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

50 Crazy Facts About Japan You Won’t Believe

Top 10 Least Expensive Hybrid Cars to Save the Planet With

The 10 Biggest ‘Gate’ Controversies in History

The 10 States with the Highest Nursing Shortages Leaving Their Hospitals Depleted

The 10 Best Value Investment Blogs that Every Investor Must Read

The 6 Cheapest Boarding Schools in Europe 2015

The 5 Most Expensive Cars To Insure in the World

The 10 Most Common Genetically Modified Foods

10 Self-Made Billionaires Who Came From Nothing

The 10 Most Expensive Cities to Live in North America

The 13 Most Expensive Headphones in the World to Represent

The Top 20 Wealthiest Soccer Teams in 2014

4 BuzzWorthy Cannabis Stocks And Some Smoking Derivative Plays

The 10 Healthiest Fast Food Chains in America to Dine At

The 5 Most Expensive Cat Food Brands You Can Spoil Your Kitty With

The 6 Best eCommerce Platforms for Small Businesses

The 10 Worst Mistakes an Entrepreneur Can Make

The 5 Most OP Characters in League of Legends to Carry Games and Crush Foes With

The 5 Best Foods to Eat Before Running that Will Help You Pound the Pavement

10 Glaring Plot Holes in The Walking Dead that a Zombie-Filled Bus Could Drive Through

The 5 Biggest Celebrity Stoners Who Love Their Reefer

The 10 Most Overrated Movies Of All Time by Out-of-Touch Critics

Top 6 Least Expensive Cruise Destinations For 2015 that Will Take You to Paradise

10 States with Lowest Substance Abuse Rates in America

The 14 Most Watched TV Finales Ever

The 10 Best Selling Role Playing Games of All Time for PC

10 Most Influential Papers In Economics

Top 8 Biggest Charities in the US

10 Worst Celebrity Career Moves Ever

Top 10 Best Paid Tennis Stars in the World

10 Cities with High Demand for Nurses

6 of the Worst Greeting Card Messages Ever Crafted

How to Make Money in ArcheAge and Build Your Empire

10 Foods To Eat To Lower Cholesterol Levels

The 10 Most Hated Television Characters of All Time

The 30 Worst Halloween Costume Ideas Ever Brought to Horrible Life

10 Vocational Skills in Demand Today with Jobs Waiting to be Filled

10 Best Places to Visit in Central and South America

The 10 Greatest Empires in History Which Nearly Conquered the World

The 6 Cheapest Boarding Schools In America 2015

5 Clear Reasons LoL is Better than DotA, Continues to Rule MOBAs

The Only 9 Teams with a Chance to Win the Super Bowl

The 15 Most Common Phobias in America that Induce Fits of Panic

Top 6 Least Expensive Tourist Destinations in 2014

Jim Goetz, Peter Fenton, Jim Breyer: Top 6 Venture Investors for 2014

Top 15 Billionaires in 2014

5 Pitfalls To Avoid When Buying a Franchise

Top 20 Medical Schools in the US – 2014 Rankings

4 Business Strategies that Turned Jamie Oliver into the World’s Richest Chef

6 Qualities That Make You A Good Team Player

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!