Seres expects its experimental C. difficile therapy to launch in the first half of 2023 if it’s approved by FDA

Shares of Seres Therapeutics Inc. jumped 14.2% in premarket trading on Tuesday after the company shared data from a Phase 3 open-label study that confirmed the safety and efficacy of its experimental C. difficile treatment. Seres has already initiated a rolling application for the therapy with the Food and Drug Administration; the new batch of data will also be included in the application, which is expected to be completed “by mid-2022,” the company said. Seres said if the drug is approved, it expects it will launch in the first half of next year. The company already inked a deal with the privately held Nestlé Health Science to jointly commercialize the experimental therapy in the U.S. and Canada. Seres shares are down 61.2% this year, while the broader S&P 500 has declined 13.3%.

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