Today: 28 February 2026
Subscribe
Browse Category

NASDAQ:OTLK 13 November 2025 - 1 January 2026

Outlook Therapeutics stock drops after FDA issues another Lytenava CRL for wet AMD

Outlook Therapeutics stock drops after FDA issues another Lytenava CRL for wet AMD

Outlook Therapeutics shares dropped from $1.58 to about $0.58 after hours on Dec. 31 after the FDA issued a third complete response letter declining approval for its Lytenava wet-AMD drug. The FDA said more confirmatory efficacy evidence is needed but did not specify requirements. The drug is already approved in the EU and UK. U.S. markets reopen Friday after the New Year’s holiday.
1 January 2026
··
Outlook Therapeutics stock jumps ahead of FDA’s Dec. 31 Lytenava decision

Outlook Therapeutics stock jumps ahead of FDA’s Dec. 31 Lytenava decision

Outlook Therapeutics shares closed Monday up 8.8% at $1.98, then rose about 2% in after-hours trading ahead of the FDA’s Dec. 31 decision deadline for Lytenava in wet AMD. The stock remains volatile after an August FDA rejection sent shares down nearly 70%. Trading volume has surged, with the 20-day average at 3.35 million shares. Investors are watching for the FDA’s move, which could come outside regular market hours.
30 December 2025
·
Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics shares rose about 22% after the FDA accepted its resubmitted Biologics License Application for ONS‑5010/LYTENAVA as a treatment for wet AMD, setting a PDUFA review date of December 31, 2025. The FDA classified the filing as a complete, Class 1 response, triggering a 60-day review. The move follows an August rejection over insufficient efficacy data. ONS‑5010/LYTENAVA is already approved in the EU and UK.
13 November 2025
··
Go toTop