Despite Negative FDA Panel, Needham & Company Sees Approval of Sarepta's (SRPT) Eteplirsen as Early as Next Year

Needham & Company analyst Chad Messer lowered his price target on Sarepta Therapeutic (NASDAQ: SRPT) to $20.00 (from $53.00) following the negative FDA panel but maintained his Buy rating.

Messer commented, "The FDA Advisory Committee voted 7-3 against accelerated approval for eteplirsen, with 3 members abstaining. We believe most no votes were the result of concerns for use of the external control group. The 3 abstentions (Hoffman, Green, and Romitti) were uncomfortable with approval based on current data but were moved by patient testimonies. One silver lining was that FDA Director Janet Woodcock and Deputy Director Bob Temple seemed to be open to a more flexible interpretation of FDA rules and encouraged panel members to consider patient testimonies. While we view eteplirsen's chance for accelerated approval as diminished given the negative vote, we continue to be buyers of SRPT shares particularly on any sell-off today. Regardless of accelerated approval decision, we expect full approval of eteplirsen as early as next year."

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 $14.95 yesterday.

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