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  • [Podcast] (Season 2) The Progress Profile: Alzheimer’s Research in Focus
    This podcast explores how leading Alzheimer’s experts are working to bridge the gap between clinical trial design and frontline care.
    BioPharma Dive · 3d agoRegulatoryNeutral↗ source
  • From confidence to capital: Positioning biotech for the next growth cycle
    How can biotechs be investor ready? Key takeaways from BIO International and DIA China 2026.
    BioPharma Dive · 3d agoRegulatoryNeutral↗ source
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  • Denmark’s foundation‑fueled biotech boom redraws the Nordic map
    Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy
    The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • MapLight’s schizophrenia drug dampens once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$MPLT} plummeted more than 60% on Monday after a once-daily regimen of its schizophrenia drug missed the primary endpoint in a mid-stage trial, despite the study’s ove…
    Endpoints · 3d agoNeutral↗ source
  • MapLight’s schizophrenia drug disappoints once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$MPLT} plummeted more than 60% on Monday after a once-daily regimen of its schizophrenia drug missed the primary endpoint in a mid-stage trial, despite the study’s ove…
    Endpoints · 3d agoNeutral↗ source
  • Legend CEO Ying Huang resigns; Carvykti chief named interim leader
    Legend Biotech, the developer of the blockbuster cancer therapy Carvykti, is in the market for a new CEO. Ying Huang stepped down Friday after serving as CEO since November 2020, Legend announced in a
    Endpoints · 3d agoNeutral↗ source
  • Sarepta turns to Michael Severino as CEO, looking to move past recent turmoil
    Sarepta Therapeutics has found its new CEO as it seeks to recover from a calamitous past year. Michael Severino will replace the company’s longtime leader Doug Ingram on Tuesday. Severino joins fro…
    Endpoints · 3d agoNeutral↗ source
  • AstraZeneca looks to AI to ease risk in late-stage trials, speed up filings
    AstraZeneca’s use of AI in drug design and development has not yet yielded any clinical-stage candidates, CEO Pascal Soriot said Monday, but he added it could be useful in boosting the success of l…
    Endpoints · 3d agoNeutral↗ source
  • Updated: AstraZeneca foresees blockbuster sales for Claudin 18.2 ADC, but Ultomiris flops in rare disease
    AstraZeneca said Monday that a key late-stage trial of its Claudin 18.2-targeting ADC in stomach cancer had succeeded, albeit with a caveat — but another Phase 3 trial of Ultomiris yielded subpar r…
    Endpoints · 3d agoNeutral↗ source
  • Schrödinger debuts AI agent Bunsen to use its physics software
    Three years ago, Schrödinger CEO Ramy Farid ruffled some feathers by pushing back on the AI fever of the moment. He said AI hype was at "dangerous" and "insane" levels, warning there ...
    Endpoints · 3d agoNeutral↗ source
  • 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 · 5d 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 · 6d agoNeutral↗ source
  • 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 · 6d 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 · 6d 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 · 6d 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 · 6d agoRegulatoryNegative↗ source
  • Sanofi stops development of eczema drug amlitelimab after mixed trial results
    Sanofi announced on Friday that it is halting further development of amlitelimab for atopic dermatitis, a drug it had once promoted as a potential successor to its blockbuster Dupixent. The compan…
    BioPharma Dive · 6d agoNegative↗ 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 · 6d agoNegative readoutNegative↗ 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 · 6d agoDealNeutral↗ source
  • CHMP recommends Minoryx’s ALD drug, rejects Zevra’s Meplyffa
    Minoryx Therapeutics finally scored backing from EU regulators for its neurological drug that’s faced multiple hurdles. Meanwhile, Zevra’s rare disease drug got a setback in Europe almost two years…
    Endpoints · 6d ago↗ source
  • Novo escalates legal fight with Lilly; J&J reinforces ‘dominance’ in multiple myeloma
    Novo is seeking an injunction that would halt allegedly “misleading” obesity drug ads. Elsewhere, the FDA began reviewing a highly anticipated medicine and a veteran investor landed at an AI startup.
    BioPharma Dive · 6d ago↗ 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 · 6d ago↗ source
  • Summit has less than a year of cash runway left as PD-1/VEGF verdict nears
    Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing…
    BioSpace · 6d ago↗ source
  • Roche cans one Carmot obesity asset as another shows best-in-class potential
    Acmopatide met the main goal of a Phase 2 study in type 1 diabetes, but Roche is axing the investigational drug to prioritize enicepatide for weight loss, type 2 diabetes and cardiovascular outcome…
    BioSpace · 6d ago↗ source