugyo-virus?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=Soligenix (SNGX) Stock Soars 72% On ThermoVax Platform Promise Amid Ebola Outbreak Caused By Bundibugyo Virus>Full story available on Benzinga.com</a></p> benznews Biotech Equities News SNGX Why is it moving? World Health Organization Health Care Movers & Shakers FDA Global After-Hours Center Markets General SNGX News Biotech Equities Health Care Movers & Shakers FDA Global After-Hours Center Markets General Benzinga Wed, 27 May 2026 04:48:33 +0000 Mohd Haider 52798672 at https://www.benzinga.com Chamath Palihapitiya Said This To Eli Lilly's Gene Therapy That Slashes LDL Cholesterol Up To 62% https://www.benzinga.com/markets/biotech/26/05/52768827/chamath-palihapitiya-eli-lilly-gene-therapy-ldl-cholesterol?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>Venture capitalist <strong>Chamath Palihapitiya</strong> responded “What?!?!?!” on X, amplifying analyst <strong>Cremieux</strong>‘s post describing <strong>Eli Lilly and Company</strong>‘s <a href="https://www.benzinga.com/quote/LLY"></a><a class="ticker-link" data-ticker="LLY" data-exchange="NYSE" href="https://www.benzinga.com/quote/LLY" target="_blank" rel="noopener">(NYSE:<a class="ticker" href="https://www.benzinga.com/quote/LLY">LLY</a>)</a> <strong>VERVE-102 </strong>as “a powerful, permanent gene therapy for LDL cholesterol.”</p> <p><figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"><br /> <div class="wp-block-embed__wrapper"> <blockquote class="twitter-tweet" data-width="500" data-dnt="true"><p lang="en" dir="ltr">What?!?!?! <a href="https://t.co/Pl39USIdBZ">https://t.co/Pl39USIdBZ</a></p> <p>— Chamath Palihapitiya (@chamath) <a href="https://twitter.com/chamath/status/2059013000322011216?ref_src=twsrc%5Etfw">May 25, 2026</a></p></blockquote> <script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div> <p></p></figure></p> <h2 class="wp-block-heading">What Triggered The Reaction</h2> <p>On Monday, Lilly reported positive Phase 1b data for VERVE-102, an investigational in vivo base editing medicine designed to permanently silence the PCSK9 gene in the liver, potentially replacing chronic cholesterol therapies with a single infusion.</p> <p>PCSK9 is a gene that codes for an enzyme. When it is overactive, it reduces the number of LDL receptors in liver cells. As a result, more low-density lipoprotein cholesterol remains in circulation in the bloodstream. Permanently silencing this gene is the central therapeutic approach behind VERVE-102.</p> <h2 class="wp-block-heading">Data Shows Strong Efficacy</h2> <p>Published simultaneously in The New England Journal of Medicine and presented at the European Atherosclerosis Society Congress, the Heart-2 interim analysis of 35 participants showed dose-dependent mean LDL-C reductions of up to 62% and PCSK9 ...</p><p><a href=https://www.benzinga.com/markets/biotech/26/05/52768827/chamath-palihapitiya-eli-lilly-gene-therapy-ldl-cholesterol?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=Chamath Palihapitiya Said This To Eli Lilly's Gene Therapy That Slashes LDL Cholesterol Up To 62%>Full story available on Benzinga.com</a></p> Biotech Chamath Palihapitiya Earnings LLY News FDA Events Markets General LLY US5324571083 News Earnings Biotech FDA Events Markets General Benzinga Tue, 26 May 2026 06:06:22 +0000 Mohd Haider 52768827 at https://www.benzinga.com BeOne Medicines: Recent FDA Approval Rewrites One-Drug Narrative https://www.benzinga.com/Opinion/26/05/52721582/beone-medicines-recent-fda-approval-rewrites-one-drug-narrative?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><em>The company's Sonrotoclax is the first newly approved BCL-2 inhibitor in the U.S. in nearly a decade, giving BeOne a potential new hit beyond its Zanubrutinib blood cancer therapy</em></p> <p><figure class="wp-block-image size-large"><img decoding="async" src="https://contributor-assets.benzinga.com/wp-content/uploads/2026/05/21070448/%E5%B1%8F%E5%B9%95%E6%88%AA%E5%9B%BE_21-5-2026_121037_thebambooworks.com_-1024x670.jpeg" alt="" class="wp-image-33057" /></figure></p> <p><em>image credit: Bamboo Works</em></p> <h4 class="wp-block-heading"><strong>Key Takeaways:</strong></h4> <ul class="wp-block-list"> <li>BeOne Medicines' newly approved Sonrotoclax could leverage the company's large patient base for its Zanubrutinib blood cancer treatment</li> <li>The company recently raised its full-year revenue guidance to between 43.6 billion yuan and 45.2 billion yuan, while forecasting a gross margin in the high-80% range</li> </ul> <p>For innovative drugmakers with relatively limited portfolios, the success of a single blockbuster therapy is often a key driver toward profitability. But when one product dominates for too long, investors may also begin to question the long-term stability of the company's business, worried about overdependence on a single revenue source.</p> <p><strong>BeOne Medicines Ltd.</strong> <a href="https://www.benzinga.com/quote/ONC" target="_blank" class="ticker-link" data-ticker="ONC" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ONC">ONC</a>)</a> (688235.SH; 06160.HK) formerly known as BeiGene, got a nice diversification shot in the arm in that regard last week, with the <a href="https://www1.hkexnews.hk/listedco/listconews/sehk/2026/0514/2026051400053.pdf" rel="nofollow"><strong>announcement</strong></a> that its internally developed next-generation highly selective BCL-2 inhibitor, Sonrotoclax, received accelerated approval in the U.S. The decision by the U.S. Food and Drug Administration (FDA) marks an important step in helping the company build a more comprehensive hematologic oncology portfolio.</p> <p>According to BeOne's announcement, the U.S. approved Sonrotoclax to treat adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL) who have previously received at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. The approval is the first for a new BCL-2 inhibitor in the U.S. in nearly a decade, the company said.</p> <p>Sonrotoclax was previously approved in China this January for the treatment of R/R MCL, as well as for adults with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy, including a BTK inhibitor. The approvals mean BeOne has completed its BCL-2 ...</p><p><a href=https://www.benzinga.com/Opinion/26/05/52721582/beone-medicines-recent-fda-approval-rewrites-one-drug-narrative?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=BeOne Medicines: Recent FDA Approval Rewrites One-Drug Narrative>Full story available on Benzinga.com</a></p> Biotech contributors Expert Ideas ONC Health Care FDA Opinion ONC Biotech Health Care FDA Opinion Benzinga Thu, 21 May 2026 15:13:58 +0000 Bamboo Works 52721582 at https://www.benzinga.com Guardant Health Secures FDA Approval For Expanded Liquid Biopsy Test https://www.benzinga.com/news/fda/26/05/52697018/guardant-health-secures-fda-approval-for-expanded-liquid-biopsy-test?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>The U.S. Food and Drug Administration (FDA) on Wednesday approved <strong>Guardant Health Inc.’s</strong> <a href="https://www.benzinga.com/quote/GH" target="_blank" class="ticker-link" data-ticker="GH" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/GH">GH</a>)</a> Guardant360 Liquid CDx test, expanding the company's blood-based comprehensive genomic profiling capabilities for patients <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">with advanced cancer</a>.</p> <p>The approval also transfers the seven previously approved companion diagnostic indications from Guardant360 CDx <a target="_blank" href="https://www.benzinga.com/pressreleases/26/05/b52686912/fda-approves-new-guardant360-liquid-cdx-the-largest-fda-approved-liquid-biopsy-panel-with-a-100x-e" rel="noreferrer noopener">to the updated test</a>.</p> <p>The cancer testing company said Guardant360 Liquid CDx is now the largest FDA-approved liquid biopsy panel and evaluates a genomic footprint that is 100 times wider than the earlier Guardant360 CDx test.</p> <p>The test combines genomic and epigenomic insights from a single blood sample to help clinicians make more <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">informed treatment decisions</a>.</p> <h2 class="wp-block-heading">New Platform Integrates Genomic And Epigenomic Insights</h2> <p>Guardant said the updated test is powered by its proprietary Smart Platform, an AI-enabled multiomic technology platform designed to improve circulating ...</p><p><a href=https://www.benzinga.com/news/fda/26/05/52697018/guardant-health-secures-fda-approval-for-expanded-liquid-biopsy-test?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=Guardant Health Secures FDA Approval For Expanded Liquid Biopsy Test>Full story available on Benzinga.com</a></p> GH Large Cap News why it's moving Health Care FDA Movers Trading Ideas General GH News Large Cap Health Care FDA Movers Trading Ideas General Benzinga Wed, 20 May 2026 16:07:40 +0000 Vandana Singh 52697018 at https://www.benzinga.com ImmunityBio Stock Climbs As FDA Accepts Expanded Use Filing For Bladder Cancer Drug https://www.benzinga.com/news/fda/26/05/52688145/immunitybio-stock-climbs-as-fda-accepts-expanded-use-filing-for-bladder-cancer-drug?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>ImmunityBio Inc.</strong> <a href="https://www.benzinga.com/quote/IBRX" target="_blank" class="ticker-link" data-ticker="IBRX" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/IBRX">IBRX</a>)</a> stock is up during Wednesday’s premarket session as the company is <a target="_blank" href="https://www.benzinga.com/pressreleases/26/05/b52680738/immunitybio-announces-fda-acceptance-of-supplemental-bla-for-anktiva-plus-bcg-in-bcg-unresponsive-" rel="noreferrer noopener">gaining attention following</a> the FDA’s acceptance of its supplemental Biologics License Application (sBLA) for ANKTIVA in combination with Bacillus Calmette-Guerin (BCG) for treating BCG-unresponsive non-muscle <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">invasive bladder cancer (NMIBC)</a>.</p> <h2 class="wp-block-heading">IBRX Jumps After FDA Accepts ANKTIVA sBLA For NMIBC</h2> <p>The FDA has accepted ImmunityBio’s sBLA for ANKTIVA, which is aimed at expanding treatment options for patients with BCG-unresponsive NMIBC.</p> <p>The FDA assigned a PDUFA target action date of Jan. 6, 2027, indicating a significant step forward for the company’s product pipeline.</p> <p>The supplemental application is supported by data from the QUILT 3.032 Phase 2/3 trial in 80 patients. The study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2%.</p> <div class="bz-read-next-block"<br /> data-variant="card"<br /> data-news-mode="manual" <p> ></p> <p> <strong><br /> Read ...</strong></p></div><p><a href=https://www.benzinga.com/news/fda/26/05/52688145/immunitybio-stock-climbs-as-fda-accepts-expanded-use-filing-for-bladder-cancer-drug?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=ImmunityBio Stock Climbs As FDA Accepts Expanded Use Filing For Bladder Cancer Drug>Full story available on Benzinga.com</a></p> BBP Biotech CBSE IBRX Large Cap MEME News why it's moving Health Care FDA Movers Trading Ideas General BBP MEME CBSE IBRX News Biotech Large Cap Health Care FDA Movers Trading Ideas General Benzinga Wed, 20 May 2026 12:49:56 +0000 Vandana Singh 52688145 at https://www.benzinga.com AstraZeneca Scores Key FDA Wins Across Cardiovascular And Oncology Portfolios https://www.benzinga.com/news/fda/26/05/52642817/astrazeneca-scores-key-fda-wins-across-cardiovascular-and-oncology-portfolios?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>On Monday, the U.S. Food and Drug Administration (FDA) approved <strong>AstraZeneca Plc's</strong> <a href="https://www.benzinga.com/quote/AZN" target="_blank" class="ticker-link" data-ticker="AZN" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/AZN">AZN</a>)</a> Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor, for adults with hypertension whose blood pressure remains uncontrolled despite taking other <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">antihypertensive medicines</a>.</p> <p><strong>Mineralys Therapeutics Inc.</strong> <a href="https://www.benzinga.com/quote/MLYS" target="_blank" class="ticker-link" data-ticker="MLYS" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/MLYS">MLYS</a>)</a> also has lorundrostat under FDA review for hypertension, with a <a target="_blank" href="https://www.benzinga.com/pressreleases/26/05/g52342612/mineralys-therapeutics-reports-first-quarter-2026-financial-results-and-provides-corporate-update" rel="noreferrer noopener">decision date of 22 December</a>.</p> <h2 class="wp-block-heading">AstraZeneca Secures FDA Approval For Baxfendy In Hypertension</h2> <p>The company also announced expanded FDA approvals for Enhertu in HER2-positive early breast cancer alongside partner Daiichi Sankyo.</p> <p>Baxfendy is designed to lower blood pressure by selectively blocking aldosterone production, a hormone linked to elevated blood pressure and increased cardiovascular and kidney risks.</p> <p>AstraZeneca <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2026/Baxdrostat-MNR-2026.html" rel="noreferrer noopener">said</a> nearly half of U.S. patients ...</p><p><a href=https://www.benzinga.com/news/fda/26/05/52642817/astrazeneca-scores-key-fda-wins-across-cardiovascular-and-oncology-portfolios?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=AstraZeneca Scores Key FDA Wins Across Cardiovascular And Oncology Portfolios>Full story available on Benzinga.com</a></p> AZN Biotech Large Cap MLYS News why it's moving Health Care FDA Top Stories Movers General AZN US0463531089 MLYS News Biotech Large Cap Health Care FDA Top Stories Movers General Benzinga Mon, 18 May 2026 16:59:02 +0000 Vandana Singh 52642817 at https://www.benzinga.com FDA Drug Chief Tracey Hoeg Fired Days After After Marty Makary's Exit— Says Order Came From 'Way Above' https://www.benzinga.com/news/politics/26/05/52621942/fda-drug-chief-tracey-hoeg-fired-days-after-after-marty-makarys-exit-says-order-came-from-way-above?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Tracey Beth Hoeg</strong>, acting head of the <strong>U.S. Food and Drug Administration</strong>‘s Center for Drug Evaluation and Research, was fired Friday after six months in the role, amid several <a href="https://www.benzinga.com/news/fda/26/03/51114978/controversial-fda-vaccines-chief-vinay-prasad-to-leave-agency-in-april">high-level official exits</a> from the federal public health agency.</p> <p>Hoeg confirmed the dismissal on X, saying the day marked six months as CDER head and that she was fired. She was the fifth person to run CDER in the 15 months of President <strong>Donald Trump</strong>‘s second term. Her exit comes days <a href="https://www.benzinga.com/news/fda/26/05/52453068/white-house-reportedly-preparing-to-oust-fda-commissioner-marty-makary">after Commissioner <strong>Marty Makary</strong></a> resigned.</p> <p><figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"><br /> <div class="wp-block-embed__wrapper"> <blockquote class="twitter-tweet" data-width="500" data-dnt="true"><p lang="en" dir="ltr">Today marked 6 months as head of CDER at <a href="https://twitter.com/FDA?ref_src=twsrc%5Etfw">@FDA</a> & today I was fired<br /><br />I'm incredibly grateful to have had this opportunity to serve this country & proud of the work we did<br /><br />FDA staff are smart, talented, supportive & don't get enough credit<br /><br />I learned so much & leave with no regrets <a href="https://t.co/WqpBZuRIFq">pic.twitter.com/WqpBZuRIFq</a></p> <p>— Tracy Beth Høeg, MD, PhD ...</p></blockquote></div></figure></p><p><a href=https://www.benzinga.com/news/politics/26/05/52621942/fda-drug-chief-tracey-hoeg-fired-days-after-after-marty-makarys-exit-says-order-came-from-way-above?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=FDA Drug Chief Tracey Hoeg Fired Days After After Marty Makary's Exit— Says Order Came From 'Way Above'>Full story available on Benzinga.com</a></p> AZN Government MRK News SNY Health Care Politics FDA AZN US0463531089 MRK US58933Y1055 SNY US80105N1054 News Government Health Care Politics FDA Benzinga Sat, 16 May 2026 03:52:52 +0000 Mohd Haider 52621942 at https://www.benzinga.com FDA Halts Aardvark Therapeutics Rare Disease Study https://www.benzinga.com/news/health-care/26/05/52599968/fda-halts-aardvark-therapeutics-rare-disease-study?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Aardvark Therapeutics Inc.</strong> <a class="ticker-link" data-ticker="AARD" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/AARD" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/AARD">AARD</a>)</a> said the <a href="https://www.benzinga.com/fda-calendar">U.S. Food and Drug Administration (FDA)</a> has placed a full clinical hold on its investigational new drug application for ARD-101, following the company's previously disclosed voluntary program pause.</p> <p>ARD-101 is an oral small-molecule therapy designed to stimulate gut-peptide hormone release by activating bitter taste receptors.</p> <p>The drug was being studied as a potential treatment for hyperphagia, or insatiable hunger, in Prader-Willi Syndrome, a rare genetic disorder that causes physical, cognitive, and behavioral challenges.</p> <div class="bz-read-next-block"<br /> data-variant="card"<br /> data-news-mode="manual" <p> ></p> <p> <strong><br /> Read Also:<br /> <a href="https://www.benzinga.com/analyst-stock-ratings/initiation/25/12/49371535/aardvarks-hunger-suppressing-drug-candidate-could-potentially-address-massive-10-billion-market-analyst" target="_blank" rel="noopener"><br /> Aardvark's Hunger Suppressing Drug Candidate Could Potentially Address Massive $10 Billion Market: Analyst</a><br /> </strong> </p> </div> <h2 class="wp-block-heading">FDA Places Full Clinical Hold On Aardvark's ARD-101 Program</h2> <p>The hold applies to all ongoing studies under the IND, including the Phase 3 HERO trial evaluating ARD-101 in patients with hyperphagia linked to Prader-Willi Syndrome, as well as the open-label extension study.</p> <p>The clinical-stage biotechnology company said it remains in discussions with the FDA as it works toward resolving the hold and identifying a path forward for ...</p><p><a href=https://www.benzinga.com/news/health-care/26/05/52599968/fda-halts-aardvark-therapeutics-rare-disease-study?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=FDA Halts Aardvark Therapeutics Rare Disease Study>Full story available on Benzinga.com</a></p> AARD Analyst Color Biotech Expert Ideas News why it's moving Health Care FDA Analyst Ratings Movers Trading Ideas General AARD News Analyst Color Biotech Health Care FDA Analyst Ratings Movers Trading Ideas General Benzinga Fri, 15 May 2026 14:27:05 +0000 Vandana Singh 52599968 at https://www.benzinga.com BeOne Medicines Wins Conditional FDA Nod For Cancer Drug In Rare Blood Cancer https://www.benzinga.com/news/fda/26/05/52575187/beone-medicines-wins-conditional-fda-nod-for-cancer-drug-in-rare-blood-cancer?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>The U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval to <strong>BeOne Medicines Ltd.</strong>‘s <a href="https://www.benzinga.com/quote/ONC" target="_blank" class="ticker-link" data-ticker="ONC" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ONC">ONC</a>)</a> Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma who previously received at least two lines of systemic therapy, including a <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">Bruton’s tyrosine kinase inhibitor</a>.</p> <p>The approval adds a new treatment option for patients with limited therapies after disease progression.</p> <h2 class="wp-block-heading">FDA Clears BEQALZI For Post-BTK Mantle Cell Lymphoma</h2> <p>The company described BEQALZI as a next-generation BCL2 inhibitor designed to improve potency, selectivity, and convenience compared with <a target="_blank" href="https://www.benzinga.com/pressreleases/26/05/b52536318/beone-medicines-beqalzi-sonrotoclax-approved-by-u-s-fda-as-first-and-only-bcl2-inhibitor-for-rr-ma" rel="noreferrer noopener">existing therapies in the class</a>.</p> <p>Data from the Phase 1/2 BGB-11417-201 study supported the FDA's decision. Independent review data showed an overall response rate of 52% and a complete response rate of 16%.</p> <div class="bz-read-next-block"<br /> data-variant="card"<br /> data-news-mode="manual" <p> ...</p></div><p><a href=https://www.benzinga.com/news/fda/26/05/52575187/beone-medicines-wins-conditional-fda-nod-for-cancer-drug-in-rare-blood-cancer?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=BeOne Medicines Wins Conditional FDA Nod For Cancer Drug In Rare Blood Cancer>Full story available on Benzinga.com</a></p> Biotech News ONC why it's moving Health Care FDA Movers Trading Ideas General ONC News Biotech Health Care FDA Movers Trading Ideas General Benzinga Thu, 14 May 2026 18:15:51 +0000 Vandana Singh 52575187 at https://www.benzinga.com REGENXBIO Advances Duchenne Gene Therapy Toward Accelerated Approval https://www.benzinga.com/news/health-care/26/05/52569385/regenxbio-advances-duchenne-gene-therapy-toward-accelerated-approval?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>REGENXBIO Inc. </strong><a href="https://www.benzinga.com/quote/RGNX" target="_blank" class="ticker-link" data-ticker="RGNX" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/RGNX">RGNX</a>)</a> on Thursday released topline and interim functional data from the pivotal Phase 1/2/3 AFFINITY DUCHENNE trial evaluating RGX-202, its investigational gene therapy <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">for Duchenne muscular dystrophy</a>.</p> <p>The company said the study met its primary endpoint with high statistical significance, as 93% of participants achieved at least 10% microdystrophin expression at week 12.</p> <p>REGENXBIO also reported a statistically significant correlation between microdystrophin expression <a target="_blank" href="https://www.benzinga.com/pressreleases/26/05/n52554250/regenxbio-announces-positive-topline-results-from-pivotal-phase-iii-affinity-duchenne-study-of-rgx" rel="noreferrer noopener">and functional improvement</a>.</p> <p><strong> • Regenxbio stock is testing key support levels. <a href="https://www.benzinga.com/quote/RGNX" target="_blank" rel="noreferrer noopener">Why are RGNX shares at support?</a></strong></p> <h2 class="wp-block-heading"><strong>Functional Improvement Supports Therapy Potential</strong></h2> <p>The pivotal portion of the study evaluated 31 ambulatory boys aged one year and older treated with RGX-202 at 2×1014 GC/kg.</p> <p>According to the company, average microdystrophin expression reached 71.1% across participants and 41.6% among boys older than eight years.</p> <p>In addition, 80% of participants achieved greater than 40% <a target="_blank" href="https://www.benzinga.com/markets/biotech/26/03/51196009/regenxbio-reports-duchenne-gene-therapy-progress-as-stock-slides-on-mixed-signals" rel="noreferrer noopener">microdystrophin expression</a>.</p> <p>Interim one-year functional data from nine participants aged about five to ...</p><p><a href=https://www.benzinga.com/news/health-care/26/05/52569385/regenxbio-advances-duchenne-gene-therapy-toward-accelerated-approval?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel alt=REGENXBIO Advances Duchenne Gene Therapy Toward Accelerated Approval>Full story available on Benzinga.com</a></p> Biotech disease News RGNX why it's moving Health Care FDA Movers Trading Ideas General RGNX News Biotech Health Care FDA Movers Trading Ideas General Benzinga Thu, 14 May 2026 16:03:30 +0000 Vandana Singh 52569385 at https://www.benzinga.com