VSTM Stock Soars 22% in a Month on Ovarian Cancer Combo Drug Approval

Core Insights - Verastem Oncology's shares increased by 22.2% in a month due to FDA approval of a new treatment for KRAS mutant recurrent low-grade serous ovarian cancer [1] - The FDA granted accelerated approval for the combination regimen of avutometinib and defactinib, marketed as "Avmapki Fakzynja Co-Pack," making it the first FDA-approved treatment for this indication [2][7] - The stock has surged 64.8% year-to-date, significantly outperforming the industry, which declined by 5.8% [5] FDA Approval and Treatment Details - The approval was based on results from the phase II RAMP 201 study, which showed a 44% overall response rate and a median duration of response between 3.3 to 31.1 months for patients with KRAS mutations [6] - Full approval is contingent on results from the phase III RAMP 301 confirmatory study, which will assess the treatment's efficacy in a broader patient population [3] Future Developments - Verastem is also exploring the use of the combination therapy for metastatic pancreatic ductal adenocarcinoma (PDAC), with positive results reported from the phase I/II RAMP 205 study showing an 83% overall response rate in one cohort [9][10] - The company plans to initiate a registrational phase III study for front-line metastatic PDAC in 2026 and is evaluating the combination with a KRAS G12C inhibitor for non-small cell lung cancer [12] Market Position - The Avmapki/Fakzynja combo has received Breakthrough Therapy designation and Orphan Drug designation from the FDA, indicating its potential significance in treating recurrent LGSOC [7] - The company is currently ranked 3 (Hold) by Zacks, with other biotech stocks like Bayer, Lexicon Pharmaceuticals, and Amarin holding better ranks [13]