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Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
Category AQST
Aquestive Therapeutics Inc
Three Biotech Earnings Stories Moving in Different Directions: $PGEN, $AQST and $ALLO
The May 2026 biotech earnings window produced three very different stories in Precigen, Aquestive Therapeutics and Allogene Therapeutics. They belong to the same broad sector, they all sit inside the volatile small-to-mid-cap biotechnology universe, and they all trade with catalyst sensitivity.
Aquestive Therapeutics ( $AQST ): Anaphylm after the CRL
Aquestive remains pre-commercial on Anaphylm, with a manufacturing-driven revenue base, a sizeable cash cushion and a clearly negative EBITDA profile in 2026 as it funds the resubmission and maintains a pre-launch infrastructure.
AQST Aquestive Therapeutics Inc
From the January “deficiencies” shock to a Complete Response Letter focused on packaging and administration, why the market is suddenly relieved and why the story is still a multi-quarter grind.
AQST & PHAR -Countdown Jan 31 PDUFA
We are on Friday, January 23, 2026 (Italy time). For January, in your catalyst tracker there are essentially two PDUFAs still “missing” that matter for this piece: Aquestive (AQST) with Anaphylm and Pharming (PHAR) with the pediatric Joenja sNDA (4–11 years, APDS). Both currently carry a PDUFA target action date of January 31, 2026.
AQST Aquestive Therapeutics
On 9 January 2026, Aquestive Therapeutics announced that the US FDA had identified “deficiencies” in the NDA for Anaphylm (dibutepinephrine sublingual film). These deficiencies currently preclude discussions of labeling and post-marketing commitments.
AQST Aquestive Therapeutics
Aquestive Therapeutics is a small-cap specialty pharma player built around its PharmFilm oral film technology and a mix of manufacturing revenue and proprietary pipeline assets. The stock is now tightly linked to a single binary catalyst: the FDA decision on Anaphylm, its epinephrine sublingual film for severe allergic reactions.
