OTLK - This Analyst Upgrades Vision Disorder-Focused Outlook Therapeutics' Prospects After FDA Agreement Despite Investor Concerns | Benzinga
Thursday, Outlook Therapeutics Inc (NASDAQ: OTLK) announced it completed the requested Type A Meetings with the FDA to discuss the Complete Response Letter (CRL).
The FDA informed Outlook Therapeutics that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 for the treatment of wet AMD.
Outlook Therapeutics reached an agreement in principle with the FDA on a clinical trial design that would most likely allow for the resubmission of the ONS-5010 BLA as early as the end of 2024 and subsequent approval around mid-2025.
HC Wainwright upgraded the stock to Buy from Neutral, ...