Dynavax (DVAX) PT Cut to $4 at RBC Following CRL

RBC Capital analyst Simos Simeonidis cut his price target on Sector Perform-rated Dynavax Technologies (NASDAQ: DVAX) to $4.00 (from $16.00) after the FDA has issued a CRL to the Heplisav-B BLA, a full month before the 12/15/16 PDUFA.

"While the decision itself may not be a major surprise for some investors, we were surprised to see for the first time the disclosure of cardiac events imbalance in HBV-23 given as one of the reasons for the CRL, in addition to the agency's known concerns about AESIs," Simeonidis said.

Commenting on where do we go from here, the analyst said: "The company will respond to the CRL “as quickly as possible” and expects a 6-month review. It is therefore possible that we could have another PDUFA in 2H17. Dynavax stated that the CRL does not mention the need for additional clinical trials. However, we don’t see this as any sort of a positive signal, since the FDA has not yet completed its full review and thus a decision on whether more trials are needed wouldn’t necessarily be given until then. Despite that, Dynavax disclosed it plans to bring in a pharma or financial partner, given its $109M in cash as of the end of 3Q16 and its $30M in quarterly burn."

For an analyst ratings summary and ratings history on Dynavax Technologies click here. For more ratings news on Dynavax Technologies click here.

Shares of Dynavax Technologies closed at $11.60 yesterday.

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