ARS Pharmaceuticals (SPRY), Tuesday announced the submission of Day 180 response for Neffy's Marketing Authorization Application to the Committee for Medicinal Products for Human Use of the European Medicines Agency, expecting to receive the opinion on the drug in the second quarter of 2024.Neffy or epinephrine nasal spray is an investigational drug proposed for the treatment of Type I allergic reactions including anaphylaxis.The response covers all concerns previously raised by the Committee for Medicinal Products for Human Use (CHMP), incorporating findings from a repeat dose PK/PD study of Neffy under nasal allergen challenge (NAC) conditions and updated testing concerning nitrosamine levels.Simultaneously, the biopharmaceutical company also signed an exclusive license and distribution agreement with CSL Seqirus, a subsidiary of CSL Ltd.

ARS Pharmaceuticals（SPRY）周二宣布，将向欧洲药品管理局（European Medicines Agency）人类使用药品委员会提交Neffy上市许可申请的第180天回复，预计将于2024年第二季度收到该药物的意见。Neffy或肾上腺素鼻喷雾剂是一种研究药物，拟用于治疗包括过敏反应在内的I型过敏反应。该回复涵盖了人类使用药品委员会（CHMP）先前提出的所有担忧，其中纳入了鼻过敏原激发（NAC）条件下Neffy重复剂量PK/PD研究的结果以及有关亚硝胺水平的最新测试。同时，该生物制药公司还与CSL有限公司的子公司CSL Sekirus签署了独家许可和分销协议。

to commercialize Neffy across Australia and New Zealand..

在澳大利亚和新西兰将Neffy商业化。。

Under the agreement, ARS will receive an upfront payment as well as event-driven milestone payments.Currently, ARS Pharma's stock is up 0.12 percent at $8.61 on the Nasdaq. For comments and feedback contact: editorial@rttnews.comHealth News

根据该协议，ARS将收到预付款以及事件驱动的里程碑付款。目前，ARS Pharma的股价在纳斯达克上涨0.12%，至8.61美元。如需评论和反馈，请联系：editorial@rttnews.comHealth新闻

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