Outlook Therapeutics, Inc.
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- Outlook Therapeutics, Inc. (OTLK) is a clinical-stage biopharmaceutical company focused on developing and commercializing ophthalmic formulations of bevacizumab for retinal diseases; its lead product candidate, ONS-5010/LYTENAVA (bevacizumab-vikg, bevacizumab gamma), targets wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO) via intravitreal injection as a recombinant humanized monoclonal antibody that binds vascular endothelial growth factor (VEGF) to inhibit endothelial cell proliferation, vascular leakage, and neovascularization in the retina. LYTENAVA has received Marketing Authorization from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for wet AMD treatment, with commercial launches planned in select European markets including Germany and the UK in the second quarter of 2025; in the United States, ONS-5010 remains investigational, with the Biologics License Application (BLA) resubmitted to the FDA in November 2025 following a Complete Response Letter in August 2025, accepted for review with a PDUFA target action date of December 31, 2025. Founded in 2010 and headquartered in Iselin, New Jersey, the company--formerly known as Oncobiologics, Inc. until its rebranding in November 2018--employs approximately 23 people and operates primarily in the United States, European Union, and United Kingdom, serving retina specialists and patients with retinal conditions through its pipeline emphasizing anti-VEGF therapies to address unmet needs in ophthalmology. Recent developments include a strategic commercialization collaboration with Cencora (formerly AmerisourceBergen) for global market access, third-party logistics, distribution, and pharmacovigilance services to support LYTENAVA launches; closure of a private placement in March 2024 raising up to $159 million led by Great Point Partners LLC with participation from investors including GMS Ventures, Altium Capital, Armistice Capital, and others to fund clinical programs like the NORSE EIGHT trial and general corporate purposes; and presentation of positive efficacy and safety data from NORSE EIGHT at conferences in late 2025.
Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
Outlook Therapeutics Announces Pricing of $5.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Outlook Shares Jump Following FDA Appeal Decision For LYTENAVA
Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
Oncobiologics, Inc. (OTLK) Reports Q2 Loss, Lags Revenue Estimates
Outlook Therapeutics Reports Second Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update
Outlook Therapeutics Announces Closing of $5.0 Million Registered Direct Offering
Outlook Therapeutics Announces $5.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Outlook Therapeutics Completes Federal Dispute Resolution (FDR) Meeting with FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA
Outlook Therapeutics Announces Closing of $5.0 Million Public Offering
Outlook Therapeutics Announces Pricing of $5.0 Million Public Offering
Outlook Therapeutics Announces Proposed Public Offering
Outlook Therapeutics Announces New $18.4 Million Non-Convertible Note Financing and Amendment to Existing Convertible Note
Uniqure To Rally Around 92%? Here Are 10 Top Analyst Forecasts For Wednesday
Outlook Therapeutics Provides Update Following Type A Meeting with FDA Regarding ONS-5010/LYTENAVA™ (bevacizumab-vikg)
Outlook Therapeutics Expands European Footprint with Exclusive Commercial Distribution Agreement with Mediconsult AG for LYTENAVA™ (bevacizumab gamma) in Switzerland
Oncobiologics, Inc. (OTLK) Reports Q1 Loss, Misses Revenue Estimates
Outlook Therapeutics Reports First Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update
Outlook Therapeutics Submits Type A Meeting Request to FDA Following Complete Response Letter