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Dynavax Rebounds on Same PDUFA Date for Heplisav BLA
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Shares of Dynavax Technologies Corporation (DVAX - Free Report) bounced back after the company indicated that the FDA will review its Biologics License Application (BLA) for experimental hepatitis B vaccine, Heplisav on the current Prescription Drug User Fee Act (PDUFA) date of Dec 15, 2016.
The company has announced that the FDA’s Center for Biologics Evaluation and Research cancelled its Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for Nov 16, 2016. This was followed by a significant decline in the shares of the company.
The meeting was meant for a review of the company’s BLA for Heplisav. Due to the cancellation, the remaining questions between the company and the review team would be addressed under the normal process.
However, investors heaved a sigh of relief back after the company declared that following discussions with the agency, it is optimistic on the agency’s compliance with the current PDUFA date of Dec 15, 2016.
In addition, the FDA notified the company that it plans to provide information requests related to remaining questions in the upcoming weeks.
Meanwhile, Dynavax will cooperate with the FDA to let the agency complete its review.
The FDA will review overall immunogenicity data from the phase III trial, HBV-23, to support the proposed indication in patients aged 18 years and over. The agency has, however, refused to review immunogenicity data related to sub-populations including results in individuals with diabetes. The FDA cited that these data did not address the questions that the agency had raised in its Complete Response Letter (CRL) issued in Feb 2013. These data fell outside of the review time allocated to a Class 2 resubmission. Nevertheless, the FDA has recommended the data to be submitted as a supplemental BLA following approval.
Our Take
Dynavax’s Heplisav-B is yet again facing a regulatory hurdle. In Mar 2016, The FDA had accepted the company’s BLA for Heplisav B for review and set a PDUFA action date of Sep 15, 2016. In April, Dynavax submitted individual trial data sets that had been provided in an integrated form in the Mar 2016 BLA submission as requested by the FDA. The agency had then decided to postpone the PDUFA date to Dec 15, 2016 as it needed extra time to review the large data sets. In August, the FDA informed Dynavax that its VRBPAC is scheduled to discuss the investigational vaccine during the meeting scheduled for Nov 16.
Dynavax currently has no approved products in its kitty and has been pinning hopes on Heplisav’s approval. The FDA issued a CRL in Feb 2013 to the company’s BLA as the agency had determined that the hypothetical risks of the novel adjuvant warranted a larger safety database to assess the possibility of rare autoimmune side effects. Since the FDA had requested for a larger safety database, the company added more than 5,000 additional subjects to its existing safety database in the HBV-23 trial. The HBV-23 trial evaluated the safety and immunogenicity of Heplisav-B, compared with GlaxoSmithKline’s (GSK - Free Report) Engerix-B, in adults 18 to 70 years of age. While Heplisav-B was dosed twice – at the 0 and first month, Engerix-B was dosed thrice – at the 0, first and sixth month.
Dynavax currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the healthcare sector include Actelion Ltd and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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Dynavax Rebounds on Same PDUFA Date for Heplisav BLA
Shares of Dynavax Technologies Corporation (DVAX - Free Report) bounced back after the company indicated that the FDA will review its Biologics License Application (BLA) for experimental hepatitis B vaccine, Heplisav on the current Prescription Drug User Fee Act (PDUFA) date of Dec 15, 2016.
The company has announced that the FDA’s Center for Biologics Evaluation and Research cancelled its Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for Nov 16, 2016. This was followed by a significant decline in the shares of the company.
The meeting was meant for a review of the company’s BLA for Heplisav. Due to the cancellation, the remaining questions between the company and the review team would be addressed under the normal process.
However, investors heaved a sigh of relief back after the company declared that following discussions with the agency, it is optimistic on the agency’s compliance with the current PDUFA date of Dec 15, 2016.
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In addition, the FDA notified the company that it plans to provide information requests related to remaining questions in the upcoming weeks.
Meanwhile, Dynavax will cooperate with the FDA to let the agency complete its review.
The FDA will review overall immunogenicity data from the phase III trial, HBV-23, to support the proposed indication in patients aged 18 years and over. The agency has, however, refused to review immunogenicity data related to sub-populations including results in individuals with diabetes. The FDA cited that these data did not address the questions that the agency had raised in its Complete Response Letter (CRL) issued in Feb 2013. These data fell outside of the review time allocated to a Class 2 resubmission. Nevertheless, the FDA has recommended the data to be submitted as a supplemental BLA following approval.
Our Take
Dynavax’s Heplisav-B is yet again facing a regulatory hurdle. In Mar 2016, The FDA had accepted the company’s BLA for Heplisav B for review and set a PDUFA action date of Sep 15, 2016. In April, Dynavax submitted individual trial data sets that had been provided in an integrated form in the Mar 2016 BLA submission as requested by the FDA. The agency had then decided to postpone the PDUFA date to Dec 15, 2016 as it needed extra time to review the large data sets. In August, the FDA informed Dynavax that its VRBPAC is scheduled to discuss the investigational vaccine during the meeting scheduled for Nov 16.
Dynavax currently has no approved products in its kitty and has been pinning hopes on Heplisav’s approval. The FDA issued a CRL in Feb 2013 to the company’s BLA as the agency had determined that the hypothetical risks of the novel adjuvant warranted a larger safety database to assess the possibility of rare autoimmune side effects. Since the FDA had requested for a larger safety database, the company added more than 5,000 additional subjects to its existing safety database in the HBV-23 trial. The HBV-23 trial evaluated the safety and immunogenicity of Heplisav-B, compared with GlaxoSmithKline’s (GSK - Free Report) Engerix-B, in adults 18 to 70 years of age. While Heplisav-B was dosed twice – at the 0 and first month, Engerix-B was dosed thrice – at the 0, first and sixth month.
Dynavax currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the healthcare sector include Actelion Ltd and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>