H.C. Wainwright has reiterated its Buy rating and maintained a $40.00 price target for Summit Therapeutics plc (NASDAQ:SMMT) following the U.S. Food and Drug Administration's decision to accept the company's Biologics License Application (BLA).
The price objective represents a substantial premium to Summit’s current market value, equating to about a 176% upside from the most recent trading price of $14.48. Summit was trading close to its 52-week low of $14.43 at the time the rating was confirmed.
The FDA accepted the BLA for ivonescimab - described as a PD-1 x VEGF agent - to be used in combination with chemotherapy for the treatment of EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (EGFRmut NSCLC) in patients following EGFR TKI therapy. The agency assigned a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
H.C. Wainwright highlighted the significance of the FDA's decision to accept the submission, noting that the absence of a Refuse-to-File (RTF) letter is encouraging because acceptance signals the agency considered the application sufficiently complete to proceed with a full review. The firm described the acceptance as an "incremental win and a meaningful risk-mitigating event" and said it supports the continuation of the $40.00 12-month target.
Market data cited in connection with the announcement shows Summit with an $11.17 billion market capitalization and an upcoming earnings report scheduled for March 12, according to InvestingPro data.
Other analysts have reflected similar optimism. Citizens has maintained a Market Outperform rating with a $40.00 price target, while Cantor Fitzgerald reiterated an Overweight rating and pointed to Summit’s global phase 3 HARMONi-3 study as a key milestone. The HARMONi-3 program will compare ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in the first-line setting for non-small cell lung cancer and is identified by analysts as a critical development expected in 2026.
Investors and market participants will be watching both the regulatory timeline under the PDUFA clock and progress in the HARMONi-3 trial as the company advances its clinical and commercial plans.