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 (OTLK) announced operational streamlining initiatives following internal strategic review. The company will implement a 23% workforce reduction, expecting annual savings of $1.4 million. This decision follows the recent EU and UK regulatory approvals of LYTENAVA™ (bevacizumab gamma) for wet AMD treatment.
LYTENAVA™ received NICE recommendation and has secured 10 years of market exclusivity in the EU and UK as the first authorized ophthalmic formulation of bevacizumab. The company plans to resubmit its BLA application to the FDA in Q1 2025, following the full NORSE EIGHT trial results expected in January 2025.
Outlook Therapeutics (OTLK) has received a positive recommendation from the National Institute for Health and Care Excellence (NICE) for LYTENAVA™ (bevacizumab gamma) in treating wet age-related macular degeneration (wet AMD). This marks the first positive reimbursement decision worldwide for LYTENAVA™.
The drug, which received regulatory approval in the EU and UK earlier this year, is the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment in these regions. It has secured 10 years of market exclusivity. The company anticipates its first commercial launch in H1 2025, with potential to benefit approximately 40,000 new wet AMD patients annually in the UK.
The recommendation applies to England and Wales, and follows LYTENAVA™'s Marketing Authorization by the UK MHRA. Outlook Therapeutics has partnered with Cencora for global commercial launch support.
Outlook Therapeutics (OTLK) announced an immediate executive leadership change as Russell Trenary steps down from his position as President and CEO. Lawrence Kenyon, the current Executive Vice President, CFO, and board member, has been appointed as Interim CEO.
The company, which recently received regulatory approval in the EU and UK for LYTENAVA™ (bevacizumab gamma) - the first ophthalmic formulation of bevacizumab for wet AMD treatment - maintains its plans to resubmit the BLA for ONS-5010 in Q1 2025 and commence LYTENAVA™ sales in Europe in H1 2025. The board has initiated a search for a permanent CEO through an executive search firm.
Outlook Therapeutics announced preliminary topline results of NORSE EIGHT trial for ONS-5010 in wet AMD patients. The trial did not meet its pre-specified non-inferiority endpoint at week 8 compared to ranibizumab. The ONS-5010 arm showed +4.2 letter improvement in BCVA versus +6.3 letters for ranibizumab. Despite not meeting the endpoint, the drug demonstrated vision improvement, biologic activity, and favorable safety profile. Final efficacy data is expected in January 2025, with BLA resubmission planned for Q1 2025. The company maintains European and UK marketing authorization for LYTENAVA™, with potential launch in these markets in 2025.
Outlook Therapeutics (OTLK), which recently secured regulatory approval in the EU and UK for its ophthalmic bevacizumab formulation treating wet AMD, announces its participation in the Guggenheim Healthcare Innovation Conference. CEO Russell Trenary will engage in a fireside chat on November 12, 2024, at 2:30 PM ET in Boston, MA. The management team will also conduct one-on-one meetings with qualified investors attending the conference. A live webcast will be available on the company's website, with the replay accessible for 90 days post-event.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company, announced that its President and CEO, Russell Trenary, participated in a Virtual Investor CEO Connect segment. The segment, now available for viewing, provided an overview of the company's recent achievements and upcoming milestones. Outlook Therapeutics recently gained regulatory approval in the European Union and the United Kingdom for the first authorized use of an ophthalmic formulation of bevacizumab to treat wet age-related macular degeneration (wet AMD). The company is working towards becoming the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company, announced its participation in the Virtual Investor Closing Bell Series. Russell Trenary, President and CEO, will present on Thursday, September 19, 2024, at 4:00 PM ET. The event will include a corporate overview, business outlook, and a live Q&A session.
Notably, Outlook Therapeutics recently achieved regulatory approval in the European Union and the United Kingdom for the first authorized use of an ophthalmic formulation of bevacizumab to treat wet age-related macular degeneration (wet AMD). This milestone highlights the company's progress in the ophthalmology field.
Investors can access the live video webcast on the company's website, with a replay available for 90 days post-event.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company, recently participated in the 2nd Annual Chardan Virtual Ophthalmology Conference Series. The company, which gained regulatory approval in the EU and UK for the first authorized ophthalmic formulation of bevacizumab to treat wet age-related macular degeneration (wet AMD), was featured among 8 companies at the event. The conference focused on AMD and diabetes-related ocular diseases.
As part of the virtual event, Outlook Therapeutics' executives Russell Trenary (President and CEO) and Lawrence Kenyon (CFO) participated in a fireside chat hosted by Chardan's Senior Research Analyst, Daniil Gataulin, PhD. A video webcast of this discussion is now available for viewing online.
Outlook Therapeutics (Nasdaq: OTLK) has announced the completion of enrollment for its NORSE EIGHT clinical trial, evaluating ONS-5010 in wet AMD patients. This trial, subject to a Special Protocol Assessment (SPA) agreement with the FDA, is the final anticipated clinical study before the expected resubmission of the company's Biologics License Application (BLA) for ONS-5010.
Key points:
- NORSE EIGHT is a randomized, controlled study comparing ONS-5010 to ranibizumab
- Topline results are expected in Q4 2024
- BLA resubmission is planned for Q1 2025
- The trial aims to address the clinical deficiency identified in the previous Complete Response Letter
If approved by the FDA, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA™ (bevacizumab-vikg) directly in the U.S. and is exploring partnering options for Europe and other regions.
Outlook Therapeutics (Nasdaq: OTLK), a biopharmaceutical company, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York. Russell Trenary, President and CEO, will present at the conference and be available for one-on-one meetings with qualified investors.
The company recently achieved regulatory approval in the European Union and the United Kingdom for the first authorized ophthalmic formulation of bevacizumab to treat wet age-related macular degeneration (wet AMD). A video webcast of the presentation will be available on-demand from September 9, 2024, at 7:00 AM ET for registered attendees and on the company's website for 90 days following the event.
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