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 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.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced the appointment of Dr. Julia A. Haller to its Board of Directors on August 15, 2022. Dr. Haller, an esteemed ophthalmologist and leader in retinal research, brings extensive experience and expertise, enhancing the company's strategic direction as it advances ONS-5010, an investigational ophthalmic formulation of bevacizumab. This formulation aims to provide FDA-approved treatment options for retinal diseases, addressing the need for safe and effective therapies, particularly for conditions like wet AMD.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) reported a Q3 net loss of $17.5 million, or $0.08 per share, up from a $12.2 million loss last year. The company plans to re-submit its Biologics License Application (BLA) for ONS-5010 by September 2022, following positive FDA feedback. ONS-5010, if approved, would be the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications, addressing the public health risk of off-label usage. The company has $26 million in cash, estimated to fund operations into Q1 2023, and is collaborating with partners for commercial launch preparations.
Outlook Therapeutics (Nasdaq: OTLK) announced that President and CEO Russ Trenary will present at the H.C. Wainwright 2nd Annual Ophthalmology Conference on August 17. This event focuses on the development of ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal conditions. Attendees can engage in virtual one-on-one meetings with the management team. A video webcast of the presentation will be available on-demand starting August 17 at 7:00 AM ET on the company's website, archived for 90 days.
Outlook Therapeutics (OTLK) has announced the full cash pre-payment of its unsecured convertible promissory note, dated November 4, 2020, to strengthen its financial position ahead of a potential FDA approval for ONS-5010 (bevacizumab-vikg). The repayment, which eliminates the risk of dilution from converting the note into common stock at a discount, allows the company to maintain investor confidence. The note, which had a face amount of $10,220,000, was initially amended to extend its maturity and increase interest rates, reflecting the company’s focus on upcoming regulatory hurdles.
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.