ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company, announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD (NASDAQ:AMD)).
The approval makes LYTENAVA™ the first ophthalmic formulation of bevacizumab approved for this indication in the UK and follows a recent European Commission authorization.
The company's clinical trial for LYTENAVA™ met its endpoint, leading to the MHRA's decision, which was facilitated by the International Recognition Procedure (IRP). The IRP allows reliance on a positive opinion by the European Medicines Agency for granting marketing authorization within the UK. The commercial launch of LYTENAVA™ in the UK and EU is anticipated in the first quarter of 2025.
Russell Trenary, President and CEO of Outlook Therapeutics, expressed gratitude for the efforts leading to this milestone, which paves the way for the upcoming product launch. Jedd Comiskey, Senior VP – Head of Europe for Outlook Therapeutics, also highlighted the importance of the MHRA approval in the company's commercial strategy.
Outlook Therapeutics has partnered with Cencora (NYSE: COR), a global pharmaceutical solutions organization, to support the product's launch. Cencora will provide a range of services, including pharmacovigilance, regulatory affairs, and distribution, to ensure efficient access to LYTENAVA™ for healthcare providers and patients.
LYTENAVA™ is an ophthalmic formulation of bevacizumab designed to inhibit vascular endothelial growth factor (VEGF), thereby reducing new blood vessel formation in the retina, which is a key factor in wet AMD. While approved in the EU and UK, LYTENAVA™ is still investigational in the United States and is currently being evaluated in a non-inferiority study.
This news is based on a press release statement from Outlook Therapeutics. The company's forward-looking statements involve risks and uncertainties, including those related to regulatory approvals and the impact of global economic conditions. Investors are cautioned not to place undue reliance on these statements.
In other recent news, Outlook Therapeutics has received marketing authorization from the European Commission for its ophthalmic formulation, LYTENAVA™, designed for treating wet age-related macular degeneration (wet AMD).
This approval, which extends to all 27 EU Member States, came after a thorough review of clinical trial data from the company's wet AMD program. Outlook Therapeutics has also formed a strategic partnership with Cencora to support the anticipated commercial launch of LYTENAVA™ in the EU in 2025.
Analysts from H.C. Wainwright have maintained a positive outlook on Outlook Therapeutics, reiterating a Buy rating in anticipation of regulatory approvals and the planned commercial launch of LYTENAVA™. The company is also progressing with the NORSE EIGHT study in the U.S., aimed at securing approval for the therapy.
Additionally, Outlook Therapeutics has submitted a Marketing Authorization Application to the UK's Medicines and Healthcare Products Regulatory Agency. This follows a favorable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. A decision from the European Commission is anticipated within approximately 67 days following this opinion.
These developments highlight the company's strategic efforts to secure approval for LYTENAVA™ in the United States, EU, and UK, potentially expanding to other markets. This information is based on recent press release statements.
InvestingPro Insights
As Outlook Therapeutics, Inc. (NASDAQ:OTLK) gears up for the commercial launch of LYTENAVA™, investors and industry watchers are closely monitoring the company's financial health and market performance. According to InvestingPro data, Outlook Therapeutics currently holds a market capitalization of 171.33 million USD, with a notably negative P/E ratio of -0.61 as of the last twelve months leading up to Q2 2024. This negative P/E ratio is a reflection of the company's challenges in generating profit during this period. Additionally, the company’s price has significantly retreated by 77.55% over the past year, indicating a period of volatility and investor caution.
Despite the challenges, there are signs of potential optimism from analysts, as evidenced by two analysts revising their earnings estimates upwards for the upcoming period. This could suggest a belief in the company's future prospects, particularly in light of the recent MHRA approval for LYTENAVA™. Nonetheless, InvestingPro Tips highlight that Outlook Therapeutics is not expected to be profitable this year and has been grappling with weak gross profit margins, which could be a concern for investors looking for short-term gains.
For those interested in a deeper dive into the financial metrics and strategic analysis of Outlook Therapeutics, there are additional InvestingPro Tips available. By using the coupon code PRONEWS24, readers can access these insights with up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, offering a comprehensive look at the company's potential in a competitive pharmaceutical landscape.
With the InvestingPro Fair Value estimated at 8.6 USD, significantly below the analyst target of 35 USD, there appears to be a divergence in valuation perspectives. This discrepancy could provide an interesting point of discussion for investors considering the company's future revenue streams and growth potential following the anticipated 2025 launch of LYTENAVA™ in the UK and EU markets.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.