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 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 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 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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