Shots:Zenas BioPharma has entered into an agreement with Royalty Pharma granting it royalty rights on the future sales of obexelimabAs per the deal, Zenas will receive ~$300M, consisting of a $75M upfront & 3 additional $75M each in milestones tied to P-III (INDIGO) trial achievement & FDA approvals in IgG4-RD & SLE, while Royalty Pharma…
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…
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,…
Shots:The P-I/II (BGB-11417-201) trial of sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on sonrotoclax (160 or 320mg, QD), while Part 2 enrolled 103 pts on 320mg QD after ramp-upTrial met its 1EP of improved ORR per IRC & showed significant improvements across 2EPs,…
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…
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…
Shots:PDS Biotech reported the final topline results from the P-II (VERSATILE-002) Study evaluating safety and efficacy of PDS0101 (Versamune HPV) + Keytruda in 1L R/M HPV16+ HNSCC (n=53)In the Study PDS0101 (SC) with pembrolizumab (IV) for the first 4 cycles, then as a final single dose on cycle 12. Pembrolizumab monotx. was given…
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…
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…
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…

