What's Going On With Summit Therapeutics Stock On Friday?

Core Viewpoint - Summit Therapeutics' stock is experiencing a decline following the FDA approval of Akeso Inc.'s PD-1 monoclonal antibody, penpulimab-kcqx, for treating non-keratinizing nasopharyngeal carcinoma (NPC) [1][8]. Group 1: FDA Approval and Drug Development - Akeso Inc. received FDA approval for penpulimab-kcqx in combination with cisplatin or carboplatin and gemcitabine for first-line treatment of adult recurrent or metastatic NPC [1]. - The FDA also approved penpulimab-kcqx as a single agent for adults with metastatic NPC who have disease progression after platinum-based chemotherapy and at least one other prior line of therapy [2]. - Penpulimab-kcqx is Akeso's first internally developed biologic to receive FDA approval, marking the company's entry into the U.S. regulatory system [4]. Group 2: Clinical Trials and Efficacy - The FDA approval was based on the international Phase 3 trial AK105-304 and pivotal AK105-202 study, which demonstrated the drug's clinical benefits and favorable safety profile for metastatic NPC [5]. - The Phase 3 HARMONi-6/K112-306 trial evaluated Summit Therapeutics' ivonescimab in combination with platinum-based chemotherapy, meeting its primary endpoint of progression-free survival (PFS) [6]. - Ivonescimab monotherapy showed a statistically significant improvement in PFS compared to Merck's Keytruda, achieving a hazard ratio of 0.51 in the Phase 3 HARMONi-2 trial [7]. Group 3: Market Impact and Stock Performance - Following the FDA approval, Summit Therapeutics' stock price fell by 36.8%, trading at $23.21 [8]. - The National Medical Products Administration in China approved ivonescimab for use as a monotherapy for first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC) [8].