Catalyst
Slingshot members are tracking this event:
Dynavax Receives Notification of PDUFA Extension for HEPLISAV-B to December 15, 2016
Do you think this event is important to the companies below? How will it affect their stock price?
Related Companies | Importance
|
Impact on Stocks
|
||||
---|---|---|---|---|---|---|
DVAX |
|
|
Additional Information
On April 8, in response to an FDA request, Dynavax submitted individual trial data sets that had been provided as integrated data in the March 2016 BLA resubmission. FDA then determined that the addition of these large data sets represented a major amendment to the BLA and thus extended the PDUFA action date to allow for a full review.The HEPLISAV-B BLA is based on results from clinical trials that have generated data in more than 14,000 total participants.
"The CRL is consistent with our opinion that HEPLISAV-B is approvable and we are seeking to meet with the FDA as soon as possible," said Eddie Gray, chief executive officer of Dynavax. "However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner. We will maintain our efforts on the oncology programs, including our lead cancer immunotherapy candidate, SD-101, for which we recently announced encouraging early clinical data in metastatic melanoma."
Slingshot Insights Explained
Catalyst Date
Occurred on:
Nov 14, 2016
Occurred Source:
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=999142
Related Projects
-
Don’t see a project related to the catalyst you care about?
Related Keywords
Pdufa Extension, Heplisav-b, Vaccine, Hepatitis B