Aquestive (AQST) Up as Anaphylm Pivotal Study Meets Goals

Acetive Therapeutics, Inc. Shares of AQST rose 16% on March 15 after the company met primary and secondary endpoints in the pivotal two-part phase III pharmacokinetic clinical study of Anaphylm (epinephrine) sublingual film to treat reactions severe allergies Share price gains were also boosted by the results of the FDA Type C meeting.

AQSTs Anaphylm is a non-invasive oral epinephrine product candidate. It has the potential to offer greater convenience of use compared to auto-injectors, such as EpiPen and Auvi-Q, for the emergency treatment of severe allergic reactions, including anaphylaxis.

According to data from the pivotal phase III study, Anaphylm was non-inferior to the leading autoinjectors immediately after administration. Anafil was also observed to be consistently faster than the leading autoinjectors due to time to maximum concentration (Tmax).

Tmax is an important metric used by doctors to measure the rate of epinephrine absorption at the first sign of symptoms, which is considered critical in the treatment of severe allergic reactions, including anaphylaxis.

In this case, Anaphylms Tmax has not been seen among the alternative delivery options under development.

In addition, it was also observed that in the pivotal study, Anaphylm exposure levels, as measured by area under the curve (AUC), were comparable to autoinjectors for 30 minutes after dosing. AUC is a metric used to measure the overall exposure to a drug. According to observations, Anaphylm maintained a similar level of exposure to epinephrine compared to intramuscularly injected epinephrine during these 30 minutes.

Overall, the candidate was well tolerated and no treatment-related adverse events were observed.

AQST shares have soared 668.9% in the past year versus the industry’s 4.6% decline.

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In the same press release, Aquestive reported that it has received positive feedback from the FDA in a Type C meeting, which provided the company with a clear understanding of the remaining clinical development steps needed for a pre-approval meeting drug application (NDA) with the FDA during the second half of the year. The company plans to file an NDA for Anaphylm to treat severe allergies in late 2024, subject to a positive pre-NDA meeting.

The FDA has also recommended that Aquestive begin its pediatric study evaluating Anaphylm for the same indication after the completion of the remaining adult studies.

This is aligned with the recommendations of the regulatory body.

Please note that the Anaphylm brand is conditionally approved by the FDA, the final approval of which is subject to regulatory approval of the product candidate.

Acetive Therapeutics, Inc. Price and consensus

Acetive Therapeutics, Inc.  Price and consensus

Acetive Therapeutics, Inc. Price and consensus

Acetive Therapeutics, Inc. price-consensus-chart | Acetive Therapeutics, Inc. Quotation

Zacks Rank and stocks to watch

This currently carries a Zacks Rank #3 (Hold).

Some top-rated pharma/biotech stocks are ADMA Biologics ADMA, FibroGen FGEN i Adicet Bio, Inc. ACET. While ADMA has a Zacks Rank #1 (Strong Buy), FGEN and ACET currently carry a Zacks Rank #2 (Buy). You can see the full list of current Zacks #1 Rank stocks here.

Over the last 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the ADMA 2025 EPS estimate has increased from 32 cents to 50 cents. ADMA shares are up 92.3% in the past year.

ADMA beat estimates in three of the trailing four quarters and matched in one, giving an average earnings surprise of 85%.

In the last 30 days, the Zacks Consensus Estimate for FibroGens 2024 EPS has decreased from $1.14 to $1.09. For the same period, FibroGens 2025 loss per share estimate is pegged at 6 cents. In the past year, FGEN shares have fallen 89.7%.

FGEN beat estimates in two of the four subsequent quarters, missing the mark on the other two occasions, giving an average negative surprise of 2.26%.

Over the past 30 days, the Zacks Consensus Estimate for Adicet Bios 2023 EPS has remained flat at $3.39. During the same period, the consensus estimate for loss per share for Adicets 2024 has remained constant at $1.81. In the past year, ACET shares have fallen 73.4%.

ACET beat estimates in two of the four subsequent quarters, missing the mark on the other two occasions, with an average negative surprise of 8.36%.

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