Outlook Therapeutics, Inc. - OTLK STOCK NEWS

Outlook Therapeutics (OTLK) announced a reorganization of BioLexis, its strategic shareholder, which will be renamed Tenshi Healthcare Pte Limited. The reorganization enhances GMS Holdings' position, allowing for direct ownership of Outlook Therapeutics shares. Outlook Therapeutics has submitted a Biologics License Application (BLA) for its investigational therapy ONS-5010 (bevacizumab-vikg) to the FDA, marking a key milestone for the company. This submission is supported by three completed clinical trials aimed at treating retinal diseases.

Outlook Therapeutics (Nasdaq: OTLK) announced that CEO Russ Trenary will present at the Wet AMD and DME Drug Development Summit from April 5-7, 2022, in Boston, Massachusetts. His session, titled Enhancing the Standard of Care in Wet AMD, BRVO, & DME, is scheduled for April 6, 2022, at 9:45 AM EST. The company aims to launch ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases, supported by three clinical trials. If approved, ONS-5010 will be available in multiple global markets.

Outlook Therapeutics has submitted its Biologics License Application (BLA) to the FDA for ONS-5010, branded as LYTENAVA™ (bevacizumab-vikg), targeting wet age-related macular degeneration (wet AMD). If approved, it will be the first FDA-approved ophthalmic formulation of bevacizumab. This submission is bolstered by positive results from the NORSE clinical trials, which demonstrated significant vision improvement and a favorable safety profile. The company anticipates marketing approval by late 2022 or early 2023, aiming to replace unapproved IV bevacizumab.

Outlook Therapeutics has appointed Alicia Tozier as Senior Vice President of Marketing and Market Access. With extensive experience in ophthalmology and a proven track record in launching therapies, Tozier is expected to enhance Outlook's commercialization strategies. The company anticipates submitting a Biologics License Application for ONS-5010, its ophthalmic formulation of bevacizumab, to the FDA in Q1 2022, aiming for potential approval and launch in late 2022 or early 2023. ONS-5010 could provide a safe alternative for retinal treatments currently reliant on unapproved formulations.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that Dr. Lawrence Lee will present pivotal Phase 3 data from the NORSE TWO trial on February 26, 2022, regarding ONS-5010, an investigational ophthalmic formulation of bevacizumab for treating wet AMD. The trial results indicated promising safety and efficacy, and if approved by the FDA, ONS-5010 could mitigate risks associated with off-label use of existing formulations. The presentation will take place at the RANZCO 52nd Annual Scientific Congress.

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.