On Friday, Aquestive Therapeutics, Inc. AQST hosted a digital investor day highlighting the corporate’s Anaphylm (epinephrine) Sublingual Movie and AQST-108 (epinephrine) Topical Gel.
Aquestive stated it accomplished enrollment in its remaining supportive examine for Anaphylm, the oral allergy syndrome (OAS) problem examine. Following the completion of dosing, the examine is anticipated to be accomplished within the fourth quarter of 2024.
The corporate stays on monitor to carry the FDA pre-New Drug Utility (NDA) assembly within the fourth quarter of 2024.
Aquestive stays centered on finishing an NDA submission with the FDA within the first quarter of 2025 and initiating a full product launch of Anaphylm, if permitted by the FDA, on the finish of 2025 or within the first quarter of 2026.
The corporate accomplished its first human scientific examine for AQST-108 and plans to develop AQST-108 for Alopecia areata (patchy hair loss), which impacts as many as 6.7 million individuals within the U.S.
The corporate expects to carry a pre-Investigational New Drug (IND) assembly with the FDA within the first quarter of 2025 and to begin the Part 2 examine within the second half of 2025.
H.C. Wainwright raised the worth goal for Aquestive Therapeutics to $10 from the prior $9 per share with a Purchase ranking, reflecting the addition of AQST-108 to the valuation evaluation.
The analyst attributes a 30% likelihood of approval to AQST-108 for Alopecia areata and an 85% likelihood to Anaphylm for anaphylaxis.
In June 2022, the FDA permitted Eli Lilly And Co LLY / Incyte Company’s INCY oral Olumiant (baricitinib) for adults with extreme alopecia areata.
Only a 12 months after, in June 2023, the FDA approved Pfizer Inc’s PFE oral Litfulo (ritlecitinib) for people 12 years of age and older with extreme alopecia areata.
Given the steep record costs of remedies like Litfulo, which prices round $49K per 12 months, Aquestive expects a topical alopecia areata remedy with no black field warning to seize vital market share if priced at a 25% low cost to JAK inhibitors.
If permitted, the analyst anticipates that AQST-108 may very well be priced at roughly $37K yearly. Even with peak market penetration charges beneath 2%, the drug is projected to surpass $1 billion in annual U.S. gross sales.
Value Motion: AQST inventory is up 6.14% at $5.01 eventually test Monday.
Picture through Shutterstock
Learn Subsequent:
Market Information and Information dropped at you by Benzinga APIs
© 2024 Benzinga.com. Benzinga doesn’t present funding recommendation. All rights reserved.
