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, Inc.（納斯達克股票代碼：AQST）舉辦了虛擬投資者日，重點介紹了該公司的Anaphylm（腎上腺素）舌下膠片和AQST-108（腎上腺素）外用凝膠。
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，它完成了口腔過敏綜合徵（OAS）挑戰性研究Anaphylm的剩餘支持性研究的入組。劑量完成後，該研究預計將於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.
該公司仍有望在2024年第四季度舉行FDA新藥申請（NDA）預先會議。
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仍然專注於在2025年第一季度完成向美國食品藥品管理局提交的保密協議，如果獲得美國食品藥品管理局的批准，則在2025年底或2026年第一季度啓動Anaphylm的全面產品發佈。
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.
該公司完成了對AQST-108的首次人體臨床研究，並計劃開發針對斑禿症（斑片性脫髮）的AQST-108，這種脫髮影響了美國多達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.
該公司預計將在2025年第一季度與美國食品藥品管理局舉行研究前新藥（IND）會議，並於2025年下半年開始第二階段研究。
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，評級爲買入，這反映了AQST-108萬億美元的估值評估的增加。
The analyst attributes a 30% probability of approval to AQST-108 for Alopecia areata and an 85% probability to Anaphylm for anaphylaxis.
分析師將AQST-108批准的脫髮概率爲30％，過敏反應的批准概率爲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，美國食品藥品管理局批准了禮來公司（紐約證券交易所代碼：LLY）/Incyte Corporation（納斯達克股票代碼：INCY）口服Olumiant（巴瑞替尼），用於患有嚴重脫髮的成人。
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.
僅僅一年後，即2023年6月，美國食品藥品管理局批准了輝瑞公司（紐約證券交易所代碼：PFE）的口服Litfulo（ritlecitinib），適用於12歲及以上的嚴重脫髮患者。
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.
鑑於像Litfulo這樣的治療的標價很高，每年費用約爲4.9萬美元，Aquestive預計，如果價格比JaK抑制劑有25％的折扣，那麼在沒有黑匣子警告的情況下，局部脫髮治療將佔據可觀的市場份額。
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.
如果獲得批准，分析師預計AQST-108的年定價可能約爲3.7萬美元。即使峯值市場滲透率低於2％，該藥物在美國的年銷售額預計仍將超過10億美元。
Price Action: AQST stock is up 6.14% at $5.01 at last check Monday.
價格走勢：週一最後一次檢查時，aQst股價上漲6.14％，至5.01美元。
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