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OTLK FDA decision: Apr 7, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✕ COMPLETE RESPONSE LETTER

Outlook Therapeutics Inc., LYTENAVA (bevacizumab-vikg) · 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%

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Specialist biotech funds holding OTLK, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
Perceptive Advisors3,139,216$5.0 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

Was LYTENAVA (bevacizumab-vikg) approved by the FDA?

Not in this review cycle. A Complete Response Letter, declining to approve the application for LYTENAVA (bevacizumab-vikg) in its current form, was announced on April 7, 2026. A CRL is not final; the primary source is linked on this page.

Which company is behind LYTENAVA (bevacizumab-vikg)?

LYTENAVA (bevacizumab-vikg) is an Outlook Therapeutics Inc. (OTLK) program. The company announced the FDA decision on April 7, 2026; the primary source 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.