BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)

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-up Trial met its 1EP of improved ORR per IRC & showed significant improvements across 2EPs,…

ByRidhi Rastogi3 days ago

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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 settings HERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…

ByRidhi Rastogi4 days ago

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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 development As 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…

ByDipanshu DixitAugust 26, 2025

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PDS Biotech Reports Final P-II (VERSATILE-002) Survival Data for PDS0101 + Keytruda in 1L HPV16+ Head & Neck Cancer

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…

ByPrince GiriAugust 26, 2025

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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 achondroplasia Trial 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…

ByRidhi RastogiAugust 22, 2025

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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 options Approval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…

ByRidhi RastogiAugust 20, 2025

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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 2025 Rilzabrutinib, a reversible covalent BTK inhibitor, is…

ByRidhi RastogiAugust 14, 2025

NEWS

Greywolf Therapeutics Reports First Patient Dosing in P-I/II (EAST-1) Trial of GRWD0715 for Axial Spondyloarthritis

Shots: Greywolf Therapeutics has dosed its first patient with GRWD0715 in P-I/II (EAST-1) trial (n=~141) for the treatment of axial spondyloarthritis (axSpA) The P-I study will assess safety & tolerability of GRWD0715 in ~24 healthy participants & ~36 axSpA pts to utilize the results with proof-of-mechanism data for selecting the active dose for P-II trial…

ByRidhi RastogiAugust 13, 2025

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Insmed Reports the US FDA’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The US FDA has approved Brinsupri (10 & 25mg) for treating NCFB pts (≥12yrs.); it is now available in the US. MAA is under EMA & MHRA review with a Japan filing planned in 2025 & potential launches in 2026 pending approvals Approval was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial…

ByRidhi RastogiAugust 13, 2025

NEWS

Expedition Therapeutics Enters a ~$645M Licensing Deal with Fosun Pharma for XH-S004

Shots: Fosun Pharma has granted Expedition global rights to develop, manufacture, & commercialize XH-S004, excl. Mainland China, Hong Kong SAR, & Macau SAR, where Fosun will retain its rights As per the deal, Fosun will receive $120M incl. upfront & development milestone payments, with ~$525M in sales milestones XH-S004 (DPP-1 inhibitor, PO) is being investigated…

ByRidhi RastogiAugust 12, 2025

BeOne Medicines Reports Topline P-III (BGB-11417-201) Trial Data on Sonrotoclax in R/R Mantle Cell Lymphoma (MCL)

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

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

PDS Biotech Reports Final P-II (VERSATILE-002) Survival Data for PDS0101 + Keytruda in 1L HPV16+ Head & Neck Cancer

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

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

Greywolf Therapeutics Reports First Patient Dosing in P-I/II (EAST-1) Trial of GRWD0715 for Axial Spondyloarthritis

Insmed Reports the US FDA’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Expedition Therapeutics Enters a ~$645M Licensing Deal with Fosun Pharma for XH-S004

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