Vertex Pharmaceuticals Incorporated VRTX
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) is a cardio-renal-metabolic drug developer. Its lead program, Povetacicept, is in Phase 3 for IgA nephropathy. Its next catalyst on record is povetacicept: FDA PDUFA action date for accelerated approval in IgAN (November 30, 2026).
Upcoming catalysts
- November 30, 2026povetacicept — FDA PDUFA action date for accelerated approval in IgAN
The FDA accepted our biologics license application for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ALYFTREK | Cystic fibrosis (2-5 years) | small molecule | Approved |
| Povetacicept | IgA nephropathy | biologic-other | Phase 3 |
| Povetacicept | Primary membranous nephropathy | biologic-other | Phase 3 |
| Inaxaplin | APOL1-mediated kidney disease | small molecule | Phase 3 |
| Suzetrigine | Diabetic peripheral neuropathy | small molecule | Phase 3 |
| Atumelnant | Congenital adrenal hyperplasia | small molecule | Phase 3 |
| Atumelnant | ACTH-dependent Cushing's syndrome | small molecule | Phase 2 |
| VX-017 | Type 1 diabetes | cell therapy | Phase 1 |
Recent results and decisions
- Nov 2, 2026submitted Povetacicept BLA for IgAN is under priority review by FDA with PDUFA date November 30, 2026.
The BLA submission for accelerated approval of povetacicept in IgAN is under priority review by the U.S. FDA, with an assigned PDUFA target action date of November 30, 2026.
Filing - Nov 2, 2026positive Phase 1 data for VX-828 triple therapy in CF showed 6.6 mmol/L mean sweat chloride reduction at 4 weeks compared to TRIKAFTA baseline.
Treatment with the VX-828 triple combination therapy resulted in a 6.6 mmol/L mean reduction in sweat chloride at 4 weeks of treatment and a 9.4 mmol/L mean reduction through 4 weeks of treatment, compared to a baseline on TRIKAFTA.
Filing - Nov 2, 2026positive Phase 2b AMPLIFIED study of inaxaplin showed 42.7% UACR reduction in modest proteinuria cohort and 17.3% UACR reduction in Type 2 diabetes cohort.
Vertex announced positive results from the Phase 2b AMPLIFIED study of inaxaplin in people with AMKD with modest proteinuria (improvement in urine albumin to creatinine ratio [UACR] of -42.7%, and urine protein to creatinine ratio [UPCR] of -44.7%) and people with AMKD and Type 2 diabetes (improveme
Filing
14 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.