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GLP-1 antagonist avexitide claims Phase 3 win in post-bariatric hypoglycemia (PBH)
Amylyx Pharmaceuticals reported a pivotal Phase 3 success for avexitide (a GLP-1 receptor antagonist) in post-bariatric hypoglycemia (PBH), announcing a 55% reduction in the rate of serious...
FDA policy on generative AI medical devices
The FDA solicited public input on how the agency should regulate generative AI-enabled medical devices, aiming to sharpen questions around risk assessment, premarket evaluation, and postmarketing...
Carcinoma immunotherapy pipeline sees China follow-up pressure on ivonescimab
Updated data from Akeso and Summit Therapeutics’ China-based Harmoni-6 trial for ivonescimab (a PD-1/VEGF bispecific) showed the PFS benefit narrowing with longer follow-up. The updated dataset...
Argenx pushes Vyvgart Hytrulo Phase 3 success in autoimmune myositis subtype
Argenx said its subcutaneous, prefilled-syringe FcRn antagonist Vyvgart Hytrulo (efgartigimod alfa) met primary endpoint results in immune-mediated necrotizing myopathy (IMNM) within a late-stage...
Biotech deals: Leo Pharma acquires dersimelagon from Tanabe for rare photosensitivity skin diseases
Leo Pharma agreed to acquire Tanabe Pharma’s oral rare-disease candidate dersimelagon in a deal potentially worth up to $435 million, targeting two genetic, sunlight-sensitive conditions:...
Genomics diagnostics: Craif funds U.S. clinical work on urine-based pancreatic cancer test
Craif raised $33 million in a Series D to support U.S. clinical trial development for its urine-based pancreatic cancer assay, with the company preparing a U.S. laboratory scale-up in San Diego....
Organ preservation: Bridge to Life secures $110M for HOPE system expansion
Bridge to Life said it secured $110 million to expand commercialization of its Vitasmart hypothermic oxygenated perfusion (HOPE) system, which preserves donor organs prior to transplant. The...
AI-powered liquid biopsy coverage: Freenome initiates research-backed investor interest
TD Cowen initiated coverage of Freenome with a Buy rating and a $17 price target, citing differentiated liquid biopsy chemistry and commercial partnership momentum with Abbott and Roche. The...
CAR T rights reshuffle: Janssen exits CD20/CD19 CAR T development; Abelzeta regains rights
Janssen Biotech discontinued development of prizloncabtagene autoleucel (C-CAR039), an anti-CD20/CD19 bispecific CAR T therapy, and Abelzeta Pharma regained all rights outside China. The decision...
Clinical trial setbacks in wet AMD: EyePoint Duravyu Phase 3 fails non-inferiority
EyePoint Pharmaceuticals reported that Duravyu (vorolanib intravitreal insert) failed to meet its Phase 3 LUGANO primary goal of non-inferiority versus aflibercept (Eylea) in wet age-related...
Endocrine breakthrough for post-bariatric hypoglycemia
Amylyx Pharmaceuticals reported Phase 3 success for avexitide (a GLP-1 receptor antagonist) in post-bariatric hypoglycemia, a rare condition marked by dangerous blood-sugar crashes after...
Regulatory expansion for FcRn antagonist Vyvgart Hytrulo in myositis
Argenx’s Vyvgart Hytrulo (subcutaneous efgartigimod alfa) cleared a major Phase 3 milestone in immune-mediated necrotizing myopathy, with the drug meeting statistical significance in a key...
Large oncology deal: BioMarin acquires Alesta to replenish bone pipeline
BioMarin announced it will acquire Alesta Therapeutics in a $275 million deal, aiming to restock its late-stage rare bone-disorder pipeline after prior transaction churn. The Alesta buyout adds an...
CAR T rights shuffle: Janssen exits CD20/CD19 program
Janssen Biotech discontinued development of its CD20/CD19 CAR T bispecific, prompting Abelzeta Pharma to regain worldwide rights to prizloncabtagene autoleucel (C-CAR039). The rights transfer...
FDA action: IND clearance for ALDH2 inhibitor ANS-858
Amygdala Neurosciences received FDA IND approval for ANS-858, a selective, reversible, orally bioavailable ALDH2 inhibitor initially designed for alcohol use disorder and other substance use...
Oncology imaging collaboration: Navinci and BrainZell expand spatial proteomics
Navinci and BrainZell entered a collaboration to apply Navinci’s in situ PLA technology to spatial proteomics experiments in brain organoids. The companies said they will use the platform to...
ADC early clinical signal: Boan’s CD228-targeted BA-1302
Shandong Boan Biotechnology reported early antitumor activity for BA-1302, a CD228-targeted antibody-drug conjugate, in a Phase Ia trial in China. The initial dataset includes responses among...
Platform and funding: Craif raises $33M to advance urine pancreatic cancer test to US trial
Craif secured a $33 million Series D financing to support a US clinical trial of its urine-based pancreatic cancer assay. The Nagoya University spinout plans to scale its San Diego laboratory,...
Corporate strategy: Fresenius launches €200M fund for emerging biotech talent
Fresenius established Fresenius Ventures, a dedicated corporate venture capital fund backed with more than €200 million over the next five years. The move signals a structured effort by the...
Regulatory and clinical setback: Eyepoint’s Duravyu Phase 3 fails primary endpoint
Eyepoint said its Phase 3 LUGANO study of Duravyu (vorolanib intravitreal insert) did not achieve non-inferiority versus Eylea aflibercept in wet age-related macular degeneration. The...