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Argo Biopharma Inks a ~$5.3B Deal with Novartis for Multiple Cardiovascular Assets, Expanding their Existing Partnership

Shots:Argo has entered into an additional strategic collaboration with Novartis for multiple CV assetsNovartis has obtained an option to license ex-China rights to two discovery-stage molecules for sHTG & mixed dyslipidemia, plus first negotiation rights to BW-00112 (ANGPTL3), a P-II asset. Deal also incl. a reciprocal P&L-sharing license for a hepatic siRNA asset…

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IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)

Shots:IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rightsIDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…

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Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Shots:The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settingsHERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…

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AbbVie Acquires Gilgamesh Pharmaceuticals’ Bretisilocin to Expand Psychiatry Pipeline for ~$1.2B

Shots:AbbVie has signed a definitive agreement to acquire Gilgamesh Pharmaceuticals’ Bretisilocin for moderate-to-severe major depressive disorder (MDD), currently in clinical developmentAs per the deal, AbbVie will acquire Gilgamesh’s bretisilocin program for ~$1.2B, including upfront and milestone payments. Gilgamesh will spin off Gilgamesh Pharma Inc. to retain its team and other programs, including blixeprodil…

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Tyra Biosciences Doses First Patient in P-II (BEACH301) Trial of Dabogratinib to Treat Achondroplasia

Shots:Tyra Biosciences has dosed its first patient with dabogratinib (FGFR3 inhibitor) in P-II (BEACH301) trial for the treatment achondroplasiaTrial will evaluate dabogratinib in children (3–10 yrs) with achondroplasia & open growth plates across 2 cohorts: treatment-naïve & previously treated with growth-accelerating therapy, enrolling up to 10 pts per dose level (0.125, 0.25, 0.375…

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Health Canada Grants Conditional Approval to Iovance’s Amtagvi (Lifileucel) for Advanced Melanoma

Shots:Health Canada has granted conditional approval (NOC/c) to Amtagvi for adults with unresectable or metastatic melanoma progressing after prior systemic therapy, incl. PD-1 inhibitor &, if BRAF V600 positive, then BRAF ± MEK inhibitor, with no suitable alternative optionsApproval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…

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Sanofi

Sanofi’s Rilzabrutinib Secures the EMA’s Orphan Drug Designation to Treat IgG4-Related Disease

Shots:The EMA has granted ODD to rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD)Rilzabrutinib (PO) is being evaluated in a P-II trial for IgG4-RD with glucocorticoids vs glucocorticoids alone, showing reduced flares, improved disease markers, & steroid sparing over 52 weeks; data presented at EULAR 2025Rilzabrutinib, a reversible covalent BTK inhibitor, is…

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