MBRX - Seres completes regulatory submissions seeking FDA nod for lead asset

• Seres Therapeutics, Inc. ( NASDAQ: MBRX ), a biotech focused on microbiome therapeutics, added ~7% in the pre-market trading Wednesday after the company announced the completion of the rolling submission process seeking FDA approval for its lead asset SER-109.
• With the Biologics License Application, MBRX expects U.S. approval of SER-109 as a treatment for the prevention of recurrent C. difficile infection (rCDI).
• An oral microbiome therapeutic, SER-109, is backed by FDA Breakthrough Therapy designation, which allows the company to win priority review for the BLA. If granted, MBRX expects the potential approval and market launch of SER-109 in 1H 2023.
• The company has partnered with Nestlé Health Science, a unit of Swiss consumer products company Nestle ( OTCPK:NSRGY ) ( OTCPK:NSRGF ), to market SER- 109 in the U.S. and Canada.

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