Outlook Plunges to Record as Eye Drug Fails to Win FDA Nod (2)

(Updates to add BTIG analyst commentary and latest trading.)

Outlook Therapeutics plunges 83% to a record low after saying the US FDA issued a Complete Response Letter to the Biologics License Application, or BLA, for ONS-5010 — an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.

• Agency concluded it could not approve the BLA during this review cycle due to several chemistry, manufacturing and control issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence
• OTLK said it will request a meeting with the FDA and then will be able to discuss next steps ...