=Puma Biotechnology (PBYI) reported earnings on Wed 9 Aug 2017 (a/h)

Puma Biotech. misses by $0.06; announces upcoming milestones 

• Reports Q2 (Jun) loss of $1.38 per share, excluding non-recurring items, $0.06 worse than the two analyst estimate of ($1.32).
• "During the second quarter of 2017, we achieved a significant milestone for Puma with the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee meeting, which led to last month's FDA approval of NERLYNX (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. This marked a major milestone for breast cancer patients and for Puma," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Despite advances in early stage HER2-positive breast cancer treatment, there continues to be a need to reduce the risk of disease recurrence. NERLYNX has been demonstrated to significantly reduce that risk and offers physicians and their patients another treatment option. NERLYNX is now commercially available by prescription in the United States. We are also working with the European Medicines Agency (EMA) on their review of our marketing authorization application (MAA) for this indication and we expect the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, to issue an opinion regarding the MAA for neratinib in the first quarter of 2018....In the second half of this year, we anticipate the following clinical milestones: (i) presentation of the 5-year disease free survival (DFS) data from the ExteNET Phase III trial of NERLYNX as an extended adjuvant treatment in HER2-positive early stage breast cancer in the third quarter of 2017 and (ii) reporting additional data in the fourth quarter of 2017 from the Phase II trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer using loperamide, budesonide and colestipol antidiarrheal prophylaxis."