Shares of Arena Pharmaceuticals Inc. nearly doubled in price in premarket trading Friday, the day after Food and Drug Administration advisers recommended approval for its potential weight-loss drug lorcaserin.
An FDA panel voted 18-4 on Thursday for the drug, despite concerns over cardiac risks. The FDA is not bound to follow the recommendations of its advisory panels, but it generally does. It has set a target date of June 27 for deciding whether to approve sales of the drug.
The panel vote came a couple days after regulators gave a favorable assessment of the drug, which the FDA had rejected in 2010 after scientists raised concerns about health issues that included tumors in laboratory animals.
Arena, based in San Diego, re-applied for approval and submitted more data.
A review of all the research studies by the FDA staff, posted online Tuesday, stated that new analysis Arena submitted suggests there's only a "negligible risk" of tumors in people taking the drug. However, questions remain about it possibly increasing the risk of high blood pressure in diabetics or damaging heart valves.
Arena shares more than doubled in premarket trading on Friday, rising $3.89 to $7.55. The stock had closed 2011 trading at $1.87.
Lorcaserin is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval. Shares of another weight-loss drug developer, Orexigen Therapeutics Inc., climbed 45 cents, or 13.4 percent, to $3.80 in premarket trading Friday.
Shares of the third company, Vivus Inc., rose slightly Thursday in after-hours trading. It had closed at $22.69 per share on Thursday.
- Food and Drug Administration