Shares of Dynavax Technologies Corporation DVAX surged 40.3% after the company reported positive preliminary top-line results from a phase III trial, HBV-23, on investigational hepatitis B vaccine, Heplisav-B.
The trial compared the safety and immunogenicity of Heplisav-B with that of Glaxo SmithKLine’s GSK Engerix-B in patients aged 18 to 70 years.
Patients in the Heplisav-B arm received two doses, at zero and one month, while those in the Engerix-B arm received three doses at zero, one and six months.
Co-primary endpoints of HBV-23 included the evaluation of the overall safety of Heplisav-B with respect to clinically significant adverse events, and the noninferiority of seroprotection in participants with diabetes mellitus. The trial met its both co-primary endpoints. Data from the trial showed that the rates of clinically significant adverse events were consistent with randomization and similar to rates in the prior trials. It was also seen that Heplisav-B led to a statistically significant higher rate of seroprotection than Engerix-B in diabetic participants as well as in all participants in the group.
Our Take
Positive results from the HBV-23 trial should offer investors some relief. Based on these results, Dynavax plans to resubmit the Biologics License Application (BLA) to the FDA for Heplisav-B by the end of the first quarter of 2016 with a six-month review period.
We remind investors the FDA had issued a complete response letter (CRL) to Dynavax stating that the BLA for Heplisav-B could not be approved as hypothetical risks warranted a larger safety database to assess the possibility of rare autoimmune side effects. Consequently, in Apr 2014, Dynavax initiated HBV-23 to provide a sufficiently-sized database for the FDA to complete its review of the BLA.
The trial was fully enrolled by Sep 2014. The independent Data and Safety Monitoring Board completed its all three prespecified reviews related to safety data from HBV-23 and recommended the study to continue unchanged.
In the revised BLA, Dynavax expects to address all issues raised by the FDA in its CRL by submitting results from HBV-23, along with previous clinical data.
We remind investors that Dynavax currently does not have any approved products in its kitty. Hence, a potential approval by the FDA will significantly boost the company’s growth prospects.
Meanwhile, it entered into a collaboration agreement with Merck & Co. Inc. MRK in 2015, whereby Merck’s Keytruda and MK-1966 will be investigated in combination with Dynavax’s pipeline candidate, SD-101.
Dynavax currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the healthcare sector is Baxalta, Inc. BXLT sporting a Zacks Rank #1 (Strong Buy).
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