With the aim of extending its cash runway while it focuses its development efforts in immuno-oncology, Dynavax (DVAX -4.5%) suspends manufacturing of hepatitis B vaccine candidate HEPLISAV-B and cuts global headcount by 38%. It will book the majority of the ~$3M restructuring charge this quarter. The company says the changes should reduce cash burn by 40%.
Going forward, it expects to incur HEPLISAV-B costs of less than $1M per month while it works through the CRL it received from the FDA in November. Operating costs related to its oncology program should be less than $60M per annum.
The company's lead oncology candidate is SD-101, an intratumoral TLR9 agonist, in early/mid-stage development for solid tumors and blood cancers.
Dynavax Technologies (NASDAQ:DVAX) craters 74% premarket on robust volume in response to its announcement that it has received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) seeking approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults at least 18 years old against hepatitis B virus (HBV) infection.
The CRL requests clarification regarding specific adverse events of special interest (AESIs) and a numerical imbalance in a small number of cardiac events in the HBV-23 study. It also cites the need for new analyses of the integrated safety database across different time periods and post-marketing commitments.
The agency stated that it had not yet completed its review of the company's responses received in early October that included the AESIs and the numerical imbalance in cardiac events. Dynavax says its responses included an extensive analysis that supports its view that the imbalance was due to an unexpectedly low number of events in the comparator arm.
The CRL did not specify the need for additional clinical trials nor any concerns with rare serious autoimmune events.
The company plans to meet with the agency as soon as possible.
Dynavax (DVAX -9.7%) bulls are feeling a bit "penned in" this morning on the heels of an article just published by TheStreet's Adam Feuerstein delving into the prospects for FDA approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] after it canceled the Advisory Committee meeting to review the company's Biologics License Application (BLA). Normally, Ad Comm reviews are done ~45 - 60 days before the agency's action date (PDUFA). A positive vote by the majority of Committee members typically portends approval. The PDUFA date for the HEPLISAV-B BLA is December 15.
On occasion, Ad Comm meetings are canceled, normally a bearish development, but there have been strong opinions on both sides of the aisle in this case. Mr. Feuerstein wondered if a historical look at previous cancellations would be informative on HEPLISAV'B's potential fate. An unnamed investor did just that.
Going back to 2008, the FDA has canceled 15 previously scheduled Ad Comm meetings, 13 of which were eventual rejections. In the two cases where drugs were approved, Bristol-Myers Squibb's (BMY +1.2%) Yervoy (ipilimumab) and Celgene's (CELG +0.9%) Pomalyst (pomalidomide), the agency stated in its announcements that "...the issues for which the FDA was seeking scientific input of the committee have been resolved." Clear language implying that the agency had no lingering questions that needed answering before giving its nod to the products.
The FDA's wording is a bit different for the rejections, mentioning the need to "review and resolve outstanding issues." Investors may feel like "China watchers" as they try to decipher the agency's intentions, but even the most ardent of bulls may want to put a hedge in place before mid-December.
In a regulatory filing, Dynavax (NASDAQ:DVAX) reports that it has received requests for information from the FDA review team regarding its Biologics Licence Application (BLA) seeking approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. The company says the team's questions are in line with its expectations.
Dynavax is working with the review team to resolve all remaining questions in order to ensure the completion of its review by the scheduled action date (PDUFA) of December 15.