Puma sinks on delayed Ph III readout

Puma Biotechnology Inc. (NASDAQ:PBYI) said Thursday in its 1Q18 earnings report that data from the Phase III NALA trial are not expected until 4Q18 due to a slower than expected event rate. On March 1, the company guided to a 1H18 read out for NALA but on a March 18 call the company mentioned the slow event rate and pushed the guidance to late June. On Thursday's call, Puma President and CEO Alan Auerbach added that if the event rate continued to slow, the milestone could be pushed further to 2019. Puma lost $13.50 (21%) to $51.80 on Thursday.

The NALA trial is evaluating neratinib in combination with capecitabine in HER2-positive metastatic breast cancer patients who have received two or more prior HER2-directed regimens. The trial’s co-primary endpoints are progression-free survival (PFS) and overall survival (OS)...