AQUESTIVE THERAP. DL-,001

At the H.C. Wainwright conference, Aquestive highlighted Anaphylm as a new treatment option for severe allergies and announced it will resubmit the approval application to the FDA later this month. The company emphasizes rapid absorption (therapeutic blood levels in ~5 minutes), revised packaging and a targeted launch model with 75 field sales representatives aiming to reach 8,000 healthcare professionals. Source data point to a US market potential of up to ~$2 billion and peak global sales for Anaphylm of around $1 billion, with management saying funding (RTW, Oaktree) extends well into 2028. Key hurdles remain FDA approval, reimbursement by insurers and getting physicians and patients to switch from autoinjectors to the new product. » Mere på de.investing.com

Aquestive Therapeutics will resubmit the Anaphylm NDA before the end of Q3 after revised packaging, labeling and instructions significantly reduced pouch-opening, film-tearing and administration errors in validation studies. Management assumes a six-month FDA review but says the agency could designate a two-month review; regulatory filings in Canada, Europe and the U.K. are planned starting in Q4. Q2 revenue rose 38% to $13.8 million and adjusted EBITDA loss narrowed to $5.2 million, while reported net loss widened to $22.9 million due mainly to an $11.7 million debt-extinguishment charge; the company reiterated 2026 revenue guidance of $46–50 million. Aquestive ended June with $98.5 million cash, completed a $150 million facility with Oaktree, and expects potential post-approval funding of $75 million from RTW and $20 million from Oaktree. » Mere på finance.yahoo.com

Aquestive reported Q2 revenue of $13.82 million, beating analysts’ estimates, while reported EPS of -$0.18 missed expectations, mainly due to a one-time $11.7 million charge from debt repayment. Adjusted EBITDA improved markedly and operating business grew; the company holds $98.5 million in cash. Aquestive reaffirmed its full-year guidance (revenue $46–50 million, adjusted non-GAAP EBITDA loss $30–35 million) and plans to refile the NDA for Anaphylm with the FDA before the end of Q3. The next catalyst is the FDA review of Anaphylm; risks remain timing, commercial uptake and continued losses. » Mere på de.investing.com

Aquestive Therapeutics' stock jumped 9.4% premarket after the company reported positive topline results from two approval‑relevant studies of Anaphylm (dibutepinephrine). The human‑factors validation study and the pharmacokinetic self‑administration study address concerns raised in the FDA complete response letter from January 2026. Aquestive confirms planned NDA resubmission for the third quarter of 2026 and says Anaphylm has the potential to become the first approved non‑invasive epinephrine product for treating anaphylaxis. » Mere på de.investing.com

Aquestive Therapeutics says it will resubmit the NDA for Anaphylm, its oral epinephrine rescue medication, in Q3 2026 after receiving a Complete Response Letter and is addressing FDA-identified human-focused deficiencies. The company reported Q4 revenue of $13.02 million, slightly below consensus, while Alliance Global cut its price target from $12 to $9 but kept a Buy rating. Management says the commercial infrastructure remains transferable to the revised timeline and continues to back Anaphylm’s market potential. » Mere på finance.yahoo.com