Outlook Therapeutics faced a major setback on Wednesday as the U.S. Food and Drug Administration (FDA) rejected its proposed treatment for wet age-related macular degeneration (AMD). The biopharmaceutical company’s shares plummeted to an all-time low in response to the news.
The shares of the Iselin, N.J., company were trading at just 26 cents, marking an 82% decline. They even hit a rock-bottom of 25 cents early in the trading session.
Outlook had sought FDA approval for ONS-5010, the first ophthalmic formulation of bevacizumab to be used in retinal indications. However, the FDA raised concerns regarding chemistry, manufacturing, and controls, and requested further confirmatory clinical evidence.
The company stated that it will hold discussions with the FDA to address these concerns before deciding on its next steps.
As of June 30, Outlook had approximately $33.7 million in cash and equivalents. The company believed that this amount would be sufficient to sustain its operations until the anticipated approval of ONS-5010 in the third quarter of this year and potentially beyond.
