Zacks Investment Research | Dec 25, 2018 09:34PM ET
It was a busy week for the biotech sector with regulatory updates. The FDA approved Alexion’s the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here .
Acorda Gets FDA Nod ForParkinson's Disease Drug: Acorda announced that the FDA has approved its Parkinson's disease (PD) drug Inbrija (levodopa inhalation powder). The product was approved for treating OFF periods (return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa) in PD patients, who are receiving carbidopa / levodopa regimen. Inbrija is expected to be launched during the first quarter of 2019. The FDA was expected to make its decision on Inbrija in October. However, in September the FDA delayed its verdict by three months and set an action date of Jan 5, 2019. The FDA approval thus comes slightly earlier than expected.
FDA Approves Stemline’s Drug: Stemline Therapeutics, Inc (NASDAQ:STML) received FDA approval for its CD123-targeted therapy, Elzonris (tagraxofusp-erzs; SL-401) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously treated populations. The therapy will be available in early 2019. BPDCN is an aggressive hematologic malignancy. The therapy is also under review in the United States.
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