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HanchorBio Out-Licenses HCB101 to Shanghai Henlius Biotech For ~$202M

Shots:HanchorBio entered into an out-licensing agreement with Shanghai Henlius Biotech and granted exclusive rights to develop and commercialize HCB101 in Greater China, Southeast Asia, and MENAUnder the terms and agreement, HanchorBio will receive $10M upfront and up to $192M in development and regulatory milestones, plus tiered royaltiesHenlius will also oversee development, production,…

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Amgen

Amgen Reports Data from the P-III (FORTITUDE-101) Study Evaluating Bemarituzumab in FGFR2b+ 1L Gastric Cancer

Amgen’s P-III (FORTITUDE-101) study (n=547) met its 1EP at interim analysis, showing statistically significant OS improvement with bemarituzumab + CT (mFOLFOX6) vs PBO + CT in FGFR2b+ unresectable locally advanced/metastatic G/GEJ cancer (FGFR2b ≥10% IHC 2+/3+)P-III (FORTITUDE-101) study 2EPs include PFS and ORR; the safety profile of bemarituzumab + CT was consistent with prior…

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Neurocrine Biosciences Initiates P-I Study of NBIP-01435 to Treat CAH

Neurocrine initiated a P-I first-in-human study of NBIP-01435 to assess safety, PK/PD, tolerability, and immunogenicity in healthy adults via SC injection for the potential treatment of congenital adrenal hyperplasia (CAH)NBIP-01435 (CRF1 antagonist) aims to improve androgen control and reduce glucocorticoid dosing. In Dec’24, the FDA approved Neurocrine's crinecerfont, an oral CRF1 antagonist, to treat…

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Vetigenics Doses First Patient in CHECKMATE K9 Study Evaluating VGS 001 + VGS 002 in Dogs with Solid Tumors

Shots:Vetigenics initiated dosing in a multisite CHECKMATE K9 pilot study evaluating the safety and preliminary efficacy of VGS 001 (anti‑cCTLA‑4 mAb) + VGS 002 (anti‑cPD‑1 mAb) in dogs with various solid tumorsEarly data from single-agent use demonstrated strong safety and encouraging therapeutic responses in DogsVGS 001 is an anti‑cCTLA‑4 mAb and VGS…

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Bio-Thera New

Bio-Thera Solutions Reports First Patient Dosing in P-III Study Evaluating BAT8006 for Pt Resistant Ovarian Cancer

Shots:Bio‑Thera reported the dosing of the first patient in a P‑III study assessing the efficacy of BAT8006 vs. the investigator’s choice of single-agent CT in individuals with Pt resistant high‑grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancerEarly clinical Data (N=133; irrespective of FRα expression or treatment history) presented at ASCO’25, from…

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Royalty Pharma Purchases Revolution Medicines’ Royalty Rights of Daraxonrasib for ~2B

Shots:Royalty Pharma acquiring Revolution Medicines’ royalties for daraxonrasib (P-III RASolute 302), providing up to $1.25B across five $250M milestone tranches, plus an additional $750M debt facility in three tranchesRevolution received the $250M upfront, with future payments tied to P-III data (2026), FDA approval (by Jan 2028), and sales milestones, allowing access to further…

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Xcell Biosciences and ThermoFisher Enter Into a Joint Research Collaboration to Advance Cell Therapies

Shots:Xcell Biosciences entered into a strategic collaboration with ThermoFisher Scientific to advance the development of Treg and TIL cell therapies for autoimmune and solid tumor treatmentsThe joint research aims to develop methodologies for enhancing the efficacy of Tregs and TILs, while streamlining and scaling cell therapy manufacturing for improved accessibility and reproducibility across…

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