ZURICH Swiss healthcare provider Galenica's
(GALN.S) Ferinject anemia drug has hit a delay after the U.S.
Food and Drug Administration requested more safety data from
The FDA had sent a so-called "non-approvable letter" and
cited concerns about the benefit/risk ratio in the intended
patient population as well as the proposed dosing regimen, the
group said in a statement on Wednesday.
The news comes as a surprise as the FDA advisory panel
backed Ferinject, which is known in the United States as
Injectafer, in February, which sparked a rally in Galenica
The panel accepted then that data showed Ferinject's
benefits had outweighed its risks for women who cannot tolerate
oral iron, or have an unsatisfactory response to it.
"Very negative for Galenica, since the advisory committee
was positive. This comes as a big negative surprise, prices
below 350 must be expected," a Zurich-based trader said.
Galenica shares closed at 374.50 francs on Tuesday. Trading
will resume at 0800 GMT.
(Reporting by Katie Reid; editing by Rory Channing)