STOCKHOLM, Sweden — Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) today announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. Following full...
treatment News
STOCKHOLM, Sweden — Calliditas Therapeutics AB(NASDAQ: CALT), (NASDAQ STOCKHOLM: CALTX) today announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at...
STOCKHOLM, Sweden — Calliditas Therapeutics (Formerly known as Pharmalink), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved in...
STOCKHOLM, Sweden — Calliditas Therapeutics (Formerly known as Pharmalink) (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) , announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN), were presented at the ISN World Congress of Nephrology in Buenos Aires, Argentina...
STOCKHOLM, Sweden — Calliditas Therapeutics (Calliditas), an Asahi Kasei company, announced today that primary safety endpoints of a Phase 2a, randomized, double-blind, placebo-controlled trial of setanaxib in patients with Alport syndrome were presented in a High-Impact Clinical Trials session at the American Society of Nephrology Kidney Week in Houston, Texas, on Saturday,...
OSLO, Norway & BOSTON, Mass. – Calluna Pharma AS, a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CAL101, its lead clinical candidate currently being evaluated in...
OSLO, Norway & BOSTON, Mass. — Calluna Pharma AS, a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced that the first patients have been dosed in the Phase 2 AURORA study of CAL101 for IPF. AURORA is a randomized, double-blind, placebo-controlled trial designed...
LUND, Sweden — Camurus (NASDAQ STO: CAMX) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for market authorization of Oczyesa®, octreotide subcutaneous depot (CAM2029), for the maintenance treatment in adult patients with acromegaly who have responded to and...
SAN FRANCISCO, California — Including transarterial radioembolization with Yttrium-90 (Y90-TARE) as a neoadjuvant treatment for locally advanced intrahepatic cholangiocarcinoma (CCA) may improve survival outcomes and resection rates compared with chemotherapy alone, according to the results of a recent retrospective analysis presented at the 2024 American Society of Clinical Oncology (ASCO)...
RAMAT GAN, Israel — Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the treatment of...