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 dedicated to developing treatments for addiction and related disorders. The company's primary focus is on creating personalized therapies that address the unique needs of individuals suffering from substance abuse. Adial's flagship product, AD04, is a serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in patients with specific genetic profiles. AD04 has shown promise in reducing excessive drinking in heavy drinking patients and has been investigated in the company's ONWARD™ pivotal Phase 3 clinical trial. The active ingredient in AD04 is ondansetron, which is commonly used to prevent nausea and vomiting, and now brings potential benefits in addiction treatment.
Adial leverages its expertise in pharmacogenomics to develop therapies that are tailored to the genetic makeup of patients. This approach has the potential to revolutionize the treatment of addiction by providing more effective and safer treatment options. The company recently regained compliance with Nasdaq's listing requirements by maintaining a stockholders' equity of at least $2.5 million. Adial has also been active in forming strategic partnerships, including an agreement with Adovate, LLC, which could yield up to $83 million in milestone payments and commercial royalties.
Adial's intellectual property portfolio is robust, with multiple patents protecting the combination of its genetic diagnostics and AD04 for the treatment of AUD, Opioid Use Disorder (OUD), and other dependencies. The company's recent awards include the 2023 Best Practices Technology Innovation Leadership Award from Frost & Sullivan. Financially, Adial is in a stable position, with cash and cash equivalents allowing it to fund operations into the first quarter of 2025. The company's research and development expenses have been judiciously managed, ensuring that resources are effectively utilized.
Recent studies have underscored the safety and efficacy of AD04, highlighting its favorable liver safety profile compared to placebo and its potential to treat other addictive disorders like gambling and obesity. Adial has initiated new activities related to its clinical development plan, including two parallel Phase 3 clinical trials of AD04 to support its approval in the shortest timeframe possible. The company is also engaging with the FDA to refine its study designs and enhance the likelihood of regulatory success.
Adial Pharmaceuticals continues to make significant strides in its mission to develop innovative solutions for addiction treatment, offering hope to millions affected by these disorders worldwide.
Adial Pharmaceuticals has announced that its lead drug candidate, AD04, targeted for the treatment of Alcohol Use Disorder (AUD), was featured on the Local 12: Healthy Perspective news segment. This follows a prior feature on WKRC in Cincinnati, which has reached numerous media outlets nationwide. AD04 is currently being evaluated in a Phase 3 clinical trial and has demonstrated promising results, reducing the frequency and quantity of alcohol consumption with no significant safety concerns reported. The drug may also treat other addictive disorders.
Adial Pharmaceuticals (ADIL) reports that its lead drug candidate, AD04, for treating Alcohol Use Disorder (AUD), has gained exposure on multiple television news programs. The coverage highlights the potential of AD04 to help individuals control cravings. The company is currently conducting a Phase 3 clinical trial for AD04, which previously demonstrated promising results in reducing drinking frequency and severity without significant safety concerns. This media attention is expected to raise awareness about AUD, especially during the holiday season.
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.
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