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Biotech Stocks Facing FDA Decision In June 2020

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The FDA has been focusing mainly on COVID-19-related review since March. But that said, the regulatory decision on drugs proposed for rare tumors and life-threatening diseases has not been deferred.

As the novel coronavirus continues to spread across the globe, companies are working on tests, medications, and vaccines to bring this pandemic to a halt.

A number of notable firsts have been achieved on the regulatory front in the month of May.

Everlywell COVID-19 Test Home Collection Kit, developed by Everlywell, Inc., was authorized by the FDA on May 16, becoming the first standalone at-home sample collection kit that can be used with certain authorized tests.

On May 6, Novartis' Tabrecta received FDA approval, becoming the first targeted therapy to treat NSCLC with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping).

Eli Lilly and Co.'s (LLY) Retevmo, greenlighted on May 8, is the first therapy for patients with lung and thyroid cancers with a certain genetic mutation or fusion.

The first drug for fourth-line treatment of advanced gastrointestinal stromal tumors, Qinlock, developed by Deciphera Pharmaceuticals, Inc. (DCPH) secured FDA approval on May 15.

So far this year, 20 novel drugs have won the FDA stamp of approval compared to 11 during the same period in 2019. The number of novel drugs approved for the full year of 2019 was 48.

Now, let's take a look at the biotech stocks awaiting a regulatory decision in the month of June.

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