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The Week Ahead In Biotech: Correvio, Intra-Cellular Therapies Await FDA Decisions

Biotech stocks have been buoyant in recent sessions, as reflected by the iShares NASDAQ Biotechnology Index (NASDAQ: IBB), which traded higher for the fourth straight week. The year-end rally that's powering the broader market upside is partly responsible

Benzinga · 12/22/2019 17:08

Biotech stocks have been buoyant in recent sessions, as reflected by the iShares NASDAQ Biotechnology Index (NASDAQ: IBB), which traded higher for the fourth straight week. The year-end rally that's powering the broader market upside is partly responsible for the upside.

As the year tapers to the close, a look back shows a decent number of new molecule entity approvals and record M&A activity. Big pharma stocks continue to trade at or near the year's highs.

In the upcoming year, stock selection will play a pivotal role, as fears surrounding drug pricing and elections wane, Morgan Stanley said in a recent note.

PDUFA Dates

The FDA is set to rule on Correvio Pharma Corp's (NASDAQ: CORV) NDA for Brinavess, or vernakalant HCl in intravenous formulation, an antiarrhythmic drug that's being evaluated for the rapid onset atrial fibrillation to sinus rhythm for non-surgery patients.

The PDUFA action date is planned for Tuesday. A FDA panel, which met Dec. 10, voted against approval of the drug.

Intra-Cellular Therapies Inc (NASDAQ: ITCI) awaits FDA verdict on its schizophrenia drug Lumateperone, with the decision expected Friday.

Several catalysts, including clinical readouts and NDA/BLA filings, with the timeframe of fourth quarter/December could play out over the next week.

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