Aquestive Therapeutics Stock Price, News & Analysis

Aquestive Therapeutics (NASDAQ: AQST) has secured a $75 million strategic funding agreement with RTW Investments to support the potential launch of Anaphylm™, a sublingual film for emergency treatment of allergic reactions. The funding is contingent on FDA approval and other conditions.

The financing will strengthen Aquestive's balance sheet through 2027 and support the commercialization of Anaphylm, potentially the first oral rescue medication for severe allergic reactions. Under the agreement, RTW will receive a tiered single-digit percentage of annual U.S. net sales, subject to a cap.

Aquestive Therapeutics (NASDAQ:AQST) reported Q2 2025 financial results and significant progress with its lead product candidate Anaphylm™, an oral sublingual film for epinephrine delivery. The FDA accepted the NDA for Anaphylm with a PDUFA date of January 31, 2026. The company is preparing for a Q1 2026 U.S. launch while expanding globally to Canada and EU.

Q2 2025 financial highlights include revenue of $10.0 million, up 3% year-over-year excluding one-time items, and a net loss of $13.5 million. Cash position stands at $60.5 million as of June 30, 2025. The company maintains its 2025 guidance with expected revenue of $44-50 million.

The company is also advancing AQST-108, a topical gel treatment for alopecia areata, with IND submission planned for Q4 2025. Manufacturing operations remain stable with continued production of Suboxone® and other partnership products.

Aquestive Therapeutics (NASDAQ:AQST) has scheduled its second quarter 2025 financial results announcement and business update for August 11, 2025 after market close. The company will host a conference call for investors on August 12, 2025, at 8:00 a.m. ET.

Interested participants must register in advance to obtain call-in details. A live webcast will be available on the Investors section of Aquestive's website and will be archived for 30 days following the presentation.

Aquestive Therapeutics (NASDAQ: AQST) has promoted Sherry Korczynski to Chief Commercial Officer, effective July 22, 2025. Korczynski, who joined the company in February 2024 as Senior Vice President of Sales and Marketing, brings over two decades of commercial experience, including strategic oversight of the EpiPen® brand at Mylan.

In her new role, Korczynski will lead the global commercial strategy for Anaphylm, the company's potentially first-ever device-free, orally delivered epinephrine product for anaphylaxis care. Her extensive background includes leadership positions at ANI Pharmaceuticals, Eagle Pharmaceuticals, Mylan (now Viatris), and Eli Lilly & Company.

Aquestive Therapeutics (NASDAQ: AQST) has announced significant progress in its international expansion for Anaphylm™, its needle-free epinephrine sublingual film for severe allergic reactions. The company has secured a New Drug Submission meeting with Health Canada for Q3 2025 and submitted an initial briefing book to the European Medicines Agency (EMA).

These developments follow the FDA's acceptance of Anaphylm's New Drug Application with a PDUFA date of January 31, 2026. Aquestive brings substantial experience with six FDA-approved drugs and products available across six continents. The oral administration of Anaphylm addresses key challenges of traditional auto-injectors, including needle phobia and device malfunction concerns.

Aquestive Therapeutics (NASDAQ:AQST), a pharmaceutical company focused on innovative medicine delivery technologies, has announced its participation in the upcoming Leerink Partners Therapeutics Forum. The event, scheduled for July 9, 2025, will focus on immunology, inflammation, and metabolism.

The company's management team will participate in panel discussions and conduct one-on-one meetings with investors during the forum.

Aquestive Therapeutics (NASDAQ: AQST) announced upcoming presentations of positive data for Anaphylm™, their investigational epinephrine sublingual film, at the CFAAR Food Allergy Summit in Chicago. The presentations will showcase results from pharmacokinetic and pharmacodynamic studies, previously presented at the 2025 AAAAI Annual Meeting.

If approved by the FDA, Anaphylm would become the first and only orally delivered epinephrine treatment for severe allergic reactions in the United States. Two posters will be presented on June 28, 2025, focusing on the drug's physicochemical properties under extreme conditions and its pharmacological responses.

Aquestive Therapeutics (NASDAQ: AQST) announced FDA acceptance of its New Drug Application for Anaphylm, with a PDUFA target date of January 31, 2026. Anaphylm is positioned to be the first-ever orally delivered epinephrine treatment for severe allergic reactions including anaphylaxis in the US. The innovative drug delivery system is thinner than a credit card, requires no special storage, and can be easily carried in a phone case, wallet, or pocket. According to clinical data, Anaphylm demonstrates rapid oral epinephrine absorption. The FDA may conduct an Advisory Committee meeting for approval. Dr. David Stukus from Nationwide Children's Hospital emphasized that while epinephrine is the only FDA-approved first-line treatment for anaphylaxis, many at-risk individuals don't carry it consistently due to administration fears and device bulkiness.

Aquestive Therapeutics (NASDAQ: AQST) reported Q1 2025 financial results and key business updates. The company has submitted an NDA for Anaphylm™, their oral sublingual film for severe allergic reactions, with potential FDA approval and launch in Q1 2026. Q1 financial results showed total revenues of $8.7 million, down 28% from Q1 2024, with a net loss of $22.9 million. The company is focusing resources on Anaphylm's pre-commercial preparations, while de-emphasizing other programs. Their pediatric trial for ages 7-17 demonstrated consistent PK profiles with adult data. The company has revised its 2025 guidance, now expecting total revenue of $44-50 million and adjusted EBITDA loss of $47-51 million. Cash position stands at $68.7 million as of March 31, 2025.