16:15 , Aug 16, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Lung cancer Cell culture studies suggest inhibiting IKK or its scaffold protein NEMO in combination with inhibition of MC-1 could help treat STK11-deficient lung cancer. In a human STK11-deficient lung cancer cell line, the MC-1...
19:55 , May 12, 2017 |  BC Week In Review  |  Clinical News

Array planning melanoma combo NDA submission on Phase III data

Array BioPharma Inc. (NASDAQ:ARRY) reported top-line data showing that twice-daily 45 mg oral binimetinib (MEK162) plus once-daily 300 mg oral encorafenib (LGX818) significantly improved median progression-free survival (PFS) vs. encorafenib monotherapy in Part 2 of...
19:55 , May 12, 2017 |  BC Week In Review  |  Clinical News

Array planning melanoma combo NDA submission on Phase III data

Array BioPharma Inc. (NASDAQ:ARRY) reported top-line data showing that twice-daily 45 mg oral binimetinib (MEK162) plus once-daily 300 mg oral encorafenib (LGX818) significantly improved median progression-free survival (PFS) vs. encorafenib monotherapy in Part 2 of...
00:19 , May 11, 2017 |  BC Extra  |  Clinical News

Array gains on Phase III melanoma data

Array BioPharma Inc. (NASDAQ:ARRY) gained $1.41 (20%) to $8.43 on Wednesday after reporting that 45 mg binimetinib (MEK162) plus 300 mg encorafenib (LGX818) significantly improved median progression-free survival (PFS) over encorafenib monotherapy in Part 2...
21:31 , Mar 21, 2017 |  BC Week In Review  |  Clinical News

Binimetinib regulatory update

Array withdrew its NDA for binimetinib monotherapy to treat neuroblastoma Ras viral (v-Ras) oncogene (NRAS)-mutant melanoma. FDA's Oncologic Drugs Advisory Committee was to discuss the candidate's NDA at a March 29 meeting. The PDUFA date...
23:02 , Mar 20, 2017 |  BC Extra  |  Company News

Array withdraws binimetinib NDA

Array BioPharma Inc. (NASDAQ:ARRY) said it withdrew its NDA for binimetinib (MEK162) monotherapy to treat neuroblastoma Ras viral (v-Ras) oncogene (NRAS)-mutant melanoma. FDA's Oncologic Drugs Advisory Committee was to discuss the candidate's NDA at a...
07:00 , Sep 1, 2016 |  BC Extra  |  Company News

FDA accepts Array's binimetinib NDA

Array BioPharma Inc. (NASDAQ:ARRY) said FDA accepted for filing an NDA for binimetinib ( MEK162) to treat advanced neuroblastoma Ras viral (v-Ras) oncogene (NRAS)-mutant melanoma. The PDUFA date is June 30, 2017. Array said FDA...
00:09 , Apr 2, 2016 |  BC Extra  |  Clinical News

Array discontinues ovarian cancer Phase III

Array BioPharma Inc. (NASDAQ:ARRY) said it will discontinue the Phase III MILO study of binimetinib ( MEK162) to treat low-grade serous ovarian cancer after an interim analysis of the progression free survival primary endpoint "crossed...
08:00 , Dec 21, 2015 |  BC Week In Review  |  Clinical News

Binimetinib: Phase III data

The open-label, international Phase III NEMO trial in 402 patients with unresectable or metastatic NRAS mutation-positive melanoma showed that twice-daily 45 mg binimetinib met the primary endpoint of improving median PFS vs. 1,000 mg/m 2...
02:33 , Dec 17, 2015 |  BC Extra  |  Clinical News

Array gains after binimetinib meets in Phase III

Array BioPharma Inc. (NASDAQ:ARRY) jumped $0.79 to $4.62 after lead candidate binimetinib ( MEK162) led to an improvement in progression-free survival (PFS) over dacarbazine in the Phase III NEMO trial to treat neuroblastoma Ras viral...