Terns Pharmaceuticals Receives Fast Track Designation From the FDA for TERN-101, an FXR Agonist for the Treatment of NASH
29.10.2019 12:00:00 EET | Business Wire | Press release
Terns Pharmaceuticals, Inc., a global biopharmaceutical company focused on discovering and developing innovative therapies to treat non-alcoholic steatohepatitis (NASH) and cancer, today announced that TERN-101, an investigational farnesoid X receptor (FXR) agonist, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of NASH.
“Receiving Fast Track Designation for TERN-101 is an important step in bringing this promising treatment to patients as soon as possible, and we look forward to working with the agency as we advance TERN-101 through clinical development,” said Erin Quirk, M.D., Chief Medical Officer of Terns. “We are pleased that the U.S. FDA recognizes the potential for TERN-101 to address the unmet treatment need for patients with NASH, who currently have no therapeutic options.”
In Phase 1 studies to date, TERN-101 demonstrated clinical pharmacokinetic properties consistent with once-daily dosing. At The International Liver Congress™ 2019 in Vienna, Terns presented preclinical data demonstrating that TERN-101 reduced liver steatosis, inflammation, ballooning, and fibrosis in a preclinical model of NASH.
TERN-101 and TERN-201, Terns’ semicarbazide-sensitive amine oxidase (SSAO) inhibitor, are both in development for the treatment of NASH and were initially discovered and developed by Eli Lilly and Company. Terns signed a global, exclusive license agreement with Eli Lilly in 2018 to develop, manufacture, and commercialize TERN-101 and TERN-201.
About FDA Fast Track Designation
Fast Track is a process designed to facilitate the expedited development and review of new drugs to treat serious or life-threatening conditions and which have demonstrated the potential to fill an unmet medical need. The purpose is to advance new drugs earlier for patients who need them. Fast Track addresses a broad range of serious conditions.
A drug that receives Fast Track designation is eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug’s development and ensure collection of appropriate data needed to support drug approval
- More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
- Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA1.
About TERN-101 and Farnesoid X Receptor (FXR) Agonism
TERN-101 is a potent non-bile acid FXR agonist being developed as a therapeutic for NASH. FXR is a nuclear receptor that is highly expressed in the liver and small intestine. Bile acids (BA) are natural ligands of FXR, and their binding with and activation of FXR is critical to the regulation of cellular pathways that modulate BA synthesis, lipid metabolism, inflammation, and fibrosis. FXR agonism and activation has demonstrated improvement over placebo in regression of histological liver fibrosis without progression to NASH in a late-stage study, demonstrating the potential for FXR agonists to be a new treatment modality for NAFLD and NASH.
About NASH
Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease (NAFLD), which is caused by the accumulation of excess fat in the liver. NASH is associated with chronic liver inflammation and liver cell injury, and it can lead to fibrosis, cirrhosis, and eventually liver cancer or liver failure. Global rates of NAFLD and NASH are increasing rapidly, in tandem with rising rates of obesity. There is currently no approved medication for the treatment of NASH.
About Terns Pharmaceuticals
Terns Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company that is focused on the discovery and development of medicines for chronic liver disease and cancer. Based in China and the United States, the company is advancing a pipeline of drug candidates for the treatment of non-alcoholic steatohepatitis (NASH) and cancer, across multiple modalities. Terns leverages world class expertise in disease biology, medicinal chemistry, and clinical development in order to bring promising new therapies to patients in China and other global markets.
For more information, visit www.ternspharma.com and www.ternspharma.com.cn
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20191029005039/en/
Contact information
US Media Contact:
Margaret Robinson
+1 (415) 690 0084
China Media Contact:
Zhou Zhou
+86 13482103703
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
FDA Authorizes ZYN ULTRA Nicotine Pouches Following Scientific Review21.8.2026 22:11:00 EEST | Press release
Philip Morris International Inc. (NYSE: PM) today announces that the U.S. Food and Drug Administration (FDA) issued Marketing Granted Orders to PMI’s U.S. affiliate, Swedish Match USA, Inc., authorizing the marketing of 11 ZYN ULTRA moist oral nicotine pouch products, including all 9mg variants and one 11mg variant. Additional 11mg variants remain under scientific review. Today’s action further enhances PMI’s leadership role in the smoke-free category. “We are delighted with the FDA’s decision to authorize a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” said Stacey Kennedy, PMI U.S. CEO. “We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.” ZYN ULTRA positions the brand to further extend its category leadership among legal-age consumers of nicotine products. Like the flagship FDA-authorized ZYN pouches, ZYNULTRA, with its higher moisture content, is fre
58% of Consumers Say They Don't Care Whether a Product is a National Brand or Private Label. They Just Buy What They Need21.8.2026 13:00:00 EEST | Press release
As fast-moving consumer goods (FMCG) prices rose 26% globally between 2021 and 2025, consumers have become more deliberate about where they save and where they spend. NielsenIQ (NYSE: NIQ) has released new findings showing that private label is no longer viewed simply as a lower-cost substitute, but as a credible competitor across value, mainstream, and premium segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260819950224/en/ Private label is no longer just a value play. The findings, published in NIQ’s latest report, A Tale of Two Consumers: The Polarized Mindsets Reshaping Global Consumption, created in collaboration with World Data Lab, show how consumer polarization is redefining value and reshaping competition on the shelf. The report also draws on insights from NIQ's 2025reportFinding Harmony on the Shelfwhich documented changing perceptions of private label products. Key findings from these reports include: 58
Tanium Reappoints Co-Founder Orion Hindawi as CEO to Drive Next Chapter of Growth20.8.2026 22:10:00 EEST | Press release
Tanium, a leader in Autonomous IT, today announced that Co-Founder and Executive Chairman Orion Hindawi has been appointed Chief Executive Officer, effective immediately. Dan Streetman is stepping down as CEO and as a member of the Board after leading Tanium for the last three years, during which time Tanium scaled its go-to-market operations and secured strong industry analyst recognition for innovation within the Tanium platform. Streetman will continue to advise Tanium as part of the transition and co-founder David Hindawi will return to the role of Chairman of the Board. With this foundation in place, this transition positions Tanium to deepen its Autonomous IT capabilities and further expand AI offerings across its portfolio and strengthen customer and partner engagement. The Hindawis co-founded Tanium in 2007 to build the central nervous system of enterprise security, giving organizations unified visibility and control over their endpoints. During his prior tenure as CEO from 201
PCI Energy Solutions to Join Mitsubishi Electric, Reinforcing Long-Term Commitment to Customers, Employees, and the Energy Industry20.8.2026 20:46:00 EEST | Press release
PCI Energy Solutions ("PCI"), a leading U.S.-based provider of enterprise software for energy management and optimization, announced today that it has entered into a definitive agreement to be acquired by Mitsubishi Electric Corporation. The agreement was executed on August 20, 2026 (Japan Standard Time). The Transaction represents a strong endorsement of PCI's business, technology, employees, customer relationships and position in the energy industry. Mitsubishi Electric intends to retain PCI's core management team following completion of the Transaction, enabling PCI to preserve leadership continuity, industry expertise and its customer-focused operating model while benefiting from Mitsubishi Electric's global scale, complementary capabilities and long-term investment capacity. The agreement has been signed, but the Transaction has not yet closed. PCI and Mitsubishi Electric will continue to operate as separate companies until closing, which is subject to applicable regulatory approv
Perma-Pipe Secures More Than $67 Million in New Orders in the Second Quarter of 202620.8.2026 20:02:00 EEST | Press release
Perma-Pipe International Holdings, Inc. (Nasdaq: PPIH), a global leader in engineered piping and corrosion protection solutions, today announced that the Company secured more than $67 million in new orders during the second quarter of fiscal 2026, representing strong demand across its strategically important end-markets and geographies. The orders further strengthen Perma-Pipe's backlog and provide increased visibility into future revenue growth. The Company's backlog remains well diversified across geographies, customers and end-markets. The Company continued to see strong demand across its core Oil & Gas and infrastructure markets, while also securing important new business in emerging applications, including advanced leak detection and monitoring solutions. During the quarter, Perma-Pipe secured sizable Oil & Gas awards in both MENA and Canada, reinforcing the Company's position as a trusted supplier to customers undertaking significant energy infrastructure investments. The Company
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom