Verastem Stock Price, News & Analysis

Verastem Oncology (Nasdaq: VSTM) announced promising results from partner GenFleet Therapeutics' Phase 1/2 study of GFH375 (VS-7375) in advanced non-small cell lung cancer (NSCLC) patients with KRAS G12D mutation. The drug demonstrated an impressive 68.8% overall response rate (ORR) at the recommended Phase 2 dose of 600mg QD, and 57.7% ORR across all dose levels.

The study included 142 patients, with 28 having advanced NSCLC. Among NSCLC patients, all had metastatic disease, 64.3% received at least two prior therapies, and 96.4% had prior anti-PD1/PD-L1 therapy. At 600mg QD, the disease control rate reached 93.8%. The safety profile showed manageable adverse events, primarily Grade 1 or 2, with no treatment-related deaths reported.

Verastem Oncology (Nasdaq: VSTM) reported Q2 2025 financial results and significant business updates. The company achieved $2.1 million in net product revenue from AVMAPKI FAKZYNJA CO-PACK in its first six weeks following FDA approval for KRAS-mutated recurrent low-grade serous ovarian cancer. The company ended Q2 with $164.3 million in cash, providing runway into H2 2026.

Key highlights include the first patient dosed in the VS-7375 Phase 1/2a trial for KRAS G12D advanced solid tumors, Fast Track Designation for VS-7375, and positive updated data from the RAMP 205 trial in metastatic pancreatic cancer showing 83% overall response rate. Q2 financial results showed a net loss of $25.9 million, or $0.39 per share, with total operating expenses of $45.9 million.

The company continues to advance multiple clinical programs, including the Phase 3 RAMP 301 trial nearing completion of planned enrollment and expansion of the VS-7375 trial with four new cohorts.

Verastem Oncology (NASDAQ:VSTM), a biopharmaceutical company focused on RAS/MAPK pathway-driven cancer treatments, will host a conference call and webcast to discuss its second quarter 2025 financial results on Thursday, August 7, 2025, at 4:30 PM ET.

Investors can access the call by dialing (800) 715-9871 (U.S.) or (646) 307-1963 (international) with passcode 1210516. The webcast and presentation slides will be available on the company's investor relations website, with a replay available after the event.

Verastem Oncology (Nasdaq: VSTM) has received Fast Track Designation (FTD) from the FDA for VS-7375, its oral KRAS G12D inhibitor, for treating KRAS G12D-mutated pancreatic cancer in both first-line and previously treated settings.

VS-7375 is currently being evaluated in a U.S. Phase 1/2a clinical trial, with plans for global expansion. The study began at a 400mg QD dose, based on efficacy data from GenFleet Therapeutics' China trial. The trial will assess the drug as monotherapy in pancreatic and non-small cell lung cancer, and in combination with cetuximab for advanced solid tumors, including colorectal cancer.

Notably, the KRAS G12D mutation affects 37% of pancreatic cancers and is the most prevalent KRAS mutation in human cancers. Initial safety and efficacy results from GenFleet's Phase 1 study were presented at ASCO 2025.

Verastem Oncology (Nasdaq: VSTM) announced the publication of primary results from its Phase 2 RAMP 201 trial in the Journal of Clinical Oncology, evaluating avutometinib plus defactinib in recurrent low-grade serous ovarian cancer (LGSOC).

The study demonstrated significant efficacy with an overall response rate of 31% across all patients, with particularly strong results in KRAS-mutant patients (44% ORR) compared to KRAS wild-type (17% ORR). The median progression-free survival was 12.9 months overall, extending to 22.0 months in KRAS-mutant patients. Notably, 82% of patients showed tumor reduction regardless of KRAS mutation status.

The combination therapy showed a favorable safety profile with only 10% discontinuation rate due to adverse events. The most common side effects included nausea (67%), increased creatine phosphokinase levels (60%), and diarrhea (58.3%).

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company focused on RAS/MAPK pathway-driven cancer treatments, has granted stock options to four new employees. The inducement grants, issued under Nasdaq Listing Rule 5635(c)(4), consist of options to purchase 45,000 shares of common stock at an exercise price of $4.29 per share.

The options will vest over four years, with 25% vesting on the one-year employment anniversary and the remaining vesting quarterly over three years, subject to continued service with the company.

Verastem Oncology (Nasdaq: VSTM) announced the publication of updated results from their Phase 1 FRAME study in Nature Medicine, evaluating the combination of avutometinib and defactinib in solid tumors, particularly low-grade serous ovarian cancer (LGSOC).

The study demonstrated significant efficacy with an overall response rate (ORR) of 42.3% and median progression-free survival (mPFS) of 20.1 months in LGSOC patients. For patients with KRAS mutations, the results were even more promising, showing an ORR of 58.3% and mPFS of 30.8 months. In patients without KRAS mutations, the ORR was 33.3% with 8.9 months mPFS.

The safety profile was favorable, with only 4% of LGSOC patients discontinuing treatment due to adverse events. The most common side effects included rash (90%), elevated creatine phosphokinase (56%), AST elevation (43%), hyperbilirubinemia (38%), and diarrhea (38%). The study, conducted by the Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, established the foundation for the recent FDA approval of this combination therapy in KRAS-mutated recurrent LGSOC.

Verastem Oncology (Nasdaq: VSTM) has announced the dosing of its first patient in a U.S. Phase 1/2a clinical trial for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, targeting advanced KRAS G12D mutant solid tumors.

The trial, VS-7375-101, will begin with a monotherapy dose escalation phase starting at 400 mg, based on efficacious dosing from GenFleet Therapeutics' China study. The company plans to expand into monotherapy cohorts for pancreatic cancer and non-small cell lung cancer, while simultaneously evaluating VS-7375 in combination with cetuximab for colorectal cancer.

This milestone follows Verastem's recent FDA approval, commercial launch, and positive results in first-line metastatic pancreatic cancer treatment.

Verastem Oncology reported promising updated data from GenFleet Therapeutics' Phase 1 study of GFH375 (VS-7375) in China, showing significant efficacy in treating KRAS G12D mutant cancers. The oral inhibitor demonstrated a 52% overall response rate (ORR) in pancreatic ductal adenocarcinoma patients and 42% ORR in non-small cell lung cancer patients. The study enrolled 62 patients, with 98% having metastatic disease. Safety data showed no dose-limiting toxicities across all dose levels, with mostly Grade 1/2 treatment-related adverse events. Based on these positive results, Verastem is advancing VS-7375's clinical program in the U.S. with a Phase 1/2a trial, starting at 400mg dosing. The company aims to evaluate the drug both as monotherapy and in combination treatments for various advanced solid tumors.