Outlook Therapeutics, Inc. (NASDAQ: OTLK) saw a 3.72% increase in stock price at $0.4626 at the end of the last trading session. The analyst upgrade was followed by the increase in OTLK stock. The stock began to gather traction when CapitalOne, an analyst company, raised its rating from “Equal-Weight” to “Overweight,” but maintained the $5 price objective.

Furthermore, the momentum of the stock price is being positively impacted by the recent events. Outlook Therapeutics (OTLK) requested a Special Protocol Assessment (SPA) last week in order to proceed with the necessary extra sufficient and carefully supervised investigation of ONS-5010. The FDA (U.S. Food and Drug Administration) provided formal validation of the NORSE EIGHT planned clinical trial protocol, which was followed by the submission.

As previously reported, the FDA notified OTLK that it may carry out a non-inferiority trial comparing ONS-5010 to ranibizumab in a 3-month investigation involving treatment-naïve patients with an initial efficacy objective at two months after the Type A discussion with the FDA in October 2023. Outlook Therapeutics then filed its clinical study protocol and asked the FDA for input in a Type A meeting. Since then, the FDA has sent written comments on the procedure, which OTLK has adopted.

Outlook Therapeutics is requesting additional confirmation from the FDA regarding the revised protocol in the SPA request. If successful, the FDA must provide evidence of a second sufficient and well-controlled clinical trial to bolster the second round of submission of the ONS-5010 Biologics License Application (BLA) for wet AMD. It is anticipated that the FDA will respond to the SPA by early February 2024.

By the end of 2024, Outlook Therapeutics plans to resubmit the BLA with the findings of NORSE EIGHT and the additional CMC work to address the problems mentioned by the FDA in the August 2023 Complete Response Letter in order to support approval.