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Tessera Therapeutics Receives U.S. FDA Fast Track and Orphan Drug Designations for its Lead In Vivo Gene Editing Program TSRA-196 for the Treatment of Adults with AATD

SOMERVILLE, Mass., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Tessera Therapeutics, the biotechnology company pioneering a new approach in genetic medicine known as Gene Writing™, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track and Orphan Drug designations to TSRA-196, its lead in vivo gene editing program. TSRA-196 is being jointly developed with Regeneron for the treatment of adults with alpha-1 antitrypsin deficiency (AATD) who are homozygous for the PiZ allele

articleRegeneron Pharmaceuticals, Inc.February 23, 20264/company/regeneron-pharmaceuticals-inc/news/tessera-therapeutics-receives-us-fda-fast-track-and-orphan-drug-designations-for-its-lead-in-vivo-gene-editing-program-tsra-196-for-the-treatment-of-adults-with-aatd
Tessera Therapeutics Receives U.S. FDA Fast Track and Orphan Drug Designations for its Lead In Vivo Gene Editing Program TSRA-196 for the Treatment of Adults with AATD

About this update from Regeneron Pharmaceuticals, Inc.

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More updates from Regeneron Pharmaceuticals, Inc.

Orphan Druggenetic mutationAATFood and Drug AdministrationAATDgenetic medicineunderlying causedesignationFast Track designationTesseraalpha-1 antitrypsin deficiencyalpha-1 antitrypsin