Wedbush Says Sarepta (SRPT) May File for Accelerated Approval in H1 2014
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Price: $115.62 -0.8%
Rating Summary:
30 Buy, 9 Hold, 1 Sell
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Up: 11 | Down: 18 | New: 17
Rating Summary:
30 Buy, 9 Hold, 1 Sell
Rating Trend:
Up
Today's Overall Ratings:
Up: 11 | Down: 18 | New: 17
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Wedbush today maintained an Outperform rating on Sarepta Therapeutic (NASDAQ: SRPT) with a price target of $60.00. Analyst Christopher N. Marai thinks Sarepta will file for accelerated approval in the first half of 2014.
"Timing of upcoming FDA meetings and confirmatory/Phase III trials suggests to us that a formal submission for accelerated approval could occur in H1:14. While an announcement to file for AA may come from SRPT in the near term, we note that the actual submission is likely to occur in H1:14, following complete enrollment of their confirmatory Phase III trial. We estimate that prior to accepting a filing, the FDA and SRPT, would like to conclude CMC discussions (Q3/Q4), potential manufacturing ramp up (by Q4), discuss design of the confirmatory trial (Q3/Q4) and complete enrollment of the trial (late Q1:14). We estimate that trial enrollment will be the gating factor in this process. Sarepta has noted that a confirmatory/Phase III is likely to include international sites which could expedite enrollment," said Marai.
For an analyst ratings summary and ratings history on Sarepta Therapeutic click here. For more ratings news on Sarepta Therapeutic click here.
Shares of Sarepta Therapeutic closed at $39.46 yesterday.
"Timing of upcoming FDA meetings and confirmatory/Phase III trials suggests to us that a formal submission for accelerated approval could occur in H1:14. While an announcement to file for AA may come from SRPT in the near term, we note that the actual submission is likely to occur in H1:14, following complete enrollment of their confirmatory Phase III trial. We estimate that prior to accepting a filing, the FDA and SRPT, would like to conclude CMC discussions (Q3/Q4), potential manufacturing ramp up (by Q4), discuss design of the confirmatory trial (Q3/Q4) and complete enrollment of the trial (late Q1:14). We estimate that trial enrollment will be the gating factor in this process. Sarepta has noted that a confirmatory/Phase III is likely to include international sites which could expedite enrollment," said Marai.
For an analyst ratings summary and ratings history on Sarepta Therapeutic click here. For more ratings news on Sarepta Therapeutic click here.
Shares of Sarepta Therapeutic closed at $39.46 yesterday.
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