Akeso and Summit Report P-III (HARMONi-2) Trial Data on Ivonescimab for PD-L1-Positive Advanced NSCLC

Shots: Akeso and Summit has reported the P-III (HARMONi-2/AK112-303) trial data assessing ivonescimab monotx. vs Keytruda in Chinese pts with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression Trial showed improvement in OS (2EP), with results to be presented in future. In the primary analysis, trial met it 1EP of improved PFS,…

ByRidhi RastogiSeptember 3, 2026

NEWS

Akeso and Summit Report P-III (HARMONi-GI1) Trial Data on Ivonescimab + CT for 1L Advanced Biliary Tract Cancer

Shots: Akeso and Summit have reported interim analysis from the P-III (AK112-309/HARMONi-GI1) trial assessing ivonescimab + CT vs durvalumab + CT for the 1L treatment of advanced biliary tract cancer (BTC) Trial met its 1EP of OS, plus achieved all key 2EPs of PFS & ORR; data will be presented at the academic conference & published…

ByRidhi RastogiAugust 26, 2026

NEWS

Summit and Akeso Reports NMPA Approval for Ivonescimab + CT for 1L Squamous NSCLC

Shots: Chinese NMPA has approved ivonescimab + CT for the 1L treatment of pts with advanced squamous NSCLC (sqNSCLC), based on the global P-III (HARMONi-6) trial The trial, sponsored by Akeso, assessed ivonescimab + CT vs Tevimbra + CT to treat Chinese pts with 1L sqNSCLC irrespective of PD-L1 expression, showing improved OS & PFS;…

ByRidhi RastogiAugust 13, 2026

NEWS

Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)

Shots: The US FDA has accepted the NDA of bezuclastinib for the treatment of NonAdvSM, with no advisory committee meeting planned or review issues identified yet (PDUFA: Dec 30, 2026) NDA was backed by SUMMIT trial, which met its 1 & 2EPs, showing sustained, deepening clinical benefit through 48wks., plus impact on bone mineral density…

ByRidhi RastogiMarch 18, 2026

NEWS

Cartography Biosciences and Pfizer Forge ~$865M Deal for Discovery of Tumor-Selective Antigens

Shots: Cartography has entered into a strategic collaboration with Pfizer to discover tumor-selective antigens, leveraging Cartography’s ATLAS & SUMMIT platforms Under a multi-year deal, Cartography will discover & validate tumor-selective antigens in an undisclosed cancer, with Pfizer holding opt-in rights for research, development & commercialization; Cartography retains full ownership of its lead asset CBI-1214 Cartography…

ByRidhi RastogiJanuary 7, 2026

NEWS

Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for NonAdvanced Systemic Mastocytosis

Shots: The US FDA has received the NDA of bezuclastinib for the treatment of NonAdvanced Systemic Mastocytosis (NonAdvSM) NDA was supported by the SUMMIT trial, which met its 1 & 2EPs, showing clinical benefit across all symptom domains, incl. 11 individual patient-reported symptoms as well as the most severe symptom, along with correlated biomarker reductions…

ByRidhi RastogiDecember 31, 2025

NEWS

Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

Shots: Cogent Biosciences has reported the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx. in pts with imatinib-resistant or intolerant GIST; the US FDA’s NDA filing is planned for H1’26 As of Sep 30, 2025, trial met its 1EP of improved PFS (mPFS: 16.5 vs 9.2mos.) & showed ORR of 46% vs…

ByRidhi RastogiNovember 11, 2025

EVENTS

Global PHT Expo & Summit 2023, An International Conference & Exhibition on Pharma, Healthcare & Technology

Weece Events is glad to invite you to attend the Global PHT Expo & Summit 2023 which is an International Conference & Exhibition on PHARMA, HEALTHCARE & TECHNOLOGY focusing on the Future of the Global Pharma & Healthcare Ecosystem in a digitally transforming world. The event is happening from 15-17th Feb 2023 at Hyatt Centric,…

BySenior EditorJanuary 25, 2023

INSIGHTS+

PharmaShots’ Key Highlights of Fourth Quarter 2022

Shots: The fourth quarter of 2022 highlights approvals, multiple clinical trial results, and numerous deals. There are major alliances in this quarter which include Johnson & Johnson acquired Abiomed for ~$16.6B, Takeda entered into an agreement to acquire NDI-034858 from Nimbus Therapeutics for ~$6B In the fourth quarter of the year, BeiGene’s Brukinsa received EC’s…

BySenior EditorDecember 29, 2022

Akeso and Summit Report P-III (HARMONi-2) Trial Data on Ivonescimab for PD-L1-Positive Advanced NSCLC

Akeso and Summit Report P-III (HARMONi-GI1) Trial Data on Ivonescimab + CT for 1L Advanced Biliary Tract Cancer

Summit and Akeso Reports NMPA Approval for Ivonescimab + CT for 1L Squamous NSCLC

Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)

Cartography Biosciences and Pfizer Forge ~$865M Deal for Discovery of Tumor-Selective Antigens

Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for NonAdvanced Systemic Mastocytosis

Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

Global PHT Expo & Summit 2023, An International Conference & Exhibition on Pharma, Healthcare & Technology

PharmaShots’ Key Highlights of Fourth Quarter 2022

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