Tuesday’s Movers and Shakers: Cummins, Dynavax & More

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Dynavax Clarifies

Dynavax Technologies Corporation (NASDAQ:DVAX) shares are 27% higher after the company provided a regulatory update on its lead product candidate HEPLISAV-B. Only a few days earlier, Dynavax shares fell sharply after the FDA cancelled a scheduled November 16 Vaccines and Related Biological Products Advisory Committee meeting over the drug’s BLA. According to the update, Dynavax said:

“During recent conversations between Dynavax and the FDA, the Agency communicated decisions to enable compliance with the current Prescription Drug User Fee Act (PDUFA) date of December 15, 2016… The FDA informed Dynavax that it plans to provide information requests related to remaining questions in the upcoming weeks. Dynavax is prepared to address these questions expeditiously in order to enable the FDA to complete its review as soon as possible.”

The company also added:

“The FDA also confirmed to Dynavax that it will review the overall immunogenicity data from HBV-23, the company’s most recent pivotal Phase 3 trial, to support the proposed indication for adults 18 years of age and over. However, the Agency has decided it will not review immunogenicity data related to sub-populations including results in individuals with diabetes because these data were not a direct response to the FDA’s February 22, 2013 Complete Response Letter and therefore fell outside of the review time allocated to a Class 2 resubmission. Thus, it was suggested the data should be submitted as a supplemental BLA following approval.”

The number of funds from our database with holdings in Dynavax Technologies Corporation (NASDAQ:DVAX) fell by six quarter-over-quarter to 23 at the end of June.

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Barron’s Bounce for Barnes & Noble 

Barnes & Noble, Inc. (NYSE:BKS) has surged by over 10% largely on the back of a favorable Barron’s article published over the weekend. In the column, writer Andrew Bary argues that the company’s earnings will likely increase over the next few years despite the perception that Barnes & Noble is being squeezed by Amazon.com, Inc. (NASDAQ:AMZN). Bary likes Barnes & Noble’s 5.3% yield and thinks shares have a 50% upside. A total of 21 funds tracked by us had a bullish position in Barnes & Noble, Inc. (NYSE:BKS) reporting period, unchanged from that of the previous quarter.

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ExOne Lifted By Improved Sentiment

ExOne Co (NASDAQ:XONE) shares are 5.6% in the green today due to General Electric Company (NYSE:GE)’s $1.4 billion collective purchase of two European 3D printing companies, Arcam AB and SLM Solutions Group AG. Because of GE’s purchase, sentiment in the sector has improved, and more traders are willing to hold ExOne Co (NASDAQ:XONE) in their portfolios. Shares of the company are up by over 34% year-to-date.

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Disclosure: none

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