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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

NEW YORK, January 1, 2026, 04:59 ET — Market closed Outlook Therapeutics, Inc. (Nasdaq: OTLK) shares fell sharply in after-hours trading on Dec. 31 after the U.S. Food and Drug Administration again declined to approve its ONS-5010/LYTENAVA (bevacizumab-vikg) filing for wet age-related macular degeneration. The stock closed down 15.51% at $1.58 and slid to $0.58 after hours. Nasdaq The decision is the third complete response letter the company has received on the application, following earlier FDA letters in August 2023 and August 2025, Ophthalmology Times reported. The drug is already authorized in the European Union and the UK and has
1 January 2026
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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
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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
13 November 2025
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Stock Market Today

Costco stock price retakes $1,000 — what traders are watching before Monday

Costco stock price retakes $1,000 — what traders are watching before Monday

7 February 2026
Costco closed Friday up 1.2% at $1,001.16, regaining the $1,000 level as about 2.36 million shares changed hands. January net sales rose 9.3% to $21.33 billion, with comparable sales up 7.1% and online sales surging 34.4%. Wells Fargo raised its price target to $950, maintaining a neutral rating. The next earnings call is set for March 5.
Johnson & Johnson stock price: What to watch after talc-case law firm ouster and new AFib data

Johnson & Johnson stock price: What to watch after talc-case law firm ouster and new AFib data

7 February 2026
Johnson & Johnson shares rose 0.9% to $239.99 Friday after a New Jersey appeals court disqualified Beasley Allen from state talc cases, citing improper coordination with a former J&J attorney. The ruling affects about 3,600 state lawsuits, while a related federal motion is pending. J&J also reported early 12-month pilot data for its investigational AFib device at a cardiology meeting.
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