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U.S. FDA approves Rigel Pharma’s treatment for a type of leukemia

Dec 1 (Reuters) – Rigel Pharmaceuticals (RIGL.O) said on Thursday the U.S. health regulator has approved its drug for the treatment of patients with a type of leukemia, sending its shares up 14% in extended trading.

The Food and Drug Administration approved the drug, which will be sold under the brand Rezlidhia, for the treatment of a type of cancer of the blood and bone marrow called acute myeloid leukemia in patients with a susceptible genetic mutation.

Approval for the oral drug was supported by data from the company’s mid-stage study, which showed a 35% rate for complete remission of the cancer with a complete or partial recovery in blood count.

Rezlidhia will be the company’s second treatment to get approval from the FDA after Tavalisse for a rare bleeding disorder called immune thrombocytopenic purpura.

Rigel acquired the drug through a licensing agreement with Forma Therapeutics under which Rigel got the rights to develop, manufacture and commercialize Rezlidhia and the latter received an upfront payment of $2.0 million.

Forma can get an additional $17.5 million in certain near-term regulatory and first commercial sale milestones, as well as another $215.5 million on achievement of certain development and commercial targets.

Rigel said it plans to work with potential partners to further develop and commercialize the product outside the United States.

Reporting by Leroy Leo in Bengaluru; Editing by Maju Samuel

Our Standards: The Thomson Reuters Trust Principles.

Abdullah Anaman
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