Verastem Stock Price, News & Analysis

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.

Verastem Oncology (VSTM), a biopharmaceutical company focused on developing treatments for RAS/MAPK pathway-driven cancers, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The company's management team will engage in a fireside chat on June 4, 2025, at 4:20 pm ET in New York. Investors and interested parties can access a live webcast of the presentation through the "Events & Presentations" section of Verastem's website, with a replay available for approximately 90 days afterward.

Verastem Oncology (VSTM) reported positive results from the RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib combined with standard chemotherapy in frontline metastatic pancreatic ductal adenocarcinoma (PDAC). The dose level 1 cohort, selected as the recommended Phase 2 dose, achieved an impressive 83% overall response rate (10/12 patients). Of these responses, 8 were confirmed and 2 unconfirmed patients remain on treatment. Across all five dose cohorts, 92% (48/52) of evaluable patients showed tumor reduction. The company plans to initiate a registrational Phase 3 trial in 2026. The safety profile remained consistent with previous reports, with no new safety concerns. Verastem will host an R&D investor webcast on June 2, 2025, to discuss these results and present updated data on VS-7375, their oral KRAS G12D inhibitor.

Tempus AI (NASDAQ: TEM) has announced a collaboration with Verastem Oncology to develop a companion diagnostic (CDx) test for KRAS-mutant recurrent low-grade serous ovarian cancer (LGSOC). The partnership follows Tempus' successful confirmatory testing in Verastem's Phase 2 RAMP-201 trial, which led to the FDA's accelerated approval of the combination treatment using avutometinib and defactinib. Tempus' FDA-approved xT CDx assay is being used as an investigational assay in Verastem's global Phase 3 RAMP-301 trial to assess KRAS status in LGSOC patients. LGSOC is a rare ovarian cancer affecting younger women, representing 6-10% of serous ovarian cancers, with high recurrence rates and poor chemotherapy response. The xT CDx test can detect alterations in 648 genes and microsatellite instability status using DNA from tumor tissue and matched normal specimens.

Verastem Oncology (VSTM) reported Q1 2025 financial results and significant business updates. The company achieved a major milestone with the FDA approval of AVMAPKI™ FAKZYNJA™ CO-PACK on May 8, 2025, for treating adult patients with KRAS-mutated recurrent LGSOC. The company ended Q1 with $117.6 million in cash, strengthened to $192.6 million pro-forma after an April private placement. Key pipeline developments include: U.S. IND clearance for VS-7375 (oral KRAS G12D inhibitor) with Phase 1/2a study planned for mid-2025, completed enrollment in RAMP 205 trial's initial cohorts for pancreatic cancer, and continued RAMP 203 trial enrollment in lung cancer. Financial results showed a net loss of $52.1 million ($0.96 per share) for Q1 2025, with operating expenses of $44.2 million. The company plans to present updated clinical data at the upcoming 2025 ASCO Annual Meeting.

The FDA has granted accelerated approval to Verastem Oncology's (NASDAQ: VSTM) AVMAPKI™ FAKZYNJA™ CO-PACK, marking the first-ever treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy. The approval, based on the Phase 2 RAMP 201 study, came ahead of the June 30, 2025 PDUFA date. The trial demonstrated a 44% overall response rate in patients with KRAS mutant recurrent LGSOC, with duration of response ranging from 3.3 to 31.1 months. The oral combination therapy will be commercially available within one week. The approval is contingent upon verification of clinical benefit in a confirmatory trial. Verastem is launching Verastem Cares™ program to support patient access and reimbursement in the U.S.