Sparsentan receives Orphan Drug Designation for primary IgA nephropathy in Japan
TOKYO, JAPAN, December 2, 2024 — Renalys Pharma, Inc., a late-stage clinical biopharmaceutical company announces that sparsentan, in-licensed from Travere Therapeutics, Inc. (“Travere”) and currently in phase III clinical trials in Japan, has received Orphan Drug Designation from the Japanese Ministry of Health, Labour and Welfare for the indication of primary IgA nephropathy as of November 27, 2024. […]
Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy
FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data showing long-term durable benefit on proteinuria and kidney function preservation that accrued over two years Conversion to full approval based on results from the PROTECT Study, where FILSPARI delivered superior long-term kidney function preservation […]
Renalys Pharma announces first patient dosed in registrational Phase III clinical trial of sparsentan for IgA nephropathy in Japan
TOKYO, JAPAN, July 18, 2024 — Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys Pharma”) announced today that the first person was dosed in its registrational Phase III clinical trial of sparsentan for the treatment of IgA nephropathy in Japan. In April this year Renalys submitted an Investigational New Drug (IND) Application for sparsentan to the […]
Renalys Pharma Closes ¥6.0Bn Series A Financing to Advance Kidney Disease Treatments Across Asia
Financing Round Co-led by Catalys Pacific and SR One, Investment to Drive the Development of Sparsentan for IgA Nephropathy in Japan and Other Asian Countries TOKYO, JAPAN, July 17, 2024 — Renalys Pharma, Inc., a late-stage clinical biopharmaceutical company has completed a ¥6.0Bn Series A financing. The financing was led by Catalys Pacific and […]
Travere Therapeutics Reports First Quarter 2024 Financial Results
FDA grants Priority Review for sNDA to convert FILSPARI® (sparsentan) from accelerated approval to full approval for the treatment of IgAN in the U.S.; PDUFA target action date of September 5, 2024 Received 511 new patient start forms (PSFs) for FILSPARI in Q1 2024; Total of 1,963 PSFs received since launch Net product sales of FILSPARI totaled $19.8 million for the […]
The Japan Kidney Association and Renalys Pharma Form Collaborative Agreement to overcome kidney disease
The Japan Kidney Association, a nonprofit organization, (Headquarters: Bunkyo-ku, Tokyo; “Japan Kidney Association”) and Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys Pharma”) entered into a collaborative agreement on May 1, 2024, with the aim to develop innovative therapies and raise the awareness to overcome kidney disease. “Kidney disease is increasing against a background of changing […]
Renalys Pharma Submits an IND Application for a Phase III Clinical Trial of sparsentan for IgA Nephropathy in Japan
Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; “Renalys Pharma”) announced that it has submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) for a Phase III clinical trial in Japan. The Phase III study is a multicenter, open-label, single arm study in Japanese patients with IgA nephropathy, […]
Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy
Renalys Pharma Is Launched To Bring New Innovative Medicines To Patients In Japan and Other Countries In Asia
Co-founded by Catalys Pacific and SR One, Renalys Pharma is an exemplification of how game-changing life-science biopharma can be created through investor partnerships Tokyo, Japan, January 25, 2024 — Catalys Pacific, a transpacific life science investment firm, and SR One, a transatlantic life sciences investment firm, today announced the launch of Renalys Pharma, Inc., a […]
Travere Completes Successful pre-NDA Meeting for FILSPARI in IgAN; Provides Regulatory Updates for both IgAN and FSGS
