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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Japanese entrepreneur Yusaku Maezawa has selected ten crewmembers, comprising artists, content creators, and athletes, to fly with him on SpaceX's Starship around the Moon on the dearMoon mission. SpaceX's first private lunar flight with dearMoon crew, including two backups, is planned to take place in 2023. Maezawa announced the crew for the mission in a YouTube video and a tweet. SpaceX, owned by Elon Musk, has launched 40 satellites of British communications network OneWeb into orbit. From NASA's Kennedy Space Center or KSC in Florida, Falcon 9 rocket on Thursday evening carried the satellites. The Falcon 9's first stage separated, and it then returned to Earth to make a landing on a SpaceX pad at the nearby Cape Canaveral Space Force Station. Google, owned by Alphabet Inc., plans to merge its teams working on Maps products and the mapping service Waze with effect from December 9, reports said. The decision to consolidate processes comes as the search giant is facing pressure to streamline operations and cut costs. The restructuring is expected to reduce overlapping work across the Waze and Maps products.
Follow RTT