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 announced pivotal updates regarding ONS-5010 / LYTENAVA™ and financial results for the fiscal year ending September 30, 2020. The company reported a net loss of $48.9 million, or $0.67 per share, an increase from $36.0 million in the previous year. All planned clinical trials for ONS-5010 are fully enrolled or completed, with pivotal data from the Phase 3 trial expected in mid-2021, followed by a BLA submission. Outlook anticipates engaging with regulatory authorities in Europe and plans further registration trials for diabetic macular edema and branch retinal vein occlusion.
Outlook Therapeutics, Inc. (Nasdaq: OTLK) announced it has regained compliance with Nasdaq's minimum bid price requirement after its common stock closed at $1.00 or greater for 10 consecutive trading days. This achievement comes as the company advances ONS-5010/LYTENAVA™, its ophthalmic formulation of bevacizumab, aimed at obtaining FDA approval for retinal diseases such as wet AMD, DME, and BRVO. Outlook is set to file for a new BLA under the 351(a) pathway for ONS-5010 initially targeting wet AMD.
Outlook Therapeutics (NASDAQ: OTLK) has established a Global Retina Advisory Council to enhance the development and commercialization of ONS-5010, an investigational ophthalmic formulation of bevacizumab for retinal conditions like wet AMD. Mark Humayun, MD, PhD, will chair the council, supported by Firas Rahhal, MD. The company aims to file a Biologics License Application (BLA) for ONS-5010 in mid-2021, expecting FDA approval by mid-2022. This initiative addresses issues related to unapproved repackaged IV bevacizumab, potentially leading to wider adoption among clinicians.
Outlook Therapeutics, a clinical-stage biopharmaceutical company, recently held a KOL Roundtable featuring Dr. Firas Rahhal, who discussed the treatment landscape for wet AMD and the potential of ONS-5010/LYTENAVA™ (bevacizumab-vikg). This investigational drug aims to be the first FDA-approved ophthalmic formulation of bevacizumab. The management provided insights on the ongoing Phase 3 clinical trials and plans for commercialization, expecting to file a BLA in 2021. ONS-5010 could address treatment shortcomings and offer a viable alternative to expensive anti-VEGF therapies currently in use.
Outlook Therapeutics, a clinical-stage biopharmaceutical company, has secured a $10.2 million unsecured promissory note for $10 million in cash proceeds. The funding aims to pay off existing demand notes and support ongoing development of its ophthalmic formulation, ONS-5010, for retinal diseases, including wet AMD. The note carries a 7.5% interest rate and matures on January 1, 2022. Outlook is focused on submitting its Biologics License Application (BLA) for ONS-5010 in late 2021 and seeks a commercial partner by year-end.
Outlook Therapeutics has achieved full enrollment of 195 subjects in the NORSE THREE clinical trial for its investigational product ONS-5010/LYTENAVA™ in under one month, ahead of schedule.
All trials for ONS-5010 for wet AMD are now fully enrolled or completed, aiming for a Biologics License Application (BLA) submission in the second half of 2021. The market potential for ONS-5010 is significant, with an expected entry into the estimated $13 billion global market for anti-VEGF therapies.
Outlook Therapeutics (Nasdaq: OTLK) will host a live KOL Roundtable discussion on October 29, 2020, at 10:00 AM ET. Management, including Lawrence Kenyon and Terry Dagnon, alongside Dr. Firas M. Rahhal, will discuss their lead product, ONS-5010, the first FDA-approved ophthalmic formulation of bevacizumab-vikg for retinal diseases. Investors can access the webcast on their website, with a replay available post-event.
Outlook Therapeutics has initiated an open-label safety study for ONS-5010, an investigational formulation of bevacizumab-vikg aimed at treating wet AMD and other retinal diseases. This study is crucial for gathering safety data to support a new Biologics License Application (BLA) to the FDA, expected to be filed in 2021. Approximately 180 patients will be enrolled, receiving three doses of the drug. If approved, ONS-5010 will become the first FDA-approved ophthalmic formulation of bevacizumab-vikg, addressing a significant market estimated at over $13 billion.
Outlook Therapeutics (Nasdaq: OTLK) announced that Lawrence Kenyon, its President, CEO, and CFO, will participate in the BIO Investor Forum Digital from October 13-15, 2020. The firm aims to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg (ONS-5010) for retinal diseases such as wet AMD, DME, and BRVO. The corporate presentation will be available on-demand during the conference. Interested investors can schedule virtual one-on-one meetings via the conference portal.
Outlook Therapeutics, a late clinical-stage biopharmaceutical company, has announced that Lawrence Kenyon, the President, CEO, and CFO, will present at two investor conferences in September 2020. The presentations will include a fireside chat and Q&A sessions. Key details are:
- H.C. Wainwright 22nd Annual Global Investment Conference: September 14, 2020, at 4:30 PM EDT
- Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: September 21, 2020, at 2:30 PM EDT
Management will also participate in virtual one-on-one meetings with investors. Webcasts will be available post-event on their website.
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