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April 08, 2025 08:45 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD

Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 ISELIN, N.J., April 08, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that...
February 28, 2025 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration

ISELIN, N.J., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United...
February 19, 2025 09:00 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference

On-demand video webcast now available here ISELIN, N.J., Feb. 19, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval...
February 14, 2025 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2025 and Provides Corporate Update

ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) resubmission on track to meet target of Q1 CY2025LYTENAVA™ (bevacizumab gamma) on track for first commercial launches in...
February 04, 2025 09:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Participates in Virtual Investor “What This Means” Segment

Dr. Jennifer Kissner, SVP Clinical Development, discusses the 12-week safety and efficacy results for NORSE EIGHT clinical trial Watch the “What This Means” segment here ISELIN, N.J., Feb. 04, 2025...
January 31, 2025 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Appoints Faisal G. Sukhtian as Chairman of the Board of Directors

ISELIN, N.J., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United...
January 23, 2025 09:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Announces Presentation of Efficacy and Safety Results from NORSE EIGHT Clinical Trial Evaluating ONS-5010 for the Treatment of Wet AMD

Data presented at Hawaiian Eye and Retina 2025 MeetingResults confirmed that intravitreal ONS-5010 provided early and sustained anatomic improvements, with steady gains in BCVA and reliable,...
January 22, 2025 09:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® to Present at LIVE! with Webull Corporate Connect: Healthcare Investment Webinar

ISELIN, N.J., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United...
January 16, 2025 06:00 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Announces Complete Twelve Week Efficacy and Safety Results of NORSE EIGHT Clinical Trial

ONS-5010 demonstrated to be non-inferior to Lucentis at 12 weeksBLA resubmission on track for calendar Q1 2025Entered into agreements for warrant inducement transaction expected to result in up to...
January 08, 2025 09:15 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Participates in Virtual Investor “What This Means” Segment

Jedd Comiskey, Senior Vice President, Head of Europe, highlights the recent NICE recommendation of LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD Access the segment here ISELIN, N.J.,...