Outlook Therapeutics Inc Stock Price, News & Analysis

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.