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...
treatment News
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...
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...
NEWTOWN, Pa. — Traws Pharma, Inc. (NASDAQ: TRAW), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced the publication of key clinical efficacy data for rigosertib, a legacy Traws Pharma oncology asset for which development and commercialization partners are...
TORONTO, Ontario & SAN FRANCISCO, Calif. — Treadwell Therapeutics, a privately held clinical-stage biotechnology company pioneering and advancing novel first-in-class medicines for unmet needs in cancer, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ocifisertib (CFI-400945), a first-in-class, investigational PLK4 inhibitor for the...
A wave of new therapies is starting to reshape the treatment landscape for people with rare anemias, but the authors of a new review also caution that more research is needed to better understand which therapies are right for which patients. Writing in Frontiers in Medicine, the authors began by...
Data from the QUASAR long-term extension study demonstrate more than 70% of patients were in clinical remission and more than 40% of patients were in endoscopic remission at Week 92 SAN DIEGO, Calif. — Johnson & Johnson (NYSE: JNJ) today announced new data from the TREMFYA® (guselkumab) Phase 3 QUASAR long-term...
Atlanta – In a post hoc analysis of the phase 2 NOBILITY trial, researchers found that treatment with obinutuzumab—an antibody that targets a protein expressed on certain immune cells—was superior to placebo for preserving kidney function and preventing flares in patients with lupus nephritis, a kidney condition associated with the...