Alkermes (NASDAQ:ALKS) is up 1.5% after disclosing it’s gotten a tentative FDA approval for Vumerity (diroximel fumarate) for treating relapsing forms of multiple sclerosis.
Final approval is subject to the “expiration of a period of patent protection and/or exclusivity.”
The company says it believes this period relates
to the term of a patent of the reference listed drug product that’s set
to expire Oct. 20.
It filed its new drug application in December
2018, and certified to applicable patents of the reference listed drug
product assuming a PDUFA action date in December 2019, aiming for a
commercial launch as soon as possible after that.
https://seekingalpha.com/news/3506769-alkermes-plus-1_5-percent-tentative-vumerity-approval
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