Outlook Therapeutics Shares Plumb New Depths After FDA Setback

By Colin Kellaher

Outlook Therapeutics shares collapsed to an all-time low Wednesday after the U.S. Food and Drug Administration rejected the biopharmaceutical company's proposed treatment for wet age-related macular degeneration, or wet AMD.

Shares of the Iselin, N.J., company were recently changing hands at 26 cents, down 82%, after touching an all-time low of 25 cents early in the session.

Outlook, which was seeking approval of ONS-5010 as the first ophthalmic formulation of bevacizumab for use in retinal indications, said the FDA flagged several issues related to chemistry, manufacturing and controls and asked for further confirmatory clinical evidence.

Outlook said it will be able to discuss its next steps after it meets with the FDA to discuss the agency's concerns.

Outlook earlier this month said it had $33.7 million in cash and equivalents as of June 30, which it said at the time would be sufficient to fund its operations through an anticipated approval ONS-5010 in the third calendar quarter and potentially through the rest of the year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

August 30, 2023 10:11 ET (14:11 GMT)

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