Novartis AG (NYSE:AG) on Wednesday released positive topline results from its pivotal Phase 3 RemIND trial of oral remibrutinib in chronic inducible urticaria (CIndU).
The Disease
The primary endpoint was met for the three most prevalent types of CIndU, achieving significantly higher complete response rates versus placebo at Week 121. The most common types include:
Minor skin pressure, scratching, or rubbing triggers itchy, red, linear wheals in Symptomatic dermographism patients.
Cold urticaria: Exposure to cold temperatures—air, water, or objects—triggers itchy red welts (hives).
Cholinergic urticaria is triggered by a rise in body temperature and sweat, causing small, itchy red bumps or wheals.
First Targeted Therapy
These data represent an important advance in the treatment of CIndU, demonstrating the potential of remibrutinib to be the first targeted therapy for CIndU.
“The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria (CSU),” said Angelika Jahreis, Global Head, Immunology Development, Novartis.
Regulatory Pathway
Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of remibrutinib for symptomatic dermographism.
Technical Analysis
Novartis is currently showing strong bullish momentum, trading well above its key moving averages.
With an RSI of 83.54, Novartis stock is in overbought territory, which typically indicates that the stock may be due for a pullback or consolidation. However, this high RSI also reflects strong buying pressure, suggesting that momentum could continue in the short term.
The MACD is above its signal line, indicating bullish momentum for Novartis.
NVS Price Action: Novartis shares were up 0.98% at $167.80 during premarket trading on Wednesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
Photo via Shutterstock
Recent Comments