First Patient Dosed in Ph 3 Study of ASP2138 in CLDN18.2+ve and HER2-neg locally advanced unresectable or metastatic GEJ adenocarcinoma September 2, 2026
Updated NEST Ph 2 Publication Reporting Deep Pathologic Responses and No Observed Recurrences with Neoadjuvant BOT+BAL in Resectable Colon Cancer September 2, 2026
Ivonescimab + Chemo Demonstrates Statistically Significant OS Benefit vs Durvalumab + Chemo in 1L Advanced BTC in China September 2, 2026
NMPA Approves ATLED® (Fanregratinib) for the Treatment of Patients with FGFR2-Fusion/Rearrangement Intrahepatic Cholangiocarcinoma September 2, 2026
SYS6090 (JMT108) Granted Fast Track Designation by FDA for Treatment of Patients with MSS/pMMR mCRC September 2, 2026
FDA Fast Track Designation for Varsetatug masetecan (Varseta-M) for R/R Metastatic CRC September 2, 2026
FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab + Chemo in 1L HER2+ Advanced Gastroesophageal Adenocarcinoma September 2, 2026
IDEAYA Biosciences Announces Clinical Collaboration with Genentech in MTAP-Deleted KRAS G12D-Mutant Pancreatic Cancer August 25, 2026
FDA Fast Track Designation Granted to ERAS-0015 in Patients with Metastatic Pancreatic Adenocarcinoma August 25, 2026
Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally advanced rectal cancer August 25, 2026
FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study August 25, 2026
Patient enrollment completed in Ph 3 TIGeR-PaC Trial for Locally Advanced Pancreatic Cancer August 20, 2026
FDA Fast Track designation for spevatamig in advanced and metastatic biliary tract carcinoma August 20, 2026
FAILED TRIAL: Ph 2 DeFianCe study of sirexatamab (DKN-01) in 2L CRC did not meet primary endpoint of PFS improvement August 20, 2026
ACR-2316 advances into dose expansion portion of Ph 1/2 study in SCLC, squamous NSCLC, lung adenocarcinoma (adNSCLC), endometrial, cervical, and GEJ cancers August 11, 2026
First Patient Dosed in Registrational Study of IBI363/TAK-928 in Combination with Bevacizumab in Late-Line Advanced CRC in China August 11, 2026
CRL issued for ongoing ITM-11 NDA citing CMC and third-party commercial facility inspection-related items August 11, 2026
Olomorasib receives FDA Breakthrough Therapy designation for the treatment of previously treated KRAS G12C-mutant advanced pancreatic cancer August 5, 2026
IDE892 Initiates Part 2 Monotherapy Expansion in Ph 1/2 Study in MTAP-Deleted Pancreatic & Lung Cancers August 5, 2026
Final subject received last dose of Ampligen (rintatolimod) in Ph 2 DURIPANC trial of Ampligen + Imfinzi for the treatment of metastatic pancreatic cancer August 5, 2026
