Terns Pharmaceuticals Announces Orphan Drug Designation Granted to TERN-701 for the Treatment of Chronic Myeloid Leukemia
11 Marzo 2024 - 9:05PM
Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq:
TERN), a clinical-stage biopharmaceutical company developing a
portfolio of small-molecule product candidates to address serious
diseases, including oncology and obesity, today announced that the
U.S. Food and Drug Administration (FDA) granted Orphan Drug
Designation for TERN-701 for the treatment of chronic myeloid
leukemia (CML). TERN-701, the Company’s internally discovered
allosteric BCR-ABL tyrosine kinase inhibitor (TKI), is in Phase 1
clinical development with interim data from initial dose escalation
cohorts expected in the second half of 2024.
“CML is a serious leukemia that requires chronic, life-long
treatment,” said Emil Kuriakose, MD, chief medical officer of
Terns. “Allosteric TKIs are a novel class of inhibitors that are
highly selective and have demonstrated significantly improved
clinical efficacy, safety and tolerability compared to prior
generation active-site TKIs. Orphan drug designation for TERN-701
underscores the FDA’s recognition of the unmet need for people
living with CML and Terns’ commitment to developing new treatment
options.”
FDA Orphan Drug Designation is granted to investigational
therapies addressing rare medical diseases or conditions that
affect fewer than 200,000 people in the United States. Orphan drug
status provides benefits to drug developers, including assistance
in the drug development process, tax credits for clinical costs,
exemptions from certain FDA fees and seven years of post-approval
marketing exclusivity.
About Terns PharmaceuticalsTerns
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
developing a portfolio of small-molecule product candidates to
address serious diseases, including oncology and obesity. Terns’
pipeline includes three clinical-stage development programs
including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1
receptor agonist, a THR-β agonist and preclinical GIPR modulator
programs. For more information, please
visit: www.ternspharma.com.
Contacts for Terns
InvestorsJustin Nginvestors@ternspharma.com
MediaJenna UrbanBerry & Company Public
Relationsmedia@ternspharma.com
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