What happened
Sorrento Therapeutics (SRNE.Q -14.29%) didn't have a case of the Mondays at all. The company's stock zoomed 6.7% higher today on very encouraging news from across the pond.
So what
After U.S. market hours on Friday, Sorrento divulged that the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) has authorized the company to begin a phase 2 efficacy trial of its COVIDROPS, an experimental stem-cell drug to combat COVID-19. The regulator's decision is based on safety data from an earlier study conducted in the U.S. by the California-based biotech.
Image source: Getty Images.
The trial will be a double-blind clinical study involving 350 participants afflicted with COVID who are asymptomatic or mildly symptomatic. They will receive a 10-milligram or 20-milligram dose, or a placebo. This research will accompany both a phase 2 trial in the U.S., and a separate study in Mexico.
Sorrento said that if COVIDROPS prove efficacious and safe to administer in the three trials, the company will apply for Emergency Use Authorization from the Food and Drug Administration. It will also seek similar authorization in the U.K., the European Union, India, and Mexico, among other jurisdictions.
Now what
While much of the world is covered by coronavirus vaccines, there is still a need for an authorized drug to treat instances of infection. Sorrento's COVIDROPS getting the green light for important clinical testing is indisputably good news for the company...and, hopefully, for a planet with regions still in the grip of the pandemic.
