Aquestive Therapeutics plans to resubmit its Anaphylm application to the FDA in Q3 2026 with over $150M in cash projected at launch.
Aquestive Therapeutics announced plans to resubmit its Anaphylm application to the FDA in the third quarter of 2026. The company projects it will have more than $150M in cash at the time of launch, bolstering its financial position for commercialization.
Management highlighted progress over the past 62 days, including a Type A face-to-face meeting with the FDA and submission of a pediatric investigational plan. The company did not disclose prior cash projections or consensus estimates for comparison.
No immediate market reaction was reported following the announcement.