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  • Upcoming Q2 earnings from Moderna, AstraZeneca, GSK and others highlighted in weekly pharma preview
    The Endpoints Weekly newsletter signals a busy earnings week for major pharmaceutical companies, with Q2 results slated from Moderna, AstraZeneca, GSK, Bristol Myers Squibb and several others. It…
    Endpoints · 19d agoEarningsNeutral↗ source
  • Biogen's Alzheimer's trial data ignites excitement and uncertainty over tau-targeting therapies
    Biogen recently shared results from a late-stage Alzheimer's trial that tested a therapy aimed at the tau protein, a key hallmark of the disease. The findings have sparked enthusiasm among researc…
    Endpoints · 20d agoNeutral↗ source
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  • Amgen submits new analysis to FDA to defend continued availability of Tavneos
    Amgen has provided the FDA with a fresh analysis concerning its rare-disease therapy Tavneos, aiming to address the agency’s concerns. The company says the independent reevaluation supports the dr…
    Endpoints · 20d agoRegulatoryNeutral↗ source
  • Sanofi scraps most atopic dermatitis trials after amlitelimab fails to outperform standard care
    Sanofi announced it is halting all but one ongoing trial for amlitelimab, an OX40‑ligand antibody acquired through its $1.4 billion purchase of Kymab. The decision follows the Phase 3 COAST‑1 stud…
    BioSpace · 20d agoNegative readoutNegative↗ source
  • Scribe Therapeutics raises $129 million in rare early-stage IPO to fund epigenetic heart disease therapy
    Scribe Therapeutics, founded by Jennifer Doudna, completed an IPO raising nearly $129 million, selling 8.58 million shares at $15 each. It is the first gene‑editing company to go public in more tha…
    BioSpace · 20d agoDealPositive↗ source
  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 20d agoRegulatoryNegative↗ source
  • Merck grants royalty-free licenses for experimental HIV prevention pill to generic makers in 129 low-income countries
    Merck announced voluntary licensing agreements that let generic manufacturers produce its experimental HIV prevention pill, known as alimatravir, in low- and middle-income markets. The deals cover…
    STAT · 20d agoDealPositive↗ source
  • FDA panel backs compounding of epitalon, rejects emideltide in narrow vote
    The FDA advisory committee voted to allow compounding pharmacies to produce the peptide epitalon, while narrowly voting against allowing the production of emideltide. The decision follows the pane…
    STAT · 20d agoRegulatoryNeutral↗ source
  • Fatal gene-editing trial in China sparks ethics and oversight concerns
    A six-year-old girl in China died after receiving an experimental brain-directed CRISPR therapy, according to a report in Science. The tragedy has intensified calls for stronger ethical review and…
    STAT · 20d agoRegulatoryNegative↗ source
  • FDA panel backs compounding pharmacies to produce four peptide drugs, amid insulin pen shortage and Merck HIV pill license
    An FDA advisory committee voted to allow compounding pharmacies to prepare four peptide-based medicines, a decision hailed by supporters of peptide therapeutics. The briefing also mentioned that M…
    STAT · 20d agoRegulatoryPositive↗ source
  • EU regulators back Minoryx’s ALD therapy while rejecting Zevra’s rare-disease drug
    The EU Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Minoryx Therapeutics' drug for adrenoleukodystrophy, marking a significant regulatory step after previous c…
    Endpoints · 20d agoRegulatoryNeutral↗ source
  • Summit Therapeutics faces under a year of cash runway as FDA decision on ivonescimab looms
    Summit Therapeutics reported that its cash and short-term investments total just over $690 million, which the company says is insufficient to fund operations for a full year. The biotech’s lead ca…
    BioSpace · 20d agoRegulatoryNeutral↗ source
  • Roche drops Carmot’s acmopatide after Phase 2 success, shifts focus to enicepatide for weight loss and diabetes
    Roche announced it will stop developing acmopatide, an investigational obesity treatment acquired from Carmot Therapeutics. Acmopatide had met its primary endpoint in a Phase 2 trial in type 1 dia…
    BioSpace · 20d agoNeutral↗ source
  • U.S. drug shortages stem from weak regulation, not China competition, says expert
    In 2025 the United States faced 216 active drug shortages, limiting access to lifesaving medicines for patients. While the White House and national‑security officials have framed the problem as a…
    STAT · 20d agoRegulatoryNegative↗ source
  • White House science blueprint pushes billions toward AI firms, away from university life-science research
    The White House Office of Science and Technology Policy released a report titled “Science: A New Golden Age.” The document outlines a new direction for U.S. federal science funding. The plan calls…
    STAT · 20d agoRegulatoryNegative↗ source
  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 21d agoCRLNegative↗ source
  • Scribe Therapeutics launches $129M IPO, kicking off second-half biotech listing spree
    Scribe Therapeutics, a nine-year-old biotech co-founded by CRISPR pioneer Jennifer Doudna, announced its initial public offering. The company priced the IPO at about $128.7 million, raising roughl…
    Endpoints · 21d agoDealPositive↗ source
  • Ipsen's Bylvay fails Phase 3 trial in children with biliary atresia
    Ipsen announced that its experimental therapy Bylvay did not meet its primary endpoint in a Phase 3 trial targeting biliary atresia in infants. Biliary atresia is a rare pediatric liver disorder i…
    Endpoints · 20d agoNegative readoutNegative↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 20d agoDealNeutral↗ source
  • Sanofi halts development of Kymab-derived OX40L antibody for atopic dermatitis
    Sanofi announced that it will no longer pursue the OX40L antibody program it was developing with Kymab for the treatment of atopic dermatitis. The drug was being positioned as a potential follow‑on…
    Endpoints · 20d agoNegative↗ source
  • Novo Nordisk seeks court order to halt Lilly GLP-1 ads as Merck announces HIV PrEP partnership
    Novo Nordisk asked a New Jersey federal court to temporarily block Eli Lilly's GLP-1 advertisements, claiming the ads are misleading. Merck disclosed that it has entered into a partnership focused…
    Endpoints · 20d agoDealNeutral↗ source
  • Senate moves forward bill to require warning labels on ultra-processed foods and ban child-targeted junk-food ads
    The Senate Health, Education, Labor and Pensions Committee voted to advance a bill that would require the FDA to place prominent warning labels on ultra-processed foods high in sugar, salt or satur…
    STAT · 20d agoRegulatoryNeutral↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 21d agoCRLNegative↗ source
  • FDA advisory panel backs compounding pharmacies to produce four popular peptides, defying prior committee advice
    The Food and Drug Administration’s advisory panel voted to allow compounding pharmacies to manufacture four peptide drugs that have gained popularity among health‑seeking individuals. The recommend…
    STAT · 20d agoRegulatoryPositive↗ source
  • Michael Ehlers leaves Ascidian Therapeutics to head R&D at Formation Bio; Black Diamond co-founder passes away at 67
    Michael Ehlers has stepped down as chief executive of Ascidian Therapeutics, the exon‑editing company he co‑founded, to take on the role of head of research and development at Formation Bio, an AI‑…
    Endpoints · 20d agoNeutral↗ source