Shire (SHPGY) to Withdraw BLA for Replagal, FDA Needs Controlled Trials for Approval

Shares of Shire plc (Nasdaq: SHPGY) are falling as the company has just announced the withdrawal of its BLA for replagal. The company said the FDA indicated a need for added controlled trials before approval was granted. Shire said the FDA showed no concerns about the safety profile of replagal. The company doesn't expect an impact on 2012 financials due to the delay.

The stock last traded at $103.78, down about 1.6 percent from Tuesday's close.

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