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OTLK FDA decision: Apr 7, 2026

Updated ·next FDA decision on the calendar
✕ COMPLETE RESPONSE LETTER

Outlook Therapeutics Inc., LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NO · Wet age-related macular degeneration (wet AMD).

Run-up into the decision (T-120 → T+5)

PDUFA 4/7/26$2.47$0.19810/21/25
Daily close, T-120 (10/21/25) through T+5. Run-up high $2.47 on 12/23/25, low $0.198 on 3/25/26 (T-120 to T-1). FDA decision 4/7/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-07
OutcomeCRL
Drug / candidateLYTENAVA (bevacizumab-vikg) / ONS-5010 - (NO
CompanyOutlook Therapeutics Inc.
120-day run-up (T-120→T-1)-84.7%

Questions

Was LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NO approved by the FDA?

Not in this review cycle. On April 7, 2026 the FDA issued a Complete Response Letter, declining to approve the application for LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NO in its current form. A CRL is not final; the primary source is linked on this page.

Which company is behind LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NO?

LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NO is a Outlook Therapeutics Inc. (OTLK) program. The FDA decision came on April 7, 2026; the company's own announcement is linked on this page.

How did OTLK stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), OTLK moved -84.7%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.