March 30, 2022

Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne

Santhera and ReveraGen have announced 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. This is the first step…

Learn More

March 17, 2022

Santhera and ReveraGen Present Efficacy and Safety Data with Vamorolone in Duchenne

Santhera and ReveraGen have shared an update on the evidence of clinical efficacy and safety of vamorolone in participants with Duchenne, based on the positive outcome of the pivotal Phase 2b VISION-DMD study and additional Phase…

Learn More

November 23, 2021

Santhera and ReveraGen Announce Positive Topline Results with Vamorolone after Completion of the VISION-DMD Study

PPMD is pleased to share the announcement from Santhera Pharmaceuticals and ReveraGen BioPharma, Inc., of new topline results after completion of the VISION-DMD study at week 48. VISION-DMD was a pivotal double-blind Phase 2b study…

Learn More

October 27, 2021

Calling All Individuals with Becker Muscular Dystrophy – We Need You!

Do you or a loved one have a diagnosis of Becker muscular dystrophy? If so, please read these important updates which are focused on how we can help individuals with Becker and their families. Becker…

Learn More

September 27, 2021

ReveraGen and Santhera Announce FDA Orphan Grant Funding for Clinical Trial with Vamorolone in Becker Muscular Dystrophy

PPMD is pleased to share that ReveraGen Biopharma and Santhera Pharmaceuticals announced that ReveraGen has received a $1.2 million grant from the FDA under their “Clinical Studies of Orphan Products Addressing Unmet Needs of Rare…

Learn More

July 6, 2021

Recently Reported Updates from PPMD’s 2021 Virtual Annual Conference

PPMD’s 2021 Virtual Annual Conference: Recently Reported Updates As a new addition to PPMD’s 2021 Virtual Conference, PPMD invited industry partners to share new data with the community live during the Conference in a series…

Learn More

June 1, 2021

Santhera & ReveraGen Announce Positive & Statistically Significant Topline Results in VISION-DMD Study

Santhera and ReveraGen today announced positive and statistically significant results from the 24-week readout of the VISION-DMD study of vamorolone in Duchenne. The companies report that study demonstrated strong efficacy across primary and secondary endpoints…

Learn More

April 28, 2021

Santhera and ReveraGen Announce New 2.5-year Treatment Data with Vamorolone in Duchenne

Today Santhera and ReveraGen shared 2.5-year treatment data with vamorolone in Duchenne. In the announcement below the companies reported on data from 46 patients who have participated in two open-label extension studies covering 2.5 years,…

Learn More

March 4, 2021

Santhera Announces Completion of First 6-Month Period of VISION-DMD Trial with Vamorolone in Duchenne

Santhera Pharmaceuticals has reached an important milestone in the VISION-DMD study of vamorolone in people with Duchenne, conducted by partner ReveraGen Biopharma Inc. The company today announced that it has completed the last visit of…

Learn More

February 1, 2021

Santhera Shares Community Update on Phase 2b Trial for Vamorolone

Santhera Pharmaceuticals has shared an update with the community regarding the phase 2b trial for vamorolone, which the company expects to have data from in the second quarter of 2021. The update includes contact information…

Learn More