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 (Nasdaq: OTLK) announced the presentation of safety data from the NORSE THREE trial for ONS-5010 (LYTENAVA™), an ophthalmic formulation of bevacizumab, at the EURETINA Virtual 2021 conference. The study, involving 197 subjects with retinal diseases like wet AMD, showed no unexpected safety trends. It aims to support a biologics license application (BLA) submission in early 2022, potentially granting ONS-5010 12 years of market exclusivity if approved. The company also reported positive results from the NORSE TWO trial, indicating significant efficacy.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced that C. Russell Trenary, its CEO, will participate in a fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The company is focusing on developing ONS-5010/LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. A video webcast of the chat will be available on-demand starting September 13 at 7:00 AM ET. The company aims to submit its BLA for ONS-5010 to the FDA, positioning itself as a leader in treating retinal indications.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) reported positive results from its pivotal Phase 3 NORSE TWO trial of ONS-5010 (bevacizumab-vikg) for treating wet age-related macular degeneration (wet AMD). The trial achieved statistically significant primary (p = 0.0052) and secondary (p = 0.0043) endpoints, with 41% of subjects gaining at least 15 letters of Best Visual Acuity Change (BVCA). The company plans to submit a Biologics License Application (BLA) in Q1 2022, aiming for FDA approval and 12 years of exclusivity. Financially, Outlook reported a net loss of $12.2 million for Q3 2021.
Outlook Therapeutics announced that President and CEO Russell Trenary will participate in the panel The Greatest Unmet Needs Facing Ophthalmology Today at the H.C. Wainwright Ophthalmology Virtual Conference on August 17, 2021. This event highlights Outlook's progress in developing ONS-5010 / LYTENAVA™, the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases. Recent clinical trials for ONS-5010 show promising results for treating wet AMD, addressing the absence of approved formulations and the risks associated with repackaged IV bevacizumab.
Outlook Therapeutics announced positive results from the pivotal Phase 3 NORSE TWO trial for ONS-5010 (bevacizumab-vikg) in treating wet AMD. The study met its primary efficacy endpoint, with 41% of patients gaining at least 15 letters in visual acuity (p = 0.0052). ONS-5010 demonstrated a favorable safety profile, consistent with earlier trials. The company plans to submit a Biologics License Application to the FDA in the first quarter of 2022, aiming to offer an FDA-approved alternative to off-label bevacizumab injections widely used for retinal diseases.
Outlook Therapeutics appointed C. Russell Trenary III as President and CEO, marking a significant leadership transition. Trenary, with over 35 years of experience in ophthalmic product launches, joins the company as it prepares to submit a Biologics License Application (BLA) for ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab for retinal conditions. The company remains on track to report pivotal safety and efficacy data from its NORSE TWO study in Q3 2021, with an anticipated BLA filing in Q1 2022. Current CEO Lawrence A. Kenyon will continue as CFO.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced its selection for inclusion in the Russell 2000® Index, effective June 25, 2021. This milestone reflects the company's growth and aims to enhance market exposure. The Russell 2000® Index represents approximately 10% of the market capitalization of the broader Russell 3000® Index and is a performance benchmark for small-cap stocks. Lawrence A. Kenyon, CEO, expressed optimism about the company's future value creation through this increased visibility.
Outlook Therapeutics has completed patient dosing in its pivotal NORSE TWO trial for ONS-5010, an ophthalmic formulation of bevacizumab targeting wet AMD. Topline data are expected in Q3 2021, with plans to file a Biologics License Application (BLA) in Q1 2022. The trial enrolled 228 patients across 39 sites, assessing visual acuity improvements against LUCENTIS. If approved, ONS-5010 will hold 12 years of market exclusivity. Pre-commercialization planning is underway, along with parallel registration trials for additional retinal diseases.
Outlook Therapeutics hosted a virtual Clinical Day on May 20, 2021, highlighting the clinical progress of ONS-5010, an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD). The management team, along with leading retinal specialists, discussed the completion of two out of three pivotal trials, with promising topline results anticipated in the third quarter of 2021. If approved, ONS-5010 will be the first FDA-approved ophthalmic formulation of bevacizumab, potentially addressing inadequacies in current treatment options.
Outlook Therapeutics (Nasdaq: OTLK) reported promising financial results and clinical updates on its investigational drug ONS-5010 for wet AMD. The company announced a net loss of $13.1 million for Q2 2021, an improvement from $17.5 million the previous year. Cash reserves increased to $37.2 million following a successful funding round. Positive topline data from the NORSE THREE safety study confirmed a favorable safety profile. The pivotal Phase 3 NORSE TWO study's results are expected in Q3 2021, supporting a planned BLA filing by Q1 2022 for ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab.
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