The FDA has rejected the marketing application for Dynavax’s ($DVAX) hepatitis B vaccine Heplisav-B. The setback prompted Dynavax to start looking for a partner that can get the vaccine over the finish line at the third time of asking.
Dynavax attributed the complete response letter, in part, to the FDA's inability to assess additional details it provided in October before the end of the review period. The details were submitted to allay the FDA’s concerns about specific adverse events of special interest and an imbalance in the number of cardiac events seen in one trial of Heplisav-B. The FDA cited these concerns, as well as others relating to safety analyses and postmarketing commitments, in its CRL.
The list of issues raised by FDA is free from potentially killer blows to the program. Dynavax said the FDA requested no additional clinical trials, nor did it flag worries about autoimmune adverse events. The occurrence of autoimmune diseases including Wegener’s granulomatosis led the FDA to place a hold on a clinical trial of Heplisav-B back in 2008. And the regulator brought up the link again when it first rejected the vaccine in 2012.
Those positives from the CRL are offset by the need to put more time and money into the program, and a further delay to the day Dynavax may be able to start recouping its investment in the vaccine. Faced with this situation, Dynavax is looking for a partner to help prepare for yet another run at the FDA.
“The time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner,” Dynavax CEO Eddie Gray said in a statement.
Merck ($MRK) had the license to Dynavax until it walked away after getting a look at Phase III data in 2008. That severance is one of many twists Dynavax has faced over the past decade. In 2016 alone, Dynavax’s prospects have waxed and waned as a Phase III success was followed by the FDA delaying its decision, scrapping an advisory committee meeting and asking for additional information.
The stock took another downward turn following news of the CRL. Investors wiped more than 70% off the value of the stock in premarket trading.