June 30 Quick Takes: Flagship re-ups in Seres as biotech nears market; new PDUFA for Provention

Flagship returned to support a company that it incubated more than a decade ago, investing in a $100 million registered direct offering by microbiome company Seres Therapeutics Inc. (NASDAQ:MCRB). Seres sold 31.7 million shares at $3.15 per share to a group of investors that, beyond Flagship Pioneering, included Federated Hermes Kaufmann Funds, Heights Capital Management, Janus Henderson Investors and Nestlé Health Science. The funding will go in part toward ramping up commercialization and manufacturing of C. difficile therapy SER-109 for the U.S. market. Flagship invested in Seres’ series A and B rounds; Nestlé, which shares rights to SER-109, invested in the company’s 2015 series D round. J.P. Morgan was placement agent on the deal.

Provention Bio Inc. (NASDAQ:PRVB) said FDA delayed the PDUFA for teplizumab until Nov. 17, to give itself time to review additional information that the company submitted last month in response to an agency information request. FDA rebuffed the company’s prior BLA for the humanized anti-CD3 mAb in July 2021, citing product quality issues. Provention added that, if approved, teplizumab would become the first disease modifying therapy on the market to delay Type I diabetes. ...