Outlook Therapeutics Makes Significant Progress in FDA Approval Process

Shares of Outlook Therapeutics have experienced a major boost in premarket trading following the announcement of two significant advancements in the company's pursuit of U.S. Food and Drug Administration (FDA) approval for its proposed treatment for wet age-related macular degeneration (wet AMD).

Outlook Therapeutics' shares, which closed at 34 cents on Monday, have surged by 35% to 46 cents in premarket trading.

A noteworthy development is Outlook Therapeutics reaching an agreement with the FDA to conduct a 90-day non-inferiority study of ONS-5010. Successful completion of this study would fulfill the agency's requirement for a second well-controlled trial, addressing the concerns raised by the FDA when they initially rejected the company's application for the drug last year. This progress underscores Outlook Therapeutics' commitment to delivering an effective treatment.

In addition, Outlook Therapeutics has secured securities-purchase agreements with select institutional and accredited investors, generating up to $172 million in gross proceeds. These funds will be utilized to support the further development of ONS-5010. The company anticipates that this financing will be adequate to cover potential FDA approval and facilitate the commercial launch of the drug.

The initiation of the new study is expected in the first quarter, paving the way for a potential resubmission of Outlook Therapeutics' ONS-5010 application to the FDA before the end of this year.

Overall, these two significant milestones represent considerable progress for Outlook Therapeutics as it moves closer to gaining FDA approval for its breakthrough wet AMD treatment.