Shares of drug developer Pharmasset (NASDAQ: VRUS) climbed early on Tuesday after the company hit a "home run" with results from a mid-stage study of a potential hepatitis C virus treatment.
The Princeton, N.J., based company said results from a study of the drug candidate labeled PSI-7977 showed that 91 percent of the subjects enrolled, or 43 out of 47 patients, had undetectable levels of the virus 12 weeks after their treatment stopped. The company is studying a 400-milligram dose of PSI-7977 used in combination with two other treatments in patients with a form of the hepatitis C virus who had not been treated previously.
In other news, officials at the FDA dropped a bombshell on the anti-clotting drug Xarelto this morning, noting in an agency review that Bayer (OTCBB: BAYZF.PK) and Johnson & Johnson (NYSE:JNJ) had offered insufficient data on safety as well as efficacy for preventing strokes among atrial fibrillation patients, urging an advisory committee to send researchers back to the clinic for another study. In a matter of minutes shares of Bayer dropped 12%, a substantial drop for a big pharmacutical company stock.
“There is a lack of substantial evidence that rivaroxaban will have its desired effect when used as recommended in labeling,” the FDA reviewers wrote. Also, “there is insufficient information about the drug to determine whether it is safe for use with its proposed labeling.”The staff reviewers are worried about Xarelto actually leading to future strokes or other risks.
On Thursday, the company faces a panel of medical experts advising the Food and Drug Administration on whether the blood thinner Xarelto should be marketed to ward off strokes in people with an abnormally fast heart rhythm.
Just days ago, many analysts believed the drug would get approval. "We think the FDA advisory panel will be concerned that there's a 'rebound' effect with discontinuing Xarelto," Wells Fargo analysts said in a research note last Thursday. "However, our consultants do not believe this will be a deal breaker."
Here is a look at some of the other movers in healthcare during early trading on Tuesday:
Gainers (% price change)
Corcept Therapeutics Inc.
RTI Biologics Inc.
DUSA Pharmaceuticals, Inc
Losers (% price change)
Cytori Therapeutics Inc
China Medical Tech., Inc
NPS Pharmaceuticals, Inc.
WuXi PharmaTech (Cayman
Most Actives (dollar volume)
Johnson & Johnson
Bristol Myers Squibb Co.
Merck & Co., Inc.
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