Outlook Therapeutics Appoints Interim CEO and Plans Product Launch

Outlook Therapeutics, Inc. (NASDAQ: NASDAQ:), based in Iselin, New Jersey, has announced the immediate exit of its President and CEO, Russell Trenary. Stepping into the role of interim CEO is Lawrence Kenyon, who has also served as the Executive Vice President and CFO for the company. Outlook Therapeutics specializes in developing ophthalmic formulations and currently has a market cap of $43 million.

Earlier this year, the company received approval for its product, LYTENAVA™, in both the European Union and the United Kingdom. Outlook Therapeutics is gearing up for the launch of this treatment for wet age-related macular degeneration (AMD) in adults, which is planned for the first half of 2025. The company’s stock has seen significant challenges, with a decline of over 78% in the past year, according to InvestingPro data.

Lawrence Kenyon has been with the company since September 2015 and previously held the positions of President and CEO from August 2018 to July 2021. The company has begun a search for a permanent CEO with the help of an executive search firm. Executive Chairman Randy Thurman expressed appreciation for Trenary’s contributions to the company and welcomed Kenyon’s leadership during this transitional phase.

Outlook Therapeutics is dedicated to advancing ONS-5010/LYTENAVA™ for retinal diseases, including wet AMD, which is a leading cause of blindness in older adults. InvestingPro notes that the company currently has a "Weak" overall financial health score; however, analysts remain positive, showing a consensus recommendation of "Strong Buy."

Additionally, the company has plans to resubmit a Biologics License Application (BLA) for ONS-5010 in the United States in the first quarter of 2025. This resubmission will follow a clinical trial expected to bolster the application. If the FDA approves ONS-5010/LYTENAVA™, it would mark the first ophthalmic formulation of bevacizumab for retinal indications in the U.S.

The press release from Outlook Therapeutics also included forward-looking statements regarding the commercial launch and the BLA resubmission, which carry risks and uncertainties related to pharmaceutical development, regulatory approvals, and market conditions. These factors include global conflicts, interest rates, inflation, and potential banking challenges.

Outlook Therapeutics aims to fill a significant gap in retinal disease treatment and is actively advancing its commercial strategies to bring its product to market. This update is derived from the company's official statements.

In other recent developments, Outlook Therapeutics faced several notable changes. Following the announcement of clinical study results, Chardan Capital Markets revised its rating for the company from Buy to Neutral. The Phase 3 NORSE 8 study for Lytenava, an ophthalmic formulation of bevacizumab, did not achieve its primary endpoint of non-inferiority at the 8-week interval. Nevertheless, the company reported improvements in Best Corrected Visual Acuity (BCVA), suggesting a positive outlook for Lytenava's future.

Despite the downgrade from Chardan Capital Markets, other firms like BTIG and H.C. Wainwright have upheld their Buy ratings, with adjusted price targets set at $9.00 and $30.00, respectively. Moreover, ONS-5010, another product from the company, also did not meet the non-inferiority endpoint in the NORSE 8 trial, yet Outlook Therapeutics remains on track to resubmit a BLA for ONS-5010 within the year.

ONS-5010 has already secured regulatory approval in the EU and the UK for treating wet AMD. In a significant milestone, Outlook Therapeutics has completed patient enrollment for its pivotal NORSE EIGHT clinical trial, which positions the company closer to potentially resubmitting a BLA for ONS-5010 in the U.S.

These announcements represent the latest efforts from Outlook Therapeutics to develop effective treatments for retinal conditions and improve patient outcomes.

CEO, Launch, Pharmaceutical