Aquestive's (AQST) Libervant Accepted for FDA Review, Stock Up
Aquestive Therapeutics, Inc. AQST announced the FDA’s acceptance of its new drug application for Libervant (diazepam) Buccal Film, in pediatric patients between two and five years of age. The NDA is seeking approval for the drug in the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
A decision from the regulatory body is expected on Apr 28, 2024.
The company further reported that Libervant has already received tentative approval from the FDA for the same indication in patients aged 12 years and older in August 2022. However, Aquestive is yet to gain U.S. market access for Libervant for patients aged 12 years and older, which is subject to the expiration of an existing orphan drug market exclusivity of a previously FDA-approved drug that is scheduled to expire in January 2027.
Per the company, intermittent, stereotypic episodes of frequent seizure activity in patients include seizure clusters and acute repetitive seizures.
Aquestive’s stock jumped 4.7% in the last trading session in response to the encouraging news. Year to date, shares of AQST have shot up 74.1% against the industry’s 4.9% fall.
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Currently, Diastat (diazepam) Rectal Gel is the only approved treatment available to pediatric patients aged two years and older for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
In the press release, Aquestive reported developing Libervant using its proprietary PharmFilm technology as an alternative to the device-based products, currently available for patients with refractory epilepsy. Libervant is an orally administered film formulation of diazepam, which is in contrast to the rectal gel and nasal spray products.
Subject to approval, management expects Libervant’s method of use to be a better treatment option for the pediatric patient population.
Aquestive Therapeutics, Inc. Price and Consensus
Aquestive Therapeutics, Inc. price-consensus-chart | Aquestive Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Aquestive currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector are Dynavax Technologies DVAX, Corcept Therapeutics CORT and Better Therapeutics BTTX, each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 26%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has gone up from 75 cents to 78 cents. The estimate for Corcept’s 2024 earnings per share has also improved from 81 cents to 83 cents. Year to date, shares of CORT have climbed 62.7%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has remained constant at 98 cents. During the same period, Better Therapeutics’ 2024 loss per share has remained constant at 80 cents. Year to date, shares of BTTX have lost 44.8%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.
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