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Biotech Stocks Facing FDA Decision In September

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As we near the end of another month, it's time to take a look at some of the news stories that made headlines on the regulatory front.

Roche's Evrysdi secured FDA approval to treat patients two months of age and older with spinal muscular atrophy on August 7, becoming the first oral treatment for this disease. Evrysdi is the third FDA-approved medication for spinal muscular atrophy after Biogen's Spinraza and Novartis' Zolgensma.

The FDA gave speedy approval to NS Pharma's Viltepso for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping on August 12. Viltepso is the third DMD drug to be greenlighted - the other two are Exondys 51, approved in September 2016, and Vyondys 53, approved in December 2019, both developed by Sarepta Therapeutics.

On August 17, Roche's Enspryng received the official stamp of approval from the FDA for neuromyelitis optica spectrum disorder, a rare disease affecting optic nerves and spinal cord. Enspryng is the third approved treatment for this disorder. Viela Bio's Uplizna and Alexion Pharmaceuticals' Soliris are also approved to treat NMOSD.

So far this year, 36 novel drugs have passed muster with the FDA compared to 26 during the same period (Jan- Aug) in 2019.

Let's take a look at the companies that await a ruling from the FDA in September.

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