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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 MENA Under the terms and agreement, HanchorBio will receive $10M upfront and up to $192M in development and regulatory milestones, plus tiered royalties Henlius will also oversee development, production,…
July 1, 2025
AbbVie to Acquire Capstan Therapeutics for ~$2.1B
Shots: AbbVie has entered into a definitive agreement to acquire Capstan Therapeutics, including its P-I CPTX2309 and proprietary tLNP platform for in vivo RNA delivery to treat B-cell-mediated autoimmune diseases As per the deal, Capstan will receive up to $2.1B in cash, pending customary closing conditions and regulatory approvals CPTX2309 is a tLNP delivering mRNA…
July 1, 2025
Bio Usawa Biotechnology and Bioeq AG Partner to Expand Access to Vision-Saving Treatments Across Sub-Saharan Africa 
Shots:  Bio Usawa Biotechnology and Bioeq AG entered into an agreement to make ranibizumab biosimilar for serious retinal diseases, accessible to millions in Sub-Saharan Africa   The partnership gives Bio Usawa exclusive rights to register and market Bioeq’s ranibizumab biosimilar, BioUcenta, advancing access to essential biologics in Sub-Saharan Africa   BioUcenta, an intravitreal injection, blocks abnormal retinal…
July 1, 2025
Fresenius Kabi
Fresenius Kabi Launches Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) in the US 
Shots:  Fresenius Kabi launched Conexxence and Bomyntra, biosimilar of Prolia & Xgeva (denosumab) for all indications of the reference products across the US  Conexxence (denosumab-bnht) 60 mg/mL, available in PFS, is approved for adults at high risk of fractures, including those with osteoporosis, pts. on cancer treatments affecting bone density, or long-term glucocorticoids   Bomyntra (denosumab-bnht)…
July 1, 2025
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…
July 1, 2025
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…
July 1, 2025
Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA
S Shots: 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 included EMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized…
June 30, 2025
Sobi Reports the US FDA Approval of Gamifant for Macrophage Activation Syndrome in Still’s Disease
Shots: The US FDA has approved Gamifant (emapalumab-lzsg) for treating hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still's disease, including systemic Juvenile Idiopathic Arthritis (sJIA), in pts of all ages who are unresponsive, intolerant to glucocorticoids, or have recurrent MAS Approval was based on pooled data from two pivotal trials, P-III (EMERALD) and P-II (NI-0501-06),…
June 30, 2025
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