Outlook Therapeutics Inc Stock Price, News & Analysis

Outlook Therapeutics is poised to submit a Biologics License Application (BLA) for its ophthalmic formulation of bevacizumab (ONS-5010), targeting critical retinal diseases. Key highlights include the appointment of a new SVP for commercial operations and a successful $57.5 million equity offering, bolstering its financial standing. Positive data from the NORSE TWO Phase 3 trial indicates significant visual improvements for patients. The company aims for commercial launch post-FDA approval, anticipated in early 2023, which could secure 12 years of market exclusivity.

Outlook Therapeutics, a biopharmaceutical company focused on developing the first FDA-approved ophthalmic formulation of bevacizumab, will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, at 10:40 AM ET. The President & CEO, C. Russell Trenary III, will lead the presentation, followed by one-on-one virtual meetings with investors. A live video webcast of the presentation will be available on the company's investor website, with a replay accessible for 90 days. Outlook aims to commercialize ONS-5010 as the first FDA-approved formulation for retinal diseases.

Outlook Therapeutics has appointed Joel Prieve as the new Senior Vice President of Commercial Operations, bringing nearly 20 years of experience in commercial operations and specialty biopharmaceutical distribution. His role will be critical as the company anticipates submitting a Biologics License Application (BLA) for ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab, in Q1 2022. Outlook Therapeutics aims for a potential commercial launch in late 2022 or early 2023 and is also preparing for regulatory submissions in Europe.

Outlook Therapeutics, a biopharmaceutical company, will present at the Telluride Retina Film Festival from February 3-5, 2022. The event will feature a corporate overview highlighting the company's efforts to develop ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab for retinal treatments, including wet AMD and DME. If approved, ONS-5010 will be marketed in the U.S., U.K., Europe, Japan, and other regions. Outlook Therapeutics aims to submit its BLA to the FDA under the PHSA 351(a) pathway.

Outlook Therapeutics advances ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab, aiming for BLA submission this quarter. The company expects 12 years of market exclusivity in the $13 billion global anti-VEGF market if approved. A strong balance sheet supports capital needs during this phase. Outlook plans to conduct the NORSE SEVEN study comparing vial vs. pre-filled syringe delivery systems for ONS-5010. They have initiated pre-commercial planning and discussions with payors and retina community for potential launch.

Outlook Therapeutics (Nasdaq: OTLK) announced a live video webcast presentation on January 25, 2022, at 3:00 PM ET during the Virtual Investor 2022 Top Picks Conference. CEO C. Russell Trenary III will lead the corporate presentation and an interactive Q&A session. Investors can submit questions live or in advance via the conference website. The company is focused on developing ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications like wet AMD and DME. A replay of the webcast will be available for one year.

Outlook Therapeutics, a biopharmaceutical company, has announced that CEO C. Russell Trenary III will participate in the upcoming H.C. Wainwright BioConnect Conference from January 10-13, 2022. The company is developing ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD and DME. A video webcast of the fireside chat will be available on-demand starting January 10, 2022. Outlook Therapeutics aims to submit ONS-5010 to the U.S. FDA, potentially becoming the first approved ophthalmic bevacizumab in several key markets.

Outlook Therapeutics reported significant clinical progress for ONS-5010 (bevacizumab-vikg) in 2021, highlighting positive results from the Phase 3 NORSE TWO trial for wet AMD, demonstrating statistically significant efficacy (p = 0.0052) and strong safety data. The company successfully closed a $57.5 million equity offering, funding anticipated approval for the ONS-5010 BLA expected in early 2023. A comprehensive pre-commercialization plan is underway, targeting a multi-billion dollar market amidst existing unapproved alternatives. Outlook aims to establish ONS-5010 as a safe, cost-effective treatment option.

Outlook Therapeutics announced that Francesco Bandello, MD, FEBO, will present pivotal safety and efficacy data from the NORSE TWO trial for ONS-5010 / LYTENAVA at the 9th International Congress on OCT and OCT Angiography in Rome on December 18, 2021. This investigational formulation targets wet age-related macular degeneration (wet AMD). Dr. Bandello emphasized the potential significance of these results for retinal specialists and patients. The presentation is scheduled for 5:48 AM ET.