Core Insights - Adial Pharmaceuticals, Inc. has welcomed the recent passage of the 2026 Appropriations Bill, which includes directives for the FDA and NIDA to establish alternative clinical trial endpoints for substance use disorder treatments, including Alcohol Use Disorder (AUD) [1][2][5] Group 1: Legislative Impact - The legislation directs the FDA to consider non-abstinence-based endpoints such as reduced cravings and disorder severity, reflecting clinically meaningful improvements for patients [2][3] - This directive aligns with the NIAAA's updated definition of recovery, which emphasizes improvements in functioning and symptom reduction as valid treatment goals [3] Group 2: Company Strategy and Product Development - Adial's lead investigational therapy, AD04, is designed to treat AUD using a precision medicine approach, aligning with the newly established non-abstinence recovery outcomes [4][5] - The collaboration between federal agencies to define alternative endpoints is expected to strengthen the regulatory framework for innovative therapies like AD04, potentially accelerating development timelines and broadening clinical relevance [4][5] Group 3: Market Context - AUD remains a significant public health challenge, affecting millions with limited treatment options that achieve durable outcomes [5] - Adial believes that regulatory clarity around alternative endpoints will enhance the regulatory path for AD04 and support the company's strategy to address the unmet need in AUD with precision-based therapies [5][6]