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  • Virginia federal judge says FDA should reconsider mifepristone restrictions
    At a time when the federal government is evaluating restrictions on medication abortion, a federal judge determined that the last administration imposed too many. A Virginia federal judge ordered…
    Endpoints · 3h ago↗ source
  • The patent cliff is looming and CDMOs need to be prepared, Fujifilm CEO says
    As drugmakers prepare for the looming biopharma patent cliff, 2026 has so far been a year for dealmaking. Now, contract manufacturers need to broaden their services to keep up, Fujifilm Biotechnolo…
    Endpoints · 3h ago↗ source
  • Capricor's DMD therapy lacks efficacy, FDA says ahead of adcomm
    The FDA is again questioning the efficacy of Capricor's cell therapy for Duchenne muscular dystrophy, this time ahead of an advisory committee meeting on Wednesday. The agency's review team said…
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Endpoints · 3h ago↗ source
  • Six wellness peptides win backing from FDA advisory committee
    After two days of meetings, an FDA advisory committee last week voted to lift restrictions on six popular health and wellness peptides, setting aside FDA staff concerns about a lack of safety and e…
    Endpoints · 4h ago↗ source
  • Yarrow to begin trading as it targets Graves; FDA approves Otsuka's ADHD pill
    Plus news about Outlook Therapeutics, Gossamer Bio, Apnimed and Entera Bio. 📈 Yarrow closes merger to go public: Yarrow Bioscience is developing an anti-TSHR antibody for Graves’ disease and thy…
    Endpoints · 5h ago↗ source
  • UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy
    In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor's assertion that a Phase 3 trial met its primary outcome measures.
    BioSpace · 5h ago↗ source
  • MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout
    While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb's Cobenfy is likely to hold its market share.
    BioSpace · 6h ago↗ source
  • Gossamer regains rights to lung disease asset from Chiesi after Phase 3 fail
    Despite a Phase 3 miss, Gossamer Bio is full steam ahead for its lung disease asset, pointing to previous “review issues” at the FDA as one of the reasons to continue development.
    BioSpace · 6h ago↗ source
  • MapLight’s schizophrenia drug dampens once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$MPLT} plummeted more than 60% on Monday after a once-daily regimen of its schizophrenia drug missed the primary endpoint in a mid-stage trial, despite the study’s ove…
    Endpoints · 6h ago↗ source
  • MapLight’s schizophrenia drug disappoints once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$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 · 6h ago↗ source
  • Sarepta names former AbbVie R&D exec Michael Severino as next CEO
    After leaving Tessera Therapeutics earlier this month, Michael Severino will take over Sarepta Therapeutics as the biotech awaits two key regulatory decisions in Duchenne muscular dystrophy.
    BioSpace · 7h ago↗ source
  • RA Capital launches rare disease company Oak Hill Bio onto Nasdaq via SPAC
    Rare disease biotech Oak Hill is headed to the Nasdaq through a SPAC merger with RA Capital-sponsored Research Alliance Corporation III (RACC) to fund a rare genetic disease candidate.
    Fierce Biotech · 7h ago↗ 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…
    Endpoints · 8h ago↗ source
  • AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure
    AstraZeneca remains "very much on track" to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said durin…
    BioSpace · 8h ago↗ source
  • Otsuka’s ADHD approval opens up new drug class with $615M opportunity
    Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
    BioSpace · 8h ago↗ 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 f…
    Endpoints · 9h ago↗ source
  • Argenx deepens immuno expertise with $2.2B Forte Biosciences buy
    The star of the takeover is Forte Biosciences' investigational antibody therapy, FB102, which has shown early potential in vitiligo and celiac disease.
    BioSpace · 9h ago↗ 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 · 10h ago↗ 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 · 10h ago↗ 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 · 10h ago↗ source
  • Apnimed aspires for up to $160M IPO as sleep apnea pill launch nears
    Apnimed has detailed its plans for an initial public offering, with the biotech intending to raise as much as $160 million to fund the launch of its sleep apnea pill.
    Fierce Biotech · 10h ago↗ source
  • Argenx to pick up autoimmune biotech Forte Biosciences for $2.2B
    Argenx will spend $2.2 billion to buy Forte Biosciences and its anti-CD122 monoclonal antibody that’s under investigation for autoimmune diseases. The Belgian-Dutch pharma said Monday it will pay…
    Endpoints · 10h ago↗ source
  • MapLight shares sink on mixed phase 2 schizophrenia readout
    MapLight Therapeutics’ stock plummeted more than 60% this morning after the neuro outfit dropped mixed results for a phase 2 trial of its experimental schizophrenia treatment.
    Fierce Biotech · 11h ago↗ source
  • FDA approves Freenome colorectal cancer blood test to be marketed by Abbott
    The FDA has approved Freenome’s new blood-based colorectal cancer test, SimpleScreen CRC, which Abbott will exclusively market in the U.S.
    Fierce Biotech · 11h ago↗ source
  • InnoCare’s oral TYK2 inhibitor clears phase 3 psoriasis test
    InnoCare Pharma announced Monday that its oral tyrosine kinase 2 (TYK2) inhibitor fadeucravacitinib met the primary endpoint in a phase 3 trial of adults with moderate-to-severe plaque psoriasis.
    Fierce Biotech · 11h ago↗ source