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,…
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…
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…
SShots:Omeros submitted an MAA to the EMA for narsoplimab to treat TA-TMA, with data demonstrating a 61% response rate and a 3x improvement in OS vs matched external controls; over 130 pts treated under expanded access data were also includedEMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized…
Shots:UCB reported the P-III study (n=87; ages 1-35yrs.) of adjunctive fenfluramine vs. PBO in CDKL5 Deficiency Disorder (CDD) diagnosis and uncontrolled seizure pts.The P-III study met its 1EP (median % reduction in countable motor seizure frequency) and most key 2EPs. Fenfluramine was well tolerated with a consistent safety profile in prior DS/LGS studiesUCB…
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…
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…
Shots:Gilead signed a research partnership with Kymera to develop an oral molecular glue degrader (MGD) targeting cyclin-dependent kinase 2 (CDK2) for the treatment of breast cancer and other solid tumorsKymera will receive a total of up to $85M in upfront and option exercise payments and is eligible for up to $665M, plus high…
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…
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…

