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ARRY

Array BioPharma

$19.37

-0.19 (-0.97%)

12:07
06/23/18
06/23
12:07
06/23/18
12:07

Array BioPharma announces updated results from Phase 3 BEACON CRC trial

Array BioPharma announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAFV600E-mutant metastatic colorectal cancer. The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival for patients treated with the triplet was 8 months and is similar between patients receiving one prior line of therapy and patients receiving two prior lines of therapy. The confirmed overall response rate was 48% and among the 17 patients who received only one prior line of therapy the ORR was 62%. The triple combination was generally well-tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue, anemia, increased blood creatine kinase and increased aspartate aminotransferase. The presentation also referenced updated, mature Phase 2 results for the doublet of encorafenib and cetuximab that showed a mOS of 9.3 months, mPFS of 4.2 months and an ORR of 24%. The data cutoff for that analysis was January 2018 with the last patient enrolled in April of 2015. Enrollment in the randomized portion of the BEACON CRC trial is ongoing.

  • 23

    Jun

  • 30

    Jun

  • 30

    Jun

ARRY Array BioPharma
$19.37

-0.19 (-0.97%)

05/10/18
JPMS
05/10/18
NO CHANGE
JPMS
Array BioPharma added to Focus List at JPMorgan
05/10/18
JPMS
05/10/18
NO CHANGE
Target $185
JPMS
Overweight
Array BioPharma added to Analyst Focus List at JPMorgan
JPMorgan analyst Anupam Rama added Array BioPharma (ARRY) to his firm's Analyst Focus List as a growth strategy and reiterates an Overweight rating on the shares. The analyst lowered his price target for the stock to $18 from $19 after taking out MEK + I/O from his model. He believes, however, that Roche's (RHHBY) Phase 3 IMblaze370 trial failure was largely priced in. Rama recommends buying Array at current levels ahead of the "multiple" mid-year pipeline catalysts.
06/15/18
PIPR
06/15/18
NO CHANGE
Target $21
PIPR
Overweight
Array should be bought ahead of June 30 PDUFA, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff is confident in Braftovi plus Mektovi approval in BRAF-mutant melanoma by the June 30 FDA action date. Array BioPharma presented at ASCO Phase III data showing median overall survival of 33.6 months for the combo versus 16.9 months for Zelboraf control, Tenthoff tells investors in a research note. This "best-in-class efficacy and tolerability will differentiate the combo on launch," the analyst contends. He recommends buying Array shares by June 30 and reiterates an Overweight rating on the name with a $21 price target.
06/20/18
CANT
06/20/18
NO CHANGE
Target $24
CANT
Overweight
Array BioPharma shares could have more room to advance, says Cantor Fitzgerald
Cantor Fitzgerald analyst Mara Goldstein believes Array BioPharma's combination of binimetinib/encorafenib has the "potential to be best-in-class and take a market-leader position." The FDA action date is June 30. Further, the analyst sees opportunity in BRAF+ CRC based on the safety lead-in portion of the Beacon study, which she believes could expand the potential market, with updated results to be presented on June 23. Goldstein thinks Array shares "could have further room to advance" and keeps an Overweight rating on the name with a $24 price target.

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