Aquestive Therapeutics Stock Price, News & Analysis

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.

Aquestive Therapeutics (NASDAQ: AQST) has announced its participation in the upcoming Citizens Life Sciences Conference taking place from May 7-8, 2025, in New York City. The company's management team will conduct a fireside chat on May 8th at 10 am ET and will be available for one-on-one meetings with investors on the same day.

The fireside chat will be accessible via webcast on the company's website under the "Events and Presentations" page in the Investors section, with a replay available for 30 days after the event.

Aquestive Therapeutics (NASDAQ: AQST), a pharmaceutical company focused on innovative medicine delivery technologies, has scheduled its first quarter 2025 financial results announcement for May 12, 2025, after market close. The company will host a conference call for investors on May 13, 2025, at 8:00 a.m. ET to discuss the quarterly results and provide business updates.

Investors can participate by registering in advance to obtain call-in details. A live webcast will be available on Aquestive's Investors website section, with a 30-day archive available after the call.

Aquestive Therapeutics (NASDAQ:AQST), a pharmaceutical company focused on developing innovative medicines and delivery technologies, has announced its participation in the upcoming Piper Sandler Spring Biopharma Symposium in Boston. The company's management team will conduct investor meetings during the event scheduled for April 17, 2025.

Aquestive Therapeutics (NASDAQ: AQST) has announced positive topline pharmacokinetic (PK) results from its pediatric study of Anaphylm™, an epinephrine sublingual film for severe allergic reactions. The study, involving 32 patients aged 7-17 weighing over 30kg, demonstrated consistent PK profiles with previous adult studies, with no serious adverse events reported.

The company has completed and submitted its New Drug Application (NDA) to the FDA, with expected acceptance in Q2 2025. If approved, Anaphylm™ would become the first-ever sublingual film treatment for anaphylaxis, with a planned commercial launch in Q1 2026. The pediatric study results support potential label inclusion for this age group.

Aquestive Therapeutics (NASDAQ: AQST) has initiated the NDA filing process for Anaphylm™, their non-device epinephrine sublingual film, with expected launch in Q1 2026 if approved. Initial pediatric trial results for ages 7-17 align with expectations.

Q4 2024 financial highlights: Revenue decreased 10% to $11.9 million, with net loss of $17.1 million ($0.19 per share). Full year 2024 saw revenue increase 14% to $57.6 million, though net loss widened to $44.1 million ($0.51 per share).

Key developments include:

• AQST-108 epinephrine topical gel Phase 2a trial to begin Q2 2025
• Libervant® received FDA approval for patients aged 2-5 years with Orphan Drug Exclusivity until April 2031
• Proforma cash position of approximately $93.0 million as of December 31, 2024

Aquestive Therapeutics (NASDAQ:AQST) has announced its participation in two major investor conferences in March 2025. The company will attend:

• Leerink's Global Biopharma Conference 2025 (March 10-12), featuring a fireside chat on March 10th from 4:20-4:50pm EST
• Barclays 27th Annual Global Healthcare Conference (March 11-13), with management available for meetings on March 12th

The Leerink conference presentation will be webcast and available on the company's investor relations website under 'Events and Presentation,' with replay access for 30 days post-event. Management will be available for one-on-one meetings at both conferences.