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Calliditas Therapeutics Shares Drop 10% After PDUFA Date Pushed Back

By Chris Wack

 

Calliditas Therapeutics AB shares were down 10% to $22.16 after the company said the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act goal date for its New Drug Application seeking accelerated approval for Nefecon to Dec. 15.

Volume for the stock was $156,000 shares at 12:40 p.m. ET, compared to its 65-day average volume of 27,000 shares. The stock hit its 52-week low of $20.50 on Aug. 20.

In March, Calliditas filed for FDA approval using the Accelerated Approval Program, based on the proteinuria endpoint as previously discussed with the Agency, reflecting data from the 200 patients in Part A of its trial.

In its review of the NDA, the FDA has requested further analyses of the trial data which the company has provided to the FDA. The FDA has classified these analyses as a major amendment to the NDA, extending the PDUFA goal date to December.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

September 15, 2021 13:02 ET (17:02 GMT)

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