Outlook Therapeutics Inc (OTLK)

[maverick_1]

Fortunately I sold and took a small loss!:

8:27a ET 5/31/2022 - Dow Jones
Outlook Therapeutics Withdraws Wet AMD Treatment Application
Mentioned: OTLK

By Will Feuer

Outlook Therapeutics Inc. said it has voluntarily withdrawn its biologics license application for its experimental wet age-related macular degeneration treatment while it responds to the U.S. Food and Drug Administration's request for additional information.

The company said it plans to re-submit a revised application for its experimental treatment, called ONS-5010, or bevacizumab-vikg, by September.

"We are continuing to have productive discussions with the FDA and are committed to providing the additional information necessary to support the application," Chief Executive Russell Trenary said. "We look forward to a successful resubmission and ultimately the potential approval of ONS-5010 for the treatment of wet AMD."

Shares of Outlook Therapeutics tumbled almost 38% to $1.05 in premarket trading.

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration and other retinal diseases, Outlook Therapeutics said.

Some 1.8 million Americans aged 40 years and older are affected by age-related macular degeneration, according to the U.S. Centers for Disease Control and Prevention. Age-related macular degeneration is the leading cause of permanent impairment of reading and fine or close-up vision among people aged 65 years and older, the agency says.

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