| Drug / Therapy | LIBERVANT |
| Indication | acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 to 5 years of age and 12 years of age and above |
| Decision Type | PDUFA |
| Conditions | acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 to 5 years of age and 12 years of age and above |
| Interventions | LIBERVANT |
Aquestive Therapeutics (AQST) operates in the CNS sector. The current BiotechSign Score is 11 (Grade: F).
Biotech companies frequently raise capital through secondary offerings, ATM programs, and convertible notes. Before or after major FDA decisions, dilution events are common. Understanding a company's dilution history is critical for managing risk around catalyst dates.
The PDUFA date for LIBERVANT by Aquestive Therapeutics (AQST) is scheduled for March 29, 2027. This is the target date for the FDA to make a decision on this application.
LIBERVANT is being developed by Aquestive Therapeutics for the treatment of acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 to 5 years of age and 12 years of age and above. It is under FDA review.
If LIBERVANT receives FDA approval, Aquestive Therapeutics (AQST) would be able to market the drug in the United States for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 to 5 years of age and 12 years of age and above. This typically leads to significant stock price movement for biotech companies. Investors should monitor the PDUFA date closely.
Biotech companies often raise capital through share offerings, which can dilute existing shareholders. You can check the current dilution risk for AQST on DilutionWatch at dilutionwatch.com/stock/AQST.html.
You can view the full BiotechSign company profile for Aquestive Therapeutics (AQST) at biotechsign.com/company/AQST, which includes the BiotechSign Score, signal history, clinical trial data, and insider trading activity.
This page is for informational purposes only and does not constitute investment advice. FDA decision dates are subject to change. Clinical trial outcomes are inherently uncertain. Biotech stocks are highly volatile — past performance does not guarantee future results. Always consult a qualified financial advisor before making investment decisions. BiotechSign is not a registered investment advisor.