BOSTON, Mass. — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancer, today announced the publication of preclinical research supporting the application of its lead candidate, TTX-MC138, for the treatment of glioblastoma multiforme (GBM). The article was published...
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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...
NANJING, China and GAITHERSBURG, Md. — TransThera Sciences Inc. (“TransThera”) announced the publication of clinical results from a US-based Phase 2 trial evaluating tinengotinib in patients with Cholangiocarcinoma (CCA) on The Lancet Gastroenterology and Hepatology (Impact Factor: 38.6). Cholangiocarcinoma (CCA) is an aggressive malignancy of the bile ducts, frequently driven by FGFR2 fusions-genomic...
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, Calif. — Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that today the U.S. Food and Drug Administration (FDA) has extended the review timeline of its supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target action date is...
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 – Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced completion of patient enrollment in the Phase 3 PROTECT Study. The pivotal PROTECT Study is evaluating the safety and efficacy of sparsentan for the treatment of IgA nephropathy (IgAN), a rare kidney disorder that often progresses to end-stage kidney disease...
SAN DIEGO, Calif. – Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that following further review of the supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS), an advisory committee is no longer needed. The sNDA...
SAN DIEGO, Calif. — Travere Therapeutics, Inc., today announced the Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking priority review for traditional approval of FILSPARI® (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS). The submission is supported by results from...