Aquestive Therapeutics, Inc. (NASDAQ: AQST) has revealed the initial topline data from Part 3 of the EPIPHAST trial. Following the positive results, shares of the pharmaceutical company jumped 13.1% in the extended trading session on Wednesday.
The EPIPHAST trial was designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of AQST-109 epinephrine oral film in patients with Type I allergic reactions, including anaphylaxis (serious systemic hypersensitivity reaction) versus intramuscular injection of epinephrine. The data demonstrated that AQST-109, first-of-its-kind oral medicine, has a favorable and well-tolerated profile.
Official Comments
Aquestive CEO Dan Barber said, “The latest study results from the first three arms of Part 3 of the EPIPHAST study confirm, once again, our ability to deliver significant levels of epinephrine through the oral mucosa.”
“We are anxious to share this data with the FDA following the completion of the upcoming head-to-head study with EpiPen. We continue to believe AQST-109 has the potential to transform how patients and caregivers treat anaphylaxis,” Barber added.
Approvals
The EPIPHAST study was conducted after receiving Health Canada’s clearance. Later, in March 2022, AQST-109 received the Fast Track designation from the U.S. Food and Drug Administration (FDA).
Furthermore, Aquestive plans to submit more data related to AQST-109 to the FDA in the fourth quarter of 2022.
Wall Street’s Take
Recently, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating and a price target of $8 (804.77% upside potential).
Consensus among analysts is a Strong Buy based on 5 unanimous Buys. The average Aquestive price target of $9.80 implies 1,008.35% upside potential from current levels. However, shares have lost 78.43% over the past year.
Insiders Trading
Corporate Insiders are very positive about Aquestive. According to the TipRanks Insiders page, corporate insiders have bought shares worth $151,600 in the past three months. Per the SEC (Securities and Exchange Commission) filings and TipRanks’ Insider Trading Activity tool, a number of Informative Buys were recorded recently.
Bottom-Line
In the current turbulent markets amid fears of an impending recession, investors look for companies with strong fundamentals. With a suite of various products and services, even in tough times, healthcare companies seem to be more resilient than other sector companies. As a result, based on analysts’ and insiders’ bullish stance, investors looking for potential long-term gains may add Aquestive to their portfolio, considering it an attractive entry point.
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