FDA issues Complete Response Letter (CRL) for resubmitted ONS-5010 BLAOutlook Therapeutics plans to work with FDA to address the Agency’s issuesCompany to host a conference call and webcast today, August 28th at 8:30 AM ET ISELIN, N.J., Aug. 28, 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 the U.S. Food and Drug Administration (FDA) has issue ...

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]

Core Viewpoint - Outlook Therapeutics, Inc. has announced a public offering of 9,285,714 shares of common stock at a price of $1.40 per share, along with warrants to purchase an additional 18,571,428 shares, aiming to raise approximately $13.0 million in gross proceeds [1][2]. Group 1: Offering Details - The public offering includes common stock sold in combination with warrants, where each share sold comes with a warrant to purchase two additional shares at an exercise price of $1.40 [1]. - The offering is expected to close on May 27, 2025, pending customary closing conditions [1]. - BTIG, LLC is acting as the sole book-running manager for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital and other general corporate purposes [2]. Group 3: Company Overview - Outlook Therapeutics focuses on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg), aimed at enhancing the standard of care for retinal diseases [5]. - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for treating wet age-related macular degeneration (wet AMD) [5]. - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and the UK in the second quarter of 2025, while the product remains investigational in the United States [5].

Core Viewpoint - Outlook Therapeutics, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, aimed at enhancing the standard of care for bevacizumab in treating retina diseases [1][2] Group 1: Offering Details - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1] - The net proceeds from the offering will be utilized for working capital and other general corporate purposes [2] - BTIG, LLC is serving as the sole book-running manager for the offering [2] Group 2: Regulatory and Product Information - The securities are being offered under a shelf registration statement declared effective by the SEC on April 5, 2024 [3] - Outlook Therapeutics is focused on the development of ONS-5010/LYTENAVA™ (bevacizumab-vikg), which is the first ophthalmic formulation of bevacizumab approved for wet age-related macular degeneration in the EU and UK [5] - The company plans to initiate the commercial launch of LYTENAVA™ in the EU and UK in the second quarter of 2025, while the product is still investigational in the U.S. [5]