Dynavax Technologies, Inc. (NASDAQ: DVAX)
On Thursday, during yet another dismal day for the equity markets, Dynavax stock gained $8.52 on news of better than expected Phase 3 clinical study results of the company’s experimental Hepatitis B vaccine, Heplisav-B.
Dynavax’s Phase 3 study was benchmarked against Engerix-B, the Hepatitis-B vaccine currently sold by GlaxoSmithKline (GSX). The company reported that its vaccine, Heplisav-B, showed a 95.4% rate of peak seroprotection, in contrast with only 81.3% for Glaxo’s Engerix-B. The Dynavax study focused especially on patients with diabetes mellitus, who don’t respond well to current vaccines and treatments. In the mellitus study, the seroprotection rate for Heplisav-B was 90%, as compared to 65.1% for Engerix-B. The studies also showed that the two vaccines had similar safety profiles. Dynavax plans to file for U.S. approval with the FDA soon and anticipates launching Heplisav-B during the third quarter of 2016. Analysts expect both the FDA approval and the vaccine launch to go as expected. Investors Business Daily
Dynavax CEO Comments
In a written statement from the Dynavax press release, Eddie Gray, Chief Executive Officer said,
“We are delighted to report these topline results from HBV-23 and confirm our intention to resubmit the HEPLISAV-B BLA by the end of March. These results support our belief that HEPLISAV-B, if approved, could offer benefits to adults at risk for hepatitis B, particularly given that these significant differences in seroprotection were demonstrated in a controlled setting, where compliance is optimized.” Yahoo Finance
DVAX Analysis
Thursday’s broad market sell off capped the worst four-day start to a new year in market history. Needless to say, DVAX’s 40% gain on more than 18 times average daily volume was impressive. But will the move have follow through in this hit-and-run trading environment? Did investors betting on the company’s ability to capture a significant share of the multi-billion dollar Hepatitis-B vaccine market fuel the DYAX buying? Or was it just traders chasing one of the few bullish stocks on the day? DYAX did close at highs of the day while both S&P and IBB sold off and closed at or near their lows of the day. If DYAX remains bullish, resistance levels are near $30, $30.50, $31.50 and the 52-week high at $32.49. If the broader markets continue to flush, DYAX support sits near the whole dollar levels from $29 to $24. A break of $23.70 should quickly fill the gap to $23.07.
Dynavax Company Profile
Dynavax Technologies Corporation (Dynavax) is a clinical-stage biopharmaceutical company. The Company uses toll-like receptor (TLR) biology to discover and develop vaccines and therapeutics. Its development programs are organized under three areas of focus: vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. The Company’s pipeline of product candidates includes HEPLISAV-B, an investigational adult hepatitis B vaccine, is in Phase III clinical trials; SD-101, a cancer immunotherapy candidate, is in Phase I/II clinical trials; AZD1419, a candidate drug for asthma, is in Phase II clinical trials planning; DV1179 is an inhibitor of TLR 7 and TLR 9 for autoimmune and inflammatory diseases, is in Phase I clinical trials. DV230-Nanoparticle is a second generation adjuvant. DV230-Nanoparticle is in preclinical stage. Google Finance
