Pen­ny stock forges ahead with an NDA for Duchenne treat­ment, seek­ing pri­or­i­ty re­view

Af­ter set­backs and de­lays, the Swiss biotech San­thera is look­ing to have its treat­ment for Duchenne mus­cu­lar dy­s­tro­phy get past the FDA.

San­thera, along with Rever­a­Gen Bio­Phar­ma, an­nounced it has com­plet­ed the rolling sub­mis­sion for an NDA to US reg­u­la­tors and is seek­ing a pri­or­i­ty re­view for va­morolone to treat Duchenne. San­thera states that the “core” of its NDA is the pos­i­tive da­ta from a Phase IIb tri­al that show the safe­ty and ef­fec­tive­ness of the drug.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER