Biotech Stocks Facing FDA Decision In May 2019


The FDA decision on Sanofi’s (SNY) dengue vaccine Dengvaxia is expected on May 1, 2019.

Dengvaxia was approved in Europe last December. The vaccine is also approved in several endemic countries in Latin America and Asia.

If approved by the FDA, Dengvaxia would represent the first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need, particularly in the US territories of Puerto Rico and the US Virgin Islands where dengue is endemic.

Dengue is a mosquito-borne viral infection causing a severe flu-like illness. Severe dengue is a potentially lethal complication of dengue. Up to 50-100 million infections are now estimated to occur annually in over 100 endemic countries, according to the World Health Organization.

In February of this year, Philippines banned the Dengvaxia vaccine, following Sanofi’s failure to submit post-approval commitment documents.

SNY closed Thursday’s trading at $41.21, down 0.65%.