Vertex Pharmaceuticals Inc (NASDAQ:VRTX) shares are rising in extended trading Monday after the company announced positive interim results for one of its Phase 3 trials.
- Vertex Pharmaceuticals stock is trading in a tight range. What’s next for VRTX stock?
Vertex Reports Positive Results For All Endpoints
Vertex announced positive data from a pre-specified week 36 interim analysis of its ongoing phase 3 RAINIER trial of povetacicept in immunoglobulin A nephropathy.
Povetacicept is an engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines.
The trial met its primary objective, achieving a 52% reduction from baseline in urine protein to creatinine ratio (UPCR) at Week 36, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo.
Vertex said the trial also met its secondary objective. Patients treated with povetacicept demonstrated a 77.4% reduction from baseline in serum galactose deficient IgA1 and 85.1% of patients with baseline hematuria achieved hematuria resolution.
“The Phase 3 RAINIER 36-week interim analysis results in IgAN are remarkable. With its clinical profile, dosing and administration advantage, and breadth of potential indications, povetacicept demonstrates best-in-class potential and establishes renal medicine as Vertex’s fourth franchise alongside cystic fibrosis, hematology and acute pain,” said Reshma Kewalramani, president and CEO of Vertex.
The FDA has granted rolling review of the Biologics License Application (BLA) for povetacicept in IgAN. Vertex plans to complete its full BLA submission by the end of March for potential accelerated approval. Final analysis of the RAINIER Phase 3 trial is expected after two years of treatment.
VRTX Stock Surges After The Bell
VRTX Price Action: Vertex shares were up 6.32% in after-hours Monday, trading at $490 at the time of publication, according to Benzinga Pro.
Image: courtesy of Vertex.
Recent Comments