Rigel Pharmaceuticals Shares Leap Premarket on FDA OK of Rezlidhia

By Colin Kellaher

Shares of Rigel Pharmaceuticals Inc. jumped more than 40% in premarket trading Friday after the biotechnology company said the U.S. Food and Drug Administration approved Rezlidhia for certain leukemia patients.

The South San Francisco, Calif., company said the approval covers Rezlidhia for adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test.

Rigel in August said it had inked an exclusive license agreement with Forma Therapeutics Holdings Inc. to develop, manufacture and commercialize the drug, which was under FDA review at the time with a target action date of Feb. 15, 2023.

Danish pharmaceutical company Novo Nordisk AS acquired Forma in October in a $1.1 billion deal.

Rigel said it will be responsible for the launch and commercialization of Rezlidhia in the U.S., adding that it plans to work with potential partners to further develop and commercialize the drug outside the U.S.

Rigel shares, which closed Thursday at 68.4 cents, were recently up nearly 43% to 97.7 cents in premarket trading.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

December 02, 2022 06:59 ET (11:59 GMT)

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