Pharmacyclics, Inc. (PCYC)

[surf1944]

6:31AM Pharmacyclics announces NDA filing for ibrutinib accepted in two B-cell malignancies by the FDA; triggers a $75 mln milestone payment to the co (PCYC) 111.70 : Co announced that the FDA has accepted for filing its New Drug Application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma and previously treated chronic lymphocytic leukemia /small lymphocytic lymphoma. On June 28, 2013 Pharmacyclics submitted a NDA under section 505(b) of the Food, Drug & Cosmetic Act for ibrutinib. On Aug 27, 2013 the FDA notified Pharmacyclics that they have completed their filing review and determined that the application is sufficiently complete to permit a substantive review. The FDA's acceptance of the NDA triggers a $75 mln milestone payment to Pharmacyclics under its Collaboration Agreement with Janssen Biotech, a subsidiary of Johnson & Johnson (JNJ)