Summit Therapeutics plc (NASDAQ: SMMT) said the U.S. Food and Drug Administration has accepted its initial Biologics License Application for ivonescimab, intended for patients with second-line or later EGFR-mutated non-small cell lung cancer. The submission was accepted on the basis of data from the Phase 3 HARMONi study, which evaluated ivonescimab in previously treated patients with EGFR-mutated disease. The FDA has assigned a Prescription Drug User Fee Act action date of November 14, 2026.
Shares of Summit have recently underperformed, falling 6.61% over the past week and trading at $15.40, a level close to the company's 52-week low of $15.17. The price action comes amid continuing clinical development and fresh analyst commentary on the company's prospects.
Citizens has maintained a Market Outperform rating on Summit, reiterating a $40.00 price target that the firm says is grounded in discounted earnings-per-share and revenue-multiple analysis. That view is consistent with the broader analyst community's tilt toward the stock: InvestingPro data noted a consensus recommendation score of 1.62, indicating overall bullishness. Individual analyst targets reported range from $12.26 to $43.15, reflecting a wide spread of opinions about the company's valuation and prospects despite a weak financial health score noted for Summit.
Citizens also highlighted that Summit is running multiple Phase 3 studies for ivonescimab, with pivotal readouts anticipated in 2026 and 2027. The firm pointed to the company's reported cash position as of the fourth quarter of 2025 - $710 million - and judged this balance sufficient to fund the ongoing clinical development programs.
In a related regulatory note, Summit has had a separate Biologics License Application accepted for ivonescimab in combination with chemotherapy. That filing targets patients with certain forms of non-small cell lung cancer who have previously been treated with tyrosine kinase inhibitors. The FDA's goal action date for this filing is likewise November 14, 2026.
Several research firms have reaffirmed or adjusted their views following the regulatory updates. H.C. Wainwright reiterated a Buy rating on Summit with a $40.00 price target. Citizens reaffirmed its Market Outperform rating, citing updated guidance on the ivonescimab clinical program. Cantor Fitzgerald continues to carry an Overweight rating, emphasizing the global phase 3 HARMONi-3 study as a material upcoming milestone. Barclays moved its rating from Underweight to Equalweight and raised its price target to $18.00, citing the company's BLA timeline for the fourth quarter of 2025 as the rationale for the change.
The regulatory acceptance and the cluster of analyst opinions underscore competing forces facing Summit's stock: nearer-term regulatory milestones and funding adequacy on one hand; market skepticism reflected in recent share weakness and the company's financial health assessment on the other. Investors will be watching the PDUFA timeline and the series of Phase 3 readouts expected in 2026 and 2027 for clearer signals on commercial potential and revenue prospects.
Contextual note: The details above are based on Summit Therapeutics' disclosure of the FDA acceptance, the HARMONi Phase 3 dataset as the basis for the filing, the November 14, 2026 PDUFA date, the company's reported cash balance at the end of 2025, and the analyst ratings and price targets provided by Citizens, H.C. Wainwright, Cantor Fitzgerald, Barclays, and InvestingPro-derived consensus figures.