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Adagene Inc. (ADAG) announced that the FDA has designated muzastotug, in combination with Merck's anti-PD-1 therapy, KEYTRUDA, as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer without current or active liver metastases. The company noted that the Fast Track Designation enables more frequent FDA interactions and may allow for rolling review of future marketing applications as Adagene continues the ongoing randomized Phase 2 and prepares for the registration trial, planned to begin in 2027.

Peter Luo, CEO and President of R&D at Adagene, said: "We are deeply encouraged by the responses we are seeing with muzastotug in combination with pembrolizumab and believe this therapy has the potential to reshape the treatment paradigm by offering patients an opportunity for extended survival with an improved quality of life. We look forward to sharing updated topline Phase 1b/2 clinical data over the next few months as we continue advancing this program with urgency and purpose."

Shares of Adagene are up 16% to $1.95 in pre-market trade on Tuesday.

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