UAE IND Approval obtained for NEO212 Following Successful Ph 1 Completion, Advancing Toward Global Ph 2 Development June 23, 2026
IND application for HLX3902 approved in China for treatment of metastatic CRPC and solid tumors June 23, 2026
Positive Pre-IND Feedback from Received US FDA for CLD-401; IND enabling studies to continue with IND submission targeted by end of 2026 June 23, 2026
FDA cleared CTA for LILRB4/CD3 targeting TCE bispecific antibody (6MW5311) for the treatment of AML, CMML, and Multiple Myeloma June 17, 2026
TCX-001 approved by SwissMedic for First-in-Human Ph 1 trial in patients with R/R AML and CLL June 17, 2026
FDA accepted supplemental BLA filing for adjuvant Tecentriq and Tecentriq Hybreza in combination with chemo in stage III dMMR or MSI-H colon cancer and granted Priority Review; PDUFA: 9 October 2026 June 17, 2026
FDA Clearance Received to Complete Enrollment in REGAIN Recurrent GBM Trial and Addition of Two US Clinical Sites June 17, 2026
Alignment with FDA obtained on 80 mg QD as RP3D and on the 2L+ patient population for the ENABLE-2 pivotal trial of ELVN-001 in CML patients June 17, 2026
US FDA Fast Track Designation for VS-7375 for the Treatment of KRAS G12D-Mutated Locally Advanced or Metastatic NSCLC June 10, 2026
FDA accepts NDA for giredestrant in ER+ve early-stage breast cancer with positive Ph 3 results in the curative setting June 10, 2026
FDA Accepts NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC with Priority Review & PDUFA target action date of Nov 27, 2026 June 2, 2026
FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084) for Certain Patients with 1L Metastatic KRAS G12C-Mutant NSCLC June 2, 2026
