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. (Nasdaq: OTLK) is a biopharmaceutical company centered on ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma), an ophthalmic formulation of bevacizumab for retina diseases such as wet age-related macular degeneration (wet AMD). News about Outlook Therapeutics typically focuses on clinical, regulatory, and commercial milestones related to this product candidate and its marketed formulation in Europe and the UK.
Readers following OTLK news can expect updates on interactions with the U.S. Food and Drug Administration (FDA), including Biologics License Application (BLA) submissions, complete response letters (CRLs), Type A meetings, and review classifications such as Class 1 reviews with specified PDUFA goal dates. These regulatory developments are central to understanding the potential U.S. path for ONS-5010/LYTENAVA™ as an investigational treatment for wet AMD.
In addition, Outlook Therapeutics issues news on its European and UK activities, including Marketing Authorizations granted by the European Commission and the MHRA, the commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK, and early commercial performance indicators such as initial sales into distribution channels. Company announcements may also cover efforts to expand into additional European markets and explore collaborations with commercial and distribution partners in other regions.
Corporate and financial news items provide insight into Outlook Therapeutics’ leadership changes, strategic hires in areas like corporate strategy and business development, stock-based inducement grants, and periodic financial results that reference revenue from LYTENAVA™ sales and spending patterns related to clinical trials and launches. Conference participation, investor presentations, and scientific meeting appearances are also common topics. For investors and observers interested in the evolution of ophthalmic bevacizumab therapies and wet AMD treatment approaches, the Outlook Therapeutics news feed offers a focused view of the company’s progress.
Outlook Therapeutics announced a public offering of 40 million shares of common stock at $1.25 per share, totaling expected gross proceeds of $50 million. The offering was increased due to demand, with H.C. Wainwright & Co. as the sole book-running manager. A 30-day option for an additional 6 million shares is also available. GMS Ventures, linked to a major stockholder, indicated interest in purchasing up to $20 million of the offering. Proceeds will support the development of ONS-5010, a potential FDA-approved ophthalmic treatment.
Outlook Therapeutics announced an underwriting agreement with H.C. Wainwright & Co. for 8,000,000 shares of common stock at $1.25 per share, projected to raise approximately $10 million. The offering closes on November 29, 2021, pending customary conditions. An additional 1,200,000 shares may be purchased by the underwriter. The funds will be utilized for working capital and corporate purposes, supporting the ONS-5010 development program. The shares are offered under an effective SEC registration statement.
Outlook Therapeutics has announced highly significant results from the Phase 3 NORSE TWO trial of ONS-5010, an ophthalmic formulation of bevacizumab, designed for wet age-related macular degeneration (wet AMD). The trial demonstrated that 41.7% of patients gained at least 15 letters in vision and met both primary and secondary endpoints. The company plans to submit a BLA to the U.S. FDA in Q1 2022, aiming for ONS-5010 to be the first FDA-approved ophthalmic bevacizumab, which could provide significant benefits for AMD patients.
Outlook Therapeutics (Nasdaq: OTLK) will host a Virtual Investor Roundtable Event on November 16, 2021, at 9:00 AM ET. Management, including President C. Russell Trenary and COO Terry Dagnon, will discuss the development of ONS-5010 (LYTENAVA™), the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. Key thought leaders, Firas M. Rahhal, MD, and Robert L. Avery, MD, will join the discussion. A live video webcast will be accessible on their website and a replay will be available for one year.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that Dr. Firas M. Rahhal will present pivotal Phase 3 data from the NORSE TWO trial on November 13, 2021. This presentation will cover the safety and efficacy of ONS-5010 / LYTENAVA™, an investigational ophthalmic formulation of bevacizumab for retinal conditions. The event takes place during the Retina Subspecialty Day at the American Academy of Ophthalmology (AAO) 2021 Annual Conference in New Orleans. If approved, ONS-5010 is expected to be the first FDA-approved ophthalmic formulation of bevacizumab, targeting wet AMD and other retinal diseases.
Outlook Therapeutics presents at Eyecelerator@AAO 2021 Conference
ISELIN, N.J., Nov. 3, 2021 - Outlook Therapeutics (Nasdaq: OTLK) announced that CEO C. Russell Trenary will present at the Eyecelerator@AAO 2021 Retina Showcases in New Orleans on November 11, 2021, from 1:10 PM to 1:15 PM EST. The company focuses on developing ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases such as wet AMD and DME. If approved, it could be the only FDA-approved ophthalmic formulation of this drug in various global markets.
Outlook Therapeutics presented strong safety data from the NORSE THREE study of ONS-5010 at the 39th Annual Meeting of the American Society of Retina Specialists. The trial demonstrated no unexpected safety trends, with adverse events primarily related to injection procedures. ONS-5010 is being developed as the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. The company plans to submit a BLA in early 2022, which, if approved, could lead to 12 years of marketing exclusivity for ONS-5010. This formulation aims to replace off-label alternatives currently in use.
Suber Huang, MD, MBA, FASRS will present safety data from Outlook Therapeutics’ NORSE THREE registration trial on October 12, 2021. The study focuses on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational formulation for retinal indications. The presentation will occur at the 2021 Annual Meeting of the American Society of Retina Specialists in San Antonio, Texas, highlighting safety results in patients with wet AMD, DME, and BRVO. If approved, ONS-5010 is expected to be the first FDA-approved ophthalmic formulation of bevacizumab.
Outlook Therapeutics will showcase its innovations at the OIS Retina Innovation Showcase on October 7, 2021. C. Russell Trenary, President and CEO, will present the company's mission to introduce the first FDA-approved ophthalmic formulation of bevacizumab for retinal conditions. The presentation is set for 8:55 AM CT, followed by a panel with Jeff Evanson, Chief Commercial Officer, at 4:35 PM CT. Their product, ONS-5010/LYTENAVA™, aims to treat wet AMD, DME, and BRVO, targeting U.S. and international markets.
Outlook Therapeutics announced new 12-month safety data from the pivotal Phase 3 NORSE TWO trial for its investigational ophthalmic formulation ONS-5010 (bevacizumab-vikg) targeting wet age-related macular degeneration (AMD). The results confirm a strong safety profile consistent with previous trials. Topline findings reveal 41% of patients treated with ONS-5010 gained at least 15 letters in visual acuity compared to 23% with ranibizumab. Plans for a Biologics License Application submission to the FDA are set for Q1 2022, aiming for ONS-5010 to be the first FDA-approved ophthalmic bevacizumab.