SAN DIEGO, Calif. — Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today announced that it received Fast Track designation from the U.S. Food and Drug...
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NEW TAIPEI CITY, Taiwan — Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CBL-514 for Dercum’s disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by inducing adipocyte apoptosis, and is the first drug to receive...
NEW TAIPEI CITY, Taiwan — Caliway Biopharmaceuticals announced that the United States Food and Drug Administration (U.S. FDA) has accepted the CBL-514 Investigational New Drug (IND) application of CBL-0202 DD Phase 2 Study to treat Dercum’s Disease. Dercum’s disease is a rare disease characterized by the growth of painful lipomas....
NEW TAIPEI CITY — Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum’s disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by selectively inducing adipocyte apoptosis, and is the first...
CBL-514, Caliway’s novel small molecule drug, was selected for data presentation at the World Orphan Drug Congress USA 2025, highlighting its promising Phase 2 study results (CBL-0201DD) for Dercum’s Disease Treatment. The Phase 2 topline results met all primary and secondary endpoints, with 64.5% of painful lipomas showing ≥ 50% dimension reduction or...
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...
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,...