By Colin Kellaher


Shares of Outlook Therapeutics surged in premarket trading Tuesday after the biopharmaceutical company reported a pair of advances in its efforts to win U.S. Food and Drug Administration approval of its proposed treatment for wet age-related macular degeneration, or wet AMD.

Outlook shares, which closed Monday at 34 cents, were recently up 35% to 46 cents in premarket trading.

Outlook said it reached agreement with the FDA on a 90-day non-inferiority study of ONS-5010 that, if successful, would satisfy the agency's requirement for a second adequate and well-controlled trial to address issues the FDA raised last year when it rejected the Iselin, N.J., company's initial application for the drug.

Outlook also said it inked securities-purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010, adding that it expects the financing would be sufficient to take the drug through potential FDA approval and fund its commercial launch.

Outlook said it expects to begin the new study in the first quarter, paving the way for a potential resubmission of its ONS-5010 application to the FDA by the end of the year.


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


(END) Dow Jones Newswires

01-23-24 0848ET