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

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  • The European Commission (EC) has granted marketing authorization to PTC Therapeutics Inc's (NASDAQ: 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 (OTCMKTS: 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.

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