This Week in Biotech: Dynavax Technologies Corporation (DVAX), Zogenix, Inc. (ZGNX)

Page 1 of 2

With the SPDR S&P Biotech Index up 23% over the trailing-12-month period, it’s evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let’s have a look at some of the rulings, studies, and companies that made waves in the sector last week.

We received a wide variety of news this week out of the biotech sector including FDA decisions, buyout rumors, drug recalls, and even earnings reports, so let’s not waste any time and just dig right in.

On the FDA front, Dynavax Technologies Corporation (NASDAQ:DVAX) and Zogenix, Inc. (NASDAQ:ZGNX) received news that sent them decisively in opposite directions.

Dynavax Technologies CorporationDynavax Technologies Corporation (NASDAQ:DVAX), maker of Heplisav, a vaccine for hepatitis-B, received a complete response letter on Monday for its experimental drug — and the news was worse than investors imagined. The FDA noted that the data provided was insufficient to adequately determine the safety of the drug for the 18- to 70-year-old target audience and remained concerned about the potential for Heplisav to cause rare autoimmune events. Had this simply been a matter of conducting additional safety trials, I would have declared this a victory for Dynavax Technologies Corporation (NASDAQ:DVAX) and assumed Heplisav would be approved within 12 to 18 months. Because of the latter concern regarding autoimmune events, Heplisav could be a tough sell, and even if it does get approved by the FDA, it may be with restricted use labeling. To top things off, Dynavax’s CFO, Christine Larson, stepped down midweek. All told, Dynavax Technologies Corporation (NASDAQ:DVAX) shares tumbled 33% this week.

On the flipside, Zogenix, Inc. (NASDAQ:ZGNX) shares rallied 46% after the FDA announced that it was delaying its PDUFA decision on Zohydro ER for moderate to severe pain management. Although the FDA didn’t list a reason for the extension, it did note that the extension would be brief and last up to only a few weeks. This led many on the Street to assume that Zohydro ER may be approved sooner than later. The FDA is under no obligation to agree with its panel, but it is worth noting that it often does and its panel voted overwhelmingly (11-2 with one abstention) against recommending approval because of the potential for abuse of the drug.

Page 1 of 2
blog comments powered by Disqus
Insider Monkey Headlines
Insider Monkey Small Cap Strategy
Insider Monkey Small Cap Strategy

Insider Monkey beat the market by 52 percentage points in 24 months Click to see monthly returns in table format!

Lists

Best States To Practice Medicine

The 10 Best States to Have a Business

The 12 Most Expensive Apple (AAPL) Apps in the Market

The 10 Richest Billionaires in the World

10 Biggest Kickstarter Failures

The 10 Best Places to Work At

The Top 10 of Google Inc (GOOGL)’s Most Expensive Acquisitions

13 Best Cities to Visit in South America

10 Most Expensive Works of Art of All Time

The 10 Richest Banks in the World

The 10 Best-Paying Jobs in America (2014)

7 Most Expensive Foods in the World

The World’s Top 10 Earning Authors

Five Wicked and Very Expensive Items (and Other “Stuff”) Sold on eBay

10 Biggest Celebrity Bankruptcies

The Top 10 Highest Paid CEOs in 2014

The 10 Most Expensive Real Estate Cities in America

10 Most Expensive States To Live In America

The 10 Best Airlines in the World

The 10 Best-Selling Cars in 2014

The 10 Best Industries to Invest In

The 10 Most Expensive States to Own a Car In

Top 10 Business Schools in US: 2014 Rankings

Top 20 Female Billionaires in 2014

6 Movies That You Should Watch to Better Understand The Cold War

Top 15 Best Paying Jobs for Women in 2014

Top 6 Things Rich People Do Differently Every Day

5 Retirement Mistakes To Avoid (and Einstein’s Famous Quote)

11 Smartest People in the World

6 Films About the Financial World You Need To Watch (While “The Wolf” is Not Around)

Warren Buffett and Billionaires Are Crazy About These 7 Stocks

The Top 10 States With Fastest Internet Speeds

10 Best Places to Visit in USA in August

Top 10 Cities to Visit Before You Die

Top 10 Genetically Modified Food In the US

15 Highest Grossing Movies Opening Weekend

5 Best Poker Books For Beginners

10 Strategies Hedge Funds Use to Make Huge Returns

Top 10 Fast Food Franchises to Buy

10 Best Places to Visit in Canada

Best Summer Jobs for Teachers

10 Youngest Hedge Fund Billionaires

Top 10 One Hit Wonders of the 90s

Fastest Growing Cities In America

Top 10 U.S. Cities for Freelancers

Top 9 Most Popular Free iPhone Apps

Top 10 Least Expensive Private Business Schools in the US

Top 15 Most Expensive Countries in the World – 2014

Top 6 Tax Scams and How to Protect Yourself

Top Businesses to Invest In

Subscribe

Enter your email:

Delivered by FeedBurner

X

Thanks! An email with instructions is sent to !

Your email already exists in our database. Click here to go to your subscriptions

Insider Monkey returned 47.6% in its first year! Wondering How?

Download a complete edition of our newsletter for free!