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  • BridgeBio secures $1 billion in equity financing ahead of three upcoming drug launches
    BridgeBio Pharma announced it has raised about $1 billion through a preferred equity transaction. The new capital will strengthen its balance sheet as the company prepares three potential drug lau…
    Endpoints · 1mo agoDealNeutral↗ source
  • Angitia halts Phase 3 trial of AGA111 for degenerative disc disease
    Angitia Biopharmaceuticals announced that it has ended the Phase 3 study of its investigational therapy AGA111 in patients with degenerative disc disease who had undergone lumbar interbody fusion.…
    Endpoints · 1mo agoNegative readoutNegative↗ source
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  • Merck ends Phase 2 trial of Alzheimer’s drug MK-1167 from partner Neuphoria
    Merck announced it has terminated a mid-stage Phase 2 study of an experimental Alzheimer’s therapy. The drug, called MK-1167, is an oral candidate that was being developed in collaboration with bi…
    Endpoints · 1mo agoNegative↗ source
  • WuXi AppTec seeks court order to remove itself from U.S. Pentagon's Chinese military-linked company list
    WuXi AppTec has filed a petition for a preliminary injunction to halt its inclusion on the Pentagon's list of firms with alleged ties to the Chinese military. The company says the designation is d…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Ipsen to acquire Memo Therapeutics and its kidney infection candidate
    French drugmaker Ipsen announced a new acquisition, agreeing to buy Memo Therapeutics along with its experimental kidney infection drug. This marks Ipsen's second transaction announced within a wee…
    Endpoints · 1mo agoDealPositive↗ source
  • Upcoming FDA decisions in Q3 2026 could signal agency flexibility
    The piece highlights five FDA actions slated for the third quarter of 2026 that industry participants are tracking. Observers say the outcomes may reveal how flexible the agency will be under its…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • 92Bio revives experimental T cell engager previously handed to Amgen
    92Bio, a small California biotech, announced it is bringing back an experimental T‑cell engager it originally created before transferring the program to Amgen. The company said the candidate will…
    Endpoints · 1mo agoNeutral↗ source
  • Sanofi’s Pompe disease enzyme therapy clears Phase 3 in infants, opening US label expansion
    Sanofi announced that its next‑generation enzyme replacement therapy for Pompe disease met its primary endpoints in a registrational Phase 3 trial involving infants with the severe infantile‑onset…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • BeOne’s Brukinsa cuts risk of progression or death by 43% in frontline mantle cell lymphoma Phase 3 trial
    BeOne Medicines reported that its BTK inhibitor Brukinsa achieved a significant benefit in a Phase 3 trial for patients with mantle cell lymphoma who received the drug as first‑line therapy. The s…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Ipsen to buy Kartos Therapeutics for $450M, gaining Phase 3 myelofibrosis drug navtemadlin
    French pharmaceutical company Ipsen announced it will acquire California-based Kartos Therapeutics, paying $450 million upfront. The acquisition gives Ipsen control of navtemadlin, an MDM2 inhibito…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • FDA approves Viridian's Lumvoa, positioning it against Amgen's Tepezza in thyroid eye disease
    The Food and Drug Administration has granted approval for Viridian Therapeutics' drug Lumvoa to treat thyroid eye disease, an autoimmune condition that can cause eye pain, bulging and vision proble…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Beeline Medicines raises $126.3M, bringing total Series A funding to $426.3M for immune‑drug development
    Beeline Medicines announced an additional $126.3 million in Series A financing, pushing the total raised to $426.3 million. The capital boost was disclosed on Tuesday and follows an earlier spring…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • House panel launches probe into Bristol Myers and Pfizer's China trial sites
    A congressional committee has opened an inquiry into the use of clinical trial sites in China by Bristol Myers Squibb and Pfizer. The panel is focusing on facilities that the committee chair says…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • FDA picks seven firms, including Eli Lilly and Fujifilm, for PreCheck pilot to speed factory inspections
    The FDA announced that it has selected seven companies to join the inaugural PreCheck pilot, a program designed to accelerate the review of manufacturing facilities. The cohort includes large drug…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • AbbVie and Genmab's Epkinly shows positive combo results, moving toward label expansion in DLBCL
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a successful outcome when tested together with a commonly used cancer therapy. The data indicate that the combination was…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Sarepta receives FDA decision deadline for exon-skipping therapies, appoints Anna Protopapas as Flare CEO
    The U.S. Food and Drug Administration has set a deadline for a decision on Sarepta Therapeutics' exon‑skipping drug program, with the agency expected to rule by the end of February. The timing is…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Unicycive Therapeutics receives second FDA complete response letter for kidney drug amid manufacturing problems
    Unicycive Therapeutics' chronic kidney disease drug, a phosphate binder called oxylanthanum carbonate (OLC), has been rejected by the U.S. Food and Drug Administration for a second time. The FDA c…
    Endpoints · 1mo agoCRLNegative↗ source
  • Beeline Medicines secures $126M from Bain Capital, CPPIB and Bristol Myers to expand immunology pipeline
    Beeline Medicines, a spinout from Bristol Myers Squibb, announced it has received an additional $126 million in financing. The new capital comes from existing investors Bain Capital and the Canada…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA reviewers recommend against adding seven peptides to bulk drug list for compounding
    FDA reviewers have advised that seven widely used peptides should not be added to the FDA's bulk drug substance list for compounding. Their recommendation comes before an upcoming advisory committe…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Abivax reports ulcerative colitis trial cancer rates align with expectations
    Abivax released new data from its Phase 3 trial of an ulcerative colitis candidate. The data show that the number of cancer cases observed was within the range normally expected for ulcerative col…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Biotech firms raise record funds in 2026, with $2.1 bn round for Isomorphic Labs
    After a few slow years, the biotech financing landscape is showing signs of recovery, though investors remain cautious about where they place capital. A recent PharmaVoice reader poll found that 2…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Anthropic launches Claude Science, AI platform aimed at bioscience and drug discovery
    Anthropic, known for its Claude Code AI coding assistant, announced a new product called Claude Science aimed at the life‑science sector. The platform is designed to help biopharma researchers wit…
    Endpoints · 1mo agoPositive↗ source
  • Health tech executives grow confident in AI, survey shows sharp shift in attitudes
    A yearly survey conducted by Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan Mangini reveals that confidence in using artificial intelligence within healthcare has risen sharply over t…
    Endpoints · 1mo agoPositive↗ source
  • Virtual mental-health firms accelerate AI chatbot development using therapy session data
    People are turning to artificial intelligence for daily tasks, companionship and emotional support, prompting virtual mental‑health providers to explore AI solutions. Companies that were previousl…
    Endpoints · 1mo agoNeutral↗ source