July 30 U.S health regulators have denied
approval to Regeneron Pharmaceuticals Inc's
experimental drug to prevent gout flares, dashing the hopes of
the company of expanding usage of the drug that is already on
the market for another indication.
The agency requested additional clinical data, including
additional chemistry, manufacturing and controls information
related to a proposed new dosage form for the drug, Arcalyst,
Regeneron said in a statement.
The drug is approved to treat a group of rare genetic
auto-inflammatory diseases. Regeneron said it was reviewing the
FDA's requests and will determine the appropriate next steps
The New York-based company's shares closed at $135.47 on
Monday on the Nasdaq.