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ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ: NASDAQ:OTLK) has announced the completion of patient enrollment for its pivotal NORSE EIGHT clinical trial of ONS-5010, an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD (NASDAQ:AMD)). The study completion is a significant step toward the potential resubmission of a Biologics License Application (BLA) for ONS-5010 in the United States.
The NORSE EIGHT trial, which is under a Special Protocol Assessment (SPA) with the FDA, is the final anticipated clinical trial required before the expected BLA resubmission. The study is a randomized, controlled, parallel-group, masked, non-inferiority trial comparing ONS-5010 to ranibizumab, with the primary endpoint being the mean change in best corrected visual acuity (BCVA) from baseline to week 8.
Russell Trenary, President and CEO of Outlook Therapeutics, expressed gratitude to the patients, clinical site teams, and staff for enrolling the patient population in less than eight months post SPA agreement with the FDA. The company remains confident in ONS-5010's potential to meet the needs of retina specialists, patients, and payers if approved.
Topline results from the NORSE EIGHT trial are expected to be reported in Q4 CY2024, with the BLA resubmission planned for Q1 CY2025. Following discussions with the FDA to address a Complete Response Letter (CRL) regarding the ONS-5010 BLA, the FDA informed Outlook Therapeutics that a non-inferiority study could support the resubmission.
ONS-5010 has already achieved regulatory approval in the European Union and the United Kingdom for the treatment of wet AMD. If approved by the FDA, ONS-5010, to be commercialized as LYTENAVA™ (bevacizumab-vikg) in the U.S., would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD.
Outlook Therapeutics has also been addressing chemical, manufacturing, and control (CMC) issues from the CRL and expects to resolve these prior to the completion of the NORSE EIGHT study. The company is planning for the commercial launch of LYTENAVA™ in the EU and the UK for wet AMD treatment in the first half of calendar 2025 and is assessing partnering options for commercialization outside the U.S.
This announcement is based on a press release statement.
In other recent news, Outlook Therapeutics has made significant strides with its ophthalmic formulation, LYTENAVA™. The drug, designated for the treatment of wet age-related macular degeneration, recently received Marketing Authorization from the United Kingdom's Medicines and Healthcare products Regulatory Agency. This approval, facilitated through the new International Recognition Procedure, makes LYTENAVA™ the first and only authorized ophthalmic formulation of bevacizumab to treat wet AMD in the European Union and the UK. This development marks a significant regulatory milestone for Outlook Therapeutics. Furthermore, the company has formed a strategic partnership with Cencora to support the product's commercial launch, anticipated in the first quarter of 2025. H.C. Wainwright analysts have maintained a Buy rating on Outlook Therapeutics, indicating a positive outlook toward these recent developments. These events are part of the company's strategic efforts to secure approval for LYTENAVA™ in multiple markets.
InvestingPro Insights
As Outlook Therapeutics, Inc. (NASDAQ: OTLK) progresses towards a potential BLA resubmission for its wet AMD treatment, ONS-5010, investors are closely monitoring the company's financial health and market performance. According to InvestingPro, two analysts have recently revised their earnings estimates upwards for the upcoming period, indicating a potential positive outlook on the company's financial future.
However, the company's stock has experienced significant volatility, with a notable decline over the past week. This could be reflective of the inherent risks associated with biotech firms awaiting regulatory approvals. InvestingPro data shows that Outlook Therapeutics has a market capitalization of $159.44 million, but operates with a negative P/E ratio of -1.12, suggesting that it is not currently profitable. Additionally, the company has a PEG ratio of 0.1, which could indicate potential for future growth if the company's earnings trajectory improves.
InvestingPro Tips further reveal that the company does not pay dividends, which is common for growth-focused biotech companies that reinvest earnings into research and development. With a moderate level of debt and weak gross profit margins, Outlook Therapeutics' financial position is one to watch closely as it navigates the path to potential FDA approval and commercialization of its product.
For investors seeking more in-depth analysis, there are additional InvestingPro Tips available at: https://www.investing.com/pro/OTLK, which provide further guidance on the company's financial health and market performance.
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