Aquestive Therapeutics

Aquestive Therapeutics received positive FDA feedback for Anaphylm™ (epinephrine) Sublingual Film, confirming no additional adult clinical trials are necessary prior to NDA submission in Q1 2025. A pediatric trial has commenced in the U.S. and Canada.

Analysts from Leerink Partners maintain Buy ratings on Vir Biotechnology (VIR) with a $18.00 target and Sell on Moderna (MRNA) with no target specified. The consensus for VIR is a Moderate Buy with a $32.67 target, while Moderna has a Moderate Buy consensus with a $97.62 target.

Aquestive Therapeutics reports Q3 2024 financials, $78M cash, and updates on Anaphylm (epinephrine) Sublingual Film and AQST-108 (epinephrine) Topical Gel development, with pre-NDA and pre-IND meetings scheduled for Q4 2024. Libervant (diazepam) Buccal Film for ages 2-5 is available through retail channels. The company reaffirms cash runway into 2026 and will host an investment community call on November 5, 2024.

A novel epinephrine film, Anaphylm, developed by Aquestive Therapeutics, provides rapid relief for oral allergy syndrome (OAS) symptoms, with complete symptom relief in about 12 minutes. The film's effectiveness was tested in OAS patients to ensure mouth swelling does not hinder absorption. Aquestive plans to conduct further studies and submit Anaphylm for FDA approval in early 2025, aiming for a 2026 launch. The film, designed for adults and children weighing 66 pounds and more, offers a convenient alternative to auto-injectors.

Aquestive Therapeutics announces positive OAS challenge study results for Anaphylm, showing rapid symptom resolution and consistent PK profile. The study met primary and secondary endpoints, positioning Anaphylm for a pre-NDA meeting in Q4 2024.

Anaphylm (epinephrine) sublingual film rapidly resolves severe allergic reaction symptoms within 2 minutes, with a consistent pharmacokinetic profile. The Oral Allergy Syndrome (OAS) challenge study demonstrated Anaphylm's efficacy and safety, prompting Aquestive Therapeutics to seek FDA pre-NDA meeting and plan pediatric trials and NDA submission.

Aquestive Therapeutics plans to submit an NDA for its Anaphylm sublingual epinephrine film in Q1 2025, aiming for a launch in late 2025 or early 2026, pending FDA approval. The film aims to provide a non-invasive, oral alternative to traditional epinephrine delivery methods for anaphylaxis treatment.

Aquestive Therapeutics hosted a virtual investor day, highlighting its Anaphylm and AQST-108 candidates. The company completed enrollment for Anaphylm's OAS challenge study and plans to submit an NDA in Q1 2025. AQST-108, targeting Alopecia areata, completed its first human study, with a pre-IND meeting scheduled for Q1 2025. H.C. Wainwright raised Aquestive's price target to $10 with a Buy rating, attributing a 30% approval probability to AQST-108 and 85% to Anaphylm. The FDA approved treatments for severe alopecia areata in 2022 and 2023, positioning AQST-108 to capture market share if approved.