Adial Pharma Sees Clear, Cost-Effective Path Toward FDA Approval For Alcohol Use Disorder Candidate

  • Adial Pharmaceuticals Inc ADIL shares are trading higher after an update on its regulatory strategy for AD04, the company's lead compound for Alcohol Use Disorder (AUD).
  • The company said additional analysis of ONWARD data identified specific genotypes that outperformed others. The data exhibited AD04 achieved a statistically significant reduction of heavy drinking days in a subgroup of patients - the "heavy drinkers." 
  • Adial believes there is a clear, cost-effective path toward FDA approval that it plans to pursue aggressively.
  • Also Read: Adial Pharma Touts Positive Preclinical Data From Chronic Pain Candidate.
  • Based on the information collected and analyses to date, Adial has submitted a Type C meeting request to the FDA and was granted a meeting, which will be held in Q2 of 2023. 
  • The Type C meeting is expected to provide Adial with confirmation of a clear clinical development plan. 
  • As previously anticipated, an additional Phase 3 trial may be required. Adial intends to engage a U.S. partner to assist with funding the required clinical trial and to advance commercialization efforts. 
  • Adial is progressing discussions with five European country-level regulatory authorities: France, Sweden, Finland, the U.K., and Germany.
  • Meeting dates with Sweden and Germany are scheduled for March and April of 2023, respectively, and the remaining countries' schedules are pending confirmation. 
  • Price Action: ADIL shares are trading flat at $0.42 on the last check Tuesday.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsPenny StocksHealth CareGeneralBriefs
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!