Live webcast fireside chat on Tuesday, December 2nd at 10:00 AM ETISELIN, N.J., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that Bob Jahr, Chief Executive Officer of Outlook Therapeutics, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 10:00 AM ET. In addition to ...

Core Insights - The FDA has accepted the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), with a Prescription Drug User Fee Act (PDUFA) goal date set for December 31, 2025, marking a significant milestone for Outlook Therapeutics in bringing the first FDA-approved ophthalmic formulation of bevacizumab for wet age-related macular degeneration (wet AMD) to the U.S. market [1][2][7] Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg) to enhance the standard of care for retinal diseases, particularly wet AMD [6] - The company has commenced the commercial launch of LYTENAVA™ in Germany and the UK, where it has received Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) [6] Product Details - ONS-5010/LYTENAVA™ is an investigational ophthalmic formulation of bevacizumab produced in the U.S. for treating wet AMD, which is currently under review in the U.S. [3][4][7] - Bevacizumab-vikg is a recombinant humanized monoclonal antibody that binds to all isoforms of human vascular endothelial growth factor (VEGF), neutralizing its activity and reducing endothelial cell proliferation and vascular leakage in the retina [5]

Core Viewpoint - Outlook Therapeutics has re-submitted its Biologics License Application (BLA) for ONS-5010 to the FDA, aiming for approval of its ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD) [1][2] Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg) to optimize the standard of care for retinal diseases [6] - The company has commenced the commercial launch of LYTENAVA™ in Germany and the UK for wet AMD treatment [6] Product Details - ONS-5010/LYTENAVA™ is an investigational ophthalmic formulation of bevacizumab produced in the U.S. for wet AMD [3][7] - If approved in the U.S., it would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [7] - LYTENAVA™ has received centralized Marketing Authorization from the European Commission and the MHRA in the UK for wet AMD treatment [3][4] Regulatory Progress - The resubmission of the BLA is seen as a significant step in addressing issues raised in the Complete Response Letter (CRL) received in August 2025 [2] - The company is accelerating its commercial efforts in Europe while preparing for potential near-term U.S. approval [2]

Core Viewpoint - Outlook Therapeutics, Inc. has completed a Type A Meeting with the FDA regarding the complete response letter for its biologics license application for ONS-5010, an investigational treatment for wet AMD, and plans to resubmit the application by the end of 2025 [1][2] Company Overview - Outlook Therapeutics is focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg) to optimize the standard of care for retinal diseases [6] - The company has commenced the commercial launch of LYTENAVA™ in Germany and the UK for the treatment of wet AMD [6] Product Information - ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab aimed at treating wet AMD and has received centralized Marketing Authorization in the EU and the UK [3][4] - If approved in the U.S., ONS-5010/LYTENAVA™ would be the first ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [7] Regulatory Discussion - The FDA meeting was described as productive, and the company is awaiting written minutes to finalize its plans for resubmission of the BLA [2] - The company remains committed to providing a safe and effective treatment for patients, physicians, and payors in the U.S. [2]

Core Insights - Outlook Therapeutics, Inc. is focused on optimizing the standard of care for bevacizumab in treating retinal diseases [1][2] - The company will present at the EURETINA Congress on September 3, 2025, discussing advancements in retinal disease treatment [1] - ONS-5010/LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for wet AMD [2] Company Overview - Outlook Therapeutics is a biopharmaceutical company dedicated to the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg) [2] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK for the treatment of wet AMD [2] - In the United States, ONS-5010/LYTENAVA™ is currently investigational and would be the first approved ophthalmic formulation of bevacizumab for retinal indications if approved [3]

Core Viewpoint - Outlook Therapeutics, Inc. received a complete response letter (CRL) from the FDA regarding its biologics license application (BLA) for ONS-5010, indicating that the application cannot be approved in its current form for the treatment of wet age-related macular degeneration (wet AMD) [1][2][3] Group 1: FDA Response and Efficacy - The CRL cited a single deficiency related to a lack of substantial evidence of effectiveness, specifically noting that ONS-5010 did not meet the primary efficacy endpoint in the NORSE EIGHT trial [2] - The FDA recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010, while also acknowledging that the NORSE TWO trial met its primary endpoint for effectiveness [2] Group 2: Company Response and Future Plans - The company expressed disappointment with the FDA's decision but plans to meet with the FDA for further clarification on approval requirements for ONS-5010 [3] - Outlook Therapeutics remains committed to providing a safe and effective alternative to compounded Avastin and intends to continue expanding into additional markets in Europe [3] - LYTENAVA™ (bevacizumab gamma) has already received Marketing Authorization in the EU and the UK for the treatment of wet AMD and became commercially available in Germany and the UK in June 2025 [3][10] Group 3: Product Information - ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab specifically designed for the treatment of wet AMD [7][10] - If approved in the U.S., ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [11]

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retinal diseases [3] - The company is developing ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), which is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for treating wet AMD [3] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK for the treatment of wet AMD [3] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [4] - If approved, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [4] Industry Event - Outlook Therapeutics will present at the 8th Annual OIS Retina Innovation Summit on July 29, 2025, in Long Beach, CA [1] - The presentation will be part of the Innovation Showcase, led by CEO Bob Jahr [1] - The Ophthalmology Innovation Summit aims to showcase novel therapies for unmet needs in ophthalmic diseases and vision disorders, facilitating connections among entrepreneurs, clinical leaders, and investment professionals [2]

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [3] - The company has developed ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), which is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for treating wet AMD [3] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK for the treatment of wet AMD [3] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [4] - If approved, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [4] Leadership Insights - Bob Jahr, the newly appointed CEO, participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference, sharing his journey and excitement for the future of Outlook Therapeutics [2] - The on-demand video webcast of the conference is available on virtualinvestorco.com and the company's website [2]

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [9] - The company has launched LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) in Europe, specifically in Germany and the UK, for the treatment of wet age-related macular degeneration (AMD) [9] Leadership Appointment - Bob Jahr has been appointed as the Chief Executive Officer (CEO) of Outlook Therapeutics and will also join the Board of Directors [1][2] - Lawrence A. Kenyon will continue in his role as Chief Financial Officer (CFO) and remain a member of the Board of Directors [1] Executive Experience - Mr. Jahr brings over 20 years of experience in the biopharmaceutical industry, having led commercial teams across various therapeutic areas including rare disease, oncology, and hematology [3] - He has a proven track record of managing multiple billion-dollar assets and franchises [3] Strategic Importance - The appointment of Mr. Jahr is seen as timely due to the ongoing commercial launch in Europe and the potential for U.S. FDA approval in the coming months [2] - Mr. Jahr expressed excitement about joining the company at a pivotal time, emphasizing the potential of LYTENAVA™ to transform the global retina market [4] Inducement Grant - The Board of Directors approved an option for Mr. Jahr to purchase 800,000 shares of common stock as an inducement for his employment [6] - The option will be issued on July 1, 2025, with an exercise price equivalent to the closing price of the stock on that date, vesting over four years [7]

Core Insights - Outlook Therapeutics, Inc. is participating in a Virtual Investor Lunch Break Event on June 25, 2025, at 12:00 PM ET [1] - Key executives will discuss the company's commercial strategy, upcoming milestones, and current activities during the event [2] - A live video webcast will be available on the company's website, with a replay accessible for 90 days [3] Company Overview - Outlook Therapeutics focuses on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg) to enhance the standard of care for retinal diseases [4] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for the treatment of wet AMD [4] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK [4] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [5] - If approved, it would be the first ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [5]