U.S. regulators asked Sarepta Therapeutics SRPT.O on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died, but the company said it would not do so
At least four analysts lowered rating on SRPT -LSEG data
Shares down 3.1% at $13.6 premarket
FOCUS ON FDA'S DECISION
Needham ("hold") says recent developments on Elevidys negatively impacts its commercial use, paving the way for competitors
Leerink Partners ("market perform," PT: $10) notes Elevidys may be removed from the market entirely, affecting sales in the upcoming quarters
Leerink adds, the lack of clear disclosure regarding the recent death has "completely erased any remaining credibility that the management team had"
Baird ("neutral," PT: $15) says risks of the drug being removed from the market is amplified after the Food and Drug Administration asked Sarepta to voluntarily stop all shipments of Elevidys
Mizuho ("neutral," PT: $14) says the perceived lack of FDA support and mounting concerns about fatal acute liver failure may potentially hinder Elevidys adoption going forward