ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ: NASDAQ:OTLK), a developer of ophthalmic formulations with a market capitalization of $43 million, announced the immediate departure of Russell Trenary as President and CEO. Lawrence Kenyon, currently the Executive Vice President and CFO, has been appointed as the interim CEO. The company, which received approval for its product LYTENAVA™ in the EU and UK earlier this year, is preparing to launch the treatment for wet AMD (NASDAQ:AMD) in adults in the first half of 2025. According to InvestingPro data, the stock has faced significant headwinds, declining over 78% in the past year.
Kenyon, who has been with Outlook Therapeutics since September 2015, previously served as President and CEO from August 2018 to July 2021. The company has commenced a search for a permanent CEO with the aid of an executive search firm.
Executive Chairman Randy Thurman expressed gratitude to Trenary for his contributions and welcomed Kenyon's leadership during the transition. Outlook Therapeutics is focused on the development of ONS-5010/LYTENAVA™ for the treatment of retinal diseases, including wet AMD, which is the leading cause of blindness in older adults. InvestingPro analysis indicates the company currently maintains a "Weak" overall financial health score, though analysts remain optimistic with a "Strong Buy" consensus recommendation.
The company is also working toward resubmitting a Biologics License Application (BLA) for ONS-5010 in the U.S. in the first quarter of 2025, following a clinical trial expected to support the application. If approved by the FDA, ONS-5010/LYTENAVA™ would become the first ophthalmic formulation of bevacizumab for retinal indications in the U.S.
The press release included forward-looking statements regarding the commercial launch of LYTENAVA™ and the resubmission of the BLA, which are subject to risks and uncertainties outlined in the company's filings with the Securities and Exchange Commission. These filings detail the risks associated with pharmaceutical development and regulatory approvals, as well as market conditions and macroeconomic factors such as overseas conflicts, interest rates, inflation, and potential bank failures.
Outlook Therapeutics aims to address a significant need in the treatment of retinal diseases and is advancing its commercial and regulatory strategies to bring its product to market. This announcement is based on a press release statement from the company.
In other recent news, Outlook Therapeutics has experienced several significant developments. Following the release of clinical study results, Chardan Capital Markets adjusted its rating from Buy to Neutral for the biopharmaceutical company. The Phase 3 NORSE 8 study of Lytenava, an ophthalmic formulation of bevacizumab, did not meet its primary endpoint of non-inferiority at the 8-week mark. However, the company observed an improvement in Best Corrected Visual Acuity (BCVA) and cited positive indicators for Lytenava's future.
Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for Lytenava in 2025. Despite the downgrade from Chardan Capital Markets, BTIG and H.C. Wainwright have maintained their Buy ratings, adjusting their price targets to $9.00 and $30.00 respectively.
In related news, ONS-5010, another product from Outlook Therapeutics, did not meet the non-inferiority endpoint in the NORSE 8 trial. Despite this, the company plans to resubmit a BLA for ONS-5010 in 2025. ONS-5010 has already received regulatory approval in the European Union and the United Kingdom (TADAWUL:4280) for the treatment of wet age-related macular degeneration.
Lastly, Outlook Therapeutics has completed patient enrollment for its pivotal NORSE EIGHT clinical trial, marking a significant step toward the potential resubmission of a BLA for ONS-5010 in the United States. These are the latest developments in the company's ongoing efforts to bring effective treatments to market.
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