# OTLK PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/OTLK
Company: Outlook

BioPharmSignal tracks active PDUFA and FDA decision milestones associated with OTLK.

## OTLK PDUFA Milestones

- 2025-08-27 — CRL — FDA issued Complete Response Letter. The sponsor reported that FDA issued a Complete Response Letter for LYTENAVA / ONS-5010 (bevacizumab-vikg) on August 27,...
  Company: Outlook
  Source: https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-update-type-meeting-fda/
  Event detail: https://biopharmsignal.com/pdufa-calendar/OTLK/lytenava-ons-5010-bevacizumab-vikg-lytenava-bla-review-2.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/august (August 2025)
- 2025-12-31 — CRL — FDA issued Complete Response Letter. The sponsor reported that FDA issued a Complete Response Letter for LYTENAVA / ONS-5010 (bevacizumab-vikg) on December 3...
  Company: Outlook
  Source: https://www.sec.gov/Archives/edgar/data/1649989/000110465926000066/tm2534608d1_ex99-1.htm
  Event detail: https://biopharmsignal.com/pdufa-calendar/OTLK/lytenava-ons-5010-bevacizumab-vikg-lytenava-bla-review-3.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/december (December 2025)
- 2026-07-29 — PDUFA — FDA approved LYTENAVA for wet AMD. FDA approved LYTENAVA for neovascular age-related macular degeneration, making it the first FDA-approved ophthalmic bevaci...
  Company: Outlook
  Source: https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-announces-lytenavatm-fda-approval-first-and
  Event detail: https://biopharmsignal.com/pdufa-calendar/OTLK/ons-5010-lytenava-wet-amd-review-4.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/july (July 2026)

## Related Pages

- Company page: https://biopharmsignal.com/company/OTLK
- Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar

## FAQ

### What does the OTLK PDUFA calendar show?

It shows active PDUFA and FDA decision milestones associated with OTLK, including decision dates, application stage, and summary details when available.
### Where can I find more context for OTLK?

Use the BioPharmSignal company page for OTLK to read related news, stock data, sector context, and company-specific updates.
### Are these dates investment advice?

No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.