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WARREN, N.J. - Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing innovative medicines with a current market capitalization of $287 million and strong financial health according to InvestingPro metrics, today reported positive pharmacokinetic results from a pediatric study of its Anaphylm™ sublingual film, intended for patients with severe allergic reactions, including anaphylaxis. The study targeted patients aged seven to seventeen, weighing over thirty kilograms, and with a history of allergic reactions.
The completion of this pediatric study marks a significant milestone for Anaphylm, as it concludes the clinical program necessary for the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). Aquestive expects the FDA to potentially accept the NDA in the second quarter of 2025.
Daniel Barber, President and CEO of Aquestive, expressed his satisfaction with the study’s outcomes, stating that the results bolster Anaphylm’s profile as a first-of-its-kind sublingual treatment for severe allergic reactions. He highlighted the consistent pharmacokinetic profile observed in pediatric patients, which aligns with previous studies in adults. The company’s stock, which has seen volatile trading patterns with a beta of 2.76, currently trades near $2.90, down about 19% year-to-date according to InvestingPro data.
The study was conducted across multiple sites and involved a single treatment to assess Anaphylm’s pharmacokinetics, pharmacodynamics, safety, and tolerability. Thirty-two patients completed the study, and no serious adverse events were reported, confirming the treatment’s safety and tolerability.
Anaphylm, similar in size to a postage stamp, dissolves upon contact and requires no water or swallowing. Its compact and durable packaging is designed for convenience and resistance to environmental factors.
Aquestive continues to prepare for Anaphylm’s commercial launch, anticipated in the first quarter of 2026, pending FDA approval. With a healthy current ratio of 4.68 and gross profit margins of 69%, the company maintains a strong financial position to support its commercialization plans. The company also has a diverse portfolio of commercialized products and is exploring other epinephrine prodrug candidates, including a topical gel for dermatological conditions. For deeper insights into Aquestive’s financial health and growth prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports, which cover over 1,400 US stocks.
This news is based on a press release statement from Aquestive Therapeutics, Inc.
In other recent news, Aquestive Therapeutics reported its fourth-quarter 2024 earnings, revealing a net loss of $0.19 per share, which did not meet analyst expectations of a $0.13 loss. The company’s revenue also fell short, coming in at $11.87 million against a projected $13.08 million. Despite these setbacks, the full-year revenue for 2024 grew by 14%, reaching $57.6 million, indicating some growth potential. In terms of strategic progress, Aquestive has begun the FDA filing process for its ANIFILM epinephrine sublingual film application and expects the NDA acceptance in the next quarter. H.C. Wainwright has maintained a Buy rating on Aquestive, with a price target of $10, highlighting the company’s advances with Anaphylm, a non-device-based epinephrine product. The firm expressed confidence in Anaphylm’s potential, noting that the FDA may convene a Pulmonary-Allergy Drugs Advisory Committee during its review. Aquestive is also preparing for a potential advisory committee meeting, which could underscore Anaphylm’s advantages for patients.
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