Health Care & Insurance  December 16, 2015

Array BioPharma shares gain 35 percent following Phase 3 trial results

BOULDER — Array BioPharma Inc. shares rocketed up 35 percent in premarket trading Wednesday morning after the company reported promising results for one of its cancer drugs and announced plans for a regulatory submission in the first half of 2016.

In a release, officials for Boulder-based Array (Nasdaq: ARRY) said binimetinib, in a Phase 3 clinical trial looking at its ability to combat NRAS-mutant melanoma, “met its primary endpoint of improving progression-free survival” when compared with chemotherapy. Median PFS in patients receiving binimetinib was 2.8 months versus 1.5 months with chemotherapy.

Binimetinib, the company wrote, “was generally well-tolerated and the adverse events reports were consistent with previous results in NRAS melanoma patients.”

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The full results from from the company’s NEMO trial, including progression-free survival, overall survival, objective response rate and other metrics, will be presented in early 2016 at a medical group meeting, the company said.

NRAS melanoma is the fifth most common cancer among men and seventh most common among women in the United States. It occurs in 15 to 20 percent of patients with melanoma and is considered a poor prognostic factor.

The NEMO trial is looking at 402 patients with advanced NRAS-mutant melanoma, with two-thirds of them receiving binimetinib and one-third receiving chemotherapy.

Binimetinib is also in Phase 3 trials looking at its use in treating BRAF-mutant melanoma and low-grade serous ovarian cancer.

“We are excited to announce positive results from the NEMO trial, which suggest binimetinib has the potential to provide an important new treatment option for patients with advanced NRAS melanoma,” Array CEO Ron Squarer said in a prepared statement.

Array officials said they plan to file with the U.S. Food and Drug Administration for approval to market the drug in NRAS melanoma patients in the first half of next year.

The company’s shares went on a tear before markets opened Wednesday, climbing $1.34 to $5.17, up from Tuesday’s close of $3.83. Just days earlier, Array’s share price had hit a 52-week low of $3.72.

Array shares had gained a big boost and were trading above $8 earlier this year when Array acquired worldwide rights to binimetinib and encorafenib from Novartis. But the company’s share price had been slipping steadily ever since. When they hit $3.72 on Friday, it was their lowest point since hitting $2.98 on Oct. 13 of last year.

BOULDER — Array BioPharma Inc. shares rocketed up 35 percent in premarket trading Wednesday morning after the company reported promising results for one of its cancer drugs and announced plans for a regulatory submission in the first half of 2016.

In a release, officials for Boulder-based Array (Nasdaq: ARRY) said binimetinib, in a Phase 3 clinical trial looking at its ability to combat NRAS-mutant melanoma, “met its primary endpoint of improving progression-free survival” when compared with chemotherapy. Median PFS in patients receiving binimetinib was 2.8 months versus 1.5 months with chemotherapy.

Binimetinib, the company wrote, “was generally well-tolerated and…

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