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Increasing unusual call option volume: OTLK EWJ AMPG LION MGNI TENB FSK CXW LASE

Wed, 17 Jun 2026 06:49:39 -0400

Increasing unusual call option volume: OTLK EWJ AMPG LION MGNI TENB FSK CXW LASE

Form 8-K Outlook Therapeutics, For: Jun 16

Tue, 16 Jun 2026 08:46:00 -0400

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Form 8-K Outlook Therapeutics, For: Jun 16

Tue, 16 Jun 2026 08:46:00 -0400

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FDA accepts OUTLOOK THERAPEUTICS BLA resubmission for wet AMD drug

Tue, 16 Jun 2026 08:02:30 -0400

Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that the U.S. Food and Drug Administration has accepted the resubmission of a Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a treatment for neovascular age-related macular degeneration, commonly known as wet AMD.

The FDA classified the resubmission as a Class 1 review, with a Prescription Drug User Fee Act target action date of July 29, 2026.

"We are very pleased that the FDA has accepted our resubmitted BLA to review the labelling as part of the final step toward potential approval," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab

FDA accepts OUTLOOK THERAPEUTICS BLA resubmission for wet AMD drug

Tue, 16 Jun 2026 08:02:30 -0400

The FDA classified the resubmission as a Class 1 review, with a Prescription Drug User Fee Act target action date of July 29, 2026.

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab

Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD

Tue, 16 Jun 2026 08:02:00 -0400

Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026

ISELIN, N.J., June 16, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), or wet AMD. The Company has been informed that the resubmission is a Class 1 review, with a PDUFA target

Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD

Tue, 16 Jun 2026 08:02:00 -0400

Prescription Drug User Fee Act (PDUFA) goal date of July 29, 2026

Form 4 Outlook Therapeutics, For: Jun 02 Filed by: Haddadin Yezan Munther

Wed, 03 Jun 2026 18:03:00 -0400

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Form 4 Outlook Therapeutics, For: Jun 02 Filed by: Haddadin Yezan Munther

Wed, 03 Jun 2026 18:03:00 -0400

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Form SCHEDULE 13D/A Outlook Therapeutics, Filed by: GMS Ventures & Investments

Mon, 01 Jun 2026 21:31:00 -0400

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Form SCHEDULE 13D/A Outlook Therapeutics, Filed by: GMS Ventures & Investments

Mon, 01 Jun 2026 21:31:00 -0400

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Form 4 Outlook Therapeutics, For: May 28 Filed by: Sukhtian Ghiath M.

Mon, 01 Jun 2026 21:30:00 -0400

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Form 4 Outlook Therapeutics, For: May 28 Filed by: Sukhtian Ghiath M.

Mon, 01 Jun 2026 21:30:00 -0400

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Form DEFA14A Outlook Therapeutics,

Mon, 01 Jun 2026 17:02:00 -0400

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Form DEFA14A Outlook Therapeutics,

Mon, 01 Jun 2026 17:02:00 -0400

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Form DEF 14A Outlook Therapeutics, For: Jul 16

Mon, 01 Jun 2026 17:00:00 -0400

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Form DEF 14A Outlook Therapeutics, For: Jul 16

Mon, 01 Jun 2026 17:00:00 -0400

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Form 8-K Outlook Therapeutics, For: Jun 01

Mon, 01 Jun 2026 09:15:00 -0400

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Form 8-K Outlook Therapeutics, For: Jun 01

Mon, 01 Jun 2026 09:15:00 -0400

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Outlook Therapeutics resubmits drug application to FDA after appeal win

Mon, 01 Jun 2026 08:47:09 -0400

Outlook Therapeutics Inc. (NASDAQ: OTLK) announced it has resubmitted its Biologics License Application to the U.S. Food and Drug Administration for ONS-5010/LYTENAVA™ (bevacizumab-vikg) to treat neovascular age-related macular degeneration.

The resubmission follows a successful appeal of a Complete Response Letter the FDA issued in December 2026. The FDA Office of New Drugs concluded that substantial evidence of effectiveness has been established for LYTENAVA™ and that additional trials are not required.

The FDA directed its Division of Ophthalmology and Office of Specialty Medicine to work with Outlook Therapeutics on final product labeling. The resubmission received a Class 1 review designation with a PDUFA

Outlook Therapeutics resubmits drug application to FDA after appeal win

Mon, 01 Jun 2026 08:47:09 -0400

Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

Mon, 01 Jun 2026 08:46:00 -0400

ISELIN, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD).

As previously announced, Outlook Therapeutics successfully appealed the December 2026 Complete Response Letter (CRL) related to the ONS-5010 Biologics License Application reviewed by the FDA. In their decision, the FDA

Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

Mon, 01 Jun 2026 08:46:00 -0400

Form 8-K Outlook Therapeutics, For: May 29

Fri, 29 May 2026 16:32:00 -0400

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Form 8-K Outlook Therapeutics, For: May 29

Fri, 29 May 2026 16:32:00 -0400

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