FDA Accepts NDA with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST
“We are excited to announce that our bezuclastinib NDA for patients with GIST has been accepted for review by the FDA,” said Andrew Robbins, President and Chief Executive Officer of Cogent Biosciences. “We look forward to presenting the full, groundbreaking results from the PEAK trial at ASCO this weekend, and our preparations for expected bezuclastinib launches in both GIST and systemic mastocytosis later this year are well underway.”
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