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  • 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
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  • 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
  • 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    Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of the antibody-drug conjugate ifinatamab deruxtecan.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
  • 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 · 24d agoApprovalPositive↗ source
  • FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concerns
    FDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
    fda press · 23d agoRegulatoryNeutral↗ source
  • Biopharma chases new immunology targets as Humira and Dupixent set high bar
    Johnson & Johnson, Pfizer, Argenx and several other companies are expanding their immunology pipelines, seeking new targets and improvements to capture part of the market driven by AbbVie’s Humira…
    BioSpace · 24d agoPositive↗ source
  • Regenerative medicine requires diagnostics and product characterization beyond stem cell basics
    Stem cell therapies are often portrayed as a single treatment, but they actually vary widely in tissue source, cell passage, viability and delivery methods. Experts say a credible regenerative app…
    BioSpace · 24d agoNeutral↗ source
  • BioSpace report examines factors driving employee engagement in life sciences firms
    BioSpace released a new report titled "What Powers Employee Engagement" that looks at what influences staff morale in the life‑science sector. The study draws on data from the 2027 Best Places to…
    BioSpace · 23d agoNeutral↗ source
  • Genentech signs $55M upfront deal with AI firm Earendil Labs to develop bispecific cancer antibodies, potential total value over $1.5B
    Genentech announced a partnership with AI‑driven Earendil Labs that includes a $55 million upfront payment and could exceed $1.5 billion when development, regulatory and sales milestones are met. T…
    BioSpace · 26d agoDealPositive↗ source
  • Carvykti shows 5-year survival in half of multiple myeloma patients in Phase 2 study
    Johnson & Johnson and Legend Biotech reported that 10 of the 20 multiple myeloma patients treated with a single dose of Carvykti remained alive after a median follow‑up of 60.7 months, representing…
    BioSpace · 26d agoPositive readoutPositive↗ source
  • Biomanufacturers Redesign Processes to Blend Emergency Vaccine Readiness with Commercial Flexibility
    Manufacturers are overhauling their production methods to simultaneously improve rapid vaccine deployment for future health crises and maintain flexible, commercially viable manufacturing networks…
    BioSpace · 26d agoNeutral↗ source
  • ADARx raises $446 million in one of 2026's largest biotech IPOs as City Therapeutics plans its own listing
    ADARx Pharmaceuticals completed an initial public offering that raised about $446.3 million, exceeding the company’s original target. The shares were priced at $17 each, with 26.25 million shares…
    BioSpace · 26d agoDealPositive↗ source
  • Jury awards Nektar $90 million in damages after lawsuit over broken rezpeg partnership with Eli Lilly
    A jury in a US court has ordered Eli Lilly to pay Nektar Therapeutics $90 million after finding the pharma giant breached their collaboration on the experimental autoimmune drug rezpeg. Nektar and…
    BioSpace · 26d agoNegative↗ source
  • FDA approves Eli Lilly’s weekly insulin Onswik for U.S. patients, expanding competition with Novo
    The U.S. Food and Drug Administration has cleared Eli Lilly’s weekly insulin product, Onswik, for use in American patients. This marks the drug’s fourth global approval after earlier clearances in…
    BioSpace · 27d agoApprovalPositive↗ source
  • Kyverna reports one-year mobility gains and safety for CAR-T miv-cel in stiff-person syndrome, bolstering FDA filing plans
    Kyverna Therapeutics presented data from its Phase 2 KYSA-8 trial of miv-cel, a CAR-T therapy aimed at stiff-person syndrome (SPS). The study followed 26 patients for one year. At the one-year mar…
    BioSpace · 27d agoPositive readoutPositive↗ source
  • Roche signs up to $2 billion partnership with Atavistik to develop cardiometabolic drugs
    Roche announced a partnership with Atavistik Bio, a biotech focused on hematology, to pursue new small-molecule treatments for cardiovascular, renal and metabolic conditions. The agreement provide…
    BioSpace · 27d agoDealPositive↗ source
  • Eli Lilly earmarks up to $3.25 billion for partnership with InnoCare Pharma
    Eli Lilly announced an upfront payment of $100 million to Beijing‑based InnoCare Pharma to start work on drug candidates for five targets that have critical unmet medical needs. The agreement also…
    BioSpace · 27d agoDealNeutral↗ source
  • Radioligand therapy gains momentum as experts discuss expanding patient impact
    In a recent episode of the Denatured podcast presented by Curium, host Jennifer Smith-Parker spoke with Mike Patterson, CEO North America, and Sabine Brookman-May, Vice President and Head of Global…
    BioSpace · 27d agoPositive↗ source
  • FDA warns Houston compounding pharmacy of unsanitary GLP-1 production risking contamination
    FDA issued a warning letter to Empower Clinic Services, operating as Empower Pharmacy, after inspectors found unsanitary conditions at its Houston compounding site. Inspectors observed that the ph…
    BioSpace · 27d agoRegulatoryNegative↗ source
  • Acadia’s Alzheimer’s psychosis drug misses primary goal but advances on secondary data
    Acadia Pharmaceuticals reported that its investigational drug remlifanserin failed to meet the primary endpoint in the Phase 2 portion of the RADIANT trial for Alzheimer’s disease psychosis. The t…
    BioSpace · 27d agoNegative readoutNeutral↗ source
  • Merck’s eye-drug matches Lucentis in vision improvement but raises safety concerns
    Merck reported results from its Phase 2b/3 BRUNELLO trial of remigromig, a Wnt-pathway agonist for diabetic macular edema. The drug achieved non-inferior improvement in best-corrected visual acuit…
    BioSpace · 27d agoNegative readoutNegative↗ source
  • Basecamp Research secures $140 million Series C to accelerate AI-designed drug pipeline
    Basecamp Research announced closing a $140 million Series C financing round to further develop its AI-driven drug discovery platform. The round was led by venture firm S32 and included participati…
    BioSpace · 27d agoDealPositive↗ source
  • Series B funded biotechs expand hiring, Tenpoint Therapeutics raises $85M for eye-health pipeline
    Companies that secured series B rounds this year are scaling up their staff, making them attractive targets for biopharma talent. Tenpoint Therapeutics, based in Warren, New Jersey, announced an $…
    BioSpace · 28d agoDealPositive↗ source
  • AI-driven interviews risk alienating biotech and pharma job seekers, experts warn
    AI interview tools are being introduced by biotech and pharma firms to speed up candidate screening, but they can create negative experiences for applicants. Candidates described frustrations such…
    BioSpace · 28d agoNegative↗ source