Market Overview

At Long Last, Dynavax Wins FDA Approval For Heplisav

Share:
At Long Last, Dynavax Wins FDA Approval For Heplisav
Related DVAX
The Week Ahead In Biotech: Earnings, Conferences, PDUFA Dates, Clinical Trial Results And IPOs
The Daily Biotech Pulse: AbbVie's Leukemia Drug Trial Meets Endpoint, Denali Strikes Collaboration Deal

Dynavax Technologies Corporation (NASDAQ: DVAX), a clinical-stage immunotherapy company, confirmed on Thursday the U.S. Food and Drug Administration approved its two-dose vaccine 

The company failed to gain approval for its therapy in February 2013 and in November 2016. But now that the therapy has FDA approval, the company is open to, but not waiting for, a partner to market its new product, CEO Eddie Gray told Reuters.

The Analyst

Cantor Fitzgerald's Elemer Piros, Ph.D.

The Rating

Piros maintains an Overweight rating on Dynavax's stock with a price target boosted from $24 to $25. (See Piros' track record here.) 

The Thesis

Dynavax's FDA approval will be followed up with an anticipated product launch in the first quarter of 2018, Piros said in a Thursday note. The FDA's inclusion of HEPLISAV's positive data in diabetes patients in the package insert is an encouraging factor, the analyst said.

Dynavax is expected to provide further details including pricing closer to the vaccine's launch. 

The company said it has a drug supply of over 250,000 vials of its therapy that will be available prior to the launch, with an additional 750,000 vials worth of raw material on hand, according to Cantor Fitzgerald. The supply is likely sufficient to satisfy two years of demand, giving the drugmaker leeway to produce additional supply over the coming years, Piros said. 

Dynavax is well-capitalized ,with a cash and equivalents balance of $192 million — enough to develop its immuno-oncology pipeline through 2018, the analyst said. 

Price Action

Shares of Dynavax were trading higher by 13 percent early Friday at $22.80.

Related Links:

Dynavax Now Has A De-Risked Asset With Long-Term Potential

Dynavax: Buy On Weakness Ahead Of November's PDUFA Date

Latest Ratings for DVAX

DateFirmActionFromTo
Nov 2018RBC CapitalMaintainsOutperformOutperform
May 2018JP MorganUpgradesNeutralOverweight
Feb 2018JP MorganMaintainsNeutralNeutral

View More Analyst Ratings for DVAX
View the Latest Analyst Ratings

Posted-In: Cantor Fitzgerald dynavaxAnalyst Color Health Care Price Target Reiteration Analyst Ratings General Best of Benzinga

 

Related Articles (DVAX)

View Comments and Join the Discussion!

Latest Ratings

StockFirmActionPT
MOSJP MorganDowngrades33.0
BACKeefe Bruyette & WoodsDowngrades29.0
AMTMorgan StanleyDowngrades170.0
EBAYMorgan StanleyDowngrades33.0
UNITMorgan StanleyDowngrades16.0
View the Latest Analytics Ratings
Don't Miss Out!
Join Our Newsletter
Subscribe to:
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Fintech Focus
Your weekly roundup of hot topics in the exciting world of fintech.
Thank You
for registering for Benzinga’s newsletters and alerts.
• The Daily Analysts Ratings email will be received daily between 7am and 10am.
• The Market in 5 Minutes email will be received daily between 7am and 8am.
• The Fintech Focus email will be received every Friday between 2pm and 5pm.

Buybacks And Dividends In One ETF

31 Stocks Moving In Friday's Pre-Market Session