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Outlook Therapeutics Inc (OTLK) is a clinical-stage biopharmaceutical company advancing innovative ophthalmic therapies, including its lead candidate for wet age-related macular degeneration. This page offers investors and industry professionals timely updates on company developments.
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Outlook Therapeutics (OTLK) has confirmed its plan to re-submit the Biologics License Application (BLA) for its investigational drug ONS-5010 (bevacizumab-vikg) to the FDA by September 2022. This follows a voluntary withdrawal of the original submission in May 2022 to address FDA requests for additional information. The company aims to provide the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications such as wet age-related macular degeneration.
Outlook Therapeutics (OTLK) announced that the FDA has requested more information to complete its Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg) for treating wet age-related macular degeneration. The company voluntarily withdrew the BLA and aims to resubmit a revised application by September 2022. CEO Russell Trenary expressed confidence in the product's potential to be the first FDA-approved ophthalmic formulation of bevacizumab. ONS-5010 is designed to offer a safer alternative to unapproved repackaged formulations used in current treatments for retinal diseases.
Outlook Therapeutics, a pre-commercial biopharmaceutical company, will present at the H.C. Wainwright Global Investment Conference from May 23-26, 2022, in Miami, FL. The company is focused on developing ONS-5010/LYTENAVA™, an investigational therapy aimed at being the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications. The presentation will be led by Lawrence Kenyon, Chief Financial Officer, with opportunities for one-on-one meetings with investors. A video webcast of the presentation will be available on May 24, 2022.
Outlook Therapeutics (Nasdaq: OTLK) has submitted a Biologics License Application (BLA) for ONS-5010, branded as LYTENAVA™, for treating wet age-related macular degeneration (AMD). The company anticipates a PDUFA date announcement in June 2022 and is ramping up pre-launch plans, supported by sufficient funding. Financial results for Q2 2022 show a net loss of $19.7 million, compared to $13.1 million in the previous year, with cash reserves at $58.4 million. Outlook is optimistic about commercial partnerships and aims for global market registration.
Outlook Therapeutics (Nasdaq: OTLK) announced that COO Terry Dagnon will participate in the Retina World Congress 2022 from May 12-15 in Fort Lauderdale, Florida. Dagnon will discuss ONS-5010 (LYTENAVA™), an investigational formulation of bevacizumab for retinal diseases, including wet AMD. The FDA has received a Biologics License Application (BLA) for ONS-5010, which, if approved, would provide 12 years of marketing exclusivity. This product aims to address safety concerns related to off-label IV use of bevacizumab currently prevalent in the retina community.
Outlook Therapeutics (Nasdaq: OTLK) announced a live moderated video webcast on May 11, 2022, at 1:00 PM ET. President & CEO Russ Trenary will provide a corporate overview and discuss their investigational therapy, ONS-5010/LYTENAVA™, which targets retinal conditions like wet AMD. Investors can submit questions during the event. A webcast will be accessible on their website, with a replay available for 90 days. The company aims for ONS-5010 to be the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications.
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.
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