Vertex Pharmaceuticals Inc VRTX
Vertex Pharmaceuticals Inc (Nasdaq: VRTX) is a cardio-renal-metabolic drug developer. Its lead program, povetacicept, is in Phase 3 for IgA nephropathy (accelerated approval, adults). Its next catalyst on record is inaxaplin: AMPLITUDE interim analysis data (Q1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: inaxaplin — AMPLITUDE interim analysis data (Q1 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| povetacicept | IgA nephropathy | biologic-other | Phase 3 |
| povetacicept | Primary membranous nephropathy (OLYMPUS Phase 2/3) | biologic-other | Phase 3 |
| inaxaplin | APOL1-mediated kidney disease (AMPLITUDE Phase 2/3) | small molecule | Phase 3 |
| suzetrigine | Diabetic peripheral neuropathy (two Phase 3 trials) | small molecule | Phase 3 |
| zimislecel | Type 1 diabetes (Phase 1/2/3) | cell therapy | Phase 3 |
| ALYFTREK (ages 2-5) | Cystic fibrosis | small molecule | Phase 3 |
| VX-017 | Type 1 diabetes | cell therapy | Phase 1 |
Recent results and decisions
- May 4, 2026approval FDA approved label extension for ALYFTREK based on data from 564 variants, expanding eligibility to about 95% of US CF patients (~800 more people).
The U.S. Food and Drug Administration (FDA) recently approved label extensions for ALYFTREK and TRIKAFTA, expanding availability of these medicines to approximately 95% of all people with CF in the United States.
Filing - May 4, 2026approval FDA approved label extension for TRIKAFTA based on data from 521 variants, expanding eligibility to about 95% of US CF patients.
This label expansion was supported by clinical and/or in vitro data from 564 variants demonstrating response to ALYFTREK and 521 variants demonstrating response to TRIKAFTA.
Filing - May 4, 2026submitted Completed US regulatory submission for CASGEVY in children 5 to <12 years; FDA awarded a Commissioner's National Priority Voucher for accelerated review.
Vertex completed the regulatory submission in the U.S. for approval of CASGEVY in children ages 5 to less than 12 years old with SCD or TDT.
Filing
13 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.