FDA Fast Track Designation for alnodesertib in ATM-negative Metastatic CRC

“The Fast Track designation for alnodesertib underscores its first-in-class potential for third-line mCRC patients with ATM-negative tumors,” said Mike Andriole, Chief Executive Officer of Artios. “Approximately 3,000 patients with ATM-negative third-line mCRC succumb to this disease annually in the United States, with no treatment options that specifically address this protein deficiency. Alnodesertib has the potential to be the first treatment specifically for this invariably lethal disease. Additionally, we are encouraged by the durable responses this program has demonstrated across other tumor types, highlighting its ability to target replication stress across a range of solid tumors.”

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