ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical firm, has submitted a Marketing Authorization Application (MAA) to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its ophthalmic formulation of bevacizumab, ONS-5010/LYTENAVA™, aimed at treating wet age-related macular degeneration (wet AMD (NASDAQ:AMD)). This submission comes after the company received a favorable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on March 22, 2024.
The application in the UK leverages the International Recognition Procedure (IRP), which acknowledges the positive CHMP opinion and could expedite the authorization process in the UK. The MAA is backed by data from three completed clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE, which evaluated the efficacy and safety of ONS-5010 for wet AMD.
Russell Trenary, President and CEO of Outlook Therapeutics, expressed optimism about providing UK clinicians and patients with what could be the only approved ophthalmic bevacizumab for wet AMD treatment. The company anticipates a decision from the European Commission within approximately 67 days following the CHMP opinion, which would subsequently apply to all 27 EU Member States and within 30 days to Iceland, Norway, and Liechtenstein.
ONS-5010/LYTENAVA™ is designed as an intravitreal injection to inhibit vascular endothelial growth factor (VEGF), thereby reducing new blood vessel formation and vascular leakage in the retina. Currently, no FDA or European Commission approved ophthalmic formulations of bevacizumab are available, leading clinicians to use repackaged IV bevacizumab for retinal treatments, which may pose risks of contamination and inconsistent potency.
Outlook Therapeutics aims to secure approval for ONS-5010/LYTENAVA™ in the United States, EU, and UK, potentially expanding to other markets. The company has also partnered with Cencora for strategic commercialization, logistics, and pharmacovigilance services in these regions.
This report is based on a press release statement and contains forward-looking statements subject to risks and uncertainties. Actual results may differ materially from those projected due to various factors, including regulatory decisions and market conditions.
InvestingPro Insights
As Outlook Therapeutics, Inc. (NASDAQ:OTLK) forges ahead with its Marketing Authorization Application in the UK, recent data from InvestingPro suggests a challenging financial landscape for the company. Despite the potential milestone of securing approval for ONS-5010/LYTENAVA™, the company's financial health raises concerns. An InvestingPro Tip highlights that the stock has suffered a significant hit recently, with a 1 Week Price Total Return of -10.82%, and a stark 1 Year Price Total Return of -67.04%. This could be indicative of investor skepticism or broader market trends affecting biopharmaceutical firms.
Moreover, the company's struggle with profitability is evident, with an InvestingPro Tip indicating that analysts do not expect the company to be profitable this year, and it has not been profitable over the last twelve months. This is further substantiated by a Gross Profit of -21.12M USD and an Operating Income, adjusted for the last twelve months as of Q1 2024, standing at -47.76M USD.
For those considering an investment in Outlook Therapeutics, it's important to note that the company's Market Cap is currently at 176.6M USD, reflecting its size in the market. Additionally, the company does not pay a dividend to shareholders, as per another InvestingPro Tip, which may influence investment decisions for those seeking regular income streams from their investments.
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