Puma Biotechnology Inc(NASDAQ: PBYI) stock lost over 11.2% on November 9th after-hours session given their weak bottom line. For the third quarter of 2017, the group reported a net loss on $77.2 million or a loss of $2.07 per share against a net loss of $77.8 million and $72.8 million respectively in the first and second quarter of 2017. Moreover, the European regulators seeking further information regarding the approval of Nerlynx also dampened the stock sentiment. The group derived a net revenue from initial sales of NERLYNX of over $6.1 million during the quarter.
On the other hand, the group got FDA approval and launched NERLYNX in the United States during the third quarter while NERLYNX was commercially available for treating patients with early-stage HER-2 positive breast cancer, who have previously been treated with a trastuzumab containing regimen. Prescribers for NERLYNX have been over 582 unique prescribers as of October 31, which has been growing month over month.
The results for the five-year follow-up from the Phase III trial referred to as the ExteNET study, showed that after a median follow-up of 5.2 years, neratinib treatment led to 27% decrease in the risk of invasive disease recurrence or death versus placebo. Hazard ratio was 0.73 with a p-value of 0.008. The five-year iDFS rate for the neratinib arm was 90.2% and the five-year iDFS rate for the placebo arm was 87.7%.
Puma Biotechnology also has several milestones for neratinib which includes reporting additional data from their Phase II CONTROL study on the addition of budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients with HER2-positive early stage breast cancer.
For the first quarter of 2018, they expect to get a decision from the committee from more products for human use also known as the CHMP in Europe on their application for the approval of the neratinib for use in the European Union for extended adjuvant treatment of HER2-positive early stage breast cancer. They also expect the results from the Phase III trial of neratinib in third-line HER2-positive metastatic breast cancer.
Puma Biotechnology stock generated outstanding returns this year which rallied over 320% in the last six months (as of November 9th, 2017; Source: Google finance).