FDA Committee Vote Boosts Dynavax Technologies Corporation (NASDAQ:DVAX)

Dynavax Technologies Corporation (NASDAQ:DVAX)

Dynavax Technologies Corporation (NASDAQ:DVAX) shares are up over 70% on positive news from the U.S. Food and Drug Administration (FDA) and ratings upgrades from RBC Capital Markets and JP Morgan. The listed average daily volume for DVAX shares is 1.8 million but by 11:40 AM EST, over14.6 million shares had traded.

Dynavax Technologies Corporation (NASDAQ:DVAX)
One month daily candlebar graph for $DVAX

The catalyst for the share increase was news, dated last Friday, that the FDA’s Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 that for Dynavax’s HEPLISAV-B vaccine’s safety data support licensure for immunization against hepatitis B infection in adults. Established hepatitis B vaccines are administered in three doses over a six-month schedule. The HEPLISAV-B schedule is two doses over one month. Results of a published Vaccine Safety Datalink study showed that only 54 percent of adults completed the three-dose hepatitis B vaccine series in one year. Hepatitis B is a viral liver disease that can lead to cirrhosis of the liver, hepatocellular carcinoma, and death. In the U.S., the number of reported cases of acute hepatitis B increased more than 20 percent in 2015.

Eddie Gray, CEO of Dynavax, stated “Clinical studies of HEPLISAV-B have shown that the vaccine provides increased rates of seroprotection. In addition, the two-dose regimen offers the potential to increase patient compliance, which physicians and advocates agree is essential to preventing more cases of hepatitis B and achieving the public health goal of eradication. We look forward to completing our ongoing discussions with the FDA regarding an appropriate post-marketing commitment as it finalizes its review.”

Over 11% of Dynavax Technologies Corporation (NASDAQ:DVAX) outstanding shares are held short. In 2012 DVAX shares had an EPS loss, adjusted for dilution, of (-$4.10). In the years that followed losses continued but were steadily narrower: (-$3.83), (-$3.45), (-$3.25), and in 2016 the loss was (-$2.92). However, the number of outstanding shares follows a steady upward trend. In 2012 there were 17.05 million outstanding shares. By 2016 that number had steadily grown and stood at 38.51 million.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $DVAX and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Dynavax Technologies Corporation (NASDAQ:DVAX) Drops On Hepatitis B Vaccine Safety Concerns

Dynavax Technologies Corporation (NASDAQ:DVAX)

Shares of Dynavax Technologies Corporation (NASDAQ:DVAX) dropped 11.06% as investors reacted to the U.S. Food and Drug Administration raising safety concerns over its Hepatitis B Vaccine, Heplisav-B. Clinical trial results indicate that while the vaccine was effective, it was associated with more deaths compared to a rival product.

Dynavax Technologies Corporation (NASDAQ:DVAX)
One Month daily candlebar graph for $DVAX

Heplisav-B Safety Concerns

Serious heart problems on patients using the vaccine compared to those taking GlaxoSmithKline plc (ADR)(NYSE:GSK)’s Engerix-B is another concern that continues to rattle regulators. The results indicate that the vaccine might be riskier even though it proved to be effective in some cases.

Heplisav-B is designed it improves the body’s immune response to hepatitis B virus. The vaccine’s fate now lies in the hands of a panel of experts who are set to review it. While the FDA final decision is not bound by the Panel’s recommendation, its final decision will depend on the outcome of the review.

Dynavax Technologies Corporation (NASDAQ:DVAX) felt the wrath of the street on growing concerns that FDA could deal Heplisav-B a big blow following the advisory panel review. The agency has twice rejected the product in the past, citing safety concerns. Late last year the stock plunged 70% after the regulator rejected an approval bid.

Stock Performance

Taking into consideration previous rulings JP Morgan Analyst, Anupam Rama, believes the vaccine stands a 40% chance of gaining the much-needed approval. The optimism is because the vaccine has proved to be effective and highly robust amidst safety concerns. Efficacy is not expected to be an issue given the low numbers and rates of cardiac events.

Dynavax Technologies Corporation (NASDAQ:DVAX) on its part argues that the high numbers of heart problems with the use of Heplisav-B were due to fewer than expected instances in the group that used Engerix-B.

“While the finding could be attributable to chance, I cannot confidently say that there is no increased cardiovascular risk with Heplisav,” said one cardiologist consulted by the FDA.

The FDA could require Dynavax Technologies Corporation (NASDAQ:DVAX) to carry out a post marketing monitoring program on approving the vaccine

Dynavax Technologies Corporation (NASDAQ:DVAX) fate in the market hinges on the outcome of FDA ruling on the Hepatitis B vaccine. Some biotech analysts believe the stock could rise by as much as 300% on the vaccine gaining regulatory approval. However, the stock could hit lower lows in the market should the opposite turn out to be true.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $DVAX and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Why Shares of Dynavax Technologies Corporation (NASDAQ:DVAX) Are Gaining

Dynavax Technologies Corporation (NASDAQ:DVAX)

Dynavax Technologies Corporation (NASDAQ:DVAX) stock has been in rally mode ever since it reported positive results for its metastatic melanoma candidate drug, SD-101. Renewed interest in the stock comes on the heels of growing optimism that the Food and Drug Administration will approve the company’s hepatitis B vaccine, Heplisav-B.

S-101 Positive results

Data presented at the American Society of Clinical Oncology (ASCO) indicates that SD-101 produced 100% overall response rate in seven anti-PD 1/L1 patients. The drug’s complete response rate in combination with Merck’s Keytruda came in at 29%. The results indicate a meaningful increase over the use of KEYTRUDA alone with an overall response rate of 33% and complete response rate of 6%.

The trial result indicates that SD-101 did indeed boost Keytruda efficacy levels in metastatic Melanoma without an increase in side effects. Dynavax Technologies Corporation (NASDAQ:DVAX) can negotiate a commercialization deal with Merck & Co., Inc. (NYSE:MRK) given the positive SD-101 results.

“These results are supported by tumor shrinkage in patients who had previously progressed on anti-PD-1 treatment and by confirmatory laboratory biomarker assessments in tumor biopsies. If these clinical results are sustained in the ongoing trial, this combination, which mobilizes both innate and adaptive immune responses in patients, could represent an important advancement in immuno-oncology,” said Antoni Ribas of the Jonsson Comprehensive Cancer Center.

Market Opportunity

SD-101 expands Dynavax Technologies Corporation (NASDAQ:DVAX) reach into a multibillion skin cancer drug market. The ability to access such a sizeable market has caught the attention of investors. Based on the Phase ½ trial results, SD-101 should act as a near term value driver, especially after the biotechnology company inks a commercialization deal with Merck.

Heplisav-B could propel Dynavax Technologies Corporation (NASDAQ:DVAX) higher in the market after an FDA approval. Expert observers claim the odds of approval are high given its superior trial results to the current standard of care.

Approval of the Hepatitis B vaccine would present Dynavax Technologies Corporation (NASDAQ:DVAX) with a $500 million market opportunity in the United States alone. At the moment, the only major concern is that the company’s need to raise money for the vaccine’s roll out as well as the development of SD-101.

Dynavax Technologies Corporation (NASDAQ:DVAX) shed 1.90% in market value in Tuesday’s trading session to end the day at $7.75 a share.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $DVAX and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica Grey has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Shares of Dynavax Technologies Corporation (NASDAQ:DVAX) Surge then Subside

Dynavax Technologies Corporation (NASDAQ:DVAX)

Dynavax Technologies Corporation (NASDAQ:DVAX) shares spiked 25% in the pre-market on moderate volumes but as the regular session kicked in, shares fell to levels below their Friday close on volumes over 1.7 times normal. The unusual activity was due to an announcement from Dynavax concerning its HBsAg-1018 (Hepislav-B) – an investigational adult hepatitis B vaccine. The announcement stated that the Food and Drug Administration’s vaccines and related biological products advisory committee (VRBPAC) will review Heplisav-B just two weeks before the drug’s August 10 Prescription Drug User Fee Act target action date.

The VRBPAC typically meets when question still surround a drug candidate’s risk-reward profile. In this case Glaxo (GSK) and Merck (MRK) each have Hepatitis B vaccines – Engerix-B and Recombivax HB. Observers believe that the FDA feels a need to approve an additional Hepatitis-B vaccine. Working in Dynavax’s favor is that Glaxo and Merck’s vaccines do not target, nor are especially effective in, specific sub-populations such as diabetes. But Hepislab-B is not without its side-effects and the risk-reward question lingers.

Today’s trading action was likely the more interesting story though. Dynavax Technologies Corporation (NASDAQ:DVAX) shares opened the pre-market at $5.95 and hit their high of $7.50 at 7:08 AM EST. However, in less than two minutes DVAX was trading at $7.00. After 8:30 AM EST DVAX shares would not see a print over $7 again. DVAX shares continued their downward trajectory and opened at $6.40. After 10 AM EST, DVAX would only trade above $6 again briefly and frequently bounced off the $5.80 price level for the next several hours.

Four firms follow Dynavax Technologies Corporation (NASDAQ:DVAX). Two rate DVAX shares as a “Strong Buy” and two rate the shares as a “Hold”. Over 16% of the outstanding shares are held short. Given Dynavax Technologies Corporation (NASDAQ:DVAX) EPS history and its dilution frequency, the company, and its shareholders, would welcome a positive outcome from the FDA panel. In 2012 DVAX shares had an EPS loss, adjusted for dilution, of -$4.10. In the years that followed losses continued but were steadily narrower: -$3.83, -$3.45, -$3.25, and in 2016 the loss was -$2.92. However, the number of outstanding shares also is following a steady upward trend. In 2012 there were 17.05 million outstanding shares. By 2016 that number had steadily grown and stood at 38.51 million.

4/3/2017
Ticker Symbol DVAX
Last Price a/o 2:54 PM EST  $                      5.90
Average Volume                1,300,000
Market Cap (mlns)  $                  263.88
Sales (mlns) $11.00
Shares Outstanding (mlns) 44.35
Share Float (mlns) 16.27
Shortable Yes
Optionable Yes
Inside Ownership 0.20%
Short Float 16.27%
Short Interest Ratio 5.52
Quarterly Return 45.12%
YTD Return 50.63%
Year Return -70.49%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Did Market Over-React to FDA News on Dynavax Technologies Corporation (NASDAQ:DVAX)?

Dynavax Technologies Corporation (NASDAQ:DVAX)

Things are looking up for Dynavax Technologies Corporation (NASDAQ:DVAX). Back in November DVAX shares plunged 74% on news that the FDA was requesting a Complete Response Letter (CRL) from the small biotech regarding its Biologics License Application which sought approval for its Hepatitis-B vaccine (Heplisav-B) – there is no cure for Hepatitis B, and disease prevention through more effective vaccines is critical to reducing its spread. The CRL was requesting more information from the company and also included the possibility of additional testing. At the time DVAX management stated that it had submitted a response to the issues in October – before the FDA even issued the CLR.

Today news broke during pre-market trading that the FDA had accepted for review the response by Dynavax Technologies Corporation (NASDAQ:DVAX) to the CLR. This means the company will not have to seek out a larger partner to license their drug or raise additional capital for this endeavor – two possibilities that contributed to the November tanking of the stock. However this development does not confer impending commercialization upon the drug – only that the requested information is accepted for review. The FDA has reportedly assigned a Prescription Drug User Fee Act (PDUFA) action date of Aug. 10, 2017 to Heplisav-B’s regulatory filing.

Dynavax Technologies Corporation (NASDAQ:DVAX) is a clinical-stage immunology company focused on leveraging the power of the body’s innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax is developing product candidates for use in multiple cancer indications, as a vaccine for the prevention of hepatitis B and as a disease modifying therapy for asthma. Dynavax’s lead product candidates are SD-101, an investigational cancer immunotherapeutic currently in Phase 1/2 studies, and HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine.

It would be hard to emphasize the need for Dynavax Technologies Corporation (NASDAQ:DVAX) to get a product to market and generate some sales. Since 2011 they have posted EPS losses of -$3.89, -$4.10, -$3.83, -$3.45, and -$3.25 in 2015. Unfortunately, their sales have been on a downward trend while their outstanding shares have increased each and every year. $21.6 million in 2011 sales dwindled to $4.1 million in sales in 2015. Meanwhile the 12.51 million outstanding DVAX shares grew to $32.88 million in 2015.

3/1/2017
Ticker Symbol SGY
Last Price a/o 2:07 PM EST  $                      7.03
Average Volume                1,150,000
Market Cap (mlns)  $                  173.30
Sales (mlns) $4.40
Shares Outstanding (mlns) 38.51
Share Float (mlns) 38.4
Shortable Yes
Optionable Yes
Inside Ownership 0.10%
Short Float 24.24%
Short Interest Ratio 8.1
Quarterly Return -10.00%
YTD Return 13.92%
Year Return -72.08%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy. 

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.