Adagene (ADAG) said the US Food and Drug Administration granted Fast Track designation to its muzastotug drug in combination with Merck's (MRK) Keytruda for treating adults with microsatellite-stable metastatic colorectal cancer without active liver metastases.

The designation is supported by early data showing efficacy, durable responses and safety, and allows for the possibility of a rolling review of future marketing applications, Adagene said Tuesday in a statement.

Adagene plans to continue its randomized Phase 2 trial and expects a registration-enabling Phase 3 study to start in 2027.

The company's shares rose 3.6% in recent Tuesday trading.

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