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SAN DIEGO, Calif. — Transposon Therapeutics, a biotechnology company developing a platform of novel, orally administered therapies for the treatment of neurodegenerative and aging-related diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TPN-101 for progressive supranuclear palsy (PSP).     “Fast...
SAN DIEGO, CA — Travere Therapeutics Inc. (Nasdaq: TVTX) today announced the completion of a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan) in IgA nephropathy (IgAN). The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for...
SAN DIEGO — Travere Therapeutics, Inc. (NASDAQ: TVTX) announced that the interim analysis of efficacy and safety data from the ongoing Phase 3 PROTECT Study evaluating FILSPARI™ (sparsentan) in IgA nephropathy (IgAN) will be presented in late-breaking trial sessions at both the ISN World Congress of Nephrology in Bangkok, Thailand,...
Treatment with highest dose pegtibatinase led to a clinically meaningful 55% mean reduction in total homocysteine from baseline and was generally well-tolerated after 12 weeks of treatment Results provide clinical proof of concept for first potential therapy targeting the underlying enzyme deficiency in classical homocystinuria SAN DIEGO – Travere Therapeutics,...
SAN DIEGO, Calif. — Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in IgA nephropathy (IgAN) to full approval. In February 2023, the...
San Diego, Calif. – Travere Therapeutics on Friday released more data from the Phase III PROTECT and DUPLEX studies—in IgA nephropathy and focal segmental glomerulosclerosis, respectively—showing that treatment with Filspari (sparsentan) can preserve kidney function in these diseases. The results were presented at the American Society of Nephrology’s Kidney Week...