Summit Therapeutics' Clinical Trial Setback Sends Stock Tumbling

Summit Therapeutics Stock Slips as FDA Delays Decision on Duchenne Muscular Dystrophy Treatment

March 26, 2025 - Investors in Summit Therapeutics (NASDAQ: SMMT) are feeling a sense of disappointment today as the company's stock price has taken a hit following news that the FDA has delayed its decision on the biotech's Duchenne muscular dystrophy treatment.

As reported earlier this month, Summit Therapeutics had submitted its new drug application (NDA) for its experimental treatment, utrophin modulator, to the FDA for the treatment of Duchenne muscular dystrophy. The treatment is designed to slow the progression of the debilitating muscle-wasting disease.

While the FDA's delay is not uncommon, it's still a setback for Summit Therapeutics and its investors. The agency has given the company an extension to respond to questions and provide additional information related to the NDA.

The delay has sent Summit Therapeutics' stock price tumbling, with shares falling over 20% in early trading. The decline is significant, as the biotech's stock had been trading near its 52-week highs in recent weeks.

Despite the setback, Summit Therapeutics remains optimistic about the potential of its treatment. The company has stated that it is committed to working with the FDA to address any concerns and move forward with the NDA.

Investors will be watching closely as the company responds to the FDA's request and provides an update on the status of its treatment. For now, the delay has put a damper on the biotech's momentum, and its stock price is likely to remain volatile in the coming days.