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Array BioPharma Touts Approval Of Melanoma Drug

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Array BioPharma Touts Approval Of Melanoma Drug
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Array Biopharma Inc (NASDAQ: ARRY) shares were halted Wednesday after the Food and Drug Administration approved its drug candidate. 

What Happened 

The FDA approved Braftovi in combination with Mektovi for patients with unresectable or metastatic BRAF-mutant melanoma.

Array spiked 3.1 percent before being halted around 12:52 p.m. ET. Shares were volatile, last down about 2 percent after resuming trading at 2:15 p.m. Wednesday.

Why It’s Important

The therapy is thought to have an expansive market opportunity, as nearly half of patients with metastatic melanoma have the BRAF mutation.

“As presented at ASCO, BRAFTOVI [and] MEKTOVI is the first targeted treatment to demonstrate over 30 months median overall survival in a Phase 3 trial,” Array CEO Ron Squarer said in a press release. “These products represent a new standard of care for BRAF-mutant melanoma patients.”

What’s Next

The combination therapy is immediately available for order through select specialty pharmacies.

Array is in the process of submitting its trial results to global regulatory authorities.

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