DBV withdraws BLA for peanut allergy therapy

DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) lost $6.90 (49%) to $7.25 in after-hours trading on NASDAQ Wednesday after it said it withdrew a BLA under FDA review for peanut allergy therapy Viaskin Peanut.

According to DBV, FDA said the application lacked details regarding manufacturing procedures and quality control. The company said FDA did not cite safety or efficacy concerns and will resubmit the application as soon as possible. ...