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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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…

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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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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…

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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…

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November 17, 2020

ReveraGen Receives $3.3 Million NIH Grant for NDA Preparations for Vamorolone in Duchenne

The National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) has awarded a $3.3 million grant to ReveraGen Inc. to support the advancement of vamorolone towards FDA submission and…

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September 23, 2020

Santhera Announces Publication of Long-Term Clinical Data with Vamorolone in Patients with Duchenne

Santhera Announces Publication of Long-Term Clinical Data with Vamorolone in Patients with Duchenne Santhera announced a new publication in the journal PLOS Medicine describing new open-label, long-term clinical data on the safety, tolerability and efficacy…

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September 11, 2020

Santhera Announces Full Enrollment of ReveraGen’s VISION-DMD Study with Vamorolone in Duchenne

Santhera announced that ReveraGen’s VISION-DMD study for vamorolone in Duchenne has completed enrollment. Subject to a positive study outcome, this could allow for a regulatory submission to the FDA in the fourth quarter of 2021….

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September 2, 2020

Santhera Exercises Option to Obtain Worldwide Rights to Vamorolone in Duchenne and All Other Indications

We congratulate Santhera as they have exercised the option to obtain worldwide rights to vamorolone in Duchenne and all other indications. The license gives Santhera worldwide rights to vamorolone which means Santhera is responsible for…

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