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Adial Pharmaceuticals, Inc - ADILW STOCK NEWS

Welcome to our dedicated page for Adial Pharmaceuticals news (Ticker: ADILW), a resource for investors and traders seeking the latest updates and insights on Adial Pharmaceuticals stock.

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) is a clinical-stage biopharmaceutical company dedicated to developing therapies for the treatment and prevention of addiction and related disorders. The company leverages its extensive expertise in pharmacology and pharmacogenomics to create personalized treatment options.

Adial’s lead investigational drug, AD04, is a genetically targeted, serotonin-3 receptor antagonist. It is designed to treat Alcohol Use Disorder (AUD) in heavy drinking patients with specific genetic markers, as identified through Adial’s proprietary companion diagnostic genetic test. The ONWARD™ pivotal Phase 3 clinical trial demonstrated promising results in reducing heavy drinking among patients with these target genotypes, with no significant safety or tolerability concerns.

AD04’s therapeutic potential extends beyond AUD. It is believed to be effective in treating other addictive disorders such as Opioid Use Disorder (OUD), gambling, and obesity. Adial is constantly expanding its patent portfolio to cover these broader applications. Recent patents enhance the intellectual property protection around AD04, including its unique ability to target the serotonin transporter gene for treating OUD.

Adial’s innovative approach has garnered regulatory compliance and favorable feedback from both the U.S. and European agencies. The company is in active discussions with potential strategic partners to support the development and commercialization of AD04 internationally. Key patents issued in 2024 further solidify Adial’s market position in treating addiction with a personalized approach.

Financially, Adial has maintained a strong balance sheet, enabling accelerated development of AD04. The company has strategically streamlined its operations, reducing general and administrative expenses significantly in 2023. Recent financial reports indicate positive steps toward achieving regulatory milestones while maintaining a robust pipeline of development activities.

Adial also recently received significant funding from warrant exercises, which will support ongoing clinical and regulatory efforts. The company continues to advance its pharmacokinetics study for AD04, aiming to optimize the study design for upcoming Phase 3 trials under the FDA’s guidance.

Adial is committed to transforming the lives of those affected by addiction through innovative, genetically targeted treatments. With a focus on personalized medicine, the company strives to offer new hope to millions dealing with addiction disorders worldwide. For more information, visit www.adial.com.

Rhea-AI Summary
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) provided a business update and reported financial results for the 2023 fiscal year. The company made significant progress towards the potential approval and commercial launch of its lead investigational new drug product, AD04, to treat Alcohol Use Disorder. Adial received positive feedback from US and EU regulators, engaged expert advisors, and is finalizing its clinical development plan. Discussions with potential strategic partners are advancing, and the company received $4.3 million in gross proceeds from warrant exercises. Adial also announced key patents related to genetic diagnostics for the treatment of Alcohol Use Disorder and opioid use disorder. The company received awards for technology innovation and completed a reimbursement agreement with Adovate, Financially, Adial reported $2.8 million in cash and cash equivalents, with total gross proceeds of $4.3 million from warrant exercises. Research and development expenses decreased by 35%, and general and administrative expenses decreased by 37%. The net loss for 2023 was $5.1 million, an improvement from the previous year.
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Adial Pharmaceuticals, Inc. announces the immediate exercise of warrants, raising $3.5 million. H.C. Wainwright & Co. acts as the exclusive placement agent for the offering.
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Adial Pharmaceuticals strengthens its patent portfolio with a new patent covering AD04's ability to target the serotonin transporter gene for treating opioid use disorder. The patent was issued by the United States Patent and Trademark Office, highlighting the company's commitment to developing therapies for addiction and related disorders.
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Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) announces participation in Winter Wrap-Up MicroCap Rodeo Conference. CEO Cary Claiborne to present on February 20, 2024, and host one-on-one meetings with investors. Register at webcaster4.com and MicroCap Rodeo.
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Adial Pharmaceuticals expands its patent estate to cover a unique genetic diagnostic approach for treating alcohol and drug dependencies. The Company's lead drug, AD04, shows promising results in specific genotype patients, potentially revolutionizing addiction treatment.
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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) announced the appointment of Tony Goodman as Chief Operating Officer. Goodman will oversee strategic growth initiatives, clinical development, and commercial planning for AD04, as well as business development initiatives focused on partnership opportunities in the addiction treatment space. With over 23 years of experience in the pharmaceutical and biotech industries, Goodman's appointment signifies a pivotal time for the company as it prepares to advance the AD04 clinical program and potential commercialization for the treatment of alcohol use disorder.
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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) received a final development cost reimbursement payment of $350,000 from Adovate, LLC. The company is eligible for up to $83 million in total consideration, including development and approval milestones, commercial milestones, and a low, single-digit royalty. Additionally, Adial acquired a 15% equity stake in Adovate and has anti-dilution protection. This agreement is a significant milestone for Adial's business development and potential future revenue.
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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) has regained compliance with Nasdaq Listing Rule 5550(b)(1) requiring listed companies to maintain stockholders' equity of at least $2,500,000. If the Company does not evidence compliance in its next periodic report, it may be subject to delisting.
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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) reported receiving Frost & Sullivan’s 2023 North American Precision Medicine for Addiction Disorders Technology Innovation Leadership Award, closed a $4 million private placement, and extended its cash runway into Q4 2024. The company is advancing discussions with potential strategic partners and has made steady progress throughout the third quarter of 2023. Adial is pursuing a highly focused regulatory strategy and is finalizing its clinical development plan for AD04, aiming for approval in the U.S. and EU. The company is also under confidentiality agreements and in discussions with companies interested in supporting the development and commercial launch of AD04. Adial has improved its balance sheet as a result of the recent private placement and received the 2023 Best Practices Technology Innovation Leadership Award in the North American precision medicine for addiction disorders industry by Frost & Sullivan.
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Adial Pharmaceuticals, Inc. will be presenting at The Annual International Society of Addiction Medicine Conference. The presentation will highlight the effects of AD04, the Company's therapeutic agent for the treatment of Alcohol Use Disorder (AUD). The phase 3 clinical trial results support the use of AD04 as a precision medicine to treat AUD.
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FAQ

What is Adial Pharmaceuticals' main focus?

Adial Pharmaceuticals focuses on developing therapies for the treatment and prevention of addiction and related disorders.

What is AD04?

AD04 is Adial’s lead investigational new drug, a genetically targeted, serotonin-3 receptor antagonist for treating Alcohol Use Disorder (AUD) in heavy drinking patients.

What are the potential applications of AD04?

AD04 is believed to have potential applications in treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity.

What was the outcome of the ONWARD™ Phase 3 clinical trial?

The ONWARD™ Phase 3 clinical trial showed promising results in reducing heavy drinking in patients with certain target genotypes, with no significant safety or tolerability concerns.

How does Adial identify patients for AD04 treatment?

Adial uses a proprietary companion diagnostic genetic test to identify patients with specific genotypes that respond to AD04 treatment.

What recent financial achievements has Adial Pharmaceuticals announced?

Adial recently reduced its general and administrative expenses significantly and received substantial funding from warrant exercises to support clinical and regulatory activities.

What are the latest developments in Adial’s intellectual property?

Adial has expanded its patent portfolio to cover AD04’s application for treating Opioid Use Disorder (OUD) and other drug dependencies, enhancing its market position.

What is the significance of Adial’s latest patents?

Recent patents protect AD04’s unique ability to target the serotonin transporter gene for treating OUD, representing a significant advancement in Adial’s intellectual property.

What are Adial’s plans for the future development of AD04?

Adial plans to conduct two parallel Phase 3 clinical trials to support potential approval of AD04 in the shortest timeframe possible, with ongoing partnership discussions to facilitate development and commercialization.

Where can I find more information about Adial Pharmaceuticals?

For more information, visit Adial Pharmaceuticals' official website at www.adial.com.

Adial Pharmaceuticals, Inc

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