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231 stories matching this filter · ← front page

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  • Tenax Therapeutics' heart failure drug TNX-103 misses primary endpoint in Phase 3, shares plunge 85%
    Tenax Therapeutics announced that its investigational heart failure drug TNX-103 failed to meet the primary efficacy endpoint in the Phase 3 LEVEL trial. The trial, which enrolled patients with pu…
    BioSpace · 4h agoNegative readoutNegative↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 4h agoNegative readoutNegative↗ source
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  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 5h agoNegative readoutNegative↗ source
  • BioMarin drops BMN 401 after Phase 3 trial misses clinical endpoints, ending $270M Inozyme asset
    BioMarin announced it will stop development of BMN 401, an enzyme replacement therapy acquired in its $270 million purchase of Inozyme Pharma. The decision follows the Phase 3 ENERGY trial in pati…
    BioSpace · 5h agoNegative readoutNegative↗ 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 · 2h agoLayoffsNegative↗ source
  • STAT+: In surprise decision, FDA rejects radiopharma therapy expected to rival Novartis treatment
    The FDA has rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor for Novartis.
    STAT · 1h ago↗ source
  • STAT+: FDA panel to weigh Grail’s Galleri test
    China reins in its biotech innovation engine, radiopharma boom meets unexpected hurdles, and more news from The Readout
    STAT · 2h ago↗ source
  • Replimune secures FDA accelerated approval for melanoma therapy Tudriqev
    Replimune announced that the FDA has granted accelerated approval to its melanoma therapy RP1, marketed as Tudriqev, after two earlier rejections and a third expedited review. The decision reflects…
    STAT · 3d agoApprovalPositive↗ source
  • Intellia identifies HLA allele linked to severe liver enzyme spikes in ATTR gene therapy
    In November 2025, a patient died after receiving Intellia Therapeutics' investigational gene silencer for transthyretin amyloidosis, prompting a safety review of the company’s ATTR gene therapy pro…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Boston-born biotech founder Felix Wong launches AI-driven startup in California
    Felix Wong grew up near Boston, earned two degrees at Harvard and completed a post-doc at MIT before launching his biotech company in California. His startup applies artificial intelligence to ide…
    STAT · 3d agoNeutral↗ source
  • FDA grants accelerated approval to Replimune’s melanoma therapy Tudriqev after two prior rejections
    The Food and Drug Administration has granted accelerated approval to Replimune’s RP1 treatment, which will be marketed under the name Tudriqev, for patients with advanced melanoma. An advisory com…
    STAT · 3d agoApprovalPositive↗ source
  • FDA approves first mRNA seasonal flu vaccine, mFlusiva, a year after funding cuts
    The U.S. Food and Drug Administration granted approval to mFlusiva, the first mRNA‑based seasonal influenza vaccine, after its advisory committee voted unanimously that the benefits outweigh the ri…
    STAT · 4d agoApprovalPositive↗ source
  • Study uncovers tau’s role in reversing mitochondrial electron flow, offering new Alzheimer’s drug target
    A Stanford-led research team has identified a previously unknown way that the protein tau disrupts cellular function, adding to its status as a leading target in Alzheimer’s drug development. The…
    STAT · 4d agoPositive readoutPositive↗ source
  • FDA approves Takeda’s narcolepsy drug and the first mRNA flu vaccine
    The U.S. Food and Drug Administration has granted approval to a new narcolepsy treatment developed by Takeda, marking a significant addition to the therapeutic options for the sleep disorder. In a…
    STAT · 4d agoApprovalPositive↗ source
  • LifeMine Therapeutics secures $263 million in dual venture rounds to advance organ transplant aftercare drug
    LifeMine Therapeutics announced it has raised a total of $263 million through a $75 million Series D and an $188 million Series F round, opting for private financing rather than an IPO. The capita…
    BioSpace · 4d agoDealPositive↗ source
  • Braveheart Bio targets $382 million IPO to fund cardiac drug development
    Braveheart Bio announced an upsized initial public offering on the Nasdaq, aiming to raise about $382.5 million. The company will sell 21.2 million shares at $18 each under the ticker BRVE. The pr…
    BioSpace · 4d agoDealPositive↗ source
  • Tenax Therapeutics to Release Phase 3 Heart Failure Trial Results Soon
    Tenax Therapeutics announced that it will soon disclose data from its Phase 3 trial of a heart-failure treatment. The study is being watched as one of the largest binary events left for biotech st…
    STAT · 4d agoNeutral↗ source
  • AI’s role in medicine isn’t monolithic, says industry leader, urging nuanced adoption
    Priya Abani, CEO of health‑tech firm AliveCor, argues that asking whether AI is good for medicine is a question with an obvious answer: it is. She says the debate has become redundant and that the…
    STAT · 4d agoPositive↗ source
  • Braveheart Bio raises $382.5M in IPO to fund phase 3 trial of cardiac drug
    Braveheart Bio, a San Francisco biotech, completed an IPO that raised $382.5 million, exceeding its original target. The company increased the share count to 21.2 million and set the price at $18…
    Fierce Biotech · 4d agoDealPositive↗ source
  • Novo Nordisk reports mixed trial results for CagriSema and ziltivekimab, cites setbacks and seeks bolt-on deals
    Novo Nordisk's chief executive said the company has experienced "a couple of setbacks" after recent trial data. The phase 3 study of ziltivekimab, an IL‑6 ligand antibody, did not show a statistica…
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda recalls · 4d agoCRLNegative↗ source
  • FDA advisory committee meetings sow confusion, threaten trust with rare disease developers
    The Food and Drug Administration has been working to repair its relationship with rare-disease drug makers and patient groups since former commissioner Marty Makary left three months ago. Last wee…
    BioSpace · 5d agoRegulatoryNegative↗ source
  • Amgen drops Phase 1 obesity drug AMG 513, leaving MariTide as its only weight-loss candidate and eyes early-stage deals
    Amgen announced it is halting development of AMG 513, a Phase 1 obesity therapy, leaving MariTide as its sole weight‑loss asset. The company said its late‑stage pipeline is largely full, so future…
    BioSpace · 5d agoDealNeutral↗ source
  • Novo Nordisk CEO says innovation is essential as pipeline faces setbacks
    During Novo Nordisk's second-quarter earnings call, CEO Maziar Mike Doustdar said that failure is a normal part of drug development and emphasized that the company's survival depends on continual i…
    BioSpace · 5d agoEarningsNeutral↗ source
  • Five BioSpace NextGen companies debut on US markets in 2026, four actively hiring
    BioSpace NextGen honorees accounted for about one third of the 14 U.S. biotech companies that went public in 2026. The five companies together raised roughly $1.5 billion in IPO proceeds, includin…
    BioSpace · 5d agoPositive↗ source