Company Highlights Advanced Partnering Discussions as AD04 Advances Toward Phase 3GLEN ALLEN, Va., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that it received notice from Nasdaq on February 23, 2026, that the Company has regained compliance with the minimum bid price requirement set forth ...

Core Insights - The FDA's recent policy shift allows for drug approval based on one adequate and well-controlled clinical investigation plus confirmatory evidence, rather than the traditional requirement of two pivotal studies, which could significantly lower costs and accelerate the NDA submission process for Adial's lead drug candidate, AD04 [1][2][3] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with its lead investigational drug candidate, AD04, targeting Alcohol Use Disorder (AUD) in heavy drinking patients [5] - AD04 is a genetically targeted serotonin-3 receptor antagonist, and the company is preparing for a new Phase 3 clinical trial program, utilizing a proprietary diagnostic genetic test to identify target genotypes [5] Regulatory Impact - The FDA's modernization of evidentiary standards emphasizes trial quality and confirmatory support over the number of trials, which aligns with Adial's strategy to potentially conduct a single pivotal trial for AD04 [2][4] - Cary Claiborne, CEO of Adial, highlighted that this regulatory change could transform the company's development strategy by significantly lowering Phase 3 costs and improving capital efficiency [4] Clinical Development Strategy - Adial intends to engage closely with the FDA to align its evidentiary strategy for AD04 with current regulatory standards, which may enhance the strategic and economic profile of the asset [4][7] - The company believes that AD04 has the potential to treat other addictive disorders beyond AUD, including Opioid Use Disorder, gambling, and obesity [5]

GLEN ALLEN, Va., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that Cary Claiborne, CEO of Adial, will be presenting at the Oppenheimer 36th Annual Healthcare Life Sciences Conference which will be held virtually February 25 - 26, 2026. Adial’s presentation is scheduled for Wednesday, Februar ...

Market Overview - U.S. stocks traded lower, with the Nasdaq Composite falling more than 200 points on Thursday. The Dow decreased by 0.56% to 49,225.33, the NASDAQ dipped 0.89% to 22,700.74, and the S&P 500 fell 0.74% to 6,831.80 [1] - European shares also declined, with the eurozone's STOXX 600 falling 0.8%, Spain's IBEX 35 Index down 1.4%, London's FTSE 100 down 0.3%, Germany's DAX slipping 0.6%, and France's CAC 40 down 0.3% [5] - Asian markets closed mostly lower, with Japan's Nikkei falling 0.88%, China's Shanghai Composite declining 0.64%, and India's BSE Sensex down 0.60% [6] Sector Performance - Consumer staples shares gained by 0.3% on Thursday, while consumer discretionary stocks fell by 2.2% [1][2] Company Earnings - Alphabet reported fourth-quarter revenue of $113.83 billion, exceeding the Street consensus estimate of $111.31 billion. The earnings per share were $2.82, beating the consensus estimate of $2.63 [3] Commodity Prices - In commodity news, oil traded down 2.4% to $63.58, gold fell 1.5% to $4,877.70, silver decreased by 10% to $75.950, and copper fell 0.5% to $5.8225 [3][4] Economic Indicators - U.S. job openings declined by 386,000 to 6.542 million in December, compared to market estimates of 7.2 million. Initial jobless claims increased by 22,000 to 231,000, against market estimates of 212,000 [7]

Market Overview - U.S. stocks showed mixed performance, with the Nasdaq Composite falling over 400 points, while the Dow increased by 0.24% to 49,358.09 and the S&P 500 decreased by 0.89% to 6,856.40 [1] - Energy shares rose by 1.7%, while information technology stocks fell by 2.1% [1] Company Performance - Eli Lilly and Co. saw its stock jump approximately 10% after reporting fourth-quarter adjusted earnings of $7.54 per share, surpassing the consensus estimate of $6.67. The company's sales reached $19.3 billion, exceeding the consensus of $17.96 billion [2] Commodity Market - In commodity trading, oil prices increased by 0.4% to $63.46, while gold prices decreased by 0.5% to $4,909.70. Silver prices rose by 1.6% to $84.615, and copper prices fell by 3.2% to $5.8945 [3] European Market - European shares were mixed, with the eurozone's STOXX 600 gaining 0.03%, while Spain's IBEX 35 Index fell by 0.09%. London's FTSE 100 increased by 0.85%, Germany's DAX slipped by 0.72%, and France's CAC 40 gained 1.01% [4] Asian Market - Asian markets closed higher, with Japan's Nikkei surging by 0.78%, Hong Kong's Hang Seng Index gaining 0.05%, China's Shanghai Composite rising by 0.85%, and India's BSE Sensex increasing by 0.09% [5] Economic Indicators - The ISM Services PMI remained unchanged at 53.8 in January, matching the revised reading from December and exceeding market estimates of 53.5. The S&P Global composite PMI rose to 53.0 in January from a preliminary level of 52.8 and up from December's reading of 52.7 [7] - U.S. crude stocks declined by 3.455 million barrels for the week ending January 30, compared to market estimates of a 2 million-barrel draw [7]

U.S. Stock Market - U.S. stocks traded mixed, with the Dow Jones index gaining over 200 points, up 0.44% to 49,459.82, while NASDAQ dipped 0.74% to 23,082.23 and S&P 500 fell 0.16% to 6,906.91 [1] Uber Technologies, Inc. - Uber's stock fell more than 5% after reporting fiscal Q4 2025 results, with a 20% year-over-year revenue growth to $14.37 billion, surpassing analyst estimates of $14.32 billion [2] - Adjusted EPS was reported at 71 cents, missing the analyst consensus estimate of 80 cents [2] Commodity Market - Oil traded up 0.6% to $63.56, gold increased by 1.4% to $5,004.40, silver rose 7.3% to $89.350, while copper fell 1.7% to $5.9820 [3] European Markets - European shares were mostly higher, with the eurozone's STOXX 600 gaining 0.5%, Spain's IBEX 35 Index up 0.4%, London's FTSE 100 up 1.4%, Germany's DAX down 0.3%, and France's CAC 40 up 1.3% [4] Asia Pacific Markets - Asian markets closed higher, with Japan's Nikkei up 0.78%, Hong Kong's Hang Seng Index gaining 0.05%, China's Shanghai Composite rising 0.85%, and India's BSE Sensex gaining 0.09% [5] Economic Indicators - The ISM Services PMI for the U.S. was reported at 53.8, unchanged from December and above market estimates of 53.5 [6] - The S&P Global composite PMI increased to 53.0 from a preliminary level of 52.8 and up from December's reading of 52.7 [6]

Core Insights - Adial Pharmaceuticals, Inc. has welcomed the recent passage of the 2026 Appropriations Bill, which includes directives for the FDA and NIDA to establish alternative clinical trial endpoints for substance use disorder treatments, including Alcohol Use Disorder (AUD) [1][2][5] Group 1: Legislative Impact - The legislation directs the FDA to consider non-abstinence-based endpoints such as reduced cravings and disorder severity, reflecting clinically meaningful improvements for patients [2][3] - This directive aligns with the NIAAA's updated definition of recovery, which emphasizes improvements in functioning and symptom reduction as valid treatment goals [3] Group 2: Company Strategy and Product Development - Adial's lead investigational therapy, AD04, is designed to treat AUD using a precision medicine approach, aligning with the newly established non-abstinence recovery outcomes [4][5] - The collaboration between federal agencies to define alternative endpoints is expected to strengthen the regulatory framework for innovative therapies like AD04, potentially accelerating development timelines and broadening clinical relevance [4][5] Group 3: Market Context - AUD remains a significant public health challenge, affecting millions with limited treatment options that achieve durable outcomes [5] - Adial believes that regulatory clarity around alternative endpoints will enhance the regulatory path for AD04 and support the company's strategy to address the unmet need in AUD with precision-based therapies [5][6]

Core Insights - Super Micro Computer Inc (NASDAQ:SMCI) reported better-than-expected second-quarter results, leading to a significant rise in its stock price during pre-market trading [1][2] Financial Performance - The company posted quarterly earnings of 69 cents per share, exceeding the analyst consensus estimate of 49 cents by 41.68% [1] - Quarterly revenue reached $12.68 billion, surpassing the Street estimate of $10.22 billion and showing a substantial increase from $5.68 billion in the same period last year [1] Future Guidance - For the third quarter, Super Micro expects adjusted EPS of 60 cents, higher than the 53-cent analyst estimate [2] - The company anticipates revenue in the range of $12.3 billion, compared to the $10.15 billion analyst estimate [2] Stock Movement - Following the earnings report, Super Micro Computer shares increased by 10.5%, reaching $32.79 in pre-market trading [2]

Core Viewpoint - Adial Pharmaceuticals, Inc. will implement a 1-for-25 reverse stock split to comply with Nasdaq's minimum bid price requirement and enhance its capital markets profile [1][3][4] Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 27.8 million to about 1.1 million, while maintaining the ownership percentage of each shareholder [2] - The reverse stock split will take effect on February 5, 2026, at 11:59 p.m. Eastern Time, with trading on a split-adjusted basis starting February 6, 2026 [1][2] - There will be no change to the total number of authorized shares as per the Company's Certificate of Incorporation [2] Group 2: Strategic Intentions - The reverse stock split aims to bring the Company into compliance with Nasdaq's minimum bid price requirement of at least $1.00 per share [3] - The action is expected to make the bid price more attractive to a wider range of institutional and retail investors [3][4] - The Company remains optimistic about its future and is focused on advancing its lead product, AD04, for the treatment of Alcohol Use Disorder [4][5] Group 3: Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders [5] - The lead investigational drug, AD04, is a genetically targeted serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder in heavy drinking patients [5] - The Company plans to conduct a new Phase 3 clinical trial program for AD04, which has shown promising results in reducing drinking without significant safety concerns [5]

Core Viewpoint - Adial Pharmaceuticals, Inc. is implementing a 1-for-25 reverse stock split to strengthen its capital markets profile and comply with Nasdaq's minimum bid price requirement [1][3]. Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 27.8 million to about 1.1 million, while maintaining the ownership percentage of each shareholder [2]. - The reverse stock split will take effect on February 5, 2026, at 11:59 p.m. Eastern Time, with trading on a split-adjusted basis starting February 6, 2026 [1][2]. - There will be no change to the total number of authorized shares as per the Company's Certificate of Incorporation [2]. Group 2: Company Strategy and Future Outlook - The Company is optimistic about its future and is focused on advancing its lead product, AD04, a genetically targeted serotonin-3 receptor antagonist for treating Alcohol Use Disorder [3][4]. - Adial plans to conduct a new Phase 3 clinical trial program for AD04, targeting specific genotypes identified through its proprietary diagnostic genetic test [4]. - The Company believes that AD04 has the potential to treat other addictive disorders, including Opioid Use Disorder, gambling, and obesity [4].