StockNews.AI
ALGS
StockNews.AI
10 hrs

Aligos Therapeutics Receives USAN Council Approval for pevifoscorvir sodium as Nonproprietary Name for ALG-000184

1. ALGS name changes ALG-000184 to pevifoscorvir sodium, advancing HBV treatment. 2. Pevifoscorvir sodium shows excellent antiviral activity in Phase 1 studies. 3. Phase 2 B-SUPREME study began August 2025; interim data expected in 2026. 4. FDA recognizes regulatory path for further studies on pevifoscorvir sodium. 5. Company commits to innovation in liver and viral disease treatments.

7m saved
Insight
Article

FAQ

Why Bullish?

The adoption of a generic name signifies progress in ALGS's drug development. Historical precedent shows similar milestones often lead to positive stock movements.

How important is it?

The announcement signals regulatory approval progress, enhancing ALGS’s growth potential and investor interest.

Why Long Term?

The outcome of ongoing studies and data releases could significantly influence ALGS's valuation over the next couple of years.

Related Companies

October 16, 2025 08:30 ET  | Source: Aligos Therapeutics SOUTH SAN FRANCISCO, Calif., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the United States Adopted Names (USAN) Council has adopted pevifoscorvir sodium as the nonproprietary (generic) name for ALG-000184, under investigation for the treatment of chronic hepatitis B virus (HBV) infection. The USAN, consisting of members from the Food and Drug Administration (FDA), American Medical Association (AMA), United States Pharmacopeia (USP) and the American Pharmacists Association (APhA), is responsible for developing simple, informative and unique nonproprietary (generic) drug names. “The adoption of pevifoscorvir sodium, or pevy, marks the first generic name for a compound at Aligos,” stated Lawrence Blatt, PhD, MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “As we continue to progress our Phase 2 B-Supreme study, we look forward to adopting this new name. This milestone showcases our continued innovation in the liver and viral disease space and reinforces our commitment to improving patient outcomes.” Generic drug names like pevifoscorvir sodium ensure consistent identification. Standardized naming also supports international recognition and transparency across markets. About pevifoscorvir sodiumPevifoscorvir sodium (formerly known as ALG-000184) was derived from initial IP licensed from the laboratory of Dr. Raymond Schinazi at Emory University, which was further optimized by Aligos. Pevifoscorvir sodium is a potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for chronic hepatitis B virus (HBV) infection. Phase 1 studies have demonstrated after single and multiple daily doses that pevifoscorvir sodium was well-tolerated by study participants, with no safety signals observed, and demonstrated linear PK and excellent antiviral activity. In longer term Phase 1 studies, pevifoscorvir sodium 300mg QD x ≤96 weeks ± entecavir (ETV) and pevifoscorvir sodium monotherapy have demonstrated sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Pevifoscorvir sodium has a regulatory path, as acknowledged by the FDA, EMA, and NMPA (China), for subsequent studies utilizing the chronic suppressive pathway. Phase 1 96-week dosing of pevifoscorvir sodium has been completed with the final and post-treatment follow up data expected at the American Association for the Study of Liver Disease’s The Liver Meeting® in 2025. The Phase 2 B-SUPREME study initiated in August 2025, with interim data projected in 2026, and topline data anticipated in 2027. About Aligos Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus (HBV) infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses. For more information, please visit www.aligos.com or follow us on LinkedIn or X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2025 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Investor ContactAligos Therapeutics, Inc.Jordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media ContactInizio EvokeJake RobisonVice PresidentJake.Robison@inizioevoke.com

Related News