UPDATE: Canaccord Genuity Upgrades Sarepta Therapeutic (SRPT) to Buy

(Updated - April 21, 2014 1:55 PM EDT)

Canaccord Genuity upgraded Sarepta Therapeutic (NASDAQ: SRPT) from Hold to Buy with a price target of $63.00. Earlier Sarepta announced it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2014. The plan to submit an NDA for eteplirsen by the end of 2014 is based on a guidance letter from the Agency.

Analyst Ritu Baral said, "We are very encouraged by FDA willingness to assess the etep data package on longer-term follow-up from the current Ph2 trial. While FDA hasn’t been specific on what type of additional data will be sufficient to clinch the idea of etep’s benefit in the agency’s mind, experts we have spoken to all see 2+ year follow-up data as meaningful, as patients “pretty much all destabilize over 2-3 years.”

"Significant outstanding questions on how data will be gauged remain; we think the FDA will kick it to the H1/15 AdComm. We fully expect FDA will likely leave issues like duration of follow-up and the natural history 6MW benchmark to the AdComm. Because of this fluidity, we think a timeline for approval is hard to predict and could be extended if the data proves less than straightforward," he added. "Flexibility on pipeline is a positive bonus. FDA’s willingness to look at multiple exons (e.g 45, 53) within one trial with shared PBO and combined efficacy could be critical in moving the pipeline forward."

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 $24.40 yesterday.

---

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

---

You May Also Be Interested In

• HSBC Downgrades Feng Tay Enterprises (9910:TT) to Hold
• London Stock Exchange Group Plc. (LSEG:LN) (LNSTY) PT Raised to GBP88 at HSBC
• Yageo Corp. (2327:TT) (YAGOY) PT Lowered to NT$656 at HSBC