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Redhill Biopharma | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Redhill Biopharma | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Redhill Biopharma | 6-K：外国发行人报告
美股SEC公告 ·  08/26 07:06

Moomoo AI 已提取核心信息

RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced on August 26, 2024, that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to its drug opaganib for the treatment of neuroblastoma, a rare childhood cancer. This designation provides seven years of marketing exclusivity upon approval and may offer additional benefits such as faster development and review times, potential grant funding, and tax credits. Neuroblastoma is the most common cancer in infancy and accounts for 15% of pediatric cancer-related deaths in the U.S. The market for neuroblastoma treatments is expected to reach nearly $1.5 billion by the mid-2030s. Opaganib, which is also designated for cholangiocarcinoma, has shown promise in clinical data for various solid tumor cancers and is in development for multiple indications including COVID-19 and Ebola. RedHill Biopharma focuses on gastrointestinal and infectious diseases and promotes drugs such as Talicia for H. pylori infection and Aemcolo for travelers' diarrhea.
RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced on August 26, 2024, that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to its drug opaganib for the treatment of neuroblastoma, a rare childhood cancer. This designation provides seven years of marketing exclusivity upon approval and may offer additional benefits such as faster development and review times, potential grant funding, and tax credits. Neuroblastoma is the most common cancer in infancy and accounts for 15% of pediatric cancer-related deaths in the U.S. The market for neuroblastoma treatments is expected to reach nearly $1.5 billion by the mid-2030s. Opaganib, which is also designated for cholangiocarcinoma, has shown promise in clinical data for various solid tumor cancers and is in development for multiple indications including COVID-19 and Ebola. RedHill Biopharma focuses on gastrointestinal and infectious diseases and promotes drugs such as Talicia for H. pylori infection and Aemcolo for travelers' diarrhea.
红山生物制药有限公司，一家专业生物制药公司，在2024年8月26日宣布，美国食品和药物管理局（FDA）已将其药物奥帕加尼布（opaganib）授予了神经母细胞瘤的孤儿药物认定，该罕见的儿童癌症。该认定意味着在批准后将获得七年的独家营销权，并可能提供额外的好处，如更快的开发和审查时间，潜在的资助，以及税收抵免。神经母细胞瘤是婴儿最常见的癌症，占美国儿童癌症死亡的15%。神经母细胞瘤治疗市场预计将在2030年代中期达到近15亿美元。奥帕加尼布（opaganib）还被指定用于胆管癌，临床数据显示其在各种实体肿瘤癌症中显示了潜力，并且正在开发多个适应症，包括COVID-19和埃博拉。红山生物制药专注于消化道和传染病，推广如泰利西亚（Talicia） 用于幽门螺杆菌感染和Aemcolo 用于旅行者腹泻等药物。
红山生物制药有限公司，一家专业生物制药公司，在2024年8月26日宣布，美国食品和药物管理局（FDA）已将其药物奥帕加尼布（opaganib）授予了神经母细胞瘤的孤儿药物认定，该罕见的儿童癌症。该认定意味着在批准后将获得七年的独家营销权，并可能提供额外的好处，如更快的开发和审查时间，潜在的资助，以及税收抵免。神经母细胞瘤是婴儿最常见的癌症，占美国儿童癌症死亡的15%。神经母细胞瘤治疗市场预计将在2030年代中期达到近15亿美元。奥帕加尼布（opaganib）还被指定用于胆管癌，临床数据显示其在各种实体肿瘤癌症中显示了潜力，并且正在开发多个适应症，包括COVID-19和埃博拉。红山生物制药专注于消化道和传染病，推广如泰利西亚（Talicia） 用于幽门螺杆菌感染和Aemcolo 用于旅行者腹泻等药物。
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