Dynavax Technologies Corporation (NASDAQ:DVAX)

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)

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.

Cesca Therapeutics Inc (NASDAQ:KOOL)

Dynavax Technologies Corporation (NASDAQ:DVAX) Awaiting FDA Verdict

Dynavax Technologies Corporation (NASDAQ:DVAX)

Dynavax Technologies Corporation (NASDAQ:DVAX) stock continues to experience renewed investor interest based on speculation of the  outcome of a critical advisory committee meeting on July 28, 2017. The committee is set to issue a verdict on the company’s candidate drug Heplisav, a novel treatment for Hepatitis B.

Heplisav Regulatory Path

Clinical study results have already shown that the drug can provide superior protection in a wide range of patient populations. However, the U.S. Food and Drug Administration (FDA) remains concerned about Heplisav serious side effects on vaccinated patients.

Dynavax Technologies Corporation (NASDAQ:DVAX) has responded to FDA concerns that affect the drug’s regulatory path. The company and the FDA will square off on July 28 to discuss the drug in detail, while focusing on its risk to reward ratio.

Depending on the meeting’s outcome, Dynavax Technologies Corporation (NASDAQ:DVAX) stock could trade either way. Heplisav gaining FDA approval will likely strengthen investor’s sentiments. However, a negative outcome could have serious ramifications on the stock’s price.

Dynavax Technologies Corporation (NASDAQ:DVAX) has considerably trimmed the amount of money it uses on the development of the Hepatitis B drug as it awaits the FDA verdict. During the earnings call, the company said it expects operating costs on the drug to be about $1 million per month. The company is directing a good chunk of its capital to the development of its oncology business.

“In January we reduced operating cost, limited further investment in HEPLISAV-B [Hepatitis B Vaccine, (Recombinant) Adjuvanted] until after we have received approval, and focused our efforts on immuno-oncology,” said CEO, Michael Ostrach.

Dynavax Technologies Corporation (NASDAQ:DVAX) is not betting its entire future on one drug. The biotech company is currently working on other drugs that it believes have the potential to strengthen its oncology portfolio. One of the drugs in the pipeline is a T-cell booster SD-101.

Class Action Lawsuit

Dynavax Technologies Corporation (NASDAQ:DVAX) is the subject of a class action lawsuit over claims it provided materially false and misleading statements concerning the prospects of its lead drug HEPLISAV-B. Law firm Lifshitz & Miller alleges that the company’s management provided the misleading information between April 26, 2012, and November 14, 2016.

The law firm has also raised concerns about the company’s internal financial controls which it says are inadequate and deficient. Shareholders who purchased the company’s stock prior to June 10, 2013, are advised to complete an Information Request Form at the law firm.

Dynavax Technologies Corporation (NASDAQ:DVAX) stock was up by 4.02% in Monday’s trading session to end the day at $10.35 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: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

Dynavax Technologies Corporation (NASDAQ:DVAX)

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.