Pratteln, Switzerland, October 31, 2022
Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Validation confirms that the submission is complete and that the review by the EMA’s Committee for Medicinal Products for Human Use (CHMP) has begun.

Pratteln, Switzerland, and Rockville, MD, USA, October 10, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of data relating to long-term efficacy, tolerability and the impact of vamorolone on bone health in patients with Duchenne muscular dystrophy (DMD) over 2.5 years of treatment [1].

Pratteln, Switzerland, October 3, 2022
Santhera Pharmaceuticals (SIX: SANN) announces 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).

Pratteln, Switzerland, and Rockville, MD, USA, September 1, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen (US: Private) announce that JAMA Neurology has published positive results of the 24-week primary efficacy and safety analysis from the VISION-DMD study evaluating vamorolone, an investigational drug for the treatment Duchenne muscular dystrophy (DMD). Vamorolone met its primary endpoint by demonstrating statistically significant and clinically relevant improvement in time to stand from floor compared to placebo, the first functional milestone to deteriorate in young children with DMD.

Pratteln, Switzerland, and Rockville, MD, USA, August 22, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the first patient has been dosed in a Phase 2 pilot study to assess vamorolone in Becker muscular dystrophy (BMD), funded by the U.S. Food and Drug Administration (FDA). 

Pratteln, Switzerland, and Rockville, MD, USA, June 9, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of new data with vamorolone in Duchenne muscular dystrophy (DMD).

Pratteln, Switzerland, March 29, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) announce the initiation of a rolling new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Vamorolone for DMD has been granted Fast Track Designation by the FDA.

Pratteln, Switzerland, and Rockville, MD, USA, March 15, 2022
Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce presentations of efficacy and tolerability data with vamorolone in Duchenne muscular dystrophy (DMD) at the 2022 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 13-16, 2022, Nashville, TN, USA). A rolling NDA submission to the U.S. FDA for vamorolone for the treatment of DMD is planned to start at the end of March 2022.