This section highlights FDA-related milestones and regulatory updates for drugs developed by Aligos Therapeutics (ALGS).
Over the past two years, Aligos Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ALG-000184 and ALG-055009. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ALG-000184 - FDA Regulatory Timeline and Events
ALG-000184 is a drug developed by Aligos Therapeutics for the following indication: Hepatitis B.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALG-000184
- Announced Date:
- March 26, 2025
- Indication:
- Hepatitis B
Announcement
Aligos Therapeutics, Inc announced positive data from three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025, being held March 26 - 30, 2025 in Beijing, China.
AI Summary
Aligos Therapeutics, Inc. announced positive data from three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025 in Beijing, China. The company presented preliminary findings from its Phase 1 study of ALG-000184, a capsule assembly modulator aimed at treating chronic hepatitis B. The data showed significant reductions in key HBV markers in both HBeAg-positive and HBeAg-negative patients, with sustained viral suppression and no resistance detected over 96 weeks.
Additionally, positive results were shared from the Phase 2a HERALD study of ALG-055009. This novel thyroid hormone receptor beta agonist demonstrated robust reductions in liver fat in patients with metabolic dysfunction-associated steatohepatitis (MASH), including promising effects in subjects receiving GLP-1 agonists. The findings suggest that ALG-055009 may offer potential benefits as a standalone or combination therapy for liver conditions.
Read Announcement- Drug:
- ALG-000184
- Announced Date:
- November 19, 2024
- Indication:
- Hepatitis B
Announcement
Aligos Therapeutics, Inc announced positive data from one late-breaker oral and three poster presentations at the American Association for the Study of Liver Disease's (AASLD) The Liver Meeting (TLM) 2024, being held November 15 – 19, 2024 in San Diego, CA.
AI Summary
Aligos Therapeutics recently announced positive results from one late-breaker oral and three poster presentations at The Liver Meeting 2024 organized by the American Association for the Study of Liver Diseases in San Diego, CA. The studies focused on two drugs. One poster presentation highlighted ALG-000184, which showed strong antiviral effects in patients with chronic hepatitis B. The data revealed that all treated patients, regardless of HBeAg status, achieved sustained viral suppression with no signs of resistance over the treatment period.
The late-breaker oral presentation showcased ALG-055009, a thyroid hormone receptor beta agonist designed for metabolic dysfunction-associated steatohepatitis (MASH). In a 12-week study, patients experienced significant reductions in liver fat, with substantial improvements achieved even among those already on GLP-1 agonist therapy. These findings support the potential of both therapies to improve treatment outcomes in liver and viral diseases.
Read Announcement- Drug:
- ALG-000184
- Announced Date:
- July 22, 2024
- Indication:
- Hepatitis B
Announcement
Aligos Therapeutics, Inc announced that it has entered into a clinical trial collaboration agreement with Xiamen Amoytop Biotech Co., Ltd. ("Amoytop").
AI Summary
Aligos Therapeutics, Inc. has entered into a clinical trial collaboration agreement with Xiamen Amoytop Biotech Co., Ltd. Under this collaboration, Amoytop will sponsor a Phase 1b exploratory clinical study in China. The study will assess the efficacy and safety of ALG-000184 when combined with PEGBING® (mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients. This trial will be carried out once approval is received from China’s National Medical Products Administration. The goal of the study is to evaluate the combined effect of ALG-000184—a novel, oral small molecule capsid assembly modulator—with an approved CHB treatment, potentially offering a new approach to managing the disease. By joining forces with Amoytop, Aligos hopes to build on their existing relationship and work toward creating more effective treatment options for patients suffering from CHB.
Read Announcement- Drug:
- ALG-000184
- Announced Date:
- July 10, 2024
- Estimated Event Date Range:
- July 18, 2024 - July 18, 2024
- Target Action Date:
- July 18, 2024
- Indication:
- Hepatitis B
Announcement
Aligos Therapeutics, Inc announced that it will host a virtual KOL event featuring Mark Sulkowski, MD, Johns Hopkins University School of Medicine, to discuss the unmet need and current treatment landscape for patients with chronic hepatitis B (CHB), positive data from the Phase 1b study of ALG-000184, development plans, and the chronic suppression regulatory pathway on Thursday, July 18, 2024 at 3:00pm ET/12:00pm PT.
AI Summary
Aligos Therapeutics, Inc. announced a virtual Key Opinion Leader event featuring Dr. Mark Sulkowski from Johns Hopkins University School of Medicine. The event, scheduled for Thursday, July 18, 2024 at 3:00pm ET/12:00pm PT, will focus on the unmet need and current treatment landscape for patients with chronic hepatitis B (CHB). During the webcast, Dr. Sulkowski will discuss recent positive data from the Phase 1b study of ALG-000184, including its significant ability to reduce viral markers, and share insights on the chronic suppression regulatory pathway. The discussion will also cover Aligos’ future development plans for their first-in-class molecule aimed at addressing CHB, building on encouraging feedback from the FDA. This event highlights the company’s commitment to improving treatments and outcomes for patients with CHB.
Read Announcement
ALG-055009 - FDA Regulatory Timeline and Events
ALG-055009 is a drug developed by Aligos Therapeutics for the following indication: Nonalcoholic Steatohepatitis (NASH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALG-055009
- Announced Date:
- May 8, 2025
- Indication:
- Nonalcoholic Steatohepatitis (NASH)
Announcement
Aligos Therapeutics, Inc. announced positive data from eight presentations at the European Association for the Study of the Liver (EASL) Congress 2025, being held May 7 – 10, 2025 in Amsterdam, Netherlands.
AI Summary
Aligos Therapeutics, Inc. announced positive data from eight presentations at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam, Netherlands, held from May 7 to 10, 2025. The presentations highlighted key findings from multiple programs, including updated 96‐week results for ALG-000184, a novel capsid assembly modulator for chronic hepatitis B virus (HBV) infection. The data showed that both HBeAg-positive and HBeAg-negative subjects achieved robust and sustained HBV DNA suppression, with all patients reaching target reductions by Week 96. These encouraging results support the potential of ALG-000184 as a first- or best-in-class therapy for chronic HBV infection. Additionally, new insights were shared on ALG-055009, a promising agent targeting metabolic dysfunction-associated steatohepatitis (MASH) by reducing liver fat and improving lipid profiles, further emphasizing Aligos’ commitment to developing innovative treatments for liver diseases.
Read Announcement- Drug:
- ALG-055009
- Announced Date:
- September 19, 2024
- Indication:
- Nonalcoholic Steatohepatitis (NASH)
Announcement
Aligos Therapeutics, Inc announced positive topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects.
AI Summary
Aligos Therapeutics has announced positive topline results from its Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in patients with metabolic-dysfunction associated steatohepatitis (MASH). The trial, which included 102 subjects with stage 1-3 liver fibrosis, was randomized, double-blind, and placebo-controlled. Participants received one of four oral dosages for 12 weeks.
The study showed that dose groups of 0.5 mg to 0.9 mg achieved statistically significant reductions in liver fat, with up to a 46.2% placebo-adjusted median relative reduction as measured by MRI-PDFF. Additionally, significant improvements in atherogenic lipid markers such as LDL-C, lipoprotein (a), and apolipoprotein B were observed. ALG-055009 was well-tolerated, with few gastrointestinal side effects and no serious adverse events, supporting its potential for further development in MASH treatment.
Read Announcement- Drug:
- ALG-055009
- Announced Date:
- September 18, 2024
- Indication:
- Nonalcoholic Steatohepatitis (NASH)
Announcement
Aligos Therapeutics, Inc announced that the Company will share the topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects on Thursday, September 19, 2024 prior to the market open.
AI Summary
Aligos Therapeutics, Inc. announced that it will release the topline results from its Phase 2a HERALD study for ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, targeting metabolic dysfunction-associated steatohepatitis (MASH) subjects. The results will be shared on Thursday, September 19, 2024, before the market opens. This announcement marks an important milestone as the company works to develop therapies that address unmet medical needs in liver diseases.
Following the release, Aligos will host a conference call and webcast at 8:30 am ET (5:30 am PT) that will feature a detailed slide presentation. Interested parties are encouraged to register on the company’s website ten minutes before the start to access the live event. This update reflects Aligos Therapeutics’ ongoing commitment to transparency and advancing clinical research in treatments for MASH.
Read Announcement- Drug:
- ALG-055009
- Announced Date:
- May 21, 2024
- Indication:
- Nonalcoholic Steatohepatitis (NASH)
Announcement
Aligos Therapeutics announced that it has completed enrollment in the ALG-055009 Phase 2a HERALD study for metabolic dysfunction-associated steatohepatitis
AI Summary
Aligos Therapeutics announced it has completed enrollment in its Phase 2a HERALD study. The trial is designed to evaluate the safety, pharmacokinetics, and efficacy of ALG-055009, a promising thyroid hormone receptor beta agonist, as a treatment for metabolic dysfunction-associated steatohepatitis (MASH). Approximately 100 subjects with presumed MASH and stage 1-3 liver fibrosis have been enrolled and randomized to receive either one of four doses or a placebo for 12 weeks. Topline safety and efficacy data are expected in early Q4 2024.
The study will be overseen by Dr. Rohit Loomba, a leading expert in the field of liver diseases and the appointed Principal Investigator. Dr. Loomba’s extensive background in gastroenterology and noninvasive liver assessment techniques is expected to bring valuable insights to the HERALD study and contribute to advancements in MASH treatment.
Read Announcement- Drug:
- ALG-055009
- Announced Date:
- May 21, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Nonalcoholic Steatohepatitis (NASH)
Announcement
Aligos Therapeutics announced that Topline data now projected in early Q4 2024
AI Summary
Aligos Therapeutics, a clinical stage biopharmaceutical company focused on liver and viral diseases, announced an important update on its Phase 2a HERALD study for metabolic dysfunction-associated steatohepatitis (MASH). The company has now completed patient enrollment and expects topline safety and efficacy data in early Q4 2024. This data is significant as it will provide insight into the potential of ALG-055009, a promising thyroid hormone receptor beta (THR-ß) agonist specifically developed for treating MASH.
Adding to the study’s expertise, Dr. Rohit Loomba from the University of California, San Diego (UCSD) has been named the Principal Investigator. The HERALD study, which is randomized, double-blind, and placebo-controlled, includes about 100 subjects receiving varying doses of ALG-055009 over a 12-week period. This milestone marks a key step in Aligos’ goal to address unmet medical needs in liver care and potentially offer a novel treatment option for MASH patients.
Read Announcement
