Dynavax Technologies CorporationNASDAQ
Dynavax The Superior Player In Hepatitis B Vaccination
Jerad W. Starr • 14 Comments
Jerad W. Starr • 14 Comments
Tue, Oct. 4, 12:27 PM
- 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.
Mon, Oct. 3, 12:45 PM
Mon, Oct. 3, 11:01 AM
Mon, Oct. 3, 9:22 AM
Mon, Oct. 3, 6:59 AM
- 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.
- Read now Dynavax Technologies Could Capture Majority Share In The Hepatitis B Vaccination Market
- Update: Shares are up 12% premarket on light volume.
Tue, Sep. 6, 12:45 PM
Tue, Sep. 6, 11:00 AM
Tue, Sep. 6, 9:14 AM
Tue, Sep. 6, 7:27 AM
- Dynvax (NASDAQ:DVAX) issued a statement on September 4 saying the FDA intends to provide information requests in the coming weeks related to its review of the company's Biologics License Application (BLA) seeking approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)].
- The agency indicated that it will review the overall immunogenicity data from the Phase 3 HBV-23 study to support the proposed adult indication but it will not review immunogenicity data related to sub-populations including diabetics because the data were not a direct response to its February 23, 2013 Complete Response Letter (CRL). A Class 2 resubmission, which is what this is, relates only to the issues cited in the CRL. Additional data will need to be submitted as a supplemental BLA following approval. The company says the FDA has communicated that the December 15 PDUFA date should still be achievable.
- DVAX shares plummeted last Friday on the news that the FDA canceled its Ad Comm review of the BLA saying it needed more time to "review and resolve several outstanding issues."
- Previously: Dynavax plummets after Ad Comm review of hep B vaccine canceled; shares down 32% (Sept. 2)
Tue, Sep. 6, 7:06 AM
- Late Friday, the FDA cancelled its scheduled committee meeting to review the BLA for Heplisav.
- JPM says it spoke to management, and heard the following:
- DVAX expects to have outstanding questions from the FDA in the next several weeks. It did not speculate on the nature of the questions.
- "In our view, the nature of the questions will remain an overhang on DVAX shares."
- More of JPM's client note here.
- Currently DVAX is changing hands premarket at $12.51, 15% above its Friday close when it dropped 31.5%.
Fri, Sep. 2, 4:02 PM
- Dynavax (DVAX -31.7%) gets some rude treatment today. Shares are down on a 29x surge in volume on the news that the FDA has canceled the November 16 Ad Comm review of the company's BLA seeking approval of its hepatitis B vaccine, Heplisav-B. The agency says it needs more time to "review and resolve several outstanding issues."
- Previously: Dynavax's hepatitis B candidate gets Ad Comm review Nov. 16 (Aug. 5)
- Update: On September 6, the company issued a statement saying the FDA intends to provide information requests in the coming weeks. The agency indicated that it will review the overall immunogenicity data from the Phase 3 HBV-23 study to support the proposed adult indication but it will not review immunogenicity data related to sub-populations including diabetics because the data were not a direct response to its February 23, 2013 Complete Response Letter (CRL). A Class 2 resubmission, which is what this is, relates only to the issues cited in the CRL. Additional data will need to be submitted as a supplemental BLA following approval. The company says the FDA has communicated that the December 15 PDUFA date should still be achievable.
Fri, Aug. 5, 6:07 PM
- Dynavax (DVAX +4.9%) says its biologics license application for hepatitis B vaccine Heplisav-B is headed for an Advisory Committee meeting on Nov. 16.
- The vaccine candidate is under review with a Prescription Drug User Fee Act action date of Dec. 15.
- The FDA will communicate questions for its Vaccines and Related Biological Products Ad Comm to review closer to the meeting date.
- Heplisav-B combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response, Dynavax says. It's administered in two doses over one month.
Fri, Aug. 5, 5:58 PM
Wed, Jun. 15, 9:14 AM
- Results from a Phase 3 clinical trial, HBV-23, evaluating Dynavax's (NASDAQ:DVAX) hepatitis B vaccine candidate, HEPLISAV-B ([Hepatitis B Vaccine, Recombinant (Adjuvanted)] showed a higher rate of seroprotection compared to GlaxoSmithKline's (NYSE:GSK) ENGERIX-B [Hepatitis B Vaccine (Recombinant)]. The results were presented at the 76th Annual Scientific Sessions of the American Diabetes Association in New Orleans, LA.
- The randomized, observer-blinded, active-controlled study enrolled over 8,000 participants, including 1,144 adults with type 2 diabetes (diabetics are especially vulnerable to hepatitis B virus (HBV) infection).
- Diabetic patients receiving HEPLISAV-B showed a 90.0% seroprotection rate versus 65.1% for ENGERIX-B, a statistically significant difference of 24.9%. In patients aged 60 - 70, the seroprotection rate also favored HEPLISAV-B, 85.8% versus 58.5%, as did obese (body mass index >= 30) patients, 89.5% compared to 61.4%.
- The rates of adverse events were similar between the two groups.
- HEPLISAV-B's additional value proposition is a two-dose regimen (initial and one month) compared to ENGERIX-B's three-doses (initial, one month, six months).
- The FDA's action date (PDUFA) for its review of Dynavax's Biologics License Application (BLA) is December 15.
Mon, May 9, 9:02 AM
Wed, Apr. 27, 12:46 PM