AQST
Aquestive Therapeutics, Inc.5.82
-0.09-1.52%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
710.06MP/E (TTM)
-Basic EPS (TTM)
-0.70Dividend Yield
0%Recent Filings
10-Q
8-K
8-K
New patents extend Anaphylm protection
Aquestive Therapeutics bolstered its intellectual property for Anaphylm, the sublingual epinephrine film, with two new U.S. patents issued on October 8, 2025, covering proprietary compositions for oral mucosal absorption and extending protection through 2037. This strengthens defenses against competitors ahead of the FDA's PDUFA target date of January 31, 2026. Patents fortify the needle-free alternative for anaphylaxis treatment. Yet risks persist if FDA approval falters.
8-K
Anaphylm PDUFA set for 2026
Aquestive Therapeutics presented at the H.C. Wainwright 27th Annual Global Investor Conference on September 8, 2025, highlighting its lead asset Anaphylm, a needle-free sublingual epinephrine film for anaphylaxis with a PDUFA date of January 31, 2026. The company eyes a $2B U.S. market by 2031, up from $800M in 2024, driven by rising allergies and demand for easier delivery. Anaphylm peaks absorption in 12 minutes. Recent $85M equity raise extends cash runway to 2027, yet FDA approval remains uncertain.
8-K
FDA skips Anaphylm advisory
Aquestive Therapeutics announced on September 4, 2025, that the FDA will not require an advisory committee meeting for its Anaphylm sublingual epinephrine film, keeping the PDUFA target date at January 31, 2026. This needle-free alternative to auto-injectors could transform anaphylaxis treatment if approved, backed by eleven clinical studies with 967 administrations. Commercial preparations advance swiftly. Yet risks like regulatory delays loom large.
IPO
Website
Employees
Sector
Industry
ALKS
Alkermes plc
28.06-0.11
AMPH
Amphastar Pharmaceuticals, Inc.
25.61-0.70
ASBP
Aspire Biopharma Holdings, Inc.
0.10-0.00
ASRT
Assertio Holdings, Inc.
0.73-0.00
AYTU
Aytu BioPharma, Inc.
2.42+0.09
AZN
Astrazeneca PLC
91.35-0.21
ELTP
Elite Pharmaceuticals, Inc.
0.50+0.00
INDV
Indivior PLC
35.38+0.16
TEVA
Teva Pharmaceutical Industries
30.10-0.03
UTHR
United Therapeutics Corporation
500.00-0.30