EVGN - Seres hits four-month high ahead of FDA decision on lead asset

2023-04-17 13:30:07 ET

Seres Therapeutics ( NASDAQ: MCRB ) shares added ~11% on Monday to reach the highest level since December as the microbiome therapeutics company awaits the FDA decision on its biologics license application for lead candidate SER-109.

Evogene ( EVGN ), a rival biopharma with microbiome-based therapeutics in its pipeline has also added ~8% alongside a broader rally in the biotech space.

3.2M MCRB shares changed hands, compared to the 65-day average of ~1.1M, as the stock recorded the biggest intraday gain since October when investors sent the stock ~20% higher after the FDA accepted the BLA for priority review.

At the time, the agency issued April 26, 2023, as the PDUFA regulatory action date for its decision and agreed not to hold an advisory committee meeting to discuss the application targeted at the prevention of C. difficile infection.

The company expects to launch the oral microbiome therapeutic in the weeks following a potential FDA approval, Eric Shaff, Chief Executive of Seres ( MCRB ), said with the company’s Q4 results for 2022 in March.

Seeking Alpha analyst BioSci Capital Partners expects MCRB shares to rally if the FDA issues a favorable decision on SER-109.

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