Sarepta Therapeutics (SRPT) plunged late Thursday after announcing a setback for its key Duchenne muscular dystrophy drug, Exondys 51, in Europe and first-quarter sales that narrowly lagged some views.
XThe negative trend vote following the Committee for Medicinal Products for Human Use meeting likely means Exondys 51 didn't meet the regulatory hurdle for conditional approval in Europe, RBC analyst Brian Abrahams said. But that was expected, he noted.
"This could still leave the possibility open for approval and Sarepta will file for re-examination and ask for a scientific advisory group, where they may bring in DMD (Duchenne muscular dystrophy) physicians," he said in a note to clients.
Meanwhile, other regions outside the U.S., including Japan and Latin America, could start to contribute to revenue in 2019, Abrahams said. He kept his outperform rating on Sarepta stock.
Exondys 51 Launch
Still, in late trading on the stock market today, Sarepta toppled 4.7%, near 74.50, after losing 0.3%, at 78.17, by the closing bell. Shares are forming a cup-with-handle and a buy point at 83.98. Meanwhile, biotech stocks collectively closed down 1.8%.
Exondys 51 sales of $64.6 million grew 295% year over year. But revenue was just light of the consensus of analysts polled by Zacks Investment Research for $65 million. They were in line with analysts' views cited by RBC's Abrahams for $64 million to $65 million.
"Importantly, this demonstrates the continued favorable U.S. launch dynamics," he said. This also "suggests they are not seeing reauthorization-related discontinuations, which had been a key unknown going in."
A loss of 28 cents per share also narrowed from a 57-cent per-share loss at this time last year. It further beat the consensus view for a 32-cent per-share loss.
Sarepta also reiterated guidance for $295 million to $305 million in sales, close to Abrahams' view for $302 million. The consensus as polled by Zacks had predicted $304 million.
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The post Sarepta Therapeutics Plunges As Key Drug Faces Setback In Europe appeared first on Investor's Business Daily.
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