AQST - Aquestive Therapeutics: Positive Phase III Data Unlocks Additional Catalysts For 2024
2024-04-09 01:25:13 ET
Summary
- Aquestive Therapeutics has achieved positive Phase III data for their Anaphylm epinephrine sublingual film, showing comparable efficacy to auto-injectors.
- The company is moving forward with plans to file a New Drug Application (NDA) and has several upcoming catalysts, including self-administration and allergen studies.
- Anaphylm has the potential to disrupt the market dominated by auto-injectors, with global peak sales projected to surpass $1 billion.
In my previous Aquestive Therapeutics ( AQST ) article, I discussed how the company was approaching a significant milestone with the impending topline data readout for their Anaphylm (AQST-109) epinephrine sublingual film anticipated in Q1 of this year. At that time, the company had already initiated patient dosing in their Phase III pivotal study to evaluate Anaphylm’s pharmacokinetics ((PK)) and pharmacodynamics ((PD)) with the potential of a New Drug Application (NDA) filing in 2024. Well, Aquestive announced positive Phase III data in March, revealing that Anaphylm matches up to principal auto-injectors in key endpoint, including time to maximum concentration ((Tmax)), which was quicker than the comparable auto-injectors. The ticker spiked up to over $6 per share in response to the data but has faded over the past few weeks following a $75M public offering and has returned to roughly $4 per share. Although the Phase III data should be the center of attention, I believe investors should consider the potency of future Anaphylm catalysts that have been unlocked for 2024....
Aquestive Therapeutics: Positive Phase III Data Unlocks Additional Catalysts For 2024