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Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome

Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Receives Rare Pediatric Disease Designation from the FDA for TNX-2900 for the Treatment of Prader-Willi Syndrome

Tonix Pharmaceuticals | 8-K：Tonix Pharmaceuticals治療普拉德威利綜合征的TNX-2900獲得FDA罕見兒科疾病認定
SEC announcement ·  03/25 21:08
牛牛AI助理已提取核心訊息
On March 25, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to its product candidate TNX-2900 for the treatment of Prader-Willi syndrome (PWS) in children and adolescents. This designation follows the previous Orphan Drug designation by the FDA in 2022 and the clearance of the investigational new drug (IND) application in 2023. The Rare Pediatric Disease Designation could potentially lead to a transferable Priority Review Voucher for Tonix, which has recently been valued at around $100 million in sales. The FDA's recognition of TNX-2900 addresses the unmet medical need for PWS hyperphagia, for which there are currently no approved treatments. Tonix Pharmaceuticals, based in Chatham, New Jersey, is focused on developing therapeutics for central nervous system disorders and other areas, with a commercial subsidiary marketing products for acute migraine treatment.
On March 25, 2024, Tonix Pharmaceuticals Holding Corp. announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation to its product candidate TNX-2900 for the treatment of Prader-Willi syndrome (PWS) in children and adolescents. This designation follows the previous Orphan Drug designation by the FDA in 2022 and the clearance of the investigational new drug (IND) application in 2023. The Rare Pediatric Disease Designation could potentially lead to a transferable Priority Review Voucher for Tonix, which has recently been valued at around $100 million in sales. The FDA's recognition of TNX-2900 addresses the unmet medical need for PWS hyperphagia, for which there are currently no approved treatments. Tonix Pharmaceuticals, based in Chatham, New Jersey, is focused on developing therapeutics for central nervous system disorders and other areas, with a commercial subsidiary marketing products for acute migraine treatment.
2024 年 3 月 25 日，Tonix Pharmicals Holding Corp. 宣佈，美國食品藥品監督管理局 (FDA) 向其用於治療兒童和青少年的普拉德威利綜合徵 (PWS) 候選產品 TNX-2900 授予罕見兒科疾病稱號。該認定是繼美國食品藥品管理局先前於2022年認定孤兒藥以及2023年批准研究性新藥（IND）申請之後作出的。罕見兒科疾病認定有可能導致Tonix獲得可轉讓的優先審查憑證，該券最近的銷售額約爲1億美元。美國食品和藥物管理局對 TNX-2900 的認可解決了尚未得到滿足的 PWS 食慾過度的醫療需求，目前尚無批准的治療方法。Tonix Pharmicals總部位於新澤西州查塔姆，專注於開發中樞神經系統疾病和其他領域的療法，其商業子公司銷售急性偏頭痛治療產品。
2024 年 3 月 25 日，Tonix Pharmicals Holding Corp. 宣佈，美國食品藥品監督管理局 (FDA) 向其用於治療兒童和青少年的普拉德威利綜合徵 (PWS) 候選產品 TNX-2900 授予罕見兒科疾病稱號。該認定是繼美國食品藥品管理局先前於2022年認定孤兒藥以及2023年批准研究性新藥（IND）申請之後作出的。罕見兒科疾病認定有可能導致Tonix獲得可轉讓的優先審查憑證，該券最近的銷售額約爲1億美元。美國食品和藥物管理局對 TNX-2900 的認可解決了尚未得到滿足的 PWS 食慾過度的醫療需求，目前尚無批准的治療方法。Tonix Pharmicals總部位於新澤西州查塔姆，專注於開發中樞神經系統疾病和其他領域的療法，其商業子公司銷售急性偏頭痛治療產品。
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