Outlook Therapeutics, Inc. - OTLK STOCK NEWS

Outlook Therapeutics announces recent corporate highlights and financial results. The Prescription Drug User Fee Act (PDUFA) goal date for ONS-5010 is August 29, 2023. ONS-5010 is an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). Outlook Therapeutics is focused on pre-launch activities and positioning itself as an innovative leader in the anti-VEGF space. The use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately 50% of all wet AMD injections in the United States each year. ONS-5010 has been developed to address concerns related to safety and potency issues associated with using off-label, repackaged bevacizumab. Outlook Therapeutics has upcoming milestones including the completion of the NORSE SEVEN clinical trial in 2024 and the MAA decision date from the EMA’s CHMP in the EU expected in the first half of 2024.

Outlook Therapeutics, Inc. (OTLK) to participate in fireside chat at BTIG Virtual Biotechnology Conference 2023

Outlook Therapeutics (Nasdaq: OTLK) announces participation of Russ Trenary, CEO, and Glen Olsheim, Executive Director, in a live fireside chat at the H.C. Wainwright BioConnect Investor Conference on May 2, 2023, at 2:00 PM ET. The event will spotlight their work on ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab targeting retinal conditions like wet AMD. A live video webcast will be available on the company's website, with a replay accessible for 90 days. Outlook is also preparing for the PDUFA goal date of August 29, 2023, concerning their BLA submission for ONS-5010. They have partnered with AmerisourceBergen for commercial logistics related to this product.

Outlook Therapeutics (Nasdaq: OTLK) announced it is unaffected by the Federal Deposit Insurance Corporation's control of Silicon Valley Bank (SVB), as it holds no deposits or investments at SVB. The company focuses on developing ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab, targeting retinal diseases such as wet AMD, DME, and BRVO. The FDA has set a PDUFA goal date of August 29, 2023, for its BLA submission. Outlook Therapeutics partnered with AmerisourceBergen to enhance distribution and logistics services in anticipation of potential FDA approval.

Outlook Therapeutics (Nasdaq: OTLK) is advancing towards the FDA PDUFA goal date of August 29, 2023, for its investigational ophthalmic formulation ONS-5010 (LYTENAVA™) aimed at treating wet age-related macular degeneration. The company has strengthened its commercial team and raised approximately $54 million through financing efforts to support pre-launch activities. Financial results for Q1 2023 show a net loss of $18.7 million, consistent with last year's loss. Outlook anticipates cash runway through FDA approval and is preparing for a potential commercial launch in the U.S., while progressing with regulatory submissions in Europe.

Outlook Therapeutics Highlights Presentation at SVB Securities Global Biopharma Conference

On February 14, 2023, at 4:20 PM ET, Russ Trenary, President and CEO of Outlook Therapeutics (Nasdaq: OTLK), will present at the SVB Securities Global Biopharma Conference. The company aims to develop the first FDA-approved ophthalmic formulation of bevacizumab (ONS-5010) for retinal diseases. The FDA accepted its BLA submission for ONS-5010 with a PDUFA goal date of August 29, 2023. Outlook is also partnering with AmerisourceBergen for strategic commercialization to enhance distribution and patient connection ahead of potential approval.

Outlook Therapeutics has strengthened its leadership team with the appointments of Dr. Surendra Sharma as Senior VP of Medical Affairs and Glen Olsheim as Executive Director of Commercial Excellence. Both executives bring over 30 years of combined experience in the pharmaceutical industry, particularly in ophthalmic products. Their expertise will be critical as the company progresses towards the FDA approval and commercial launch of ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. The FDA’s PDUFA date for ONS-5010 is set for August 29, 2023.

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced a live video webcast presentation on January 17, 2023, at 11:00 AM ET. Russ Trenary, President and CEO, will discuss the company's efforts to develop ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab for retinal conditions, including wet AMD. The FDA has set a PDUFA goal date of August 29, 2023, for this submission. The company has strategic agreements with AmerisourceBergen for commercialization and distribution services.