FDA accepts Supplemental BLA for 1L HCC based on Ph 3 CheckMate -9DW trial demonstrating improved survival with Opdivo + Yervoy vs SoC; PDUFA: Apr 2025 August 27, 2024
Sonnet BioTherapeutics Enters into Clinical Collaboration Agreement for Ph 1/2a Study of SON-1210 + Chemo for the Treatment of Pancreatic Cancer August 22, 2024
First Patient Dosed in Ph 2 Trial of HLX53 + Serplulimab + HANBEITAI for the First-line Treatment of Locally Advanced or Metastatic HCC Patients August 22, 2024
FDA Clears IND Application for Ph 1b Study of PTM-101 for the Localized Treatment of Pancreatic Cancer August 22, 2024
Successful End-of-Phase 2 Meeting with FDA for Amezalpat (TPST-1120) to Treat 1L HCC Announced August 22, 2024
MHRA approves Zolbetuximab for the treatment of Claudin18.2+ve, HER2neg gastric/GEJ cancer August 21, 2024
Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer August 21, 2024
Enrollment completed in Ph 2/3 COMPANION-002 trial of CTX-009 + paclitaxel in patients with 2L advanced Metastatic or Recurrent Biliary Tract Cancers (BTC) August 13, 2024
FDA Clears IND Application for Ziftomenib in Advanced Gastrointestinal Stromal Tumors (GIST) August 13, 2024
Supplemental NDA of Opdivo – Yervoy Combo submitted in Japan to Expand the Use for Unresectable HCC August 13, 2024
Topline Data From ASPEN-06 Ph 2 Trial shows Evorpacept Improves Tumor Response in Patients With HER2-Positive Gastric Cancer August 7, 2024
FAILED TRIAL: Topline Results from Two Late-Stage Pamrevlumab Pancreatic Cancer Studies show primary endpoint of OS improvement not achieved August 6, 2024
FDA grants Orphan Drug Designation for Avutometinib and Defactinib for the Treatment of Pancreatic Cancer August 6, 2024
EMA validated Type II Application for Opdivo plus Yervoy for 1L Treatment of Unresectable or Advanced HCC July 23, 2024
RMC-6236 to advance to Ph 3 testing in pancreatic cancer following encouraging results from a Ph 1 study July 23, 2024
End-of-Phase-2 Meeting Outcomes and Topline Interim Ph 2 Data for BOT/BAL in MSS Colorectal Cancer announced July 23, 2024
Plans for Near-Term Resubmission of NDA for 1L Treatment Option for Unresectable HCC Following Type A FDA Meeting Reported July 17, 2024
