WebMar 16, 2024 · Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced publication in the New England Journal of Medicine (NEJM) of results from preclinical studies and a Phase 2 study evaluating the efficacy and safety of inaxaplin (VX-147) on top of standard-of-care in people with focal segmental glomerulosclerosis (FSGS) and two … WebJun 8, 2024 · Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment glomerulosclerosis (FSGS).
Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segm…
WebJun 8, 2024 · BOSTON, June 08, 2024 -- ( BUSINESS WIRE )-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration … WebJun 8, 2024 · Vertex Announces Inaxaplin (VX-147) Granted Breakthrough Therapy Designation by U.S. FDA and Priority Medicines (PRIME) Designation by the EMA - Vertex … lithophytically
Vertex Kidney Disease Drug Scores FDA Breakthrough Therapy ... - BioSpace
WebApr 10, 2024 · APOL1-Mediated Kidney Disease •Based on positive Phase 2 data for inaxaplin (formerly known as VX-147), our small molecule for the treatment of APOL1-mediated focal segmental glomerulosclerosis, or FSGS, we initiated pivotal development of inaxaplin in a single Phase 2/3 study in patients with two APOL1 mutations and … WebJun 9, 2024 · June 9, 2024, 5:25 AM · 3 min read. Vertex Pharmaceuticals Incorporated VRTX announced that the FDA has granted Breakthrough Therapy Designation (BTD) to its pipeline candidate, inaxaplin (VX-147 ... WebJun 8, 2024 · About the Inaxaplin (VX-147) Pivotal Program A randomized, double-blind, placebo-controlled Phase 2/3 adaptive study is ongoing and will first evaluate two doses … lithophytes definition