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2,422 stories matching this filter · ← front page

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  • 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 · 3mo agoNegative readoutNegative↗ 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 · 3mo agoPositive↗ source
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  • 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoPositive readoutPositive↗ source
  • American Regent recalls one lot of Papaverine Hydrochloride injection over glass particles
    American Regent announced a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP 60 mg/2 mL, after detecting visible particulate matter. The particles were id…
    fda medwatch · 3mo agoCRLNegative↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoNeutral↗ 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 · 3mo agoRegulatoryNeutral↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoRegulatoryNegative↗ 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 · 3mo 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 · 3mo 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 · 3mo agoNeutral↗ source