On Monday, Chardan Capital Markets adjusted its stance on Outlook Therapeutics Inc. (NASDAQ: NASDAQ:OTLK) stock, moving its rating from Buy to Neutral following the release of clinical study results.
The stock, which has experienced a dramatic 58% decline over the past week and trades at $2.05, is currently showing signs of being undervalued according to InvestingPro analysis.
The biopharmaceutical company, currently valued at $48.5 million, recently shared preliminary topline efficacy and safety data from its Phase 3 NORSE 8 study, which tested Lytenava, an ophthalmic formulation of bevacizumab, in patients with wet age-related macular degeneration (AMD (NASDAQ:AMD)).
The study aimed to show that Lytenava was not inferior to the established treatment, ranibizumab, also known as Lucentis. However, it did not meet the primary endpoint of non-inferiority at the 8-week mark.
Despite this, Outlook Therapeutics observed an improvement in Best Corrected Visual Acuity (BCVA) of 4.2 letters in the NORSE 8 study at 8 weeks. The company also cited the successful NORSE 2 study and a clean safety profile as positive indicators for Lytenava's future.
Outlook Therapeutics plans to re-submit the Biologics License Application (BLA) for Lytenava in the first quarter of 2025, pending the full 3-month data expected in January 2025. The company remains hopeful about the drug's path forward.
Chardan Capital Markets has expressed concerns regarding the regulatory approval process for Lytenava in the U.S., particularly because the Food and Drug Administration (FDA) requires two successful adequate and well-controlled studies for approval in wet AMD treatment. As the NORSE 8 study did not meet its primary endpoint, the firm believes it is unlikely to fulfill the FDA's requirement as the second pivotal study.
This regulatory uncertainty has led to the decision to downgrade the rating for Outlook Therapeutics and place the price target under review. InvestingPro data reveals that despite these challenges, the overall analyst consensus remains bullish, with price targets ranging from $9 to $53. Subscribers can access 13 additional ProTips and comprehensive financial metrics to better understand OTLK's investment potential.
In other recent news, Outlook Therapeutics announced the completion of patient enrollment for its pivotal NORSE EIGHT clinical trial of ONS-5010, a treatment for wet age-related macular degeneration.
Despite ONS-5010 failing to meet its pre-specified non-inferiority endpoint in the trial, preliminary data indicated an improvement in vision and confirmed the treatment's biologic activity and safety.
Analysts from H.C. Wainwright maintained a Buy rating for Outlook Therapeutics, with a steady price target of $30.00, and BTIG adjusted its price target for the company to $9.00 from the previous $50.00, while still retaining a Buy rating.
The company plans to resubmit a Biologics License Application for ONS-5010 in 2025, following a complete analysis of the NORSE EIGHT trial's month 3 data.
Outlook Therapeutics also reported that ONS-5010 has already received regulatory approval in the European Union and the United Kingdom (TADAWUL:4280) for the treatment of wet AMD. The company is preparing for a 2025 launch in Europe, where the treatment has already been approved.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.