Outlook Therapeutics Stock Nose-Dives 66% In Pre-Market – Here’s Why

Outlook Therapeutics, Inc. (OTLK) announced on Thursday that the U.S. Food and Drug Administration (FDA) has declined to approve its investigational drug Lytenava for the treatment of wet age-related macular degeneration. Shares of the company nosedived by over 66% in Thursday’s pre-market session following the announcement.

The agency cited a lack of substantial evidence of effectiveness as the basis for its decision. Age-related macular degeneration causes damage to the macula, a small area near the center of the retina, which is the part of the eye responsible for sharp, central vision. It is common among people aged 50 and older. Wet age-related macular degeneration (wet AMD) is an advanced form of AMD where abnormal, leaky blood vessels grow under the retina, leading to rapid vision loss.

On Stocktwits, retail sentiment around OTLK stock trended within ‘extremely bullish’ territory over the past 24 hours, while message volume stayed at ‘extremely high’ levels.

The agency noted in its letter to the company that the drug did not meet the primary efficacy endpoint in a study and recommended that confirmatory evidence of efficacy be submitted to support the application.

CEO Bob Jahr said that the company is very disappointed with this outcome and intends to meet with the agency to receive additional clarity on requirements for approval.

“It is important to also note that the CRL (letter) identified no other outstanding deficiencies in our BLA (application),” Jahr added.

The company also said that it intends to continue its efforts to expand Lytenava into additional markets in Europe. It has already been granted Marketing Authorization by the European Commission in the European Union and Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.

OTLK is up by 26% this year but down by 68% over the past 12 months. 

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