Optimism Around Aquestive As It Moves Forward With Severe Allergy, Baldness Candidate
Optimism Around Aquestive As It Moves Forward With Severe Allergy, Baldness Candidate
Aquestive remains focused on completing an NDA submission with the FDA in the first quarter of 2025 and initiating a full product launch of Anaphylm, if approved by the FDA, at the end of 2025 or in the first quarter of 2026.On Friday, Aquestive Therapeutics, Inc. (NASDAQ:AQST) hosted a virtual investor day highlighting the company's Anaphylm (epinephrine) Sublingual Film and AQST-108 (epinephrine) Topical Gel.
周五，aquestive therapeutics公司（纳斯达克：AQST）举办了一场虚拟投资者日，重点介绍了公司的Anaphylm（肾上腺素）舌下薄膜和AQSt-108（肾上腺素）局部凝胶。
Aquestive said it completed enrollment in its remaining supportive study for Anaphylm, the oral allergy syndrome (OAS) challenge study. Following the completion of dosing, the study is expected to be completed in the fourth quarter of 2024.
aquestive表示已完成了Anaphylm剩余支持性研究的招募工作，即口服过敏综合征（OAS）挑战研究。在剂量完成后，预计该研究将于2024年第四季度完成。
The company remains on track to hold the FDA pre-New Drug Application (NDA) meeting in the fourth quarter of 2024.
公司将继续按计划于2024年第四季度进行FDA新药申请（NDA）前会议。
Aquestive remains focused on completing an NDA submission with the FDA in the first quarter of 2025 and initiating a full product launch of Anaphylm, if approved by the FDA, at the end of 2025 or in the first quarter of 2026.
aquestive将继续致力于在2025年第一季度与FDA提交新药申请，并在2025年底或2026年第一季度获得FDA批准后启动Anaphylm的全面产品发布。
The company completed its first human clinical study for AQST-108 and plans to develop AQST-108 for Alopecia areata (patchy hair loss), which impacts as many as 6.7 million people in the U.S.
公司已完成了AQSt-108的首项人体临床研究，并计划为Alopecia areata（局部脱发）开发影响美国多达670万人的AQSt-108。
The company expects to hold a pre-Investigational New Drug (IND) meeting with the FDA in the first quarter of 2025 and to commence the Phase 2 study in the second half of 2025.
公司预计将于2025年第一季度与FDA举行预研究新药（IND）会议，并于2025年下半年开始第2阶段研究。
H.C. Wainwright raised the price target for Aquestive Therapeutics to $10 from the prior $9 per share with a Buy rating, reflecting the addition of AQST-108 to the valuation assessment.
H.C. Wainwright将aquestive therapeutics的目标股价从之前的9美元上调至10美元，评级为买入，反映了包括AQSt-108亿在内的估值评估。
The analyst attributes a 30% probability of approval to AQST-108 for Alopecia areata and an 85% probability to Anaphylm for anaphylaxis.
分析师将AQSt-108在Alopecia areata的批准概率定为30％，将Anaphylm在过敏症状中的批准概率定为85％。
In June 2022, the FDA approved Eli Lilly And Co (NYSE:LLY) / Incyte Corporation's (NASDAQ:INCY) oral Olumiant (baricitinib) for adults with severe alopecia areata.
2022年6月，FDA批准了礼来（纽交所: LLY）/ 因塞特公司（纳斯达克: INCY）的口服Olumiant（巴瑞替尼）用于重度斑秃成人。
Just a year after, in June 2023, the FDA approved Pfizer Inc's (NYSE:PFE) oral Litfulo (ritlecitinib) for individuals 12 years of age and older with severe alopecia areata.
仅一年之后的2023年6月，FDA批准了辉瑞公司（纽交所: PFE）的口服Litfulo（利替替尼）用于12岁及以上严重斑秃患者。
Given the steep list prices of treatments like Litfulo, which costs around $49K per year, Aquestive expects a topical alopecia areata treatment without a black box warning to capture significant market share if priced at a 25% discount to JAK inhibitors.
鉴于Litfulo等治疗方案的高昂价格，其每年约合4.9万美元。如果定价比JAk抑制剂低25%，Aquestive预计无需黑匣子警告的局部斑秃治疗方案将占据重要市场份额。
If approved, the analyst anticipates that AQST-108 could be priced at approximately $37K annually. Even with peak market penetration rates below 2%, the drug is projected to surpass $1 billion in annual U.S. sales.
如果获批，分析师预计AQSt-108的年均价格约为3.7万美元。即使市场渗透率低于2%，该药物预计将超过10亿美元的年销售额。
Price Action: AQST stock is up 6.14% at $5.01 at last check Monday.
价格走势：AQSt股价在上周一最后检查时上涨了6.14%，报5.01美元。
Photo via Shutterstock
图片来自shutterstock。
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