JPMorgan analyst Cory Kasimov says that while Roche's (RHHBY) positive Aphinity trial results take the near-term best-case scenario off the table for Puma Biotechnology (PBYI), the ultimate impact on Puma "remains to be seen." The future of Puma's neratinib in the adjuvant breast cancer setting largely rests on the nuances of the Roche data, namely the magnitude of benefit, the subgroups that drive the benefit and details of the safety profile, Kasimov tells investors in a research note while pointing out that Roche's press release is light on details. The analyst initially expected that positive Aphinity results would take a third of the value out of Puma shares. Kasimov adds, however, that investor feedback this morning suggests the selloff could provide an opportunity ahead of Aphinity study details at ASCO and pending neratinib data points in first half of 2017. Puma shares are down 25%, or $9.50, to $29 in pre-market trading. Roche shares are up 6% to $32.30.

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Alecensa for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer, as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor. "With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for people with early-stage ALK-positive lung cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "At Genentech, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread. This approval brings us one step closer to achieving that mission."