Adial Pharma Surges 80% On Update Of AD04

(RTTNews) - Shares of Adial Pharmaceuticals (ADIL) jumped over 80% in extended session on Monday after the company provided update on regulatory strategy for AD04 for treatment of alcohol use disorder.

Adial's lead compound, AD04, is a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD) and was recently investigated in a Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes, which were identified using the Company's companion diagnostic genetic test.

ONWARD results showed that AD04 achieved a statistically significant reduction of heavy drinking days in a subgroup of patients - the "heavy drinkers." The "heavy drinker" population, defined as patients who drank fewer than 10 drinks per drinking day prior to enrollment, accounted for approximately two-thirds of the trial population.

Adial said it has submitted a Type C meeting request to the FDA and was granted a meeting, which will be held in second quarter of 2023. Further, Adial is progressing discussions with five European country-level regulatory authorities: France, Sweden, Finland, the United Kingdom, and Germany.