2023-03-07 05:55:43 ET
- Nano-cap stock Adial Pharmaceuticals ( NASDAQ: ADIL ) added ~63% pre-market Tuesday after announcing that the FDA has granted the company’s request for a Type C meeting on its lead asset AD04, targeted at alcohol use disorder (AUD).
- The meeting, scheduled for Q2 2023, is expected to provide the company with clarity over the future clinical development of AD04.
- Charlottesville, Virginia-based firm is also seeking a U.S. partner to secure funding for an anticipated additional Phase 3 trial and, subject to a favorable regulatory outcome, for commercialization of AD04.
- Adial ( ADIL ) also looks for regulatory-level discussions with five European countries: France, Sweden, Finland, the U.K., and Germany. Meetings with authorities in Sweden and Germany are expected to take place in March and April 2023, respectively.
- The discussions with potential commercial partners in Europe are currently underway.
- Read: Seeking Alpha contributor Debra Fiakas explains Phase 3 data for AD04.
For further details see:
Adial soars 63% after regulatory update on lead asset