Shire likely to trade down 2%-3% on trial failure, says Leerink Leerink expects shares of Shire to trade down 2%-3% today after Vyvanse failed to show efficacy in its Phase 3 depression) trial. Leerink thinks concerns surrounding Shire's pipeline success could heighten following the news but keeps an Outperform rating on the stock.
Shire's NDA for lifitegrast for dry eye resubmssion acknowledged by FDA Shire announced that the FDA has acknowledged receipt of the resubmission of the New Drug Application for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act goal date of July 22.