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Adial Pharmaceuticals Announces Third-Party Sales and Distribution Agreement with Brik for Rapid Result COVID-19 Antibody Test Kits

  • CHARLOTTESVILLE, VA / ACCESSWIRE / August 6, 2020 / Adial Pharmaceuticals, Inc.
    08/06/2020
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Adial Pharmaceuticals Receives European Medicines Agency (EMA) Agreement on the Pediatric Investigation Plan (PIP) for AD04 in Alcohol Use Disorder

  • EMA Agreement paves the way for a marketing authorization in Europe after Phase 3CHARLOTTESVILLE, VA / ACCESSWIRE / July 22, 2020 / Adial Pharmaceuticals, Inc.
    Wed, Jul. 22, 2020

Adial Pharmaceuticals Announces Approval to Commence Landmark ONWARD(TM) Pivotal Phase 3 Trial in Sweden and Estonia

  • CHARLOTTESVILLE, VA / ACCESSWIRE / July 6, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL:ADILW) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received approvals in Sweden and Estonia to commence the Company's landmark ONWARD™ pivotal Phase 3 clinical trial to investigate its lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor genes. The Swedish Medical Products Agency and Swedish Ethical Review Authority have provided approval for ONWARD™ to commence in Sweden; and the Estonian State Agency of Medicines and Ethics Review Committee overseeing human trials granted approval to commence ONWARD™ in Estonia.
    Mon, Jul. 06, 2020

Adial Pharmaceuticals Announces Commencement of Landmark ONWARD(TM) Pivotal Phase 3 Trial in Poland

  • CHARLOTTESVILLE, VA / ACCESSWIRE / June 25, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has commenced its landmark ONWARD™ pivotal Phase 3 clinical trial in Poland to investigate its lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes. "We are pleased to announce we were able to begin the trial less than two weeks after we received approval from Poland's Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the relevant regional Polish ethics committees overseeing the trial," commented William Stilley, Chief Executive Officer of Adial Pharmaceuticals.
    Thu, Jun. 25, 2020

Adial Pharmaceuticals Announces Commencement of the Landmark ONWARD(TM) Pivotal Phase 3 Clinical Trial in Latvia

  • CHARLOTTESVILLE, VA / ACCESSWIRE / June 17, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has opened clinical trial sites and is recruiting trial subjects in Latvia after receiving all necessary approvals to commence the landmark ONWARD™ pivotal Phase 3 clinical trial in Latvia, including from the State Agency of Medicines of the Republic of Latvia and the Latvian Central Ethics Committee. The ONWARD™ trial is investigating Adial's lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes.
    Wed, Jun. 17, 2020

Adial Pharmaceuticals Closes Previously Announced $5.2 Million Registered Direct Offering

  • CHARLOTTESVILLE, VA / ACCESSWIRE / June 15, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) ("Adial" or the "Company"), a biopharmaceutical company focused on the development of treatments for addiction and currently conducting the ONWARD™ pivotal Phase 3 clinical trial of its lead drug candidate, AD04, for the treatment of Alcohol Use Disorder, today announced the closing on June 11,2020 of its previously announced registered direct offering of 2,820,000 shares of its common stock at a purchase price of $1.85 per share for gross proceeds of $5,217,000 priced at-the-market under Nasdaq rules. In a concurrent private placement, Adial also issued warrants to purchase 2,115,000 shares of common stock, which warrants are immediately exercisable, will expire 5 years from the date of issuance and will have an exercise price of $2.00 per share of common stock.
    Mon, Jun. 15, 2020
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Adial Pharmaceuticals Announces Approval to Commence Landmark ONWARD(TM) Pivotal Phase 3 Trial in Poland

  • CHARLOTTESVILLE, VA / ACCESSWIRE / June 11, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received all necessary approvals to commence its landmark ONWARD™ pivotal Phase 3 clinical trial in Poland to investigate its lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes. This includes the receipt of approvals from both the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the relevant regional Polish Ethics Committees overseeing the trial.
  • 06/11/2020

Adial Pharmaceuticals Receives Order for 1,000 COVID-19 Antibody Test Kits

  • CHARLOTTESVILLE, VA / ACCESSWIRE / June 10, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) ("Adial"), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received an initial firm order for the purchase of 1,000 Rapid Result COVID-19 antibody test kits. The customer intends to utilize the test kits for understanding exposure to the virus in the City of Phoenix, Arizona and surrounding communities and to advance efforts to protect the health and safety of frontline workers.
  • 06/10/2020

Adial Pharmaceuticals Announces Pricing of $5.2 Million Registered Direct Offering Priced At-The-Market

  • CHARLOTTESVILLE, VA / ACCESSWIRE / June 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) ("Adial" or the "Company"), a biopharmaceutical company focused on the development of treatments for addiction and currently conducting the ONWARD™ pivotal Phase 3 clinical trial of its lead drug candidate, AD04, for the treatment of Alcohol Use Disorder, today announced that it has entered into a securities purchase agreement with institutional investors to purchase approximately $5.2 million of its common stock in a registered direct offering priced at-the-market under Nasdaq rules and warrants to purchase common stock in a concurrent private placement. The combined purchase price for one share of common stock and a warrant to purchase 0.75 shares of common stock will be $1.85.
  • 06/09/2020

Adial Pharmaceuticals and BioLab Sciences Enter into Distribution Agreement for COVID-19 Antibody Tests

  • Antibody Testing Available for Landmark ONWARD (TM) Pivotal Phase 3 Trial Participants BioLab Sciences Grants Adial Exclusive Rights to Sell and Distribute Rapid Result COVID-19 Antibody Tests to Designated ...
  • 06/08/2020

Adial Pharmaceuticals Appoints Dr. Jack Reich to Board of Directors

  • CHARLOTTESVILLE, VA / ACCESSWIRE / May 28, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced the appointment of Dr. Jack Reich to the Board of Directors. Dr. Reich will serve on the Audit Committee as well as the Nominations and Corporate Governance Committee.
  • 05/28/2020

Op-Ed by Adial Pharmaceuticals CEO Published in the Daily Progress

  • CHARLOTTESVILLE, VA / ACCESSWIRE / May 4, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) , a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, announced ...
  • 05/04/2020

Adial Pharmaceuticals Files Post-Effective Amendments to Registration Statements For Outstanding Shares Underlying Existing Warrants and Shelf Registration Statement to Provide Financial Flexibility

  • CHARLOTTESVILLE, VA / ACCESSWIRE / April 23, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW) , a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, ...
  • 04/23/2020

Adial Pharmaceuticals Provides Update on ONWARD(TM) Phase 3 Pivotal Trial

  • CHARLOTTESVILLE, VA / ACCESSWIRE / April 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today provided an update on its landmark ONWARD™ Phase 3 pivotal trial of its lead drug candidate, AD04, in genetically identified subjects for the treatment of Alcohol Use Disorder (AUD). The number of in-clinic visits per subject has been reduced from 19 to 8.
  • 04/09/2020

Adial Pharmaceuticals Receives Issue Notification for Patent Covering AD04 for the Treatment of Opioid Use Disorder

  • CHARLOTTESVILLE, VA / ACCESSWIRE / March 26, 2020 / Adial Pharmaceuticals, Inc. (ADIL)(ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it received an Issue Notification for the issuance of a patent by the United States Patent and Trademark Office (USPTO) for the treatment of Opioid Use Disorder (OUD) with its lead drug candidate, AD04, in people that are positive for select genotypes identified using the Company's propriety companion genetic test. Including the patent term adjustment provided in the Issue Notification, the patent is expected to provide commercial exclusivity for AD04 until September 2031, plus potential Hatch-Waxman extensions.
  • 03/26/2020

Adial Pharmaceuticals Announces Modifications to the Phase 3 Pivotal Trial of AD04 to Protect Subjects from COVID-19

  • CHARLOTTESVILLE, VA / ACCESSWIRE / March 17, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that, effective immediately, the Company is modifying its pivotal Phase 3 clinical trial of the Company's lead drug candidate, AD04, for the treatment of alcohol use disorder (AUD) in genetically targeted patients. In order to better protect subjects enrolled in the Phase 3 clinical trial during the COVID-19 pandemic, the Company is in the process of modifying its protocol to reduce the number of in-person visits to clinical sites and replace certain visits with tele-medicine behavioral treatments and assessments. European regulators have encouraged sponsors of clinical trials to take action to reduce travel and potential exposure of study subjects and have indicated receptivity to modifications that achieve this end.
  • 03/17/2020

Adial Pharmaceuticals Receives Approval to Commence Phase 3 Trial in Bulgaria

  • CHARLOTTESVILLE, VA / ACCESSWIRE / February 19, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received approval to commence its Phase 3 study to investigate AD04 as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in Bulgaria in persons with certain target genotypes related to the serotonin transporter and receptor genes. This includes receiving approvals from both the Bulgarian Drug Agency and the Bulgarian Ethics Committee for Clinical Trials overseeing the study. "Bulgaria is expected be an important country in our Phase 3 trial of AD04 in biomarker-positive study participants," stated William Stilley, Chief Executive Officer of Adial Pharmaceuticals.
  • 02/19/2020

Adial Pharmaceuticals CEO Selected as a Luncheon Keynote Speaker for the 2020 Wall Street Conference and Retreat

  • CHARLOTTESVILLE, VA / ACCESSWIRE / February 14, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL;ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, is pleased to announce that the Company's CEO, William Stilley, has been selected as a luncheon keynote speaker for the 2020 Wall Street Conference and Retreat to be held in West Palm Beach, Florida on February 19-20. The Company recently announced it has commenced a Phase 3 pivotal clinical trial to investigate AD04 as a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD).
  • 02/14/2020

Adial Pharmaceuticals Commences Phase 3 Trial of AD04 for Alcohol Use Disorder

  • CHARLOTTESVILLE, VA / ACCESSWIRE / February 6, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has commenced a Phase 3 pivotal clinical trial to investigate AD04 as a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD). The trial has initially started in Finland, where Adial previously announced it had received approval to commence the trial. Adial has filed clinical trial applications (CTAs) to also conduct the trial in each of these countries where additional trial sites will be initiated on a country-by-country basis following each CTA approval.
  • 02/06/2020

Adial Pharmaceuticals Receives Approval to Commence Phase 3 Trial in Finland

  • CHARLOTTESVILLE, VA / ACCESSWIRE / January 9, 2020 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received favorable opinions from the Finnish Medicines Agency (FIMEA) and National Committee on Medical Research Ethics (TUKIJA) to commence its Phase 3 study to investigate AD04 as a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD). "Finland is the first of seven European countries in which we plan to open clinical sites as we conduct our AD04 Phase 3 trial in AUD subjects with certain target genotypes related to the serotonin transporter and receptor genes, which appeared to correlate to response to treatment with AD04 in the Phase 2b clinical trial," commented Monika Rogozinska, Chief Development Officer of Adial Pharmaceuticals.
  • 01/09/2020

Adial Pharmaceuticals Receives Notice of Allowance of Additional Patent for the Treatment of Alcohol Use Disorder with AD04 in Patients Identified Using a Molecular Genetic Biomarker

  • CHARLOTTESVILLE, VA / ACCESSWIRE / December 16, 2019 / Adial Pharmaceuticals, Inc. (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has received a Notice of Allowance for the issuance of a patent by the United States Patent and Trademark Office (USPTO), titled: "Serotonin Transporter Gene and Treatment of Alcoholism." This patent addresses a method of treating alcohol use disorder (AUD) in patients with a specific genetic biomarker in the serotonin transporter gene by administering the Company's investigational new drug product, AD04, a 5-HT3 antagonist, to patients with the TT genotype.
  • 12/16/2019

Adial Completes Validation of Genetic Biomarker Test in Collaboration with Eurofins for Upcoming Phase 3 Trial

  • CHARLOTTESVILLE, VA / ACCESSWIRE / December 13, 2019 / Adial Pharmaceuticals, Inc. ("Adial") (NASDAQ:ADIL; ADILW), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction, today announced that it has completed validation of its genetic biomarker test for its planned Phase 3 trial. The Phase 3 trial is designed to study AD04, a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder. Eurofins Genomics ("Eurofins"), a division of Eurofins Biopharma Services, a global scientific leader in bioanalytical testing, performed the laboratory validation of Adial's companion diagnostic genetic test using double strand Sanger sequencing and Fragment length analysis of polymerase chain reaction (PCR) products.
  • 12/13/2019
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