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Tag: Adial

  • 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.