Biotech Stocks Facing FDA Decision In December 2020

(RTTNews) - As November comes to a close, it's time to take a look back at some of the top news stories of the month related to FDA approvals and look ahead at what's in store for December.

A couple of firsts happened on the regulatory front in the month.

The FDA approved QBiotics Group Ltd.'s Stelfonta to treat dogs with non-metastatic, skin-based (cutaneous) mast cell tumors on November 16. This is the first approval for an intratumoral injection to treat non-metastatic mast cell tumors in dogs.

On November 17, Lucira Health Inc.'s single-use COVID-19 All-In-One Test Kit test was granted emergency use authorization for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is the first COVID-19 diagnostic test for self-testing at home to have won the emergency use approval.

Zokinvy, the first drug for the ultrarare genetic diseases Hutchinson-Gilford progeria syndrome and progeroid laminopathies that cause premature aging and death, was greenlighted by the FDA on November 20. Most patients die before the age of 15 years from heart failure, heart attack or stroke.

Oxlumo, the first drug for Primary hyperoxaluria type 1, another rare genetic disorder for which there was no FDA-approved therapy, passed muster on November 23. Primary hyperoxaluria type 1 causes recurrent kidney stones and loss of kidney function.

Now, let's take a look at the biotech stocks that await a ruling from the FDA in December.