Outlook Therapeutics downgraded to Neutral from Buy at Guggenheim

Guggenheim downgraded Outlook Therapeutics to Neutral from Buy and removing the firm’s prior $5 price target on the shares after the company received a CRL for ONS-5010 from the FDA. The company will request a Type A meeting, where it expects to learn more about exactly which aspects of the BLA were of concern and how to resolve them, but while manufacturing and CMC issues can sometimes be addressed quickly, the lack of evidence comment noted in the CRL is “less specific and could require a longer regulatory delay” and the company will be “up against the clock to resolve these issues quickly” with only $34M in cash, the analyst tells investors.