In a major blow to Outlook Therapeutics, stock of the biopharmaceutical company plummeted by more than 50% in premarket trading on Thursday. The sharp decline comes in the wake of the company’s announcement that it will be conducting an additional study of ONS-5010, a proposed treatment for wet age-related macular degeneration (wet AMD), in order to secure approval from the U.S. Food and Drug Administration (FDA).
At the time of this publication, Outlook Therapeutics Inc stock (OTLK) has witnessed a decline.
Outlook Therapeutics Inc
Current Price: $0.31
Change : -0.33
Change (%): (-51.45%)
Volume: 32.5M
Source: Tomorrow Events Market Data
Russell Trenary, President and CEO of Outlook Therapeutics, expressed confidence in the company’s ability to meet the FDA’s additional requirements for ONS-5010 approval. Trenary emphasized the pressing need within the retina community for an FDA-approved bevacizumab that adheres to ophthalmic standards for treating wet AMD. The company remains steadfast in its pursuit of providing this critical treatment option.
Outlook Therapeutics disclosed that it has reached a preliminary agreement with the FDA regarding the design of a rigorous and well-controlled clinical trial. This agreement positions the company to potentially resubmit its application for ONS-5010 by the close of the upcoming year, with the prospect of FDA approval anticipated around mid-2025.
This setback follows a previous setback in late August when the FDA rejected Outlook’s initial application for ONS-5010. The regulatory agency cited several concerns related to chemistry, manufacturing, and controls, and requested further corroborative clinical evidence.
In addition to the agreement on the clinical trial design, Outlook also reported that it has reached a consensus with the FDA on the necessary steps to address the agency’s reservations concerning chemistry, manufacturing, and controls. The company is optimistic that its efforts will be sufficient to garner approval.
As of Wednesday’s close at 63.2 cents per share, Outlook’s stock saw a significant drop early Thursday morning, with shares trading down by 57% to 27% in premarket trading.
This development underscores the challenges faced by Outlook Therapeutics in its pursuit of FDA approval for ONS-5010, highlighting the rigorous standards and extensive clinical evidence required for such groundbreaking treatments. The company will now focus on executing a comprehensive clinical trial, aiming to address the FDA’s concerns and ultimately deliver a viable solution for patients suffering from wet AMD.
