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Terns Reports FDA Breakthrough Therapy Label for TERN-701

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-- Terns Pharmaceuticals (TERN) said Monday the US Food and Drug Administration has granted breakthrough therapy designation to TERN-701 for the treatment of certain adult patients with chronic myeloid leukemia.

The designation is for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase without the T315I mutation previously treated with two or more tyrosine kinase inhibitors, Terns said.

The label is intended to expedite the development and review of potential new medicines for serious conditions or address significant unmet medical needs, it said.

Merck agreed in March to buy Terns for $53 per share, or about $6.7 billion.

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