Outlook Therapeutics launches LYTENAVA in Germany and UK

ISELIN, N.J. - Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company valued at $78.85 million, has announced the commercial availability of LYTENAVA™ (bevacizumab gamma) in Germany and the UK for treating wet age-related macular degeneration (wet AMD). The announcement has contributed to the company’s strong recent performance, with shares gaining 15% in the past week, according to InvestingPro data. This marks the introduction of the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment in the European Union and UK.

The company’s Senior Vice President, Head of Europe, Jedd Comiskey, expressed gratitude towards the team and partners for their efforts in reaching this significant milestone. He emphasized the company’s commitment to ensuring the success of LYTENAVA™ in these markets and preparing for further launches across Europe. Analysts maintain a bullish outlook on the company, with price targets ranging from $3 to $24 per share, as revealed by InvestingPro analysis.

LYTENAVA™, known as bevacizumab-vikg in the US, is a monoclonal antibody designed to bind and neutralize vascular endothelial growth factor (VEGF), which is involved in the progression of wet AMD. The drug has been authorized by the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for this indication.

The commercialization of LYTENAVA™ is supported by a strategic collaboration with Cencora, aimed at facilitating market access and efficient distribution. This partnership is expected to benefit stakeholders, including retina specialists and patients.

Currently, off-label repackaged bevacizumab is commonly used for retinal diseases in Europe, with approximately 2.8 million injections administered annually. LYTENAVA™ has the potential to mitigate risks associated with the off-label use of repackaged bevacizumab.

While LYTENAVA™ is now available in Germany and the UK, it remains investigational in the United States. Outlook Therapeutics has resubmitted a Biologics License Application (BLA) to the FDA for consideration. The company maintains a FAIR financial health rating according to InvestingPro, though investors should note its current ratio of 0.72 indicates potential short-term liquidity challenges. InvestingPro subscribers can access 8 additional key insights about OTLK’s financial position and market performance.

The information in this article is based on a press release statement from Outlook Therapeutics. The company has not provided any endorsement of claims or promotional language, and the article focuses solely on the factual content of the press release.

In other recent news, Outlook Therapeutics announced a public offering of its common stock and warrants, with proceeds intended for general corporate purposes and working capital. The company has yet to disclose the offering’s size or terms, and completion is subject to market conditions. Additionally, the U.S. Food and Drug Administration (FDA) has set an August 27, 2025, review date for the Biologics License Application of Outlook Therapeutics’ ONS-5010, an ophthalmic formulation of bevacizumab for wet age-related macular degeneration. This development follows the FDA’s acceptance of the resubmitted application, marking a critical step toward potential U.S. market entry. Analysts at Guggenheim have maintained a Buy rating on the company, with a target price of $10, highlighting the FDA’s acceptance as a positive indicator. Furthermore, Outlook Therapeutics is preparing for the commercial launch of ONS-5010 in the UK and Germany in the second quarter of 2025. In corporate governance updates, shareholders approved an increase in authorized common stock from 60 million to 260 million shares, effective March 11, 2025. The company’s financial strategy also included terminating a previous agreement with Streeterville Capital and securing a new $33.1 million convertible promissory note with Avondale Capital.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.