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.
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.
The company remains on track to hold the FDA pre-New Drug Application (NDA) meeting in the fourth quarter of 2024.
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.
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.
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.
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.
The analyst attributes a 30% probability of approval to AQST-108 for Alopecia areata and an 85% probability to Anaphylm for anaphylaxis.
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.
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.
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.
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.
Price Action: AQST stock is up 6.14% at $5.01 at last check Monday.
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