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1,163 stories matching this filter · ← front page

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  • BioVie’s Parkinson drug data prompts 50% stock drop as company shifts to composite endpoint
    BioVie announced phase 2 results for its experimental Parkinson’s therapy bezisterim, saying the data suggest a meaningful advance in treating the disease. Investors reacted sharply, wiping out ro…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ 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 · 3mo agoDealPositive↗ source
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  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Context Therapeutics drops CT-95 bispecific T-cell engager to stretch cash runway to 2027
    Context Therapeutics announced it is halting development of its bispecific T-cell engager CT-95. The company acquired CT-95 in 2024 for $3.7 million and began dosing patients in a phase 1 trial in…
    Fierce Biotech · 3mo agoNegative↗ source
  • Actimed regains full rights to S-oxprenolol, ends $126 million Faraday licensing deal
    Actimed Therapeutics announced it has reclaimed all worldwide rights to its experimental wasting disease drug S-oxprenolol, terminating the licensing agreement it had with Faraday Pharmaceuticals.…
    Fierce Biotech · 3mo agoDealNeutral↗ source
  • Vistagen's anxiety nasal spray fails to outperform placebo in phase 2 trial
    Vistagen Therapeutics reported that its experimental nasal spray fasedienol did not show a statistically significant advantage over placebo in a phase 2 study of social anxiety disorder. The trial…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source
  • PacBio appoints COO Mark Van Oene as new CEO after Christian Henry steps down
    PacBio announced that its chief operating officer, Mark Van Oene, will become president and chief executive officer effective Aug. 5 and will join the company's board. Van Oene, who joined PacBio…
    Fierce Biotech · 3mo agoNeutral↗ source
  • EMA launches consultation to streamline nonclinical development for life-threatening diseases
    EMA announced a public consultation on proposals to accelerate the nonclinical phase of drug development for diseases that are severely debilitating or life‑threatening. The agency aims to reduce…
    raps · 3mo agoRegulatoryNeutral↗ 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 · 3mo agoNegative readoutNegative↗ source
  • LifeMine Therapeutics secures $188 million Series E funding from Gates, Bezos and others
    LifeMine Therapeutics, a Massachusetts biotech, recently completed a $188 million Series E round, attracting billionaire investors Bill Gates and Jeff Bezos. The funding follows a $75 million Seri…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • FDA approves Orzeyful, first drug to treat all symptoms of narcolepsy type 1
    The U.S. Food and Drug Administration announced on August 5, 2026 that it has approved Orzeyful (oveporexton) tablets for adults with narcolepsy type 1. Orzeyful is the first therapy cleared to tr…
    fda press · 3mo agoApprovalPositive↗ source
  • Emergent BioSolutions cuts 93 jobs and eliminates chief medical officer role in new restructuring plan
    Emergent BioSolutions announced a new round of restructuring aimed at aligning the company with current business realities, disclosed alongside its second‑quarter earnings. The plan includes layin…
    Fierce Biotech · 3mo agoLayoffsNegative↗ source
  • Fecal microbiome transplant boosts peanut tolerance sixfold in early trial
    Researchers at Boston Children’s Hospital conducted a small open‑label phase 1 trial in which 15 adult participants received oral encapsulated fecal microbiome transplantation to test safety and ef…
    Fierce Biotech · 3mo agoPositive readoutPositive↗ source
  • Novo Nordisk CFO describes roller-coaster growth and stays optimistic about CagriSema after Q2 earnings
    Novo Nordisk CFO Karsten Munk Knudsen talked to Fierce after the company released its second-quarter earnings, reflecting on his nine-year tenure and the firm’s volatile performance. He recalled a…
    Fierce Biotech · 3mo agoEarningsNeutral↗ source
  • Attovia Therapeutics raises $289 million in IPO to fund anti-itch drug development
    Attovia Therapeutics completed an initial public offering that generated $289 million in gross proceeds. The company sold 17 million shares at $17 each, exceeding its original target of $182.4 mill…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Sanofi pauses phase 2 bronchiectasis trial of SAR445399 for strategic reasons
    Sanofi has halted a phase 2 study of its monoclonal antibody SAR445399 in adults with non‑cystic fibrosis bronchiectasis. The trial, which began in April, was a randomized, double‑blind, placebo‑co…
    Fierce Biotech · 3mo agoNegative↗ source
  • Eli Lilly removes Gaucher disease gene therapy trial from pipeline, citing unmet internal criteria
    Eli Lilly has announced the removal of a phase 1/2 study testing its GBA1 gene therapy for Gaucher disease type 1. The program was part of the assets acquired when the company bought Prevail Therap…
    Fierce Biotech · 3mo agoNegative readoutNegative↗ source
  • Pathos AI acquires bispecific ADC from Alphamab and secures AstraZeneca partnership
    Pathos AI announced it will pay $125 million upfront for the rights to JSKN016, a bispecific TROP2/HER3 antibody‑drug conjugate from China’s Alphamab Oncology. The agreement also includes up to $2.…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Amgen halts development of early-stage obesity drug AMG 513, shifting focus to phase-3 candidate MariTide
    Amgen announced it is stopping work on AMG 513, an early-stage obesity therapy, during its second-quarter earnings call. The decision follows a previous FDA clinical hold in early 2025 that was la…
    Fierce Biotech · 3mo agoNegative↗ source
  • Expedition Therapeutics raises $115M Series B to fund phase 2 COPD trial of DPP1 inhibitor
    Expedition Therapeutics, backed by Sanofi, announced a $115 million Series B financing round. The round was led by General Atlantic with participation from RA Capital, Vivo Capital, and existing i…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Lisata cuts 72% of workforce and sues Kuva after merger collapse
    Lisata, a solid tumor biotech, announced it is laying off roughly 72% of its employees, including its chief medical officer, as it reassesses its future. The cuts follow the collapse of a planned…
    Fierce Biotech · 3mo agoLayoffsNegative↗ source
  • Merck’s anti‑TL1A antibody misses SSc‑ILD trial but hits primary endpoints in hidradenitis suppurativa
    Merck's anti‑TL1A monoclonal antibody, tulisokibart, was evaluated in two phase 2 studies. In the systemic sclerosis‑associated interstitial lung disease (SSc‑ILD) trial, the primary endpoint was…
    Fierce Biotech · 3mo agoNeutral↗ source
  • Icon partners with Anthropic to integrate Claude AI into clinical trial planning
    Icon, a contract research organization, announced a multi-year collaboration with Anthropic to bring the Claude AI system into its clinical trial operations. The partnership will combine Anthropic…
    Fierce Biotech · 3mo agoDealPositive↗ source
  • Smith & Nephew lowers 2026 sales outlook as US knee implant revenue falls 7%
    Smith & Nephew announced a revision to its 2026 sales outlook, now expecting underlying revenue growth of about 4% versus the prior 6% target. The change follows a second‑quarter report showing re…
    Fierce Biotech · 3mo agoEarningsNegative↗ source
  • Pfizer drops two obesity programs, including Metsera-derived GLP-1 candidate, in pipeline cleanout
    Pfizer announced it is removing two clinical‑stage obesity programs as part of its quarterly pipeline cleanout. The first program, MET-224o, is an oral ultra‑long‑acting GLP‑1 receptor agonist tha…
    Fierce Biotech · 3mo agoNegative↗ source