文章核心观点 - 公司提交了针对15-30kg儿童的1mg剂量的neffy鼻喷剂的补充新药申请[1] - neffy 1mg是首个针对这一年龄段儿童的无针式肾上腺素治疗选择[2] - neffy 1mg具有多项优势,如无针头相关不良事件风险、简单易用、可耐高温等[2] 行业概况 - 美国约有600万儿童患有食物过敏,40%曾经历过严重过敏反应[2] - 超过三分之二儿童害怕注射,超过一半家长担心使用肾上腺素自动注射器[2] - 目前仅有一半患有过敏症的儿童携带了处方的肾上腺素自动注射器[4] 公司概况 - 公司专注于帮助高风险患者及其照顾者更好地保护患者免受可能导致过敏性休克的严重过敏反应[5] - 公司已获批2mg剂量的neffy用于成人及30kg及以上儿童[1] - 公司正积极推进neffy 1mg的监管审批,希望尽快为15-30kg儿童提供这一创新治疗选择[1][2]

ARS Pharmaceuticals, Inc. (SPRY) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Indiv ...

vgajic/E+ via Getty Images Investment Overview The San Diego based biotech ARS Pharmaceutical's (NASDAQ:SPRY) share price is up nearly 120% year-to-date, and at the end of August, shares made a quick >20% gain, after its lead and only product, neffy, a nasal spray, was approved for commercial use by the FDA, ahead of schedule, for the treatment of Type I Allergic Reactions. In its latest, Q2 2024 quarterly report / 10Q submission, ARS provides basic information around neffy as follows: ARS-1 (brand n ...

EURneffy offers adults and children (≥30 kg) in Europe living with severe allergic reactions the first new delivery method for adrenaline in more than 30 years in the EU European Commission decision follows FDA approval in the United States on August 9, 2024 SAN DIEGO, Aug. 26, 2024 (GLOBE NEWSWIRE) --   ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to the development of products to better protect patients from severe allergic reactions that could lead to anaphylaxis, annou ...

Earlier this month, the FDA approved ARS Pharmaceuticals Inc’s SPRY neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), for adult and pediatric patients.ARS Pharma’s Neffy is to be an alternative to EpiPen and other autoinjectors like Sanofi SA’s SNY Auvi-Q filled with epinephrine.Also Read: Allergic Reaction Focused ARS Pharmaceuticals’ Lead Candidate Shows Efficacy In Skin Disorder.Cantor Fitzgerald initiated ...

会议主要讨论的核心内容 - 公司获得FDA批准上市首个无针式肾上腺素喷鼻剂neffy,用于成人和体重大于30公斤儿童的1型过敏反应和过敏性休克的紧急治疗 [5][7] - neffy相比目前的肾上腺素自动注射器有多项优势:无针设计、小巧便携、使用简单、安全性高,可以帮助患者和照顾者更快捷、更有信心地在症状初期使用,从而改善临床结果、减少住院率、提高生活质量 [8][9][12][13][14] - 公司已完成大约700名受试者的15项临床试验,neffy的药代动力学和药效学数据显示其疗效和安全性与注射制剂相当,并已获得FDA批准纳入产品标签 [21][22][23] - 公司计划在未来几周内提交1毫克剂量的补充新药申请,用于15-30公斤体重儿童,并正在推进在其他国家和适应症的开发和注册 [19][20][25][26][27] 问答环节重要的提问和回答 - 分析师询问公司与支付方的谈判情况,公司表示已与多家大型医疗保险公司进行过广泛沟通,预计neffy将很快获得广泛报销覆盖,折扣水平也不会显著高于同类创新药品 [54][55][56][57] - 分析师询问公司对15-30公斤儿童人群的评估,公司表示这部分人群占总体患者的约15%,公司将在未来几周内提交补充申请 [59][60] - 分析师询问公司对neffy在公共场所使用的规划,公司表示由于无针设计和安全性,neffy有望像除颤器一样广泛部署在餐厅、飞机等公共场所,为过敏患者提供紧急救治 [77][78][79] - 分析师询问公司如何针对既往未获得肾上腺素处方的患者群体,公司表示将通过医生教育、公众宣传等多种方式提高这部分人群的认知和使用意愿 [82][83][84][85][86]

产品特点 - neffy是用于急救治疗过敏反应（I型），包括过敏性休克，在体重≥30kg的成人和儿童中获得批准[3] - neffy无需注射，易于携带和使用，具有更可靠的剂量[11] - neffy的剂量和使用方法：一次喷射在一侧鼻孔，如症状无改善或加重，5分钟后在同一鼻孔再次喷射[25] - neffy的安全性数据显示，不会出现与注射相关的伤害或血管注射风险[43] - neffy相比当前的带针选项，患者更有可能携带[65] - 患者使用neffy可能更快速[66] 市场机会 - 美国上市是让neffy在全球更多患者中获得的第一步，预计在2024年第三季度向FDA提交1mg剂量的申请[49] - neffy在市场增长方面具有巨大机会，当前美国严重过敏反应市场存在未满足的需求[54] - neffy的市场增长稳定，自2010年以来年复合增长率为6.5%，2023年同比增长12.7%[57] - neffy的推广响应力强，过去3年有约2000万人被诊断并接受医生治疗，其中650万人使用过肾上腺素[55] 成本和定价 - neffy的现金价格为两剂199美元[91] - neffy的患者每月平均成本为0.83美元[95] 市场反应和预期 - 医疗保健专业人士表示有巨大机会转化和扩大市场[72] - 医疗保健专业人士在neffy上市后可能会开具处方的可能性为87%[72] - neffy是唯一无针注射肾上腺素的方式，预计8周内上市[100]

The U.S. Food and Drug Administration has approved ARS Pharmaceuticals’ nasal spray as the first needle-free emergency treatment for potentially fatal allergic reactions.The spray, which will be sold under the brand name neffy, is seen as an alternative to EpiPen and other autoinjectors that are filled with epinephrine, a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.Neffy is expected to be available in the United States within eight weeks of FDA approval, the company s ...

neffy Offers Adults and Children (≥30 kg) Living with Severe Allergic Reactions the First New Delivery Method for Epinephrine in more than 35 Years Well-capitalized to Support Launch and Commercialization of neffy in the U.S., and an Expected Operating Runway of at Least Three Years ARS Pharma to Host Investor Conference Call on Monday, August 12, 2024, at 8:00 am ET SAN DIEGO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at- ...

SAN DIEGO, Aug. 07, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced its participation in the 2024 Wedbush PacGrow Healthcare Conference being held August 13-14, 2024 in New York City. Company management will participate in one-on-one meetings with investors on Wednesday, August 14, 2024. About ARS Pha ...