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 dedicated to developing and commercializing innovative monoclonal antibody (mAb) therapies for ocular diseases. The cornerstone of their pipeline is ONS-5010, also known as Lytenava™, which targets various ophthalmic indications, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO).
Outlook Therapeutics aims to address the unmet needs in ophthalmology with cost-effective and accessible treatment options. The company leverages its proprietary BioSymphony™ platform to expedite the development of these complex biologics, ensuring high standards of quality and compliance with regulatory requirements.
Recent achievements include the successful completion of Phase 3 clinical trials for ONS-5010. These promising results bring Outlook Therapeutics a step closer to FDA approval and commercialization. The company is also exploring strategic partnerships to enhance its market reach and streamline its operations.
Financially, Outlook Therapeutics shows a robust commitment to R&D, as evidenced by their investment in clinical trials and manufacturing capabilities. Their integrated approach, combining in-house development and scalable production, positions them as a competitive player in the biosimilar market.
For investors, Outlook Therapeutics represents a unique opportunity in the biopharmaceutical sector focused on ophthalmology. The company’s strategic direction and ongoing projects highlight its potential for significant growth and market impact.
Outlook Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation for treating wet AMD. This follows a similar approval by the European Commission. The commercial launch in the UK and EU is anticipated for Q1 2025. Outlook Therapeutics has partnered with Cencora to support these launches, ensuring market access and efficient distribution. The MHRA's approval marks a significant milestone, offering the first authorized ophthalmic bevacizumab for wet AMD in these regions.
Outlook Therapeutics (Nasdaq: OTLK) will present at the Virtual Investor Pitch Conference on June 18, 2024, at 12:00 PM ET. CEO Russell Trenary will deliver an elevator pitch and discuss the company's upcoming milestones, focusing on the commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg). The event will be live-streamed on the Investors section of the company's website, with a replay available for 90 days. Investors can submit questions during the live presentation.
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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