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., Jan. 08, 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) earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-rel ...

Core Article Summary - The National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA™ (bevacizumab gamma) as a treatment option for wet age-related macular degeneration (wet AMD) [1][3] - LYTENAVA™ is the first and only authorized ophthalmic formulation of bevacizumab for wet AMD treatment in the EU and UK, with 10 years of market exclusivity [3][4] - Outlook Therapeutics, the developer of LYTENAVA™, has achieved regulatory approval in the EU and UK for this treatment [2][4] Product Details - LYTENAVA™ (bevacizumab gamma) is an ophthalmic formulation of bevacizumab specifically designed for treating wet AMD [4][6] - The product works by binding to vascular endothelial growth factor (VEGF), preventing its interaction with receptors on endothelial cells, thereby reducing cell proliferation and new blood vessel formation in the retina [6] - In the US, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is currently under investigation in a non-inferiority study for wet AMD treatment [5][7] Company Strategy - Outlook Therapeutics is focused on the development and commercialization of LYTENAVA™ for retina diseases, particularly wet AMD [7] - The company plans to commercially launch LYTENAVA™ in the EU and UK in the first half of 2025 [7] - In the US, if the ongoing study is successful, Outlook Therapeutics may resubmit a Biologics License Application (BLA) to the FDA [7] Regulatory Status - LYTENAVA™ has received Marketing Authorization from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) [4][7] - The product is currently investigational in the US, with potential to become the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications [5][7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37759 Delaware 38-3982704 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Exchange Commission not la ...

Product Development and Approvals - LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU and UK, with the first commercial launch anticipated in H1 CY25[2] - The company plans to resubmit the BLA for ONS-5010 in Q1 CY2025, with final efficacy data from NORSE EIGHT expected in January 2025[6][9] - Initial commercial launches of LYTENAVA™ in Europe are planned to commence in H1 CY2025[6] - Potential US FDA approval of ONS-5010 is anticipated in H2 CY2025[6] Financial Performance - Outlook Therapeutics had cash and cash equivalents of $14.9 million as of September 30, 2024[10] - The company reported a net loss of $75.4 million, or $4.06 per basic and diluted share, for the fiscal year ended September 30, 2024, compared to a net loss of $59.0 million, or $4.72 per basic and diluted share, for the prior fiscal year[18] - Research and development expenses increased to $41.8 million in FY2024 from $26.5 million in FY2023[23] - General and administrative expenses increased to $29.9 million in FY2024 from $26.7 million in FY2023[23] - Total assets decreased to $28.8 million as of September 30, 2024, from $32.3 million as of September 30, 2023[24] - Total stockholders' deficit increased to $73.1 million as of September 30, 2024, from $14.4 million as of September 30, 2023[24]

LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK); First commercial launch anticipated in H1 CY25Received NICE recommendation of LYTENAVA™ (bevacizumab gamma) for the treatment of wet AMD ISELIN, N.J., Dec. 27, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year ...

ISELIN, N.J., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced that following an internal strategic review, the management team and Board of Directors have implemented initiatives to streamline the orga ...

ISELIN, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that Russell Trenary has stepped down as the Company’s President and Chief Executive Officer (CEO), effecti ...

NEW YORK, Dec. 2, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Outlook Therapeutics, Inc. ("Outlook" or the "Company") (NASDAQ: OTLK).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Outlook and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On November 27, ...

Outlook Therapeutics (OTLK) reported preliminary top-line results from the 90-day non-inferiority NORSE EIGHT clinical study evaluating ONS-5010 (Lytenava) to treat patients with wet age-related macular degeneration (AMD). The NORSE EIGHT study is the second of two adequate and well-controlled clinical studies evaluating ONS-5010 for the AMD indication.Per the data readout, the candidate failed to meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment with the ...

Outlook Therapeutics Inc. OTLK revealed preliminary topline results of NORSE EIGHT, the second of two clinical trials evaluating ONS-5010 in wet AMD patients.In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified noninferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the FDA.The pre-specified noninferiority endpoint was measured by mean change in best corrected visual acuity (BCVA) from baseline to week 8.Also Read: Why Is Eye Disease-Focused Outlook Therapeutic ...