Adagene (ADAG) and Palvella Therapeutics (PVLA) experienced notable premarket gains following the U.S. Food and Drug Administration's (FDA) decision to grant Fast Track designations to their respective investigational drugs. Adagene's shares surged by approximately 11% after the FDA fast-tracked their therapy combining muzastotug with Merck’s Keytruda for the treatment of metastatic colorectal cancer. Concurrently, Palvella Therapeutics received the designation for Qtorin rapamycin, targeting angiokeratomas. This designation is significant as it facilitates expedited development and review processes, potentially leading to accelerated approval and priority review for treatments addressing serious conditions
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