Seres Therapeutics Inc MCRB shares are trading higher by 13.24% to $6.12 Wednesday morning after the company announced it completed the rolling submission process for its BLA to the FDA for SER-109 for recurrent C. difficile infection. Also, Piper Sandler maintained an Overweight rating on the stock and raised its price target from $7 to $9.
What Else?
Seres Therapeutics says SER-109 has FDA Breakthrough Therapy designation, which provides the potential for priority review of the BLA. If granted, Seres anticipates the potential approval and launch of SER-109 in the first half of 2023, with SER-109 potentially becoming the first ever FDA-approved oral microbiome therapeutic.
"Completing this BLA submission marks a key milestone for Seres and, more importantly, a potential turning point for the treatment of nearly 170,000 cases of recurrent C. difficile infection each year in the United States alone," said Lisa von Moltke, MD, Chief Medical Officer at Seres.
"We look forward to continuing to work with the FDA on the review of this BLA so that, if approved, we can bring this therapeutic candidate to patients as quickly as possible with our collaborator, Aimmune Therapeutics, a Nestlé Health Science Company."
According to data from Benzinga Pro, Seres Therapeutics has a 52-week high of $11.69 and a 52-week low of $2.50.
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