29/01/2026 Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia Summit's BLA for ivonescimab + chemo accepted by the FDA for EGFRm NSCLC The Phase III IMpower030 trial of perioperative atezolizumab + chemo failed to meet EFS endpoint in NSCLC Quetzal Therapeutics' QTX-2101 received the FDA Fast Track designation for acute promyelocytic leukemia ( Ref ) The US FDA granted the Fast Track designation to Quetzal Therapeutics' QTX

January 2nd Week, 2026 Regulatory Events 🎯  Summit Therapeutics, Inc.  has submitted a biologics license application to the US FDA seeking approval for  Akeso Biopharma  & Summit's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC. (Ref 1) ❓ What are the launch timeline estimates for the regimen in this indication?   Special Designations ⭐ The US FDA granted the rege

12/01/2026 Novita Pharmaceuticals' NP-G2-044 received the FDA orphan drug designation for pancreatic cancer Eureka Therapeutics' ECT204 received the FDA RMAT designation for hepatocellular carcinomaEureka Therapeutics' ECT204 received the FDA RMAT designation for hepatocellular carcinoma Summit Therapeutics submitted a BLA seeking approval for ivonescimab + chemo in 2L+ EGFRm NSCLC AbbVie acquires ex-China rights to RemeGen's RC148 in a ~$5.6B deal Novita Pharmaceuticals' NP-

15/07/2025 The first patient has been enrolled in the Phase 3 HARMONi-GI6 trial of ivonescimab + chemo in CRC ( Ref ) The first patient...

30/06/2025 Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab...

⭐  BioNTech SE  and  Bristol Myers Squibb  entered into a global strategic partnership with a 50/50 profit/loss split to co-develop and...