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.
週五，aquestive therapeutics公司（納斯達克：AQST）舉辦了一次虛擬投資者日，重點介紹公司的Anaphylm（腎上腺素）舌下膜和AQSt-108（腎上腺素）局部凝膠。
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Anaphylm剩餘支持性研究的招募工作，即口服過敏綜合症（OAS）挑戰研究。在完成給藥後，預計該研究將於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.
該公司仍在按計劃準備於2024年第四季度舉行FDA新藥申請（NDA）前會議。
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致力於在2025年第一季度與FDA提交NDA申請，並計劃在FDA批准後於2025年底或2026年第一季度開始全面推出Anaphylm。
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.
該公司已完成了AQSt-108的首次人體臨床研究，並計劃開發AQSt-108用於脫髮斑禿（頭髮局部脫落），這種情況影響着美國多達670萬人。
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.
該公司預計將於2025年第一季度與FDA舉行預IND會議，並計劃在2025年下半年啓動第2階段研究。
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將Aquestive Therapeutics的目標股價從之前的每股9美元上調至10美元的買入評級，這反映了AQSt-108的估值評估。
The analyst attributes a 30% probability of approval to AQST-108 for Alopecia areata and an 85% probability to Anaphylm for anaphylaxis.
分析師給AQSt-108用於斑禿病的批准概率爲30%，給Anaphylm用於過敏症的批准概率爲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批准了禮來（紐交所: LLY）/ 因塞特公司（納斯達克: INCY）口服Olumiant（巴瑞替尼）治療重度斑禿成人。
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.
僅一年後，即2023年6月，FDA批准了輝瑞公司（紐交所: PFE）口服Litfulo（利替替尼）治療12歲及以上重度斑禿成人。
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.
考慮到Litfulo等治療方法的高昂價格，每年約4.9萬美元，Aquestive希望一種無黑盒警告的局部斑禿治療方法以JAk抑制劑的75%折扣價能夠佔據重要市場份額。
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.
如果獲批，分析師預計AQSt-108每年的定價約爲3.7萬美元。即使市場滲透率不到2%，該藥物預計將超過10億美元的年銷售額。
Price Action: AQST stock is up 6.14% at $5.01 at last check Monday.
股價走勢：AQSt股票在上週一最新報價爲5.01美元，漲幅爲6.14%。
Photo via Shutterstock
圖片來自shutterstock。
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譯文內容由第三人軟體翻譯。
