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DVAX

Dynavax

$10.49

0.16 (1.55%)

11:17
10/03/16
10/03
11:17
10/03/16
11:17

Dynavax jumps after receiving 'anticipated requests' for information from FDA

Earlier today, in a regulatory filing, Dynavax disclosed that Dynavax Technologies received anticipated requests for information from the U.S. Food and Drug Administration's review team in connection with the pending Biologics License Application, BLA, for HEPLISAV-B.The review team's questions are in line with the company's expectations.The company is working with the FDA to resolve remaining questions regarding the BLA in order to enable the FDA to complete its review by the scheduled Prescription Drug User Fee Act, PDUFA, action date of December 15, which remains unchanged. Shares of Dynavax are up 23% or $2.42 to $12.96 per share in morning trading.

  • 16

    Nov

  • 15

    Dec

DVAX Dynavax
$10.49

0.16 (1.55%)

04/27/16
COWN
04/27/16
NO CHANGE
Target $60
COWN
Outperform
Dynavax PDUFA extension will not impact approval chances, says Cowen
Cowen analyst Phil Nadeau does not beleive Dynavax's Heplisav PDUFA extension by 3 months will impact chances of approval. The analyst suspects that the PDUFA change has more to do with FDA managing its workload than any reflection on the substance of the BLA, since both the FDA and Dynavax had agreed upon the original format of the BLA resubmission. Nadeau continues to rate Dynavax an Outperform and top small cap pick with a $60 price target on shares.
04/27/16
RBCM
04/27/16
DOWNGRADE
RBCM
Sector Perform
Dynavax downgraded to Sector Perform from Outperform at RBC Capital
04/28/16
RBCM
04/28/16
DOWNGRADE
RBCM
Sector Perform
Dynavax downgraded on drug safety concerns at RBC Capital
As noted earlier, RBC Capital downgraded Dynavax to Sector Perform from Outperform, The firm cited concerns about the safety of the company's Heplisav-B drug as the reason for its downgrade. RBC says that the FDA's decision to request individual trial data instead of the integrated dataset shows that the agency's scrutiny of the drug's safety has increased. Target to $17 from $48.
09/06/16
WBLR
09/06/16
NO CHANGE
WBLR
Outperform
FDA panel cancelation positive for Dynavax, says William Blair
William Blair analyst Y. Katherine Xu views the FDA's decision to canceled the November 16 Vaccines and Related Biological Products Advisory Committee meeting for Heplisav as a net positive for Dynavax. The agency's decision to move straight to the PDUFA date suggests that the Heplisav package is "sufficiently strong and adequate to warrant approval in the absence of a panel," Xu tells investors in a research note. She keeps an Outperform rating on Dynavax. The stock is up 19% to $13.00 in pre-market trading.

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