Travere Completes Successful pre-NDA Meeting for FILSPARI in IgAN; Provides Regulatory Updates for both IgAN and FSGS
December 04, 2023 16:05 ET
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Travere Therapeutics, Inc.
After meeting with the FDA, Company to submit a supplemental New Drug Application (sNDA) to FDA in Q1 2024 for conversion of the existing U.S. accelerated approval of FILSPARI® (sparsentan) in IgAN to...
Travere Therapeutics Announces Late-Breaking Data from Phase 3 Studies of Sparsentan in IgAN and FSGS Published in The Lancet and The NEJM Respectively and Presented at the American Society of Nephrology (ASN) Kidney Week 2023
November 03, 2023 10:46 ET
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Travere Therapeutics, Inc.
“The totality of data from the PROTECT study demonstrates FILSPARI is effective, safe and has an important place in the IgAN treatment landscape ..."
Travere Therapeutics to Present Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023
October 13, 2023 16:30 ET
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Travere Therapeutics, Inc.
Two late-breaking high-impact oral presentations of the Phase 3 PROTECT Study of FILSPARI® (sparsentan) in IgAN and Phase 3 DUPLEX Study of sparsentan in FSGS 11 total abstracts accepted for...
US Nephrologists Embrace Current IgA Nephropathy Therapies, Yet a Thriving Pipeline Signals Fierce Market Evolution Ahead
October 13, 2023 14:24 ET
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Spherix Global Insights
Exton, Pennsylvania, Oct. 13, 2023 (GLOBE NEWSWIRE) -- The FDA's recent approvals of Calliditas' Tarpeyo (budesonide) and Travere's Filspari (sparsentan) to treat primary IgA nephropathy (IgAN) have...
Travere Therapeutics Announces Confirmatory Data from the Phase 3 PROTECT Study of FILSPARI® Demonstrating Long-Term Kidney Function Preservation in IgA Nephropathy; Narrowly Missing eGFR Total Slope Endpoint versus Active Control, Irbesartan
September 21, 2023 07:30 ET
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Travere Therapeutics, Inc.
FILSPARI® (sparsentan) achieved a clinically meaningful difference vs. irbesartan in eGFR total slope (1.0 mL/min/1.73m2 per year) [p= 0.058] and eGFR chronic slope (1.1 mL/min/1.73m2 per year)...
Eledon Reports Data from Ongoing Phase 1b Trial Evaluating Tegoprubart in Patients Undergoing Kidney Transplantation at World Congress of Nephrology
March 31, 2023 06:00 ET
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Eledon Pharmaceuticals, Inc.
Results from three participants demonstrated no incidence of acute rejection at durations of 56, 154, and 232 days Strong graft function observed in all three participants with mean eGFRs above 70...
Eledon Pharmaceuticals Reports Fourth Quarter and Full-Year 2022 Operating and Financial Results
March 30, 2023 16:01 ET
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Eledon Pharmaceuticals, Inc.
`Four patients enrolled in open-label Phase 1b kidney transplant trial with clinical data on first three patients to be presented at the World Congress of Nephrology (WCN) on March 31, 2023 Safety...
Eledon Pharmaceuticals to Report Fourth Quarter and Full Year 2022 Financial Results on Thursday, March 30, 2023
March 23, 2023 16:05 ET
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Eledon Pharmaceuticals, Inc.
IRVINE, Calif., March 23, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that it plans to release financial results for the fourth quarter and full...
Eledon to Present Data from Ongoing Phase 1b Trial Evaluating Tegoprubart in Kidney Transplantation at the World Congress of Nephrology 2023
March 23, 2023 08:00 ET
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Eledon Pharmaceuticals, Inc.
IRVINE, Calif., March 23, 2023 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the Company will present two posters at the upcoming International...
Travere Therapeutics Announces FDA Accelerated Approval of FILSPARI™ (sparsentan), the First and Only Non-immunosuppressive Therapy for the Reduction of Proteinuria in IgA Nephropathy
February 17, 2023 16:04 ET
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Travere Therapeutics, Inc.
First single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in patients withIgA nephropathy (IgAN)Interim results from the ongoing Phase 3 PROTECT head-to-head trial...