Welcome to our dedicated page for Adial Pharmaceuticals news (Ticker: ADIL), a resource for investors and traders seeking the latest updates and insights on Adial Pharmaceuticals stock.
Adial Pharmaceuticals Inc (ADIL) is a clinical-stage biopharmaceutical company pioneering personalized treatments for alcohol use disorder through advanced pharmacogenomics. This page provides investors and healthcare professionals with essential updates on ADIL's clinical trials, regulatory milestones, and strategic initiatives.
Access timely announcements about the company's lead investigational drug AD04—a serotonin-3 receptor antagonist designed for genetically identified patient groups. Stay informed about clinical study results, FDA communications, intellectual property developments, and partnership opportunities that demonstrate ADIL's progress in addiction medicine.
Key updates include progress reports on the 505(b)(2) regulatory pathway, companion diagnostic advancements, and peer-reviewed research publications. All content is curated to help stakeholders track the company's evidence-based approach to treating addictive disorders through precision medicine.
Bookmark this page for direct access to primary source materials and analysis-free reporting on ADIL's scientific and corporate developments. Check regularly for new filings, trial data disclosures, and strategic announcements that shape the company's trajectory in biopharmaceutical innovation.
Adial Pharmaceuticals (NASDAQ: ADIL) reported its fiscal year 2024 results and key developments in its AD04 program for Alcohol Use Disorder (AUD) treatment. The company successfully completed the AD04-103 pharmacokinetics study, receiving FDA confirmation for its 505(b)(2) bridging strategy and advancing towards Phase 3 trials in 2025.
Financial highlights include:
- Cash position of $3.8 million as of December 31, 2024 (up from $2.8M in 2023)
- Net loss increased to $13.2 million (compared to $5.1M in 2023)
- R&D expenses rose by $1.9 million (155%)
- G&A expenses decreased by $491,000 (9%)
The company strengthened its IP portfolio with three new US patents covering genetic-based approaches for treating AUD and other drug dependencies. Adial partnered with Boudicca Dx for companion diagnostic test development and appointed Vinay Shah as CFO.
Adial Pharmaceuticals (NASDAQ: ADIL) has received positive feedback from the FDA regarding its proposed in vitro bridging strategy for AD04, a potential addiction treatment. The FDA's response confirms the company's 505(b)(2) regulatory pathway approach, which combines results from the AD04-103 relative bioavailability food-effect study with in vitro dissolution data.
The FDA's agreement with Adial's bridging strategy marks a significant regulatory milestone, though final approval will depend on the complete New Drug Application (NDA) review. Following this confirmation, Adial is moving forward with manufacturing clinical supply materials for its planned Phase 3 clinical program in 2025.
Adial Pharmaceuticals (NASDAQ: ADIL) has been granted a new U.S. patent (No. 12,226,401) on February 18, 2025, expanding its genetic-based approach to treating and diagnosing alcohol use disorder and drug dependencies. The patent covers methods for identifying genetic markers in patients with alcohol or opioid-related disorders.
The patent specifically focuses on identifying genotypes including the AC genotype of rs17614942 in the HTR3B gene and the AG genotype of rs1150226 in the HTR3A gene. This advancement will enable healthcare providers to develop tailored treatment plans using AD04, Adial's investigational drug product. The precision medicine approach aims to optimize treatment outcomes while minimizing risks associated with standardized treatments.
Adial Pharmaceuticals (NASDAQ: ADIL) has been awarded U.S. patent number 12,221,654 on February 11, 2025, expanding its molecular genetic approach to diagnosing and treating addiction disorders. The patent covers methods for identifying patients with specific genetic markers linked to substance use disorders and treating them with AD04, the company's investigational drug.
The treatment specifically involves detecting the TT genotype of rs1042173 in the serotonin transporter gene (SLC6A4) and administering AD04 to patients. This approach is designed for treating various conditions including opioid dependence, opioid abuse, and alcohol dependence. The company aims to deliver personalized treatments by combining genetic diagnostics with precision medicine, targeting patients who may not respond to conventional therapies.
Adial Pharmaceuticals (NASDAQ: ADIL) has announced positive results from its AD04-103 pharmacokinetics study for AD04, a drug candidate being developed to treat Alcohol Use Disorder (AUD). The study, involving 30 healthy volunteers across two cohorts, demonstrated predictable bioavailability and dose proportionality in pharmacokinetic exposure.
The study confirmed that ondansetron pharmacokinetic exposure increased proportionally between AD04 0.33 mg tablets and marketed ondansetron 4 mg tablets, with no food effect on administration. These results support Adial's plans to pursue FDA approval under the 505(b)(2) regulatory pathway.
The company has submitted the results to the FDA and plans an End-of-Phase 2 meeting in the first half of the year to discuss the Phase 3 program design. The successful completion of this bridging study is expected to facilitate ongoing partnership discussions.
Adial Pharmaceuticals (NASDAQ: ADIL) has been granted U.S. patent number 12150931 on November 26, 2024, expanding its intellectual property coverage for treating alcohol and drug dependence. The patent covers broader genotype combinations identified by the company's proprietary genetic diagnostic for targeted treatment of alcohol use disorder (AUD) with AD04, their lead investigational drug. The patent specifically includes HTR3A, HTR3B, and SLC6A4 receptor sites, supporting their precision medicine approach to addiction treatment. This patent protection extends through 2031.
Adial Pharmaceuticals (NASDAQ: ADIL) announced positive topline results from the AD04-103 Pharmacokinetics Study for their alcohol use disorder treatment. The study, involving 30 healthy adult volunteers, confirmed AD04's relative bioavailability to reference ondansetron, demonstrated dose-proportional increases in pharmacokinetic exposure, and showed no food effect. The study met FDA requirements for upcoming Phase 3 trials and will help optimize the study design. Results showed AD04 0.33mg delivered lower ondansetron exposure than the 4mg reference tablet, with proportional increases across a 3-fold dose range. The company plans to engage with FDA in Q4 2024 to discuss Phase 3 study program.
Adial Pharmaceuticals (NASDAQ: ADIL) reported Q3 2024 financial results and business updates. The company achieved database lock for AD04's pharmacokinetics study in Alcohol Use Disorder (AUD) treatment. Cash position stood at $5.2 million as of September 30, 2024, expected to fund operations into H2 2025. Q3 net loss increased to $2.2 million from $1.4 million year-over-year. R&D expenses rose 399% due to clinical trial and CMC costs. The company partnered with Boudicca Dx for companion diagnostic development and secured new patent allowances.
Adial Pharmaceuticals (NASDAQ: ADIL) has appointed Vinay Shah as Chief Financial Officer, effective November 16, 2024. Shah brings over 25 years of experience in pharmaceutical and healthcare sectors, previously serving as CFO at Virpax Pharmaceuticals. His track record includes raising over $150 million at Aravive and contributing to Pacira Pharmaceuticals' IPO. The current CFO, Joseph Truluck, will resign on November 15, 2024, but will continue as a consultant through March 31, 2025, to ensure a smooth transition. Truluck's departure is not related to any disagreements with the company's operations or practices.
Adial Pharmaceuticals (NASDAQ: ADIL) has announced its participation in The ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. CEO Cary Claiborne will deliver a presentation at 8:30 a.m. ET, and management will conduct one-on-one investor meetings throughout the day. The conference brings together institutional investors, corporate clients, and industry professionals to showcase innovations and financial strategies. Investors can register to attend and schedule meetings, with the presentation available via live stream.
