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1,427 stories matching this filter · ← front page

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  • FDA says Capricor's DMD cell therapy failed to meet Phase 3 endpoints
    The FDA briefing documents released before an advisory committee meeting state that the Phase 3 trial of Capricor's deramiocel did not achieve its pre-specified primary and secondary efficacy endpo…
    BioSpace · 17d agoRegulatoryNegative↗ source
  • MapLight's schizophrenia drug fails primary endpoint in Phase 2, sending stock down over 60%
    MapLight Therapeutics saw its shares tumble more than 60% after a mid‑stage trial showed that its once‑daily schizophrenia candidate did not meet the primary efficacy endpoint, even though the over…
    Endpoints · 17d agoNegative readoutNegative↗ source
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  • FDA staff raise concerns over Capricor’s Duchenne cell therapy as shares plunge; Legend CEO resigns, AstraZeneca reports pipeline woes
    Capricor Therapeutics saw its shares tumble by nearly two‑thirds after FDA reviewers highlighted serious concerns about the data supporting its experimental Duchenne muscular dystrophy cell therapy…
    BioPharma Dive · 17d agoRegulatoryNegative↗ source
  • Sarepta appoints former AbbVie R&D chief Michael Severino as new CEO amid DMD regulatory outlook
    Sarepta Therapeutics announced that Michael Severino, who previously led Tessera Therapeutics and served as AbbVie’s head of research and development, will become the company’s chief executive. Sev…
    BioSpace · 17d agoPositive↗ source
  • Sarepta appoints former AbbVie executive Michael Severino as new CEO to drive turnaround
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer on July 28, succeeding Doug Ingram who plans to retire. Severino brings more than two decades of experi…
    BioPharma Dive · 17d agoNeutral↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, adding anti-CD122 antibody FB102
    Argenx announced it will buy Texas‑based Forte Biosciences in a transaction valued at roughly $2.2 billion. The offer of $77 per share represents an 86 % premium to Forte’s recent average price. T…
    BioSpace · 17d agoDealPositive↗ source
  • Schrödinger launches AI agent Bunsen, CEO admits earlier AI skepticism was wrong
    Schrödinger announced the debut of its new AI agent, Bunsen, which is built on the company’s physics‑based software platform. The tool is intended to help biopharma researchers model molecular beha…
    Endpoints · 17d agoPositive↗ source
  • Biotech confidence surges in 2026 as China leads growth and deal activity spikes
    Industry observers noted a marked shift in tone at two major 2026 biotech gatherings – the DIA China meeting in Shanghai and the BIO International Convention in San Diego – where participants expre…
    BioPharma Dive · 17d agoPositive↗ source
  • Denmark's foundation-driven biotech surge pulls Swedish startups across the Øresund, outpacing Nordic peers
    Denmark, and in particular its capital Copenhagen, is emerging as the leading biotech hub in the Nordic region, outpacing its neighbours in investment and talent development. Swedish biotech start…
    BioSpace · 17d agoPositive↗ source
  • Lilly, AbbVie and others pursue in-vivo CAR-T, but safety concerns loom
    Analysts at H.C. Wainwright say safety will be the decisive factor for in‑vivo CAR‑T therapies, noting that convenience and efficacy alone will not win over investors. In‑vivo CAR‑T aims to genera…
    BioSpace · 17d agoNeutral↗ source
  • Summit Therapeutics reports positive Phase 3 data for lung cancer drug ivonescimab, highlighting regulatory hurdles for US approval
    Summit Therapeutics and its Chinese partner Akeso announced that their PD-1/VEGF antibody ivonescimab showed positive results in a Phase 3 trial for non-small cell lung cancer in Western patients.…
    BioSpace · 17d agoPositive readoutPositive↗ source
  • FDA advisory panel lifts restrictions on six wellness peptides
    The FDA's advisory committee concluded its two-day meeting by voting to remove the existing limits on six widely used health and wellness peptides. Committee members said the vote overrode earlier…
    Endpoints · 17d agoRegulatoryPositive↗ source
  • MapLight’s schizophrenia pill hits primary endpoint but falls short of challenging BMS’s Cobenfy
    MapLight Therapeutics reported results from its Phase 2 ZEPHYR trial of the oral muscarinic agonist ML-007C-MA in schizophrenia. The trial met its primary endpoint, showing a statistically signifi…
    BioSpace · 17d agoPositive readoutNeutral↗ source
  • Gossamer Bio regains rights to lung disease asset from Chiesi after Phase 3 failure, eyes FDA submission
    Gossamer Bio announced that it has taken back the rights to its inhaled pulmonary hypertension candidate from partner Chiesi after the drug failed to meet its primary endpoint in a Phase 3 trial.…
    BioSpace · 17d agoNegative readoutNeutral↗ source
  • MapLight’s schizophrenia drug misses primary endpoint in Phase 2, shares tumble over 60%
    MapLight Therapeutics reported results from a mid‑stage Phase 2 trial of its experimental schizophrenia therapy. The study evaluated a once‑daily dosing regimen and failed to meet the predefined p…
    Endpoints · 17d agoNegative readoutNegative↗ source
  • AstraZeneca says Wainua failure won’t alter M&A plans, stays on track for $80B 2030 goal
    AstraZeneca said during its Q2 earnings presentation that the late‑stage failure of the antisense therapy Wainua in ATTR‑cardiomyopathy does not derail its goal of reaching $80 billion in revenue b…
    BioSpace · 17d agoDealNeutral↗ source
  • Sarepta appoints Michael Severino as CEO to steer company beyond a turbulent year
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer, taking over from longtime leader Doug Ingram. Severino is slated to start on Tuesday and joins the com…
    Endpoints · 17d agoNeutral↗ source
  • Legend Biotech CEO Ying Huang resigns, Carvykti head Max Gelman appointed interim chief
    Legend Biotech announced that its chief executive officer, Ying Huang, has stepped down after serving in the role since November 2020. Huang's resignation was reported on Friday, marking the end o…
    Endpoints · 17d agoNeutral↗ source
  • Nokia executive Pallavi Mahajan purchases 62,000 shares at $9.55 each
    Nokia reported an insider transaction by Pallavi Mahajan, a member of the senior management team. The filing indicates Mahajan bought 62,000 Nokia shares on July 24, 2026, at a price of $9.55 per…
    globenewswire health · 17d agoDealNeutral↗ 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 · 17d agoRegulatoryNeutral↗ source
  • Almac Clinical Services podcast details end-to-end clinical trial supply chain
    Almac Clinical Services released a six-part podcast that walks listeners through the clinical trial supply chain from protocol planning to patient delivery. The series, published by BioPharma Dive’…
    BioPharma Dive · 17d agoNeutral↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 17d agoNeutral↗ source
  • Vaisala executive Vesa Pylvänäinen sells 1,582 shares at €56.92 each
    Vaisala Oyj disclosed a transaction by senior executive Vesa Pylvänäinen on July 23, 2026. He disposed of 1,582 ordinary shares of the company on the Nasdaq Helsinki market at an average price of…
    globenewswire health · 17d agoNeutral↗ source
  • Vaisala senior manager Vesa Pylvänäinen disposes 1,582 shares at €56.92 each
    Vaisala Corporation disclosed that senior manager Vesa Pylvänäinen sold a portion of his holdings. The disposal involved 1,582 shares of Vaisala A shares, with a volume‑weighted average price of €…
    globenewswire health · 17d agoNeutral↗ source
  • Nokia senior manager Pallavi Mahajan buys 62,000 shares at $9.55 each
    Nokia disclosed that senior manager Pallavi Mahajan filed a transaction notice under the EU Market Abuse Regulation. The notice, dated July 24, 2026, records Mahajan's purchase of 62,000 Nokia sha…
    globenewswire health · 17d agoRegulatoryNeutral↗ source