Stock of Cogent Biosciences, Inc. (COGT) is gaining around 8 percent on Monday morning trading after the U.S. Food and Drug Administration accepted its New Drug Application for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis, and assigned a Prescription Drug User Fee Act target action date of December 30, 2026.
The company's shares are currently trading at $36.80 on the Nasdaq, up 8.12 percent. The stock opened at $36.79 and has climbed as high as $37.18 so far in today's session. Over the past year, it has traded in a range of $3.72 to $43.73.
The application was based on encouraging data from the pivotal SUMMIT trial, which demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints.
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Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.