Pathalys

Pathalys Pharma, Inc. is a private, clinical-stage biopharmaceutical company focused on addressing unmet needs in the management of end-stage kidney disease (ESKD). Their lead asset is upacicalcet, an intravenously administered small molecule calcimimetic that has the potential to control intact parathyroid hormone (iPTH) levels in patients with secondary hyperparathyroidism (SHPT) receiving haemodialysis. Upacicalcet may enable ESKD patients to achieve better control of iPTH and blood calcium levels, lowering risk for potentially severe health consequences. Upacicalcet was granted Marketing Authorization in Japan in 2021 (brand name UPASITA®). The data from the pivotal studies conducted by Pathalys has been accepted for filing by FDA and a PDUFA date of Feb ‘27 has been issued.