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. (NASDAQ: ADIL) is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addictions and related disorders. News about Adial often centers on the progress of its lead investigational drug, AD04, a genetically targeted serotonin-3 receptor antagonist being developed for Alcohol Use Disorder (AUD) in heavy drinking patients with specific genotypes.
On this page, readers can find coverage of Adial’s clinical development milestones, including updates on the ONWARD™ pivotal Phase 3 trial and preparations for a new Phase 3 adaptive program informed by End of Phase 2 (EOP2) feedback from the U.S. Food and Drug Administration (FDA). Company announcements describe FDA recognition of AUD as an unmet need, support for Adial’s adaptive trial design, and confirmation of primary efficacy endpoints based on heavy drinking days.
Adial’s news flow also highlights its precision medicine strategy. Releases describe a partnership with Genomind to validate a cheek swab genetic test that identifies SNPs in serotonergic system genes such as HTR3A, HTR3B, and SLC6A4, enabling selection of biomarker-positive patients, including those with the AG+ genotype. Additional stories cover intellectual property developments, such as provisional and international patent applications for AD04 that the company expects, once granted, to protect core assets to at least 2045.
Investors and observers can also follow capital markets and listing-related updates, including public offerings of stock and warrants, at-the-market sales agreements, Nasdaq compliance notices, and extensions related to minimum bid price requirements. Together, these items provide context on how Adial is financing and structuring its efforts to advance AD04 and its broader addiction treatment pipeline. Bookmark this page to review new regulatory, clinical, financing, and intellectual property announcements as they are reported.
Adial Pharmaceuticals (NASDAQ:ADIL, ADILW) has signed a Common Stock Purchase Agreement with Keystone Capital Partners, allowing the sale of up to $15 million in common stock over time. The company, which has over $7 million in cash as of September 30, 2020, emphasizes that there are no immediate capital-raising plans. AD04, its lead drug for Alcohol Use Disorder, showed promise in clinical trials. The partnership aims to support future growth opportunities in the underserved addiction treatment market.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced progress in its ONWARD™ Phase 3 trial for AD04, targeting Alcohol Use Disorder (AUD). All 25 investigative sites are active, with over 25% of the patient enrollment completed. The enrollment rate has improved for four consecutive months, aiming for full enrollment by Q2 2021. Preliminary data reading is expected in Q4 2021. AD04 shows promising safety with no serious adverse events reported, and the potential market for AD04 in the U.S. is estimated to exceed $35 billion, addressing an urgent public health crisis exacerbated by COVID-19.
On October 22, 2020, Todos Medical and Adial Pharmaceuticals (NASDAQ:ADIL) announced a distribution agreement granting Todos non-exclusive sub-distribution rights to the Assure/FaStep® and EcoStep® COVID-19 antibody tests. The Assure/FaStep received FDA Emergency Use Authorization for fingerstick blood samples, expanding testing environments to various healthcare settings. CEO Gerald E. Commissiong emphasized the synergy in offering complementary COVID-19 tests. This agreement follows earlier sales of these tests, indicating client demand amid the ongoing pandemic.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced that the FDA has reactivated its Investigational New Drug (IND) application for AD04, a treatment for Alcohol Use Disorder (AUD). The IND was previously on clinical hold due to insufficient manufacturing data. This reactivation allows the company to pursue U.S. expedited review programs and initiate a planned Phase 1 pharmacokinetics study. The CEO noted the urgency of addressing the AUD crisis, exacerbated by the COVID-19 pandemic. Adial is also currently enrolling patients for its pivotal Phase 3 clinical trial in Europe.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced an initial firm order for 10,000 Assure/FaStep® COVID-19 IgG/IgM Rapid Test Devices from a California-based tech firm. The FaStep test is the first FDA-approved serology point-of-care test using fingerstick blood samples, crucial for rapid COVID-19 assessment. CEO William Stilley emphasized the importance of this testing in managing the virus's prevalence as the U.S. reopens. Adial has opened multiple sales channels to distribute the test devices, enhancing their market presence.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced the FDA's emergency use authorization (EUA) for its Assure/FaStep® COVID-19 IgG/IgM Rapid Test Device, the first point-of-care test using fingerstick blood samples. Previously, the test was restricted to venous blood samples. The EUA enables sales through iRemedy's network, tapping into a projected $3.52 billion market for rapid COVID-19 tests by year-end 2020. CEO William Stilley indicated this competitive advantage could boost adoption of their antibody tests to combat the COVID-19 pandemic.
Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) has officially requested FDA expedited review for its lead drug candidate, AD04, aimed at treating Alcohol Use Disorder (AUD). The request is based on the unmet medical need for effective treatments, especially amid escalating AUD issues due to the COVID-19 pandemic. CEO William Stilley highlighted the ongoing Phase 3 clinical trial progress and the promising results from the Phase 2 trial, reinforcing AD04's potential. The drug also holds promise for additional addictive disorders, further emphasizing the importance of regulatory support.
Adial Pharmaceuticals (NASDAQ: ADIL) has partnered with iRemedy Healthcare to distribute the FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers across the U.S. The tests, which receive FDA emergency use authorization, yield results in just 10 minutes with high accuracy rates of 97.3% for IgG and 99.1% for IgM. This collaboration seeks to address the pressing market need for efficient testing solutions amid the COVID-19 crisis. CEO William Stilley highlighted the role of these tests in enhancing safety during their ongoing clinical trial for AD04, a treatment for Alcohol Use Disorder.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced its participation in the H.C. Wainwright Annual Global Investment Conference from September 14-16, 2020. CEO William Stilley will present on September 16 at 1:30 p.m. ET, with a live webcast available. Adial focuses on addiction treatments, with its lead drug AD04 targeting Alcohol Use Disorder (AUD) via a genetic approach. A Phase 2b trial showed significant effectiveness in reducing drinking behaviors without serious safety concerns. AD04 may also help treat other addictions such as opioids and gambling.
Adial Pharmaceuticals (NASDAQ:ADIL, ADILW) announced its participation in the LD Micro 500 Virtual Investor Conference from September 1-4, 2020. The CEO, William Stilley, will present on September 2 at 3:20 p.m. ET, with a live webcast available. The conference showcases key players in the small and micro-cap sector, featuring one-on-one meetings via video calls. Adial is focused on developing treatments for addictions, particularly its lead product AD04, currently in Phase 3 trials for Alcohol Use Disorder. For more information, visit Adial's website.