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116 stories matching this filter · ← front page

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  • AbbVie shares slip 4% as Q2 immunology earnings beat falls short of lofty expectations
    AbbVie’s stock fell about 4% on Friday after the company reported second‑quarter results that modestly exceeded analyst forecasts, disappointing investors who had set very high expectations. The f…
    BioSpace · 2d agoEarningsNegative↗ source
  • Biogen’s early Phase 2 data supports tau-targeting Alzheimer’s approach
    Biogen has released early Phase 2 results for its experimental Alzheimer’s therapy diranersen, indicating that reducing tau protein levels may lead to cognitive benefits. The findings add to a lon…
    BioSpace · 3d agoPositive readoutPositive↗ source
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Nephrology239
  • Arvinas CEO outlines strategy to rebuild pipeline after lead asset departure
    In a recent episode of the Denatured podcast, Arvinas President and CEO Randy Teel discussed how the company is shifting focus to an early‑stage pipeline after its lead asset was out‑licensed or di…
    BioSpace · 3d agoPositive↗ source
  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 3d agoDealPositive↗ source
  • FDA advisory panel votes 9-3 against Capricor's Duchenne therapy deramiocel
    During an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting, reviewers focused on the Phase 3 HOPE-3 trial's secondary cardiac endpoint and described the data as very fragile. The…
    BioSpace · 3d agoApprovalNegative↗ source
  • FDA advisory panel votes 9-3 against approval of Capricor’s Duchenne muscular dystrophy therapy deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee focused heavily on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, describing the data as very fragile. Committee…
    BioSpace · 3d agoRegulatoryNegative↗ source
  • Kyverna partners with ElevateBio to supply its autologous CAR-T therapy for autoimmune launches
    Kyverna Therapeutics has signed a five‑year manufacturing agreement with contract development and manufacturing organization ElevateBio. The deal makes ElevateBio the primary supplier of Kyverna's…
    BioSpace · 4d agoDealPositive↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 4d agoDealNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 4d agoLayoffsNegative↗ source
  • Otsuka receives FDA approval for Simtriyo, first norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD
    Otsuka Pharmaceutical announced that the FDA has approved its daily pill centanafadine, branded as Simtriyo, for the treatment of attention-deficit hyperactivity disorder in patients six years and…
    BioSpace · 6d agoApprovalPositive↗ 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 · 6d agoNegative readoutNegative↗ 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 · 6d agoPositive↗ 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 · 9d agoRegulatoryNeutral↗ 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 · 9d agoDealNeutral↗ source
  • How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
    Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
    BioSpace · 13d ago↗ source
  • GSK walks away from Alector pact as immuno-neurology bet fizzles
    After two high-profile trial failures over the past year, GSK is breaking off a deal that features $700 million upfront that it signed with Alector for neurodegenerative disease treatments. GSK’s e…
    Endpoints · 24d ago↗ source
  • Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal
    An arbitration panel ruled Prime didn’t breach a deal with Beam by developing a rare disease treatment. Elsewhere, European regulators are using a pancreatic cancer drug to test a new framework for…
    BioPharma Dive · 25d ago↗ source
  • Gene editing developer Scribe plots an IPO
    The California drugmaker, which has collaborations in place with Biogen, Sanofi and Eli Lilly, could be the 14th biotech to go public in 2026.
    BioPharma Dive · 27d ago↗ source
  • Cancer, immune drugmakers dominate VC funding so far in 2026
    Drug developers focusing on either disease area made up more than 40% of the number of biotech companies and amount raised so far in 2026, per BioPharma Dive data.
    BioPharma Dive · 27d ago↗ source
  • Ex-iTeos CEO starts fresh at GSK neuro partner; Genentech loses yet another key scientist
    → Michel Detheux has succeeded Rita Balice-Gordon as CEO of Danish neuro biotech Muna Therapeutics, which is partnering with GSK on Alzheimer’s treatments. Balice-Gordon will slide over to ...
    Endpoints · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • Biogen adds more immune drugs in $1B buyout of secretive startup RayThera
    The companies didn’t specify the drugs Biogen is acquiring in the deal, though patents RayThera secured provide important clues.
    BioPharma Dive · 1mo ago↗ source
  • Rapport ‘fully prepared’ to launch seizure drug solo, CEO says
    In a wide-ranging interview, Abe Ceesay detailed how Rapport built an investor syndicate and why the company is confident it can join the ranks of successful, commercial-stage brain drugmakers.
    BioPharma Dive · 1mo ago↗ source
  • Sanofi stops immune drug trial in latest research setback
    The failure adds to a series of mixed or negative readouts and leaves in doubt the future of a therapy Sanofi has viewed as a potential blockbuster.
    BioPharma Dive · 1mo ago↗ source
  • Shattuck raises $75M; Servier inks neuro ASO pact with n-Lorem Foundation
    Shattuck Labs initiates $75M public offering: The US biotech {$STTK} is selling over 10.5 million shares for $4 apiece, and issuing pre-funded warrants for certain investors. The offering is set to…
    Endpoints · 1mo ago↗ source