Jefferies reiterates Summit Therapeutics stock rating after FDA setback

Investing.com reports that Jefferies has reaffirmed its Buy rating and $30.00 price target on Summit Therapeutics plc (NASDAQ: SMMT) despite a Complete Response Letter (CRL) from the FDA. The stock saw a 13% decline following the regulatory setback. The FDA required statistically significant overall survival in the setting of second-line EGFR non-small cell lung cancer to support the effectiveness of ivonescimab plus chemotherapy in the HARMONi trial.

Summit Therapeutics had previously noted the CRL as the investor's base case, believing limited downside given the unkeyed role of second-line EGFR in the investment thesis. The stock is currently trading near its Fair Value, with further insights provided by Jefferies' Pro Research Report. Jefferies views the HARMONi-3 squamous progression-free survival data by year-end 2026 as the thesis-defining catalyst for Summit Therapeutics, projecting potential upside of 10-20% and downside of 5-10%.

Other firms have also commented on Summit Therapeutics, with Stifel lowering its price target to $37 and Citizens raising its rating to Market Outperform with a $40 price target. Summit Therapeutics has also filed a legal opinion for stock issuance and presented promising HARMONi-GI1 trial results in biliary tract cancer.