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. develops and commercializes ONS-5010/LYTENAVA, an ophthalmic formulation of bevacizumab for retina diseases, including wet age-related macular degeneration. Company news commonly covers the product’s European Commission and MHRA marketing authorizations, commercial launch activity in Germany, Austria and the UK, and U.S. regulatory communications involving the biologics license application pathway for neovascular AMD.
Updates also include capital-structure actions used to fund operations, such as public offerings, registered direct offerings, warrants, convertible-note amendments and note financing. Governance and shareholder-approval matters appear in connection with securities issuance and authorized-share requirements.
Outlook Therapeutics announced that Dr. Suber Huang will present pivotal data from the Phase 3 NORSE TWO trial for ONS-5010 (bevacizumab-vikg) targeting wet AMD at the 14th Asia-Pacific Vitreo-Retina Society Congress on December 10, 2021. The results are significant, positioning ONS-5010 as a potential FDA-approved ophthalmic formulation, which could mitigate adverse effects linked to off-label use of repackaged IV bevacizumab. If approved, this formulation will be the first on-label treatment for retinal diseases, supporting Outlook’s endeavor to enhance patient care.
Outlook Therapeutics announced the closing of an underwritten public offering of 46 million shares at $1.25 each, generating gross proceeds of $57.5 million. These funds will support the development of ONS-5010, an ophthalmic formulation of bevacizumab, with an expected biologics license application submission to the FDA in early 2023. The offering was managed by H.C. Wainwright & Co. The shares were offered under a shelf registration statement originally filed in March 2021. This move positions the company to advance its lead product for treating retinal diseases.
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.