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  • Windward Bio raises $225 million in IPO to fund Chinese-sourced respiratory drug program
    Windward Bio, backed by Sanofi, completed its initial public offering at the $225 million target, selling 10.3 million shares at $17 each. The proceeds will be used to advance two respiratory drug…
    Fierce Biotech · 13h agoDealPositive↗ source
  • Arrowhead faces challenges as Ionis's Tryngolza sales fall short, putting sHTG launch at risk
    Ionis Pharmaceuticals reported flat sales of its severe hypertriglyceridemia drug Tryngolza, generating only $9 million and cutting its annual revenue outlook to $50 million. The weak performance…
    BioSpace · 1h agoEarningsNegative↗ source
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  • HHS commits up to $25M for ibogaine and other psychotropic drugs on Veteran's Day
    HHS announced an investment of up to $25 million for ibogaine and other rapid acting psychotropic medicines aimed at serious mental illnesses such as PTSD, unveiled on Veteran's Day. Up to $4.9 mi…
    BioSpace · 1h agoDealPositive↗ source
  • Regeneron's POTS antibody shows heart-rate reduction in Phase 2, paving way for Phase 3 trial
    Regeneron reported results from its Phase 2 Pinnacle trial of a monoclonal antibody targeting postural orthostatic tachycardia syndrome (POTS), a disorder with no approved therapies. The trial enr…
    BioSpace · 3h agoPositive readoutPositive↗ source
  • Gate Bioscience eyes clinic trials with molecular gate drugs, backed by expanded $870M Lilly partnership
    Gate Bioscience is developing small-molecule drugs that block the Sec61 channel, preventing disease-causing proteins from entering cells and leading to their degradation. The company's first discl…
    Fierce Biotech · 7h agoDealPositive↗ source
  • Charles River acquires two Frontage bioanalysis labs in Pennsylvania for $470 million
    Charles River Laboratories announced it has purchased two laboratory sites from Tigermed’s Frontage in Exton, Pennsylvania, paying $470 million upfront. The labs together span about 150,000 square…
    Fierce Biotech · 7h agoDealPositive↗ source
  • Rezolute’s phase 3 trial of ersodetug meets primary endpoint in tumor hyperinsulinism
    Rezolute reported that its phase 3 Uplift study of ersodetug in tumor hyperinsulinism achieved its primary endpoint. The trial required at least nine of 16 patients to show a 50% or greater reduct…
    Fierce Biotech · 7h agoPositive readoutPositive↗ source
  • Virtuoso Surgical receives FDA De Novo clearance for robotic bladder lesion removal system
    Virtuoso Surgical's Virtuoso Endoscopy System received FDA De Novo authorization, marking the first device in a new classification for electromechanical surgical technologies that use robotic instr…
    Fierce Biotech · 13h agoApprovalPositive↗ source
  • Cellectis to cut 70% of staff as it shifts focus from allogeneic CAR-T to in vivo gene editing
    Cellectis announced that roughly seven out of ten employees will be let go as the Paris‑based biotech restructures its operations. The company previously abandoned its two clinical‑stage allogenei…
    Fierce Biotech · 13h agoLayoffsNegative↗ source
  • Windward Bio raises $175M in IPO, boosting 2026 biotech debut count to 35
    Windward Bio completed an initial public offering that raised about $175 million, selling roughly 10.3 million shares at $17 each on the Nasdaq. The proceeds are earmarked to advance its lead antib…
    BioSpace · 1h agoDealPositive↗ source
  • ObesityWeek 2026 to showcase amylin pathway and emerging weight-loss mechanisms
    ObesityWeek 2026 starts Saturday in Washington, DC, gathering weight-loss experts and biopharma companies with metabolic assets. The meeting will highlight the amylin pathway and other emerging me…
    BioSpace · 3h agoNeutral↗ source
  • Regeneron posts positive phase 2 data for baloncibart in nervous system disorder, eyes pivotal trial
    Regeneron has posted positive phase 2 data on baloncibart in postural orthostatic tachycardia syndrome, teeing the biotech up to start a potentially pivotal trial in the first half of 2027.
    Fierce Biotech · 13h agoNeutral↗ 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 · 38m agoLayoffsNegative↗ source
  • American Cancer Society updates prostate cancer screening guidance
    For the first time in 16 years the American Cancer Society (ACS) has updated its guideline for prostate cancer screening as it drives to boost detection of the disease before it spreads.
    Fierce Biotech · 8h ago↗ source
  • Eli Lilly’s Mounjaro and Merck’s oral PCSK9 inhibitor win FDA nod amid string of cardiovascular trial setbacks
    The cardiovascular drug development landscape entered the American Heart Association’s Scientific Sessions with a mix of optimism and disappointment. Recent months have seen several late‑stage tria…
    BioSpace · 22h agoRegulatoryNeutral↗ source
  • Neurosterix raises $105M Series B to advance oral M4 schizophrenia drug and adds former Karuna leaders
    Neurosterix, a spinout from Addex Therapeutics, announced a $105 million Series B financing. The round was led by RTW Investments with participation from GV, Janus Henderson Investors and others. A…
    BioSpace · 1d agoDealPositive↗ source
  • Bristol Myers Squibb reshuffles R&D leadership as chief research officer departs and CMO takes over combined unit
    Bristol Myers Squibb announced a restructuring of its research and development organization, merging the separate research and development divisions into a single unit. The new combined R&D unit w…
    Fierce Biotech · 1d agoNeutral↗ source
  • Pfizer secures up to $1.5 billion from Blackstone to fund berobenatide obesity drug development
    Pfizer announced a financing arrangement with Blackstone Life Sciences that could provide up to $1.5 billion to support the development of berobenatide, an obesity drug acquired from Metsera. The…
    BioSpace · 1d agoDealPositive↗ source
  • Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
    Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
    fda recalls · 1d agoCRLNegative↗ source
  • BMS to consolidate R&D under single leader as chief research officer exits
    Bristol Myers Squibb announced a reorganization of its research and development unit, merging early research and discovery with drug development under a single leader. Chief Research Officer Rober…
    BioSpace · 1d agoNeutral↗ source
  • Experts say predictive analytics and distributed manufacturing could curb drug shortages
    BioSpace Insights hosted a podcast episode featuring Christina Smolke, co-founder and CEO of Antheia, and Kyle Pudenz, senior vice president of data and AI product at Cencora. The conversation focu…
    BioSpace · 1d agoPositive↗ source
  • BMS consolidates R&D under chief medical officer Cristian Massacesi as chief research officer Robert Plenge exits
    Bristol Myers Squibb announced that starting Jan. 1, its chief medical officer and head of development, Cristian Massacesi, will lead a newly combined research and development unit, merging previou…
    Fierce Biotech · 1d agoNeutral↗ source
  • Biopharma layoffs rise YoY in October but overall trend points down for 2026
    October marked the first time this year that both the number of biotech and pharma firms announcing workforce cuts and the total employees affected rose compared with 2025. Three additional employ…
    BioSpace · 1d agoLayoffsNegative↗ source
  • Neurosterix secures $105M Series B to launch phase 2 schizophrenia trial
    Addex Therapeutics' spinout Neurosterix announced a $105 million Series B financing to fund its upcoming phase 2 trial of NTX-253 for schizophrenia. The round was led by a syndicate of leading lif…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Game Changer Products recalls 10 Day Forecast capsules after FDA finds undeclared sildenafil and acetaminophen
    Game Changer Products LLC announced a voluntary nationwide recall of its 10 Day Forecast capsules, a dietary supplement marketed at 3200 mg. The FDA’s analysis detected the presence of undeclared…
    fda recalls · 1d agoCRLNegative↗ source