Why Are Adial Pharmaceuticals Shares Soaring Today

Adial Pharmaceuticals Inc ADIL shares are trading higher after the company provided a summary of feedback received following recent meetings with both U.S. and EU regulators and an update on the company's current clinical development plan based on guidance received.

The authorities confirmed the primary U.S. endpoint based on the Percentage of No Heavy Drinking Days, which utilized a responder analysis of patients who reduced their alcohol consumption to zero heavy drinking days in the last 2 months of a 6-month study.

Acknowledged the results from the Phase 2 and Phase 3 post hoc analysis against the U.S. endpoint of PNHDD demonstrated the statistical significance of responder analysis of specific genotypes as helpful information for planning future studies of AD04.

Reviewed the safety data from the ONWARD trial and did not express any concerns with the data.

Regulatory feedback indicates that even though a single additional Phase 3 trial with convincing data may suffice for approval, it would be a review issue for the agencies following trial completion to determine if the data was sufficient for approval.

Therefore current planning assumptions are that Adial will need to conduct two Phase 3 trials with AD04, where the active arm of patients will be compared to a placebo, and the second trial may include a biomarker-negative patient arm to satisfy any ongoing questions from the regulators regarding efficacy parameters. 

FDA agreed to Adial's plan to comply with ICH E1A by adding a long-term safety follow-up to the planned Phase 3 trial, thereby exposing at least 100 patients to AD04 for one year.

Incorporating the above assumptions would bring AD04 to registration with the FDA in Q3 of 2025, assuming the two successful trials, with an approximate cost of $25 million.

Price Action: ADIL shares are up 98.70% at $0.40 on the last check Tuesday.