Price Target Changed • May 12
Price target increased by 62% to US$42.00 Up from US$26.00, the current price target is provided by 1 analyst. New target price is 2,943% above last closing price of US$1.38. Stock is down 91% over the past year. The company is forecast to post a net loss per share of US$7.09 next year compared to a net loss per share of US$11.93 last year. Announcement • May 01
Adial Pharmaceuticals Files New U.S. Utility Patent Application For AD04 Targeting Alcohol Use Disorder Adial Pharmaceuticals, Inc. filed a new U.S. utility application with the United States Patent and Trade Office (USPTO) directed to AD04, the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients. Once the patent is granted, it is expected to protect Adial’s core assets through at least 2045. The application is being filed with a Request for Track One Prioritized examination to expedite examination. The advantages of a Track One Prioritized examination include a substantially shorter examination time that will assist Adial with early patentability insights to refine strategy and a condensed prosecution. This application reflects a comprehensive post hoc analysis of our data and demonstrates our disciplined approach to maximizing asset value. It enhances our strategic positioning as we approach potential commercialization—both by supporting early enforcement capabilities and by increasing the attractiveness of AD04 in ongoing licensing discussions. The potential for extended exclusivity meaningfully strengthens our negotiating position with prospective partners and enhances the overall value proposition of AD04 for U.S. and global commercialization opportunities. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients. Adial is currently planning to conduct a new Phase 3 clinical trial program for the treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, with no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Announcement • Apr 29
Adial Pharmaceuticals Submits Application for AD04 Clinical Development Program to FDA Commissioner’s National Priority Voucher Pilot Program Adial Pharmaceuticals, Inc. announced the submission of the AD04 product application for consideration of the Food & Drug Administration (FDA) Commissioner's National Priority Voucher Pilot Program (CNPV). Announced in 2025, the CNPV program is designed to speed up the FDA review process for drugs that address one of five key U.S. national health priorities. It uses a collaborative review approach—similar to a “tumor board,” where experts meet to discuss cases—to help evaluate applications more efficiently. If the FDA grants a company a voucher, the Company can use it to receive faster review of a specific drug application. The benefits include more direct communication with the FDA and a “rolling review” process. Compared to other FDA priority review programs, the CNPV program is much faster—aiming for a review timeline of about 1–2 months, instead of the standard 10-12 months, once complete materials are submitted for FDA review. The vouchers cannot be transferred or sold to other companies. The program also allows for earlier engagement with the FDA before submission and includes in-depth discussions between the FDA review team and senior agency leadership to help speed decision-making. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients. Adial is currently planning to conduct a new Phase 3 clinical trial program for the treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, with no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. 
