Outlook Therapeutics, Inc. - Se
OTLKW
NASDAQ Capital Market0.03
USD
+0.00
- -
CIK
0001649989
Return %
Stock
S&P500
1Y
- -
26.53
3Y
- -
76.60
5Y
-78.56
80.11
Capital Structure
FRC
•
in mil. unless spec.Working Capital
FRC
•
in mil. unless spec.Growth Rates
FRC
•
in mil. unless spec.Quarterly Revenue
FRC
•
in mil. unless spec.Quarterly Earnings Per Share
FRC
•
in mil. unless spec.Quarterly Dividends Per Share
FRC
•
in mil. unless spec.- CEO
- None
- Sector
- Healthcare
- Industry
- Biotechnology
- Address
- DE United States of America
- IPO Date
- Jun 20, 2016
- CIK
- 0001649989
- Similar Companies
- Business
- Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), a monoclonal antibody ophthalmic formulation designed for the treatment of retina diseases, including wet age-related macular degeneration (wet AMD). The company's core products include LYTENAVA™, which is the first ophthalmic formulation of bevacizumab approved by the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for wet AMD treatment. Outlook Therapeutics is advancing the commercial launch of LYTENAVA™ in the European Union and the United Kingdom and is working toward FDA approval in the United States, where ONS-5010/LYTENAVA™ remains investigational. The company also focuses on other retinal indications such as diabetic macular edema and branch retinal vein occlusion. Founded in 2015 and headquartered in Iselin, New Jersey, Outlook Therapeutics operates primarily in the US, Europe, and the UK markets. Recent major developments include the company's successful marketing authorization in Europe and the UK for LYTENAVA™, marking its transition to a commercial-stage biopharmaceutical entity with initial commercial sales reported in those regions. The company has a pending FDA Biologics License Application (BLA) with a PDUFA date on August 27, 2025, aiming for US market entry. As part of its strategic evolution, Outlook Therapeutics appointed Bob Jahr as CEO in late 2024 to steer commercial execution and regulatory navigation. The company also streamlined operations in late 2024 to preserve capital and extend its cash runway, focusing on the upcoming commercial launch in Europe. Additionally, Outlook Therapeutics has expanded its strategic collaborations, including partnerships that enhance its development capabilities and market presence. Outlook Therapeutics’ business segments cover development and commercialization of biosimilar monoclonal antibodies for ophthalmic indications. Its primary product, LYTENAVA™, targets retinal diseases with unmet medical needs, providing an innovative therapeutic alternative. The company maintains a lean workforce and operates in the biotechnology and pharmaceutical industry, with a strategic focus on retinal disease therapies across the US and European markets. Recent financing activities and share acquisitions by strategic partners underscore ongoing investment confidence despite operating at a net loss during its clinical transition phase. Outlook Therapeutics continues to focus on expanding its therapeutic pipeline and achieving regulatory milestones to solidify its commercial footprint internationally.