At Long Last, Dynavax Wins FDA Approval For Heplisav

Dynavax Technologies Corporation 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.

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