On Monday, H.C. Wainwright increased the price target for Aquestive Therapeutics (NASDAQ:AQST) to $9.00 from the previous $7.00, while maintaining a Buy rating on the stock.
This adjustment follows the successful results from Aquestive's Phase 3 pharmacokinetic (PK) clinical study of Anaphylm Sublingual Film, which is being developed as an oral epinephrine prodrug candidate for severe allergic reactions, including anaphylaxis.
The company announced late last week that the pivotal study met both primary and secondary endpoints. The two-part, Phase 3 study was conducted to compare the PK and pharmacodynamics (PD) of Anaphylm with those of intramuscular (IM) epinephrine injections and epinephrine autoinjectors, such as EpiPen and Auvi-Q, in healthy adult subjects.
In the single dose component of the study, Anaphylm demonstrated several promising results. It achieved a geometric mean Cmax, which is the maximum concentration of the drug in the blood, comparable to that of EpiPen and Auvi-Q. It also showed favorable partial areas under the curve (AUCs) in comparison to the autoinjectors and Adrenalin IM injection within the first 60 minutes post-dosing.
Notably, Anaphylm maintained a median Tmax, the time to reach the maximum concentration, of 12 minutes, which is quicker than both EpiPen and Auvi-Q. Additionally, the drug produced significant pharmacodynamic changes in blood pressure and heart rate as early as two minutes after administration and was well tolerated with no severe adverse events reported.
The repeat dosing part of the study, which included 36 adult subjects, indicated that Anaphylm maintains epinephrine plasma concentrations comparable to or greater than those of existing injection products for all but one time point up to two hours after administration.
The positive outcome of the trial led to a reduction in the discount rate used by H.C. Wainwright, now at 11% compared to the previous 12%, which contributed to the new $9 price target. The firm reiterates its confidence in Aquestive Therapeutics with a Buy rating, reflecting the potential of Anaphylm as a significant player in the treatment of severe allergic reactions.
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