Business
Photocure partner Asieris announces that EMA has accepted Marketing Authorization Application for CEVIRA in Europe
Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that its marketing authorization application (MAA) for Cevira® (APL-1702) for the treatment of high-grade squamous intraepithelial lesions (HSIL) has been accepted by the European Medicines Agency (EMA).
About this update from Photocure Asa
[{"type":"text","content":"OSLO, Norway, Feb. 27, 2026 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that its marketing authorization application (MAA) for Cevira® (APL-1702) for the treatment of high-grade squamous intraepithelial lesions (HSIL) has been accepted by the European Medicines Agency (EMA).","length":390,"tagName":"p"},{"type":"text","content":"Asieris' media release states about APL-1702, the first-in-class photodynamic therapy product: "As a drug-device combination, it integrates hexaminolevulinate hydrochloride ointment with a disposable cervical light applicator. Its innovative design enables localized drug administration and features an intra-cavity cold light source, representing a paradigm shift in the treatment approach.","length":400,"tagName":"p"},{"type":"text","content":"The MAA submission to the EMA is primarily supported by results from the international multicenter Phase III clinical trial of APL-1702, which enrolled over 20% European patients."","length":190,"tagName":"p"},{"type":"text","content":"Cevira (APL-1702) is a photodynamic drug-device combination product in development for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL), licensed to Asieris by Photocure.","length":202,"tagName":"p"},{"type":"text","content":"Read Asieris' full media release here: https://asieris.com/asieris-announces-european-medicines-agency-accepts-marketing-authorization-application-for-apl-1702/","length":164,"tagName":"p"},{"type":"text","content":"Note to editors:","length":16,"tagName":"p"},{"type":"text","content":"All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.","length":109,"tagName":"p"},{"type":"text","content":"This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.","length":342,"tagName":"p"},{"type":"text","content":"About Cevira®Cevira® (APL-1702) is a photodynamic drug-device combination product in development. Based on the...