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Aquestive (AQST) Up on Reaffirming Anaphylm Development Pathway
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Aquestive Therapeutics, Inc. (AQST - Free Report) announced a developmental update regarding the timeline and pathway for its oral epinephrine product candidate, Anaphylm. In August 2023, the company submitted its revised protocol for the proposed pivotal pharmacokinetic (PK) study of Anaphylm to the FDA.
AQST anticipates initiating the pivotal study in the fourth quarter of 2023, following alignment with the FDA regarding the study design. Consequently, the company expects to complete regulatory filing in 2024.
Aquestive’s developmental plan for Anaphylm in the upcoming pivotal PK study comprises a standard repeat-dose study of the drug and an already approved comparator drug.
AQST’s Anaphylm is the first and only orally delivered epinephrine product candidate that has shown clinical results non-inferior to autoinjectors (such as EpiPen and Auvi-Q) for the emergency treatment of severe allergic reactions, including anaphylaxis. The non-invasive oral delivery mechanism is an easier-to-use formulation than the currently available intramuscular (IM) injections.
The stock of the company soared 11.8% on Wednesday in response to the developmental update. Year to date, shares of AQST have shot up 89.6% against the industry’s 4.6% fall.
Image Source: Zacks Investment Research
So far this year, the company has reported consistent positive study results from the Anaphylm development program.
In May 2023, Aquestive announced positive top-line results from pilot studies that were completed following the End-of-Phase 2 meeting with the FDA. These studies evaluated differences in PK results based on changes to administration instructions, additional repeat dose data on Anaphylm and the differences between approved auto-injectors.
Subsequently, in July 2023, the company announced positive top-line data from the pilot PK AQ109103 study, which was conducted to establish the finalized dosing instructions and is expected to be used in the upcoming pivotal PK study.
Per data readout from the AQ109103 study, it was observed that Anaphylm, using the finalized dosing administration instructions, delivered epinephrine as effectively as the current commercially available autoinjectors or the manual IM injection. Furthermore, the 12 mg dose strength of Anaphylm met all critical parameters in the AQ109103 study. The drug was also overall well-tolerated with an acceptable safety profile.
The brand name Anaphylm is approved by the FDA on a conditional basis, the final approval of which is subject to FDA approval of the product candidate.
We would also like to remind the investors that, earlier this month, Aquestive announced the FDA’s acceptance of its regulatory filing seeking approval for Libervant (diazepam) Buccal Film in pediatric patients between two and five years of age for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
A decision from the regulatory body is expected on Apr 28, 2024.
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.
Some better-ranked stocks in the overall medical sector are Dynavax Technologies (DVAX - Free Report) , Corcept Therapeutics (CORT - Free Report) and Better Therapeutics (BTTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 26.8%.
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 remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 57.8%.
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 also remained constant at 80 cents. Year to date, shares of BTTX have lost 63.8%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.
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Aquestive (AQST) Up on Reaffirming Anaphylm Development Pathway
Aquestive Therapeutics, Inc. (AQST - Free Report) announced a developmental update regarding the timeline and pathway for its oral epinephrine product candidate, Anaphylm. In August 2023, the company submitted its revised protocol for the proposed pivotal pharmacokinetic (PK) study of Anaphylm to the FDA.
AQST anticipates initiating the pivotal study in the fourth quarter of 2023, following alignment with the FDA regarding the study design. Consequently, the company expects to complete regulatory filing in 2024.
Aquestive’s developmental plan for Anaphylm in the upcoming pivotal PK study comprises a standard repeat-dose study of the drug and an already approved comparator drug.
AQST’s Anaphylm is the first and only orally delivered epinephrine product candidate that has shown clinical results non-inferior to autoinjectors (such as EpiPen and Auvi-Q) for the emergency treatment of severe allergic reactions, including anaphylaxis. The non-invasive oral delivery mechanism is an easier-to-use formulation than the currently available intramuscular (IM) injections.
The stock of the company soared 11.8% on Wednesday in response to the developmental update. Year to date, shares of AQST have shot up 89.6% against the industry’s 4.6% fall.
Image Source: Zacks Investment Research
So far this year, the company has reported consistent positive study results from the Anaphylm development program.
In May 2023, Aquestive announced positive top-line results from pilot studies that were completed following the End-of-Phase 2 meeting with the FDA. These studies evaluated differences in PK results based on changes to administration instructions, additional repeat dose data on Anaphylm and the differences between approved auto-injectors.
Subsequently, in July 2023, the company announced positive top-line data from the pilot PK AQ109103 study, which was conducted to establish the finalized dosing instructions and is expected to be used in the upcoming pivotal PK study.
Per data readout from the AQ109103 study, it was observed that Anaphylm, using the finalized dosing administration instructions, delivered epinephrine as effectively as the current commercially available autoinjectors or the manual IM injection. Furthermore, the 12 mg dose strength of Anaphylm met all critical parameters in the AQ109103 study. The drug was also overall well-tolerated with an acceptable safety profile.
The brand name Anaphylm is approved by the FDA on a conditional basis, the final approval of which is subject to FDA approval of the product candidate.
We would also like to remind the investors that, earlier this month, Aquestive announced the FDA’s acceptance of its regulatory filing seeking approval for Libervant (diazepam) Buccal Film in pediatric patients between two and five years of age for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
A decision from the regulatory body is expected on Apr 28, 2024.
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.
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 - Free Report) , Corcept Therapeutics (CORT - Free Report) and Better Therapeutics (BTTX - Free Report) , 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 narrowed from 24 cents to 23 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 26.8%.
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 remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 57.8%.
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 also remained constant at 80 cents. Year to date, shares of BTTX have lost 63.8%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.