Summit Therapeutics (NASDAQ:SMMT) saw its stock drop 23% in premarket trading after the company released updated longer-term follow-up data from its global trial of the investigational lung cancer therapy, ivonescimab.
The new data failed to replicate the promising results previously observed in Chinese studies, raising concerns among investors and analysts. Findings indicated potential overall survival drawbacks for patients in North America and Europe, casting doubt on the drug’s regulatory prospects.
Daina M. Graybosch, an analyst at Leerink Partners who maintains an underperform rating on the stock, said the results “confirmed the hypothesis that survival signals would degrade from China to North America & Europe and showed a signal for potential OS harm in NA & EU.” She added, “We believe it is unlikely FDA will grant approval based on HARMONi nor that Summit will partner ivo at the substantial valuation expected by investors.”
Truist analyst Asthika Goonewardene, who keeps a buy rating, described the study as a narrow “miss” on overall survival and noted that the regulatory path for ivonescimab in EGFR-mutant lung cancer remains uncertain and “reliant on an act of leniency by the FDA.”
Conversely, Citizens Bank analyst Reni J. Benjamin, maintaining a market outperform rating, expressed a more positive outlook, noting that the updated data confirm ivonescimab’s efficacy translates from Eastern to Western populations and suggested that “any weakness in Summit shares [could be seen] as a buying opportunity.”
Summit has yet to engage with the FDA regarding these latest findings, leaving the future of ivonescimab’s regulatory approval unclear.
Summit Therapeutics stock price
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