Santhera Pharmaceuticals Holding AG announced that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). At the core of the MAA submission are positive data from the pivotal Phase 2b VISION-DMD study which comprised a 24-week period to demonstrate efficacy and safety of vamorolone (2 and 6 mg/kg/day) versus prednisone (0.75 mg/kg/day) and placebo, followed by a (2) 24-week period to evaluate the maintenance of efficacy and collect additional longer-term safety and tolerability data. In addition, the filing includes data from three open-label studies in which vamorolone was administered at doses between 2 and 6 mg/kg/day for a total treatment period of up to 30 months In the U.S., Santhera expects to complete the filing of the new drug application (NDA) for vamorolone in DMD to the Food and Drug Administration (FDA) in fourth quarter of 2022.
Delayed
Other stock markets
|
5-day change | 1st Jan Change | ||
9.46 CHF | -1.97% | -3.96% | -3.57% |
08:22am | Santhera Pharmaceuticals Swings to Profit in FY23; Revenue Grows | MT |
07:00am | Santhera Pharmaceuticals Holding AG Reports Earnings Results for the Full Year Ended December 31, 2023 | CI |
Quarterly revenue - Rate of surprise
1st Jan change | Capi. | |
---|---|---|
-3.57% | 95.38M | |
+5.73% | 70.78B | |
+10.72% | 9.15B | |
-15.34% | 4.84B | |
+34.54% | 4.22B | |
+5.09% | 3.92B | |
+27.76% | 2.55B | |
-28.33% | 2.24B | |
-24.15% | 2.26B | |
+6.23% | 1.92B |
- Stock Market
- Equities
- SANN Stock
- News Santhera Pharmaceuticals Holding AG
- Santhera Pharmaceuticals Holding Ag Submits Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy