AQST DEADLINE: ROSEN, NATIONALLY REGARDED INVESTOR COUNSEL, Encourages Aquestive Therapeutics, Inc. Investors to Secure Counsel Before Important May 4 Deadline in Securities Class Action - AQST

Aquestive (AQST) reported progress in its Anaphylm resubmission to the FDA, addressing previous issues with packaging and administration. The company's recent studies showed significant improvements in ease of use and effectiveness. Aquestive aims to resubmit Anaphylm before the end of the quarter and believes the product has a strong market opportunity, potentially exceeding $1 billion annually, due to its clinical differentiation and ease of use.

Aquestive Therapeutics (NASDAQ:AQST) reported Q2 revenue of $13.8M, up 38% year over year, and a net loss of $22.9M ($0.18/share). Excluding a $11.7M debt-extinguishment loss, net loss was $11.2M. The company discussed FDA resubmission review timing for Anaphylm, cash of $98.5M, and maintained 2026 guidance of $46M to $50M revenue.

Aquestive Therapeutics, Inc. (AQST) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Aquestive Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update • Successfully completed human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film • Remains on track to resubmit Anaphyl

Aquestive Therapeutics (AQST) shares rose about 9.4% pre-open after the company reported positive topline results from two pivotal studies for its Anaphylm (dibutepinephrine) sublingual film. The data address FDA concerns from a January 2026 Complete Response Letter and the company said its NDA resubmission remains on track for Q3 2026.

Aquestive Therapeutics (AQST) reported positive human factors and PK topline results for Anaphylm, including faster median pouch open time (17s to 3s) and fewer opening and placement errors. PK Cmax was comparable vs clinician dosing (391.7 vs 357.6 pg/mL) with median Tmax 12 min. No serious adverse events were reported. Aquestive plans to resubmit the NDA in Q3 2026.

BioNTech (NASDAQ:BNTX) halted a mid-stage trial of its mRNA cancer vaccine, autogene cevumeran, due to an overall survival imbalance. The decision raises concerns about its mRNA strategy in colorectal cancer and other 'cold' tumors. BioNTech plans to continue other trials, including one for pancreatic cancer and BNT113 for head and neck cancer. The company also focuses on diversifying its oncology pipeline. According to Reuters, the news caused a 7.5% drop in BioNTech's US-listed shares.