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Outlook Therapeutics

Iselin or Cranbury*, New Jersey, United Statesir.oncobiologics.com ↗

Ownership: Public · OTLK
Employees: ~23
Development stage: NDA

Overview

Outlook Therapeutics has developed ONS‑5010/LYTENAVA™ (bevacizumab-vikg), the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and UK MHRA for wet AMD. The company plans commercial launch in the EU and UK in Q2 2025. In the US, a BLA was previously rejected with a Complete Response Letter; after additional studies including NORSE EIGHT, a new BLA submission is planned for early 2025. Clinical trials have also been initiated or are planned for DME and BRVO. If approved in the US, it would be the first FDA-approved ophthalmic bevacizumab product

Therapeutic areas: Ophthalmology
Modalities: monoclonal antibodies (mAbs)
Industry: Biotech

Drug pipeline

4 assets

bevacizumab-vikg

Approved

3 more assets in the full pipeline.

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Partnerships

Cencora — strategic commercialization agreement covering third-party logistics, distribution, pharmacovigilance services in the United States

Financials

Market cap: $119.8M
Total revenue: $9K
Enterprise value: $127M

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