COMPANY
Outlook Therapeutics
FDA-approved therapeutic company Clinical Phase 3
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retinal diseases. From company website Source · Oct 13, 2026
Trial and FDA signals
- FDA complete response letter Received an FDA complete response letter (BLA 761320, letter dated Dec 30, 2025). FDA BLA 761320 (Dec 30, 2025)
Evidence (1 event)
- Dec 30, 2025 · FDA BLA 761320
CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE Outlook Therapeutics, Inc. Attention: Jennifer Kissner, PhD Executive Vice President Iselin, NJ (street omitted) Dear Dr. Kissner: Please refer to your biologics
- Dec 30, 2025 · FDA BLA 761320
Timeline
- FDA FDA New drug/biologic (novel): LYTENAVA (bevacizumab-vikg) — BLA761320, Jul 24, 2026. Applicant at approval: Outlook Therapeutics, Inc. source ↗
- Raise Follow-on offering — Registered direct: $5M (total, as published), announced Apr 23, 2026. Source: company release on GlobeNewswire. source ↗ · Form D filed May 7, 2026 SEC Form D ↗
- Raise Follow-on offering: $5M (total, as published), announced Mar 25, 2026. Source: company release on GlobeNewswire. source ↗
- Debt Debt: $18.4M (not counted as a raise), announced Mar 16, 2026. Source: company release on GlobeNewswire. source ↗
- Raise Follow-on offering: $13M (total, as published), announced May 23, 2025. Source: company release on GlobeNewswire. source ↗
- Trial start Phase 3: A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) source ↗
- Trial start Phase 3: A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders source ↗
- Trial start Phase 3: A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders source ↗
- Trial start Phase 3: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) source ↗
- Trial start Phase 3: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) source ↗
Upcoming milestones
- 2027-12 (ESTIMATED) · Phase 3 · A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders · NCT05112861
Funding
- Follow-on offering — Registered direct: $5M (total, as published), announced Apr 23, 2026. Source: company release on GlobeNewswire. source ↗ · Form D filed May 7, 2026 SEC Form D ↗
- Follow-on offering: $5M (total, as published), announced Mar 25, 2026. Source: company release on GlobeNewswire. source ↗
- Follow-on offering: $13M (total, as published), announced May 23, 2025. Source: company release on GlobeNewswire. source ↗
- Debt: $18.4M (not counted as a raise), announced Mar 16, 2026. Source: company release on GlobeNewswire. source ↗
Clinical trials (lead sponsor) 5
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT03834753 | A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) | Phase 3 | Completed | Jun 25, 2019 | Jun 7, 2021 (actual) |
| NCT06190093 | A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) | Phase 3 | Completed | Jan 24, 2024 | Nov 7, 2024 (actual) |
| NCT04516278 | A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders | Phase 3 | Completed | Oct 1, 2020 | Feb 10, 2021 (actual) |
| NCT05112861 | A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders | Phase 3 | Active, not recruiting | Nov 15, 2021 | 2027-12 (estimated) |
| NCT03844074 | A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) | Phase 3 | Completed | Oct 1, 2018 | Jul 23, 2020 (actual) |
FDA records (last 2 years)
- FDA New drug/biologic (novel): LYTENAVA (bevacizumab-vikg) — BLA761320, Jul 24, 2026. Applicant at approval: Outlook Therapeutics, Inc. source ↗
Raises and investors new
- Raise Private raise (SEC Form D): amount sold not stated; issuer “Outlook Therapeutics, Inc.”. Verified from the SEC filing. SEC filing ↗
- Raise Private raise (SEC Form D): amount sold not stated; issuer “Outlook Therapeutics, Inc.”. Verified from the SEC filing. SEC filing ↗
Connect
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