PTC Therapeutics-Roche's Evrysdi Approved In Europe For Muscular Atrophy

The European Commission (EC) has granted marketing authorization to PTC Therapeutics Inc's PTCT Evrysdi (risdiplam) for the treatment of spinal muscular atrophy (SMA) in patients two months and older.
Evrysdi will be for SMA Type 1, Type 2, or Type 3 patients with one to four SMN2 copies.
The EC approval is based on two studies - Efficacy results from the FIREFISH study in infants aged 2 to 7 months with symptomatic Type 1 SMA and the SUNFISH study in children and young adults with Type 2 or 3 SMA.
Evrysdi is commercialized in the U.S. by Genentech, a Roche Holdings AG member RHHBY.
Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.
Price Action: PTCT shares closed 2.3% lower at $48.06 on Monday.