09/09/2026 US FDA grants Accelerated Approval for sevabertinib as first-line Tx in HER2-mutant NSCLC US FDA grants Accelerated Approval for sevabertinib as first-line Tx in HER2-mutant NSCLC (Ref) The US FDA has granted accelerated approval to Bayer’s sevabertinib (reversible HER2 tyrosine kinase inhibitor) as a first-line treatment for adults with locally advanced or metastatic HER2-mutant non-squamous NSCLC This decision follows Priority Review and Breakthrough Therapy Desi

18/05/2026 Sacituzumab tirumotecan (Sac‑TMT) delivers survival benefit in advanced endometrial cancer, meeting OS and PFS endpoints over chemotherapy FDA grants Priority Review to Bayer’s HYRNUO® (sevabertinib) for first-line treatment of HER2-mutated NSCLC Sacituzumab tirumotecan (Sac‑TMT) delivers survival benefit in advanced endometrial cancer, meeting OS and PFS endpoints over chemotherapy (Ref) The Phase 3 TroFuse-005 study of sacituzumab tirumotecan (Sac‑TMT), a TROP2-d

06/01/2026 Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis Bayer's sevabertinib received the breakthrough therapy designation for HER2-mutant NSCLC Cellenkos' CK0804 received the FDA orphan drug designation for myelofibrosis (Ref) The US FDA granted the orphan drug designation to Cellenkos' CK0804 (CXCR4hi Treg therapeutic) for treatment of myelofibrosis. Dr. Simrit Parmar, MD, Founder, Cellenkos: "Receiving Orphan Drug Designation is an important