Press release
Verastem Oncology Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Business Updates
Avutometinib plus defactinib granted priority review by FDA in December 2024, under the accelerated approval pathway, for KRAS mutant recurrent LGSOC; PDUFA
About this update from Verastem, Inc.
[{"type":"text","content":"\nAvutometinib plus defactinib granted priority review by FDA in December 2024, under the accelerated approval pathway, for KRAS mutant recurrent LGSOC; PDUFA action date set for June 30, 2025\n\nFiled an investigational new drug application in the U.S. for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor\n\nRAMP 205 trial in 1L metastatic pancreatic cancer continues to progress with an additional dose cohort added and enrollment across all dose-level cohorts on track to complete in Q1\n\nCompany cash, cash equivalents, and investments of $88.8 million as of December 31, 2024; pro forma $151.3 million including debt refinancing and equity issuance with Oberland, and equity issuance under at-the-market facility\n\n BOSTON--(BUSINESS WIRE)--\nVerastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the three months and full year ended December 31, 2024, and highlighted recent progress.\n\n“In 2024, we made tremendous progress across our pipeline programs, most notably the NDA acceptance of our novel-novel combination of avutometinib plus defactinib for Priority Review under the accelerated approval pathway for KRAS mutant recurrent low-grade serous ovarian cancer,” said Dan Paterson, president and chief executive officer of Verastem Oncology. “2025 is expected to be a transformational year with our potential to launch the first FDA-approved treatment specifically for KRAS mutant recurrent low-grade serous ovarian cancer and become a fully integrated commercial-stage company. In addition, we anticipate advancing our pipeline programs in pancreatic cancer and non-small cell lung cancer and expect to initiate a Phase 1/2a study for VS-7375, our recently licensed KRAS G12D (ON/OFF) inhibitor.”\n\nFourth Quarter 2024 and Recent Highlights\n\nAvutometinib and Defactinib Combination in Low-Grade Serous Ovarian Cancer (LGSOC)\n\n\nOn December 30, 2024, the U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) under the accelerated approval pathway and granted Priority Review for avutometinib in combination with defactinib in adult patients with KRAS mutant recurrent LGSOC and designated June 30, 2025, as the Prescription Drug User Fee Act (PDUFA) action date.\n\n\nThe NDA was based on the positive, matu...