September 3rd Week, 2026 Regulatory Events 🎯 AstraZeneca’s sBLA for perioperative durvalumab (Imfinzi; anti-PD-L1) + Astellas Pharma and Pfizer’s neoadjuvant enfortumab vedotin (Padcev; Nectin-4 ADC) was accepted and granted Priority Review by the US FDA for the Tx of MIBC patients who are ineligible/have declined cisplatin-based chemotherapy (Ref1) ❓ What are the current efficacy benchmarks for perioperative MIBC? 🎯 The US FDA approved Merck&Co/MSD's belzutifan (Welir

22/09/2026 US FDA requests additional OS evidence for Tovecimig in Biliary tract cancer despite positive COMPANION-002 efficacy results US FDA Conditionally Accepts LYRFIGTU™ Brand Name for Lirafugratinib US FDA requests additional OS evidence for Tovecimig in Biliary tract cancer despite positive COMPANION-002 efficacy results (Ref) Compass Therapeutics provides regulatory update on feedback received from the US FDA regarding Tovecimig (DLL4 × VEGF-A bispecific antibody) for

27/04/2026 Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDUFA date of Aug'26 set Tovecimig + paclitaxel significantly improved PFS and ORR in biliary tract cancer; sBLA submission planned FDA Grants Breakthrough Therapy Designation to TERN-701 in Chronic Myeloid Leukemia Relay Therapeutics Advances PI3Kα/CDK4 Triplet Toward Frontline Breast Cancer Phase 3 Trial Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDU

08/04/2026 FDA Grants Orphan Drug Status to Plus Therapeutics’ REYOBIQ™ for Pediatric Malignant Gliomas FDA Grants Orphan Drug Designation to Compass Therapeutic’s Tovecimig for Biliary Tract Cancer FDA Grants Orphan Drug Status to Plus Therapeutics’ REYOBIQ™ for Pediatric Malignant Gliomas (Ref) Plus Therapeutics’ REYOBIQ™ (rhenium Re186 obisbemeda) has been granted orphan drug status for pediatric malignant gliomas, with scope expanded to include pediatric ependymoma Regula