- Patients treated with povetacicept also demonstrated a 77.4% reduction from baseline in serum galactose deficient IgA1, a critical, disease-specific biomarker for IgA nephropathy, the company added.
- Vertex now expects to complete necessary submissions seeking approval for povetacicept in IgA Nephropathy by March.
- The company has a priority review voucher which would allow it to reduce the review time from ten months to six, it added.
Shares of Vertex Pharmaceuticals Incorporated (VRTX) rose as much as 7% after hours on Monday after the company announced positive 36-week data from its ongoing late-stage trial evaluating povetacicept in immunoglobulin A nephropathy.
IgA nephropathy or Berger’s disease is an autoimmune kidney disease occurring when immunoglobulin A (IgA) antibody clumps deposit in the kidney’s glomeruli, causing inflammation and damage.
Trial Takeaways
The company said that patients treated with povetacicept on top of standard of care achieved a 52% reduction from baseline in urine protein to creatinine ratio at week 36, meeting the study’s key goal. The reduction was consistent across subgroups, the company said.
Patients treated with povetacicept also demonstrated a 77.4% reduction from baseline in serum galactose deficient IgA1, a critical, disease-specific biomarker for IgA nephropathy, the company added.
Povetacicept was generally safe and well tolerated with a majority of adverse events (AEs) being mild to moderate. There were no serious adverse events or deaths, and no discontinuations due to infections, the company added.
Plans Ahead
Vertex now expects to complete necessary submissions seeking approval for povetacicept in IgA Nephropathy by March. The company has a priority review voucher which would allow it to reduce the review time from ten months to six, it added.
If approved, the company expects to launch povetacicept in a low volume subcutaneous auto-injector delivered once every four weeks via at-home administration.
Other companies with FDA-approved drugs for IgA Nephropathy include Travere Therapeutics and Novartis.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around VRTX shares stayed within the ‘bearish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘normal’ levels.
VRTX stock has declined 8% over the past 12 months.
Read More: VOYG Shares Decline On Double Q4 Miss Despite Record 2025 Backlog
For updates and corrections, email newsroom[at]stocktwits[dot]com.