regulatory approval: On July 22, 2014, the Company announced positive top line results from the Phase III clinical trial of Puma investigational breast cancer drug, PB272 neratinib . Based on these results, the Company stated that it plans to file for regulatory approval of neratinib in the first half of 2015, a claim that was confirmed as recently as November 13, 2014, according to Market Watch. On this news, shares of Puma fell $35.49 per share, or more than 16%, to $189.51 per share in intraday trading on December 3, 2014 and The investigation concerns whether Puma and certain of its officers and/or directors have violated Sections 10 b and 20 a of the Securities Exchange Act of 1934. On December 2, 2014, the Company reversed course and announced that the submission for regulatory approval would be delayed until the first quarter of 2016. The Company also stated that instead of filing for regulatory approval of the drug as a treatment for advanced stage breast cancer, it would now be submitting an application for approval as an early stage breast cancer treatment.
(news.financializer.com). As
reported in the news.
Tagged under Phase III clinical trial, breast cancer topics.