Outlook Therapeutics Inc - OTLK STOCK NEWS

Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced a registered direct offering of 28,460,831 shares at $0.8784 per share, expected to generate approximately $25.0 million in gross proceeds. The offering, led by GMS Ventures as the largest stockholder, is set to close on December 28, 2022. Proceeds will support the ONS-5010 development program and general corporate purposes, including debt repayment. The shares are offered under an effective Form S-3 registration statement previously filed with the SEC.

Outlook Therapeutics announced the validation of its Marketing Authorization Application (MAA) for ONS-5010 by the European Medicines Agency (EMA) for treating wet AMD. This follows the acceptance of their Biologics License Application (BLA) by the U.S. FDA with a PDUFA date of August 29, 2023. The EMA's decision is expected in early 2024, and if approved, ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. The clinical program includes three completed trials, and the company anticipates eight years of regulatory exclusivity in the EU.

Outlook Therapeutics (Nasdaq: OTLK) announced that Russ Trenary, its President and CEO, will speak at a panel discussion on December 8, 2022, at 2:45 PM ET. The event, titled “Take A Look At What's In Store For Wet AMD & Related Diabetic Eye Diseases,” is part of the Cantor Fitzgerald Medical Conference. Alongside the discussion, Outlook Therapeutics will hold in-person meetings with investors. The company is focused on launching ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases, with its BLA submission accepted by the FDA.

Outlook Therapeutics, a biopharmaceutical firm, announced that its CEO, Russ Trenary, will present at the BTIG Ophthalmology Day on November 29, 2022, at 12:30 PM ET. The company is focused on launching ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications like wet AMD, DME, and BRVO. The FDA has set a goal date of August 29, 2023, for the BLA submission for ONS-5010. This formulation aims to provide a significant treatment option in the U.S., U.K., Europe, Japan, and other markets.

Outlook Therapeutics has announced the FDA's acceptance of its Biologics License Application (BLA) for ONS-5010 / LYTENAVA™, a targeted treatment for wet age-related macular degeneration (wet AMD). The PDUFA goal date is set for August 29, 2023. If approved, ONS-5010 will provide the first FDA-approved ophthalmic formulation of bevacizumab, enhancing patient care and offering a safer alternative to off-label compounded versions. Outlook has also partnered with AmerisourceBergen for strategic commercialization to improve market access and distribution in the U.S.

Outlook Therapeutics and AmerisourceBergen have formed a strategic partnership to support the anticipated launch of ONS-5010 (LYTENAVA™), an investigational ophthalmic formulation of bevacizumab. This collaboration comes after the submission of a Biologics License Application (BLA) to the FDA, aiming to enhance market access and distribution if the product is approved. AmerisourceBergen will provide logistics, distribution, and commercialization support, targeting retinal specialists across the U.S. This relationship is expected to significantly improve treatment options for patients with wet age-related macular degeneration (AMD).

Outlook Therapeutics, a biopharmaceutical company, announces its participation in Eyecelerator @ AAO 2022, scheduled for September 29 in Chicago. President Russ Trenary will present at the Retina Showcase, while COO Terry Dagnon will join a panel on clinically relevant endpoints in approval trials. The company's investigational therapy, ONS-5010 (bevacizumab-vikg), aims to be the first FDA-approved ophthalmic formulation for retinal diseases. Outlook has submitted its Biologics License Application to the FDA, supported by a comprehensive clinical trial program.

On September 7, 2022, Outlook Therapeutics (Nasdaq: OTLK) announced that CEO Russ Trenary will present at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022, in New York. The biopharmaceutical company is focused on launching the first FDA-approved ophthalmic formulation of bevacizumab, known as ONS-5010, for retinal conditions like wet AMD. Investors can attend one-on-one meetings, and a webcast of the presentation will be available on-demand from September 12. For more details, visit the company's website.

Outlook Therapeutics has re-submitted its Biologics License Application (BLA) for ONS-5010 to the FDA, aiming to become the first approved ophthalmic formulation of bevacizumab for wet AMD. This follows improvements based on FDA feedback. The company is confident in its submission, citing compelling clinical trial data from the NORSE studies. ONS-5010 demonstrates significant efficacy with 41.7% of patients gaining at least 15 letters of vision. The company is also preparing for a potential 2023 launch by establishing partnerships and building distribution capabilities.