Every material Form 8-K Aquestive Therapeutics, Inc. has filed with the SEC since October 15, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Aquestive Therapeutics furnished a November 2026 corporate presentation under Regulation FD, with no new financial results. The deck reports $90.3 million in cash and cash equivalents as of September 30, 2026, and says up to $95 million in additional funding depends on FDA approval of Anaphylm, with no assurance either facility will become available.
$90.3 million in cash and cash equivalents as of September 30, 2026
Potential access to $75 million under a strategic funding agreement with RTW Investments, subject to conditions including FDA approval of Anaphylm
An additional $20 million potentially available under the Oaktree Capital Management debt facility, also subject to FDA approval of Anaphylm
Anaphylm PDUFA goal date is March 16, 2027, following FDA acceptance of the NDA resubmission
Aquestive reported third-quarter 2026 revenue of $7.6 million, down 41% from $12.8 million a year earlier, mainly due to the timing of Suboxone product orders. Its net loss widened to $16.5 million, or $0.13 per share, from $15.4 million, or $0.14 per share, while the company said its full-year 2026 guidance is unchanged. Shareholders face a weaker quarter, with the FDA decision on Anaphylm, due March 16, 2027, still ahead.
Q3 2026 total revenue was $7.6 million, down from $12.8 million in Q3 2025.
Net loss was $16.5 million, or $0.13 per share, versus $15.4 million, or $0.14 per share, a year earlier.
Non-GAAP adjusted EBITDA loss was $12.2 million, compared with $8.6 million in Q3 2025.
Full-year 2026 total revenue guidance of $46 million to $50 million was unchanged; cash and cash equivalents were $90.3 million at September 30, 2026.
Aquestive Therapeutics said the FDA has accepted its resubmitted New Drug Application for Anaphylm as complete and classified it as a Class 2 response, with a PDUFA goal action date of March 16, 2027. The filing does not provide financial figures, and the outcome depends on the FDA's review, which the company says it expects to complete on or before the goal date.
FDA acknowledged the Anaphylm NDA resubmission as complete and classified it as a Class 2 response
PDUFA goal action date set for March 16, 2027
Aquestive submitted the resubmission on September 16, 2026, after a January 30, 2026 Complete Response Letter
Ex-U.S. submission to Health Canada remains on track for Q4 2026
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.
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