Santhera Letter to the Community on NDA Filing for Vamorolone

Dear Duchenne Community, 

We are writing to provide some additional information to accompany our press release (attached) this week about the status of the rolling New Drug Application at the US Food and Drug Administration for vamolorone. As stated, Santhera met its target deadline of 6/28/2022, for submission of the vamorolone clinical module, and we want to acknowledge the efforts of our internal and partner teams for that great accomplishment.

However, as our press release on 6/29/22 indicated, the completion of the rolling NDA for vamorolone has been delayed due to the inspection readiness of a third-party contract manufacturing partner. At present, Santhera and the third-party contract manufacturing organization estimate that the delay will be 4-6 months. This new timeline pushes the NDA submission completion date for vamorolone to the fourth quarter of this year.

While we are disappointed by this delay, we want to take this opportunity to thank all of the patients and families who participated in the vamorolone studies, and to re-affirm our commitment to the vamorolone program and to the Duchenne patient community. We will continue to keep the community updated about the status of our NDA submission to the FDA.