Welcome to our dedicated page for Outlook Therapeutics news (Ticker: OTLK), a resource for investors and traders seeking the latest updates and insights on Outlook Therapeutics stock.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) is a biopharmaceutical company centered on ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma), an ophthalmic formulation of bevacizumab for retina diseases such as wet age-related macular degeneration (wet AMD). News about Outlook Therapeutics typically focuses on clinical, regulatory, and commercial milestones related to this product candidate and its marketed formulation in Europe and the UK.
Readers following OTLK news can expect updates on interactions with the U.S. Food and Drug Administration (FDA), including Biologics License Application (BLA) submissions, complete response letters (CRLs), Type A meetings, and review classifications such as Class 1 reviews with specified PDUFA goal dates. These regulatory developments are central to understanding the potential U.S. path for ONS-5010/LYTENAVA™ as an investigational treatment for wet AMD.
In addition, Outlook Therapeutics issues news on its European and UK activities, including Marketing Authorizations granted by the European Commission and the MHRA, the commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK, and early commercial performance indicators such as initial sales into distribution channels. Company announcements may also cover efforts to expand into additional European markets and explore collaborations with commercial and distribution partners in other regions.
Corporate and financial news items provide insight into Outlook Therapeutics’ leadership changes, strategic hires in areas like corporate strategy and business development, stock-based inducement grants, and periodic financial results that reference revenue from LYTENAVA™ sales and spending patterns related to clinical trials and launches. Conference participation, investor presentations, and scientific meeting appearances are also common topics. For investors and observers interested in the evolution of ophthalmic bevacizumab therapies and wet AMD treatment approaches, the Outlook Therapeutics news feed offers a focused view of the company’s progress.
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.
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.