Basilea Pharmaceutica AG (BSLN), a Swiss developer of an antibiotic to treat pneumonia, fell the most in two months after the company said U.S. regulators want two trials of the drug before they consider granting approval.
Basilea shares fell as much as 7.7 percent, the steepest intraday drop since June 20, and were down 5.9 percent at 74.15 Swiss francs as of 1:19 p.m. in Zurich. Before today the stock gained 93 percent this year, including reinvested dividends, compared with the Swiss Performance Index’s 19 percent advance.
The U.S. Food and Drug Administration has indicated that its guidelines requiring two trials of a drug in each disease for which a company seeks approval are still valid, Basel, Switzerland-based Basilea said in a statement today. The company said it’s continuing its discussions with the agency and may receive approval in Europe for the drug this year.
“We are concerned that the FDA is persevering with its guidance of requesting two trials per pneumonia indication,” Olav Zilian, an analyst at Helvea SA in Geneva, wrote in a note today.
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