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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：外國發行人報告
美股SEC公告 ·  08/26 07:06
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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.
redhill biopharma有限公司，一家專業的生物製藥公司，於2024年8月26日宣佈美國食品和藥物管理局（FDA）授予其用於神經母細胞瘤治療的藥物opaganib孤兒藥物專利。該專利獲得批准後將享有七年的獨家銷售權，並可能提供更快的開發和審批時間、潛在的撥款和稅收優惠等額外好處。神經母細胞瘤是嬰兒最常見的癌症，佔美國兒童癌症相關死亡的15%。神經母細胞瘤治療市場預計將在2030年代中期達到近15億美元。opaganib也被指定用於膽管癌，並在臨床數據中顯示在各種固體腫瘤癌症中有希望，並在多種適應症中開發，包括新冠病毒和埃博拉。redhill biopharma專注於胃腸道和傳染病，並推廣用於幽門螺桿菌感染的Talicia和用於旅行者腹瀉的Aemcolo等藥物。
redhill biopharma有限公司，一家專業的生物製藥公司，於2024年8月26日宣佈美國食品和藥物管理局（FDA）授予其用於神經母細胞瘤治療的藥物opaganib孤兒藥物專利。該專利獲得批准後將享有七年的獨家銷售權，並可能提供更快的開發和審批時間、潛在的撥款和稅收優惠等額外好處。神經母細胞瘤是嬰兒最常見的癌症，佔美國兒童癌症相關死亡的15%。神經母細胞瘤治療市場預計將在2030年代中期達到近15億美元。opaganib也被指定用於膽管癌，並在臨床數據中顯示在各種固體腫瘤癌症中有希望，並在多種適應症中開發，包括新冠病毒和埃博拉。redhill biopharma專注於胃腸道和傳染病，並推廣用於幽門螺桿菌感染的Talicia和用於旅行者腹瀉的Aemcolo等藥物。
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