Biotech Stocks Facing FDA Decision In February 2020

cronovirus1 jan28

February is just around the corner. It's that time to take a look back at some of the top news stories of January and look ahead at what's coming next over the horizon on the regulatory front.

A topic that has been making headlines globally is the coronavirus. On December 31, 2019, China alerted the WHO to several cases of pneumonia caused by a new coronavirus in Wuhan City, Hubei Province.

Wuhan, the Chinese city home to over 11 million people, was shut down on January 1, 2020. With the virus spreading at an accelerated space, China has now shut down nearly 13 cities to contain the virus spread. As per the latest update, 4,515 people have been infected with coronavirus and the death toll in China due to this virus outbreak has crossed 100.

In the United States, 5 confirmed cases of coronavirus have been reported, and all the 5 patients had recently traveled to Wuhan, China, the epicenter of coronavirus outbreak.

On the regulatory front, a couple of firsts have been reported in the month of January.

On January 9, 2020, Blueprint Medicines Corp.'s (BPMC) Ayvakit received FDA approval, becoming the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors.

Another first that merits mention is the FDA approval of Horizon Therapeutics' Tepezza for the treatment for thyroid eye disease on January 21, 2020.

On January 23, Epizyme Inc.'s (ENZY) Tazverik was greenlighted by the U.S. regulatory agency, becoming the first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer.

As of this writing, three novel drugs have been approved in January.

Now, let's take a look at the FDA calendar of February.

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