hares of drugmaker Cephalon Inc. rose 10 percent on Friday after its investigational cancer pain drug moved a step closer to U.S. regulatory approval.
Late Thursday the biotech company said it received an "approvable letter" from the U.S. Food and Drug Administration for Fentora, meaning the agency has requested additional information about the pain medication before it will approve the drug.
But the company said no new studies or data will be required for the treatment, called Fentora, and the labeling issues are mainly agreed upon. It also said the FDA will review Cephalon's response within 60 days.
Analysts called the news positive, given the relative lack of new information sought by the FDA.
The drug is intended to treat intense, rapid-onset pain, known as breakthrough pain, in cancer patients.
Shares of the company rose $5.59, or 10 percent, to $59.87 on Nasdaq in mid-morning trade.
Late Thursday the biotech company said it received an "approvable letter" from the U.S. Food and Drug Administration for Fentora, meaning the agency has requested additional information about the pain medication before it will approve the drug.
But the company said no new studies or data will be required for the treatment, called Fentora, and the labeling issues are mainly agreed upon. It also said the FDA will review Cephalon's response within 60 days.
Analysts called the news positive, given the relative lack of new information sought by the FDA.
The drug is intended to treat intense, rapid-onset pain, known as breakthrough pain, in cancer patients.
Shares of the company rose $5.59, or 10 percent, to $59.87 on Nasdaq in mid-morning trade.
posted by doublezero at
11:35 AM
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