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  • uniQure shares tumble 41% after Huntington’s gene therapy misses primary endpoint
    uniQure reported updated 48‑month data from its phase 1/2 trial of AMT‑130 in Huntington’s disease. The therapy showed a 44% slowing of disease progression on the composite Unified Huntington’s Dis…
    Fierce Biotech · 22d agoNegative readoutNegative↗ source
  • FDA approves Egetis Therapeutics' Emcitate for rare X linked disease shortening life expectancy to 35 years
    Egetis Therapeutics announced that the U.S. Food and Drug Administration has granted approval for its drug Emcitate. The therapy is intended for patients with a rare X linked genetic disorder that…
    Endpoints · 22d agoApprovalPositive↗ source
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  • SK pharmteco commits over $200 million to expand CDMO infrastructure, adding 100 jobs over five years
    SK pharmteco announced a plan to invest at least $200 million in building out its development and manufacturing infrastructure over the next five years. The funding is aimed at expanding the compa…
    Endpoints · 22d agoPositive↗ source
  • Ontario launches $5M QuickStart program to cut clinical trial start-up time to 45 days
    Ontario’s Clinical Trials Ontario has introduced a $5 million QuickStart program that promises to reduce the time needed to launch a clinical trial to as little as 45 days. The initiative is desig…
    Fierce Biotech · 22d agoRegulatoryPositive↗ source
  • Swedish biotech AnaCardio secures $70.9M Series B to advance heart failure drug
    Swedish biotech AnaCardio announced a Series B financing round that raised €62.5 million ($70.9 million). The capital will be used to move its chronic advanced heart failure drug toward registrati…
    Endpoints · 22d agoDealPositive↗ source
  • BioNTech to shut three German manufacturing sites after sale talks fall through
    BioNTech announced it will close three of its manufacturing facilities in Germany. The decision follows months of searching for buyers for the sites. The company said it was unable to secure a dea…
    Endpoints · 22d agoDealNegative↗ source
  • Biopharma layoffs ease in Q3 2026, but cuts still ongoing
    Recruiters note that biopharma layoff volume in Q3 2026 remained modest, suggesting the sector is moving past the large wave of cuts seen last year. Fierce recorded 21 layoff announcements between…
    Fierce Biotech · 22d agoLayoffsNegative↗ source
  • SK pharmteco hosts webinar on overcoming ADC linker-payload manufacturing challenges
    SK pharmteco’s European and North American teams presented a webinar that explored the full lifecycle of antibody‑drug conjugate (ADC) linker‑payload development, from facility design to final prod…
    BioSpace · 21d agoNeutral↗ source
  • Enanta cuts 37 jobs as it pivots toward immunology and awaits key antiviral trial readouts
    Enanta Pharmaceuticals announced it is laying off 37 employees as it refocuses resources ahead of upcoming trial readouts. The company said the decision was part of a fiscal year‑end review to rig…
    Fierce Biotech · 22d agoLayoffsNegative↗ source
  • Biotech firms must align operating models with their unique DNA, not rely on generic SMID templates
    The article points out that two biotech firms with similar head counts, pipelines and growth plans can operate very differently. One may build extensive internal development infrastructure, while t…
    Fierce Biotech · 22d agoNeutral↗ source
  • Oura cancels planned IPO citing market uncertainty despite strong demand
    Oura, known for its smart ring, announced it is withdrawing its initial public offering. The company said the decision was driven by ongoing uncertainty in the IPO market, even though it continues…
    Endpoints · 22d agoDealNeutral↗ source
  • UniQure crashes as Huntington’s gene therapy shows less slowing of disease at 4 years
    The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2…
    BioSpace · 22d ago↗ source
  • Kodiak Sciences reports Phase 3 success for Zenkuda, matching Eylea in wet AMD
    Kodiak Sciences announced that its experimental therapy Zenkuda achieved comparable efficacy to the market‑leading anti‑VEGF drug Eylea in a late‑stage trial for wet age‑related macular degeneratio…
    Endpoints · 23d agoPositive readoutPositive↗ source
  • AbbVie receives FDA approval for Parkinson’s drug Juvmo, a Cerevel acquisition asset
    AbbVie has secured FDA approval for tavapadon, marketed as Juvmo, for the treatment of Parkinson’s disease in adults. The decision follows positive results from the Phase 3 TEMPO trial. In the piv…
    BioSpace · 23d agoApprovalPositive↗ source
  • Kodiak Sciences' zenkuda and tabirafusp-ted match Eylea in Phase 3, sending stock up 166%
    Kodiak Sciences announced Phase 3 results for two investigational eye‑disease drugs, zenkuda (anti‑VEGF antibody biopolymer conjugate) and tabirafusp‑ted (anti‑IL‑6/VEGF bispecific), which performe…
    BioSpace · 23d agoPositive readoutPositive↗ source
  • Mirum receives FDA approval for Atebrioz, third therapy for ultra-rare bone disease FOP
    Mirum Pharmaceuticals announced that the U.S. Food and Drug Administration approved its ALK2 inhibitor, zilurgisertib, to be marketed as Atebrioz, for the treatment of fibrodysplasia ossificans pro…
    BioSpace · 23d agoApprovalPositive↗ source
  • Merck signs up to $2.13 billion deal with SciBrunch for preclinical KRAS inhibitor SPR2015
    Merck announced it has completed a deal with Chinese biotech SciBrunch Therapeutics, paying $400 million upfront for exclusive global rights to develop, manufacture and commercialize SciBrunch’s pr…
    BioSpace · 23d agoDealPositive↗ source
  • Nonprofits launch ultra-rare immune disease gene therapy Waskyra at $3.25 million price
    Two nonprofit organizations have received FDA approval for a gene therapy that targets an ultra-rare immune disorder. The therapy, called Waskyra, is now being launched with a list price of $3.25…
    Endpoints · 23d agoApprovalNeutral↗ source
  • Merck and Daiichi Sankyo pull accelerated approval request for lung cancer ADC
    Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of the antibody-drug conjugate ifinatamab deruxtecan. The FDA indicated that the data package did not…
    BioSpace · 23d agoRegulatoryNegative↗ source
  • Scynexis secures $214 million BARDA contract to advance oral and IV antifungal SCY-247
    BARDA awarded Scynexis a $214 million contract to develop a treatment for invasive fungal infections, including an upfront payment of about $18.5 million. The funding will support moving SCY-247,…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Tolerance Bio signs up to $560M deal for anti-IL-33 drug from Tanabe
    Tolerance Bio has licensed the rights to an anti‑IL‑33 monoclonal antibody from Mitsubishi Tanabe Pharma for use outside Japan. The antibody, previously known as MT‑2990 and to be renamed TLB‑33, w…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Precision Neuroscience raises $250M in Series D to expand brain-computer interface program
    Precision Neurosciences announced a $250 million Series D financing round that was oversubscribed. The capital injection follows previous rounds that have brought the company’s total funding to $43…
    Fierce Biotech · 23d agoDealPositive↗ source
  • Ultragenyx gains FDA approval for Fayuvi, a Sanfilippo syndrome A therapy, easing impact of recent Angelman setback
    Ultragenyx announced that the FDA has approved its drug Fayuvi for treating Sanfilippo syndrome type A, a rare neurodegenerative condition affecting children. The approval marks the company's first…
    BioSpace · 23d agoApprovalPositive↗ source
  • AstraZeneca invests $2 billion for stake in Summit Therapeutics to back its cancer drug
    AstraZeneca announced on Monday that it will invest $2 billion to acquire a minority equity stake in Summit Therapeutics. The investment gives AstraZeneca a slice of the biotech as the companies mo…
    Endpoints · 22d agoDealPositive↗ source
  • Mirum reports Phase 3 success for its acquired hepatitis D therapy
    Mirum Pharmaceuticals announced that its recently acquired chronic hepatitis delta drug met its primary endpoint in a Phase 3 trial. The study tested a once-weekly 300 mg injection, and more than…
    Endpoints · 22d agoPositive readoutPositive↗ source