Browse Category

NASDAQ:OTLK News 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.
Outlook Therapeutics stock jumps ahead of FDA’s Dec. 31 Lytenava decision

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

NEW YORK, December 30, 2025, 01:25 ET — Market closed Outlook Therapeutics, Inc. shares closed Monday up 8.8% at $1.98 after trading between $1.78 and $1.98. The stock was last up about 2% at $2.02 in late after-hours trading, with about 5.7 million shares changing hands. StockAnalysis Traders are zeroed in on a Dec. 31 deadline at the U.S. Food and Drug Administration for Lytenava (ONS-5010), the company’s wet age-related macular degeneration candidate. A Nov. 13 filing showed the FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of Dec. 31 — the agency’s target date for
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 (NASDAQ: OTLK) shares jumped today after the U.S. FDA accepted the company’s resubmitted Biologics License Application (BLA) for ONS‑5010/LYTENAVA, its bevacizumab-based eye drug for wet AMD, and set a PDUFA review date of December 31, 2025. Here’s what investors need to know. What Outlook Therapeutics announced today This morning, Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that the U.S. Food and Drug Administration has accepted the company’s resubmitted Biologics License Application for ONS‑5010 (bevacizumab‑vikg)/LYTENAVA, its investigational ophthalmic formulation of bevacizumab for the treatment of wet age‑related macular degeneration (wet AMD). GlobeNewswire+2Outlook Therapeutics+2 According to the company’s press release and

Stock Market Today

Real estate stocks rise as rate-cut bets return; XLRE ends at $41.99 ahead of payrolls and CPI

Real estate stocks rise as rate-cut bets return; XLRE ends at $41.99 ahead of payrolls and CPI

7 February 2026
U.S. real estate stocks rose Friday, with XLRE up 1.8% to $41.99 and VNQ and IYR each gaining 1.6%. The Dow closed above 50,000 for the first time as the 10-year Treasury yield ended at 4.206%. Bank of America downgraded Public Storage and Extra Space Storage, citing weak housing turnover and high borrowing costs. The delayed January jobs report is set for Feb. 11, with CPI due Feb. 13.
Go toTop