ZURICH (Reuters) - 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 clinical studies.
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 shares.
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