Mocravimod is the only S1P receptor modulator being developed as an adjunctive and maintenance treatment for blood cancers Mocravimod is being investigated in a global registration-enabling Phase 3...
Dublin, Ireland –February 27th, 2023 – Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod, today announced that it received clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for the pivotal global MO-TRANS Phase 3 study evaluating mocravimod in Acute Myeloid Leukemia (AML) patients undergoing allogeneic hematopoietic cell transplant (HCT).
DUBLIN, Jan. 23, 2023 /PRNewswire/ -- Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound mocravimod today announced that the first patients have been enrolled in the pivotal MO-TRANS global Phase 2b/3 study evaluating mocravimod in AML patients undergoing allogeneic hematopoietic cell transplant (HCT).
DUBLIN, May 31, 2022 /PRNewswire/ -- Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for mocravimod in combination with allogeneic Hematopoietic Stem Cell Transplant (HSCT) for post remission therapy of Acute Myeloid Leukemia (AML) patients. FDA's Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.
Priothera has announced plans to commence the pivotal Phase IIb/III MO-TRANS clinical trial of its investigational drug, mocravimod (KRP203), in acute myeloid leukaemia (AML) patients undergoing allogeneic hematopoietic stem cell transplant (HSCT).
DUBLIN, April 25, 2022 /PRNewswire/ -- Priothera Ltd, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, today announces that the U.S. Food and Drug Administration (FDA) has provided clearance to proceed with the Company's Investigational New Drug (IND) application to begin its pivotal Phase 2b/3 study of mocravimod (named MO-TRANS).
Priothera Ltd, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator mocravimod, today announces it...
DUBLIN, March 3, 2022 /PRNewswire/ -- Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator drug, mocravimod, today announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted orphan drug designation (ODD) to mocravimod for the treatment of Acute Myeloid Leukemia (AML) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). EMA's ODD follows a recommendation from the Committee for Orphan Medicinal Products (COMP).
At a time when the sector has fallen out of favor with venture capitalists and public markets, Irish biotech Priothera is accessing funds from the EU to advance a Phase IIb/III study of mocravimod for acute myeloid leukemia patients receiving hematopoietic stem cell transplants.