Why Is Outlook Therapeutics Stock Nosediving Today?

Outlook Therapeutics Inc OTLK shares are falling after the company received an FDA complete response letter regarding ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat Wet Age-Related Macular Degeneration (Wet AMD). 

Wet AMD is the most common cause of visual impairment among elderly patients.

While the FDA acknowledged that the NORSE TWO pivotal trial met its safety and efficacy endpoints, the Agency concluded it could not approve the application during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.

"We will request a formal meeting as soon as possible with the FDA to further understand the BLA deficiencies and how best to resolve them. Following this meeting with the FDA, the company will be able to discuss the next steps and the expected timing for resolution," said Russell Trenary, President and CEO of Outlook Therapeutics.

Price Action: OTLK shares are down 73.1% at $0.38 during the premarket session on the last check Wednesday.