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10.06.25 - 14:09
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Outlook Therapeutics® Announces SMC Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD (GlobeNewswire EN)
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ISELIN, N.J., June 10, 2025 (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 Scottish Medicines Consortium (SMC) acceptance of LYTENAVA™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet age-related macular degeneration (wet AMD). LYTENAVA™ (bevacizumab gamma) is the first and only licensed ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the United Kingdom (UK) and has an initial 10 years of market exclusivity from the date of initial marketing authorization from the Medicines and Healthcare products Regulatory Agency....
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23.05.25 - 12:33
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Outlook Therapeutics® Announces Pricing of $13.0 Million Public Offering (GlobeNewswire EN)
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ISELIN, N.J., May 23, 2025 (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 pricing of an underwritten public offering of 9,285,714 shares of its common stock, together with accompanying warrants to purchase 18,571,428 shares of its common stock. The combined public offering price of common stock and accompanying warrant is $1.40. The common stock is being sold in combination with an accompanying warrant to purchase two shares of common stock issued for each share of common stock sold. The accompanying warrant has an exercise price of $1.40 per share, will become exercisable immediately and will expire five years from the date of issuance. The offering is expected to close on May 27, 2025, subject to the satisfaction of customary closing conditions....
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22.05.25 - 22:03
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Outlook Therapeutics® Announces Proposed Public Offering of Common Stock and Warrants (GlobeNewswire EN)
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ISELIN, N.J., May 22, 2025 (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 that it has commenced an underwritten public offering of its common stock and accompanying warrants exercisable for shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering....
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28.02.25 - 14:06
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Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration (GlobeNewswire EN)
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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 Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD)....
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31.01.25 - 14:09
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Outlook Therapeutics® Appoints Faisal G. Sukhtian as Chairman of the Board of Directors (GlobeNewswire EN)
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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 Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced Faisal G. Sukhtian has been appointed as Chairman of the Board of Directors, effective immediately. Mr. Sukhtian will assume the role from Randy Thurman, who will remain on the Board as Lead Independent Director....
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16.01.25 - 12:03
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Outlook Therapeutics® Announces Complete Twelve Week Efficacy and Safety Results of NORSE EIGHT Clinical Trial (GlobeNewswire EN)
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ISELIN, N.J., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Outlook Therapeutics, or the Company) (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it has completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients. ONS-5010 demonstrated noninferiority to ranibizumab at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025....
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