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Biotech Movers: Chelsea Doubles, Vivus Dips

Regulatory rejection, approval send stocks opposite directions


Here’s a look at recent major developments and share moves in biotech stocks:

Vivus (NASDAQ:VVUS): Vivus dropped over 7% last week after European regulators again rejected its weight-loss drug for use in the region. The European Medicines Agency’s Committee for Medicinal Products (CHMP) said the drug — which has been approved in the U.S. under the brand Qsymia, but which Vivus would brand Qsiva in Europe — must be put through a cardiovascular trial.

Chelsea Therapeutics (NASDAQ:CHTP): Chelsea shares more than doubled last week on a favorable FDA ruling about data from a previous study on its hypotension drug, Northera. An FDA committee rejected the drug in spring 2012 and requested new data on Northera’s long-term efficacy in Parkinson’s patients; Chelsea successfully appealed to use the previous study, opening up the possibility that Northera could be approved as a short-term treatment. CHTP shares still are trading at about half their levels from the March rejection.

Oxygen Biotherapeutics (NASDAQ:OXBT): Oxygen Biotherapeutics fell over 30% last Friday after announcing it would sell $2.1 million in preferred stock to help fund studies and gain regulatory approval of Oxycyte, an early trial-stage drug that helps the body better deliver oxygen in patients with brain injuries or other trauma. The company also delisted itself from the SIX Swiss Stock exchange early last year.

Infinity Pharmaceuticals (NASDAQ:INFI): A Morgan Stanley analyst initiated coverage on the stock last Tuesday, rating it “overweight” and targeting $47 from its then-price of $35. That sent INFI shares nearly 19% higher last week to end above $41. The analyst was bullish about Infinity’s experimental drug, IPI-145, which it hopes to treat hematologic cancers and inflammatory diseases.

Oncolytics Biotech (NASDAQ:ONCY): ONCY shares dropped 15% last Wednesday and finished the week down just under 10% after announcing the pricing on its secondary share offering. The company offered 8 million shares at $4 per share, or a roughly 14% discount to Tuesday’s closing price. Oncolytics says it will use the money toward clinical trials of its developing cancer treatment Reolysin, among other purposes.

Kyle Woodley is the Deputy Managing Editor of As of this writing, he did not hold a position in any of the aforementioned securities. Follow him on Twitter at @IPKyleWoodley.

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