June 21, 2023

Santhera announces exclusive North America license agreement with Catalyst Pharmaceuticals for vamorolone

PPMD has learned that Santhera Pharmaceuticals has entered into an agreement granting exclusive North America license for vamorolone to Catalyst Pharmaceuticals. Santhera will continue to keep commercialization rights in Europe, while Catalyst will obtain commercialization…

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January 9, 2023

Update from Santhera & ReveraGen: FDA Acceptance of New Drug Application for Vamorolone in Duchenne

PPMD is excited to learn from Santhera and ReveraGen that the FDA has accepted the New Drug Application (NDA) for vamorolone, an investigational dissociative steroid for individuals with Duchenne. Under the Prescription Drug User Fee…

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August 22, 2022

Santhera & ReveraGen Announce First Participant Dosed in Phase 2 Pilot Study with Vamorolone in Becker

Today Santhera and ReveraGen announced they have dosed the first participant in their Phase 2 study with Vamorolone for individuals with Becker muscular dystrophy. The small pilot study was funded through an FDA grant and…

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June 29, 2022

Santhera Updates on Ongoing NDA Submission for Vamorolone in Duchenne

Today Santhera shared an update on the timeline for the submission of their New Drug Application (NDA) for Vamorolone, an investigational dissociative steroid for individuals with Duchenne. Santhera expects to complete the submission of their…

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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…

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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…

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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…

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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…

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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…

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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,…

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