Home › Decisions › OTLK 2026-03-05

OTLK FDA decision — Mar 5, 2026

✕ 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)

Daily close, T-120 (9/18/25) through T+5. Run-up high $2.47 on 12/22/25, low $0.39 on 2/6/26 (T-120 to T-1). FDA decision 3/5/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-03-05

OutcomeCRL

Drug / candidateLYTENAVA (bevacizumab-vikg) / ONS-5010 - (NO

CompanyOutlook Therapeutics Inc.

120-day run-up (T-120→T-1)-59.7%