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Tag: Adial Pharmaceuticals

  • Adial Pharmaceuticals, Inc. (ADIL) Faces Pre-market Pressure with 7% Drop

    Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) is facing a turbulent start to the week, with its pre-market price dropping an additional 7% after Friday’s 5% decline. The stock’s trading volume remains lower than average, suggesting that the recent price movement is driven by a few players rather than broad market sentiment.

    Despite the lack of significant news, investors are wary of a potential profit-taking dip in the coming days. However, bulls seem optimistic for now, riding the wave of uncertainty.

    Background

    Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders. Its lead investigational drug, AD04, targets the serotonin-3 receptor to treat Alcohol Use Disorder (AUD) in heavy drinking patients. AD04 has shown promising results in reducing heavy drinking, with no major safety concerns reported.

    The stock has seen a significant decline over the past year, falling from $14 to $1, raising concerns among investors.

    Cary Claiborne, President and CEO of Adial, expressed optimism about the progress made in 2023, particularly in refining the clinical development plan for AD04. The company is finalizing a plan to conduct two Phase 3 clinical trials in parallel to expedite potential approval in the US.

    Other Developments

    In other developments, Adial appointed Tony Goodman as Chief Operating Officer to oversee strategic growth initiatives, including clinical development and commercial planning for AD04. The company also received key patents from the US Patent and Trademark Office (USPTO) for its genetic diagnostic to detect select genotypes for the treatment of AUD and opioid use disorder (OUD) with AD04.

    Financially, Adial reported $2.8 million in cash and cash equivalents as of December 31, 2023, compared to $4.0 million in 2022. The company received $4.3 million from recent warrant exercises, which it believes will fund its operations into the first quarter of 2025.

    Conclusion

    Despite the recent price decline, Adial remains optimistic about the potential approval and commercial launch of AD04, with ongoing efforts to secure strategic partnerships and advance clinical trials. Investors will be watching closely for any updates on these developments.

  • Adial (ADIL) Stock Skyrockets: Patent Award Fuels Surge

    Adial (ADIL) Stock Skyrockets: Patent Award Fuels Surge

    Adial Pharmaceuticals, Incorporated (NASDAQ: ADIL) has witnessed a remarkable upsurge in its stock valuation, experiencing a noteworthy surge of 169.28% to $2.28 per share during the current session of trading. This surge can be primarily attributed to the disclosure of the grant of a novel patent to Adial within the United States.

    Adial (ADIL) officially disclosed the issuance of patent number 11,905,562 by the United States Patent and Trademark Office on February 20, 2024. This patent encompasses the Company’s principal investigational new drug, AD04, and its capacity to target the serotonin transporter gene for the prospective treatment of opioid use disorder (OUD).

    This latest patent underscores Adial’s ongoing expansion of its Intellectual Property portfolio, particularly focusing on pivotal aspects of its primary asset, AD04, which includes its distinctive capability to target the serotonin transporter gene. ADIL maintains the belief that AD04 harbors significant potential in addressing OUD and various other substance dependencies, extending beyond its initial application in alcohol use disorder.

    The company remains steadfast in its commitment to advancing AD04 towards commercialization for alcohol use disorder treatment, while eagerly anticipating progress in treating OUD and other related conditions in the future. Earlier this month, Adial secured patent notice aimed at broadening its scope concerning the amalgamation of its proprietary genetic diagnostic tool.

    This tool is designed to identify patients with specific genotypes for the purpose of genetically tailored treatment of alcohol use disorder (AUD) and substance dependencies like OUD. Following an in-depth post hoc analysis of its ONWARD Phase 3 trial outcomes, Adial successfully identified patients with specific genotypes exhibiting highly favorable responses to AD04 treatment.

    Encouraged by these promising findings, the integration of its genetic diagnostic tool with AD04 presents a customized treatment avenue for individuals grappling with AUD and OUD. By combining predictive capabilities to identify patients most likely to benefit from AD04 treatment with the established clinical efficacy of AD04 in reducing heavy drinking days among patients with specific genotypes, Adial envisions a transformative impact on the lives of millions affected by AUD and other dependencies.

    Notably, within the cohort possessing the target genotypes, the potential market for AD04 is estimated at approximately $40 billion in the U.S. alone. Adial remains dedicated to further unraveling the genetic underpinnings of addiction and is committed to delivering a personalized therapeutic approach through AD04.

  • Latest Extended Session Has Adial (ADIL) Stock Soaring

    Latest Extended Session Has Adial (ADIL) Stock Soaring

    Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) experienced a noteworthy surge of 7.43%, reaching $2.17 in the after-market session on Thursday. The positive momentum initiated during regular trading hours, marking a 1.00% ascent to conclude the session at $2.02. In absence of any pertinent news, recent advancements may be the impetus behind the upswing in investor sentiment towards ADIL stock.

    Notably, Adial (ADIL) has received notification from Nasdaq regarding its regaining its compliance with Listing Rule requirements. Nasdaq Listing Rule 5550(b)(1) mandates listed companies to uphold stockholders’ equity at a minimum of $2,500,000. Nasdaq will vigilantly monitor the Company’s continued adherence to the stockholders’ equity stipulation, and failure to demonstrate compliance in the subsequent periodic report may result in delisting.

    In its recent corporate update, Adial disclosed substantial progress throughout the third quarter of 2023. This encompasses favorable feedback from regulatory meetings in the U.S. and EU, advancement in strategic partner negotiations, and enhancement of the company’s financial position. ADIL is actively pursuing a targeted regulatory strategy and is finalizing its clinical development plan.

    The plan envisages the initiation of two parallel phase 3 trials with AD04 to expedite potential approval while mitigating risks. Adial’s strategic focus extends to obtaining approval in the U.S., with trial designs tailored to meet both U.S. and EU submission criteria.

    ADIL is presently engaged in confidential discussions underlining its commitment to potential collaborators, including companies expressing interest in supporting the development and commercial launch of AD04 in the U.S. and EU. The company is meticulously reviewing data and regulatory feedback from relevant agencies.

    Forming robust partnerships holds the promise of facilitating Adial’s swift entry into markets, given the anticipated widespread accessibility, reasonable pricing, and reimbursement feasibility of AD04. ADIL is dedicated to executing a refined, well-researched, and commercially compelling plan for AD04 while possessing the financial resources to embark on the next phase of its development strategy.

  • Adial Pharmaceuticals, Inc. (ADIL) Stock Surges Ahead of Inclusion in Russell Microcap Index

    Adial Pharmaceuticals, Inc. (ADIL) stock prices were up by a significant 16.21% as of the market closing on July 2nd, 2021, bringing the price per share up to USD$2.94 at the end of the trading day.

    Inclusion in Russell Microcap Index

    June 28th, 2021 saw the company announce its inclusion in the Russell Microcap Index, effective as of the market opening on the same day. Inclusion in the index is indicative of the company’s progress in advancing its lead investigational new drug product, AD04, through ADIL’s ONWARD Phase 3 trial for the treatment of alcohol use disorder. Further contributing to the addition in the index was the company’s recent acquisition of Purnovate, along with its adenosine drug development platform.

    Fast Track Designation Denied

    The company reported near the end of June 2021 that its request for Fast Track Designation for the use of AD04 in the treatment of Alcohol Use Disorder had been denied by the U.S. Food and Drug Administration. The FDA cited the company’s failure to adequately demonstrate the potential of its treatment, with the agency requesting additional comparative information in contrast to other alternative therapies.

    Gaining Approval

    As per the denial, ADIL will assess the FDA’s requirements to facilitate approval of a Fast Track Designation, which is designed to facilitate development and hasten the process of regulatory review of drugs. AD04 is currently undergoing a Phase 3 ONWARD trial, with the primary endpoint of efficacy being marked by the change from baseline in the monthly number of heavy drinking days during the last eight weeks of the 24-week treatment period.

    ONWARD Trial

    The ONWARD trial is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study that lasts a period of 24 weeks. It is designed to evaluate the efficacy, safety, and tolerability of AD04 in the treatment of patients with Alcohol Use Disorder and selected polymorphisms in the serotonin transporter and receptor genes. The ONWARD trial ensured only genetically positive patients were enrolled by genetically screening patients prior to enrollment. The primary endpoint is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period.

    Future Outlook for ADIL

    Despite the speed bump presented by the FDA’s denial of Fast Track Designation for AD04, ADIL is poised to address and resolve the issue and continue the development of its flagship treatment. Investors are hopeful for a timely resolution and the resumption and acceleration of the commercialization of AD04.

  • Why Adial Pharmaceuticals Inc. (ADIL) stock rallied in the after-hours on Monday?

    Why Adial Pharmaceuticals Inc. (ADIL) stock rallied in the after-hours on Monday?

    Adial Pharmaceuticals Inc. (ADIL) shares jumped 24.04% in after-hours on Monday, June 21, 2021, and closed the day at $3.56 per share. Earlier, ADIL’s stock lost 1.71% in Monday’s morning session and closed at $2.87 per share. ADIL shares have risen 95.24% over the last 12 months, and they have moved up 2.87% in the past week. Over the past three months, the stock has gained 14.34%, while over the past six months, it has plummeted 52.66%.

    Private placement of common stock

    On June 03, 2021, Adial Pharmaceuticals, Inc completed the $2,100,000 private placement of 700,001 shares of common stock at $3.00 per share. Keystone Capital Partners, LLC, a company controlled by a member of management, and Bespoke Growth Partners, Inc. took part in the private placement.

    Exercise of Warrants

    On February 26, 2021, Adial Pharmaceuticals, Inc. announced the exercise of 712,500 warrants from its June 2020 financing for net proceeds to the company of $1,425,000.

    50% Enrollment achieved in ONWARD™ Phase 3 Trial

    On February 25, 2021, Adial Pharmaceuticals, Inc reached 50% enrollment in the Company’s landmark ONWARD™ pivotal Phase 3 clinical trial.

    ONWARD is investigating the efficacy and safety of Adial’s lead drug candidate, the aim of AD04 is to treat people with certain target genotypes associated with serotonin transporters and receptor genes who have alcohol use disorder (AUD).

    Fast Track Application for AD04 with the FDA

    On February 23, 2021, Adial Pharmaceuticals, Inc announced that it will be filing a fast track application with the U.S. Food and Drug Administration (FDA) for its lead drug candidate, AD04.

    Completing the acquisition of Purnovate

    On January 26, 2021, Adial Pharmaceuticals closed the acquisition of Purnovate, LLC.

    Purnovate has explored the application of adenosine analogs and other chemical compounds referred to as purines, which are found throughout the body, including in DNA and RNA, to address other disease states.

    3rd U.S patent for the use of AD04 for the treatment of (OUD)

    On January 11, 2021, Adial Pharmaceuticals, Inc received its third U.S. patent relating to the use of AD04 for the treatment of opioid use disorder (OUD). The patent covers the use of the Company’s lead product, AD04, as a treatment of Opioid Use Disorder in patients with a specific genetic biomarker in the serotonin transporter gene.

    Conclusion

    Well, as of this writing there is no recent news or development which could justify its surge in the after-markets on Monday. We hope that ADIL will continue its positive momentum on Tuesday as well.

  • Why Adial Pharmaceuticals (NASDAQ: ADIL) Is Soaring Today?

    Why Adial Pharmaceuticals (NASDAQ: ADIL) Is Soaring Today?

    Shares of Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) traded up 114.89% after the company announced that it has received the Emergency Use Authorization (EUA) from FDA for Assure/FaStep® COVID-19 IgG/IgM Rapid Test Device. This Emergency Use Authorization from the FDA is the first antibody point-of-care test for COVID-19.

    The rapid test device, the blood samples were used using fingerstick as compared to other approved tests which are recently using only plasma, serum, or venous blood. After the authorization from FDA, fingerstick blood samples can be used with the FaStep COVID-19 IgG/IgM Rapid Test Device for the test in point-of-care settings, including urgent care centers, emergency rooms, doctors’ offices, hospitals, or other locations where there is a licensed healthcare professional.

    Previously, this FaStep COVID-19 IgG/IgM Rapid Test Device is used for the detection of SARS-CoV-2 antibodies in the individuals and it is used to identify the recent or previous COVID-19 infection. Various other kits were present but they haven’t got the authorization for the fingerstick blood sample.

    Shares of Adial Pharmaceuticals soared 114.89% after it gained +1.62 during the trading session of Tuesday. It has a closing price of $3.03. In the past 52-weeks of trading, this company’s stock fluctuated between the low of $1.00 and a high of $3.17. It has moved up to 203.00% from its 52-weeks low and moved down -4.42% from its 52-weeks high. Looking at its liquidity, it has a current ratio of 13.90. This company’s market capitalization has remained high, hitting $41.06 million at the time of writing.

    Adial has announced that it has started the sales of the FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals through The iRemedy Healthcare Companies, Inc. (iRemedy) network and e-commerce platform. This company has earlier filed for Expedited Review of AD04 with the FDA. AD04 is the drug candidate used for the treatment of Alcohol Use Disorder (AUD)