What happened
Several days after experiencing a pleasant share price pop on good regulatory news, Dynavax (DVAX +0.00%) repeated the feat on Thursday. An important partner for the company reported an encouraging development that morning, also in the regulatory sphere. Investors lapped up the fresh news, sending Dynavax shares skyward to a 16%-plus gain on the day.
So what
Valneva (VALN 0.18%), a vaccine maker based in France that uses a Dynavax adjuvant in its coronavirus vaccine, was the bringer of the good news. On Thursday, it announced that the European Medicines Agency (EMA) had accepted its marketing authorization application for its VLA2001 jab.
Image source: Getty Images.
This begins VLA2001's formal review process with the EMA, which is the healthcare regulator for the 27-member European Union. The next step will be a review by the EMA's Committee for Human Medical Products.
In Valneva's press release on the matter, CEO Thomas Lingelbach described the EMA's acceptance of its application as "an important step toward product approval."
"We remain fully committed and dedicated to working jointly with the regulators, the European members states and the European Commission toward making a more traditional and established COVID-19 vaccine technology available to people in Europe."
NASDAQ: DVAX
Key Data Points
Now what
Adjuvants enhance the immune responses that vaccines generate. So because Dynavax's CpG adjuvant serves that purpose in Valneva's jab, any win for VLA2001 is a win for Dynavax. Marketing authorization in the European Union would represent a major victory, too, as the sprawling economic bloc is home to nearly 450 million people.
