Positive feedback from MHRA provides alignment on the preclinical, manufacturing, clinical & regulatory pathway for ZI-MA4-1 and supports planned CTA submission October 15, 2025
Ficerafusp Alfa Granted Breakthrough Therapy Designation by US FDA for 1L HPV-Negative R/M HNSCC October 15, 2025
FDA Fast Track Designation to WTX-124 for locally advanced or metastatic cutaneous melanoma after SOC immunotherapy October 15, 2025
FDA Fast Track Designation Granted to ADCE-D01 for the Treatment of Soft Tissue Sarcoma October 15, 2025
FDA Accepts BLA for Priority Review for Orca-T® to Treat Heme Malignancies; PDUFA date April 6, 2026 October 8, 2025
Supplemental BLA for Adjuvant ENHERTU Followed by THP Accepted in the US for Patients with High-Risk HER2 Positive Early-Stage Breast Cancer October 8, 2025
FDA clears IND application for CDH17-targeting ADC SIM0609 for the treatment of advanced solid tumors October 7, 2025
Alignment with FDA obtained on study design to advance two Ph 3 trials in gastroesophageal cancers (FAPI-GO) and PDAC (FAPI-PRO), with [18F] FAPI-74 October 7, 2025
FDA recommends no BLA submission based on IOB-013 trial data; new registrational study for Cylembio for the treatment of 1L melanoma planned September 30, 2025
NDA for A400/EP0031 Accepted for Review by the NMPA for the Treatment of RET-fusion positive NSCLC September 30, 2025
Enhertu + pertuzumab granted Priority Review in the US as 1L treatment for patients with HER2-positive metastatic breast cancer September 30, 2025
FDA Granted Orphan Drug Designation to Utidelone for the Treatment of Pancreatic Cancer September 30, 2025
FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib) September 30, 2025
IND application amended with updated OS data from Ph 2 Actuate-1801 Part 3B trial of elraglusib + GnP versus GnP alone in 1L metastatic pancreatic cancer September 23, 2025
CHMP recommends EU approval of SC formulation of Lunsumio for people with R/R follicular lymphoma September 23, 2025
Two Positive EU CHMP Opinions for KEYTRUDA, for SC Administration and for New Indication for Earlier-Stage Head and Neck Cancer September 23, 2025
Type A meeting with FDA completed to discuss the CRL for RP1 + nivolumab BLA in melanoma September 23, 2025
