Naproxcinod gets thumbs down from FDA review panel |
Biotechnology Companies | |||
Written by Hugh McManus | |||
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The review panel published its opinion of naproxcinod yesterday and gave the drug a thumbs down. The stock dropped over fifty percent in response settling with a loss for the day of 40%. The FDA published a background document for the panel on Monday. As I said on Monday, the analysis wasn't very flattering for the drug: it doesn't work better than the current standard of care; it didn't function as a antihypertensive agent. The FDA is still free to approve the drug, but with a 16-1 vote against the therapy by the review panel, I'd deem it unlikely that this drug will receive marketing approval. The PDUFA date for this drug is July 24.
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