ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ: NASDAQ:OTLK) has announced that the European Commission has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), making it the first ophthalmic formulation of bevacizumab approved for treating wet age-related macular degeneration (wet AMD (NASDAQ:AMD)) in the European Union. This authorization extends to all 27 EU Member States and will soon include Iceland, Norway, and Liechtenstein.
The approval of LYTENAVA™ comes after a comprehensive review of clinical trial data from Outlook Therapeutics' wet AMD program, which includes three completed registration clinical trials. The European Commission's decision also secures ten years of market exclusivity for LYTENAVA™ in the EU.
Outlook Therapeutics has formed a strategic partnership with Cencora to support the anticipated commercial launch of LYTENAVA™ in the EU in the first quarter of 2025. Cencora, a global pharmaceutical solutions organization, will provide a range of services including pharmacovigilance, regulatory affairs, and distribution to facilitate the therapy's access to the market.
Russell Trenary, President and CEO of Outlook Therapeutics, expressed gratitude to the patients, researchers, and regulatory bodies that contributed to this milestone. Jedd Comiskey, Senior VP – Head of Europe, added that LYTENAVA™ is poised to become a significant treatment option in the EU's ophthalmology sector.
LYTENAVA™ (bevacizumab gamma) is designed to inhibit the activity of vascular endothelial growth factor (VEGF), which plays a critical role in the progression of wet AMD. By blocking VEGF's binding to its receptors, the drug aims to reduce vascular leakage and new blood vessel formation in the retina.
In addition to the EU, Outlook Therapeutics has submitted a Marketing Authorization Application to the UK's Medicines and Healthcare Products Regulatory Agency. Meanwhile, in the United States, LYTENAVA™ is undergoing a non-inferiority study for wet AMD treatment.
This news is based on a press release statement.
InvestingPro Insights
As Outlook Therapeutics, Inc. (NASDAQ: OTLK) celebrates the European Commission's approval of LYTENAVA™, investors are closely monitoring the company's financial health and market potential. According to InvestingPro data, Outlook Therapeutics currently holds a market capitalization of $184.9 million USD. Despite the positive news, the company's gross profit over the last twelve months as of Q2 2024 stands at a negative $26.45 million USD, and the operating income adjusted for the same period is also in the red at -$59.86 million USD.
InvestingPro Tips highlight that two analysts have revised their earnings upwards for the upcoming period, indicating a potential optimism in the company's future financial performance. Yet, it's important to note that analysts do not anticipate the company will be profitable this year, and Outlook Therapeutics has not been profitable over the last twelve months. Additionally, the company's price has experienced a significant decline over the last year, with a 73.22% drop in the 1 Year Price Total Return as of Y2024.D149.
For investors seeking a more in-depth analysis, there are additional InvestingPro Tips available, which can provide further insights into Outlook Therapeutics' performance and market position. As you consider these factors, remember to use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
The strategic partnership with Cencora and the anticipated commercial launch of LYTENAVA™ in the EU could be a turning point for Outlook Therapeutics. With the InvestingPro Fair Value estimated at 8.4 USD, there is a potential upside when compared to the previous close price of 7.9 USD. Nevertheless, the company's financials and the market's reception of LYTENAVA™ will be crucial in determining its future trajectory.
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