Verastem Oncology Completes Rolling NDA Submission To The FDA For Avutometinib Plus Defactinib As A Treatment For Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer; Seeking Accelerated Approval And Priority Review Of Its NDA Submission In Patients With KRAS Mutant Low-Grade Serous Ovarian Cancer; FDA Filing Decision Expected Before The End Of 2024 With Potential For FDA Approval Decision By Mid-2025
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Verastem Oncology has completed its NDA submission to the FDA for a new treatment for recurrent KRAS mutant low-grade serous ovarian cancer, seeking accelerated approval and priority review. The FDA decision is expected by the end of 2024, with potential approval by mid-2025.
October 31, 2024 | 8:14 pm
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Verastem Oncology has submitted an NDA to the FDA for a new treatment for recurrent KRAS mutant low-grade serous ovarian cancer, seeking accelerated approval and priority review. This could lead to the first FDA-approved treatment for this rare cancer.
The completion of the NDA submission and the potential for accelerated approval and priority review are significant milestones for Verastem. If approved, this would be the first FDA-approved treatment for recurrent KRAS mutant LGSOC, addressing a significant unmet medical need. This news is likely to positively impact Verastem's stock price in the short term as it represents a major step forward in their product pipeline.
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