June 13, 2017 - The case was voluntarily dismissed.

May 8, 2017 (Shareholders Foundation) - An investor in shares of Puma Biotechnology Inc (NYSE:PBYI) filed a lawsuit in the U.S. District Court for the Central District of California over alleged violations of Federal Securities Laws by Puma Biotechnology Inc in connection with certain allegedly false and misleading statements made between February 29, 2016 and May 4, 2017.

According to the complaint the plaintiff alleges on behalf of purchasers of Puma Biotechnology Inc (NYSE:PBYI) common shares between February 29, 2016 and May 4, 2017, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between February 29, 2016 and May 4, 2017, the Defendants made false and/or misleading statements and/or failed to disclose that the Company did not anticipate that the U.S. Food and Drug Administration’s (“FDA”) would ultimately approve neratinib for the treatment of breast cancer, that as such, Puma had overstated the drug’s approval prospects and/or commercial viability, and that as a result, Puma’s public statements were materially false and misleading at all relevant times.
Los Angeles, CA based Puma Biotechnology, Inc. is a biopharmaceutical company that focuses on the development and commercialization of products for the treatment of cancer.
On November 14, 2016, news of an investigation of an open-label Phase 2 clinical trial (“CONTROL”) was revealed. The investigation concerned the incidence rate of severe diarrhea (grade 3) in early stage HER2+ breast cancer patients receiving Puma Biotechnology’s Neratinib drug (the “incidence rate”).

Following this high incidence of approximately 40%, the CONTROL study reportedly investigated the incidence rate where the antidiarrheal prophylaxis Loperamide was dispensed.

The investigation reportedly showed a high incidence rate stayed at about 27% and that the CONTROL study was then extended to include a group of patients who were administered Loperamide and the corticosteroid Budesonide. The incidence rate reportedly did drop, but was still at 12.9%.

On May 4, 2017, Puma Biotechnology, Inc disclosed the resignation of Dr. Robert Charnas, the Company’s Senior Vice President, Regulatory Affairs, citing “health reasons.”

Dr. Charnas’ resignation will be effective as of May 15, 2017, nine days before the FDA scheduled review of Puma Biotechnology, Inc’s breast cancer drug neratinib on May 24.

On May 5, 2017, Fox Business published an article entitled “Why Puma Biotechnology Shares are Crashing 18.2% Today.”

Shares of Puma Biotechnology Inc (NYSE:PBYI) declined on May 8, 2017 to $28.50 per share.