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Mirati Therapeutics' Adagrasib Gets Breakthrough Therapy Designation

Shares of Mirati Therapeutics, Inc. (MRTX) gained nearly 5% in extended trading session on Thursday after the clinical-stage oncology company announced that the U.S. FDA has granted breakthrough therapy designation to adagrasib for treatment of patients with advanced non-small cell lung cancer harboring the KRAS G12C mutation.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

The designation for adagrasib is supported by preliminary results from the registrational Phase 1/2 KRYSTAL-01 trial in patients with advanced NSCLC, whose cancer had progressed following prior treatment with immunotherapy and/or chemotherapy.

Charles Baum, president and chief executive officer, said, "We look forward to submitting a New Drug Application for adagrasib in the second half of this year and further advancing adagrasib across a broad development plan with the goal of improving clinical outcomes in patients with KRASG12C mutated cancers."

MRTX closed Thursday's trading at $162.46, down $0.57 or 0.35%, on the Nasdaq. The stock, however, gained $7.48 or 4.60%, in the after-hours trade.

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