Welcome to our dedicated page for Outlook Therapeutics news (Ticker: OTLKW), a resource for investors and traders seeking the latest updates and insights on Outlook Therapeutics stock.
Outlook Therapeutics Inc (OTLKW) is a biopharmaceutical innovator advancing ophthalmic treatments for conditions like wet age-related macular degeneration (wet AMD). This page serves as the definitive source for verified company updates, offering investors and healthcare professionals timely access to critical developments.
Find curated press releases covering regulatory milestones, clinical trial progress, and strategic partnerships. Our repository includes updates on the company’s EU/UK-approved bevacizumab formulation, financial filings, and research breakthroughs—all organized for efficient tracking of this clinical-stage leader.
Regularly refreshed with official announcements, this resource helps stakeholders monitor OTLKW’s progress in addressing unmet ophthalmic needs. Bookmark this page to stay informed about pipeline advancements and market expansions directly from the source.
Outlook Therapeutics (Nasdaq: OTLK) has announced an underwriting agreement with H.C. Wainwright & Co. to offer 10 million shares of common stock at $1.00 each, aiming to raise approximately $10 million in gross proceeds. The offering will close around February 2, 2021, pending customary conditions. The company plans to use the proceeds for general corporate purposes and to support its ONS-5010 development program. The underwriter has the option to purchase an additional 1.5 million shares. This offering is conducted under an effective SEC registration statement.
On January 12, 2021, Outlook Therapeutics (OTLK) announced a podcast featuring Dr. Firas Rahhal discussing the need for an FDA-approved ophthalmic formulation of bevacizumab, specifically ONS-5010, for retinal diseases. COO Terry Dagnon and CCO Jeff Evanson elaborated on the clinical development strategy for ONS-5010, which is currently in Phase 3 trials. The drug aims to meet a market demand in the $13 billion anti-VEGF therapy market, providing a safe, cGMP-produced alternative to off-label bevacizumab. The BLA filing with the FDA for wet AMD is anticipated in the second half of 2021.
Outlook Therapeutics, a late clinical-stage biopharmaceutical company, has announced that Lawrence A. Kenyon, its President, CEO, and CFO, will present at the H.C. Wainwright BioConnect 2021 Virtual Conference from January 11-14, 2021. During this event, Kenyon will discuss the development of ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab-vikg for retinal diseases. A video webcast of the presentation will be available on-demand starting January 11, 2021, at 6:00 AM ET on their website.
Outlook Therapeutics announced pivotal updates regarding ONS-5010 / LYTENAVA™ and financial results for the fiscal year ending September 30, 2020. The company reported a net loss of $48.9 million, or $0.67 per share, an increase from $36.0 million in the previous year. All planned clinical trials for ONS-5010 are fully enrolled or completed, with pivotal data from the Phase 3 trial expected in mid-2021, followed by a BLA submission. Outlook anticipates engaging with regulatory authorities in Europe and plans further registration trials for diabetic macular edema and branch retinal vein occlusion.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced it has regained compliance with Nasdaq's minimum bid price requirement after its common stock closed at $1.00 or greater for 10 consecutive trading days. This achievement comes as the company advances ONS-5010/LYTENAVA™, its ophthalmic formulation of bevacizumab, aimed at obtaining FDA approval for retinal diseases such as wet AMD, DME, and BRVO. Outlook is set to file for a new BLA under the 351(a) pathway for ONS-5010 initially targeting wet AMD.
Outlook Therapeutics (NASDAQ: OTLK) has established a Global Retina Advisory Council to enhance the development and commercialization of ONS-5010, an investigational ophthalmic formulation of bevacizumab for retinal conditions like wet AMD. Mark Humayun, MD, PhD, will chair the council, supported by Firas Rahhal, MD. The company aims to file a Biologics License Application (BLA) for ONS-5010 in mid-2021, expecting FDA approval by mid-2022. This initiative addresses issues related to unapproved repackaged IV bevacizumab, potentially leading to wider adoption among clinicians.
Outlook Therapeutics, a clinical-stage biopharmaceutical company, recently held a KOL Roundtable featuring Dr. Firas Rahhal, who discussed the treatment landscape for wet AMD and the potential of ONS-5010/LYTENAVA™ (bevacizumab-vikg). This investigational drug aims to be the first FDA-approved ophthalmic formulation of bevacizumab. The management provided insights on the ongoing Phase 3 clinical trials and plans for commercialization, expecting to file a BLA in 2021. ONS-5010 could address treatment shortcomings and offer a viable alternative to expensive anti-VEGF therapies currently in use.
Outlook Therapeutics, a clinical-stage biopharmaceutical company, has secured a $10.2 million unsecured promissory note for $10 million in cash proceeds. The funding aims to pay off existing demand notes and support ongoing development of its ophthalmic formulation, ONS-5010, for retinal diseases, including wet AMD. The note carries a 7.5% interest rate and matures on January 1, 2022. Outlook is focused on submitting its Biologics License Application (BLA) for ONS-5010 in late 2021 and seeks a commercial partner by year-end.
Outlook Therapeutics has achieved full enrollment of 195 subjects in the NORSE THREE clinical trial for its investigational product ONS-5010/LYTENAVA™ in under one month, ahead of schedule.
All trials for ONS-5010 for wet AMD are now fully enrolled or completed, aiming for a Biologics License Application (BLA) submission in the second half of 2021. The market potential for ONS-5010 is significant, with an expected entry into the estimated $13 billion global market for anti-VEGF therapies.
Outlook Therapeutics (Nasdaq: OTLK) will host a live KOL Roundtable discussion on October 29, 2020, at 10:00 AM ET. Management, including Lawrence Kenyon and Terry Dagnon, alongside Dr. Firas M. Rahhal, will discuss their lead product, ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab-vikg for retinal diseases. Investors can access the webcast on their website, with a replay available post-event.
