Welcome to our dedicated page for Outlook Therapeutics news (Ticker: OTLK), a resource for investors and traders seeking the latest updates and insights on Outlook Therapeutics stock.
Outlook Therapeutics Inc (OTLK) is a clinical-stage biopharmaceutical company advancing innovative ophthalmic therapies, including its lead candidate for wet age-related macular degeneration. This page offers investors and industry professionals timely updates on company developments.
Access comprehensive coverage of OTLK's progress, including regulatory milestones, clinical trial results, strategic partnerships, and financial performance. Our curated news collection ensures you stay informed about critical developments in monoclonal antibody research and ophthalmic treatment advancements.
Key focus areas include updates on European Union and UK regulatory pathways, in-house manufacturing capabilities, and scientific innovations addressing unmet medical needs. All content is verified for accuracy and presented in clear language for expert and general audiences alike.
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Outlook Therapeutics has received European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation for treating wet AMD. This makes it the first ophthalmic bevacizumab formulation approved for wet AMD in the EU.
This authorization covers all 27 EU Member States and will extend to Iceland, Norway, and Liechtenstein within 30 days. The company is planning a commercial launch for Q1 2025, with ten years of market exclusivity in the EU.
Outlook Therapeutics has partnered with Cencora to support the commercial launch, providing comprehensive services such as pharmacovigilance, regulatory affairs, and distribution.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company focused on retinal disease treatments, announced its Q2 FY2024 financial results and provided a corporate update. The company reported a net loss of $114.3 million ($8.01 per share), up from $6.7 million ($0.52 per share) last year. Adjusted net loss was $22.1 million ($1.55 per share), influenced by warrant-related expenses. As of March 31, 2024, Outlook Therapeutics had $47.2 million in cash.
Key milestones include a CHMP positive opinion for ONS-5010 in the EU, UK MAA submission, NORSE EIGHT trial progress, and planned resubmission of the ONS-5010 BLA by end of CY2024. The company anticipates potential FDA approval and commercial launch of ONS-5010 in 2025.
Outlook Therapeutics hosted its inaugural quarterly update call on May 16, 2024, discussing these developments and future plans.
Outlook Therapeutics® has submitted a Marketing Authorization Application (MAA) for ONS-5010/LYTENAVA™ for the treatment of wet age-related macular degeneration (AMD) in the UK. This move follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The positive CHMP opinion was for the authorization of ONS-5010/LYTENAVA™ in the EU. The submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK was made under the International Recognition Procedure (IRP), leveraging the CHMP opinion. The successful MAA submission would provide a new treatment option for wet AMD patients in the UK.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) will report its financial results for the second quarter fiscal year 2024 on May 16, 2024. The company aims to achieve the first approval for an ophthalmic formulation of bevacizumab for retinal diseases in the US and the EU. The management will host a quarterly conference call and webcast on the same day to discuss operational and financial results.
Outlook Therapeutics, Inc. (OTLK) will present at the 2024 Retina World Congress to discuss their investigational ophthalmic formulation of bevacizumab for retinal diseases. The presentation will be led by Russell Trenary, the President and CEO, on May 9, 2024. This formulation aims to provide a safe and effective treatment option for wet AMD, addressing the current risks associated with using repackaged IV bevacizumab.
Outlook Therapeutics, Inc. (OTLK) will present at the Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase on May 4, 2024. The company aims to secure approval for an ophthalmic bevacizumab formulation for retinal disease treatment in the US and EU. Russell Trenary, President and CEO, will lead the company presentation at 8:35 AM PT.
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