Verastem surges 121% as VS-7375 data readout nears

Verastem Oncology shares have climbed 121% in three months as investors bet that VS-7375, an oral KRAS G12D inhibitor, can carry the company beyond its approved ovarian cancer drug into pancreatic, lung and colorectal tumors where the mutated target is far more common.

"VS-7375 is designed to bind both the active and inactive states of KRAS G12D, which could make it more complete than compounds that hit only one form of the protein," Manuel Hidalgo Medina, director of the Gastrointestinal Cancer Center at NYU Langone Health and an investigator in the trials, said ahead of an Oct. 14 data presentation.

The rally also reflects accelerating sales of Avmapki Fakzynja Co-Pack, the avutometinib-defactinib combination that won accelerated approval in May 2025 for KRAS-mutated recurrent low-grade serous ovarian cancer. The regimen generated $25.1 million in net product revenue in the second quarter, up 1,095 percent from a year earlier and 34 percent sequentially from $18.7 million in the first quarter.

The stakes are the difference between a single-indication product and a franchise. Verastem plans to meet the FDA before year-end to discuss phase III registration designs in first-line metastatic pancreatic cancer, colorectal cancer and advanced non-small cell lung cancer, with enrollment targeted for the first half of 2027.

VS-7375 Data Readout Looms Oct. 14

Verastem will present initial efficacy and updated safety data for VS-7375 across pancreatic, lung and colorectal cancers at an investor event on Oct. 14, building on a clinical update reported in June. The company is running three registration-directed phase II studies — TARGET-D 201 in metastatic pancreatic ductal adenocarcinoma, TARGET-D 202 in advanced non-small cell lung cancer and TARGET-D 203 in metastatic colorectal cancer — after dosing the first patients in all three by July. The lung study includes patients with asymptomatic brain metastasis, while the pancreatic and colorectal studies cover the first-line setting. Enrollment is expected to finish by year-end.

The June update from the phase I/II TARGET-D 101 study showed encouraging anti-tumor activity in the pancreatic and lung monotherapy cohorts and the colorectal combination cohort, with follow-up data still maturing. In July, Verastem struck a partnership with Erasca to test VS-7375 alongside Erasca's oral pan-RAS molecular glue ERAS-0015 in KRAS G12D-driven solid tumors.

Commercial Base Grows as Pipeline Expands

The approved ovarian cancer drug provides a revenue base while the pipeline matures. Beyond its approved use, the avutometinib-defactinib combination is being studied in first-line metastatic pancreatic cancer, where a phase Ib/IIa RAMP 205 study showed a 52 percent confirmed objective response rate when added to gemcitabine and nab-paclitaxel, with six-month overall survival and progression-free survival rates of 86 percent and 68 percent.

Verastem is running the international phase III RAMP 301 confirmatory study in recurrent low-grade serous ovarian cancer regardless of KRAS status, with top-line data expected in mid-2027. Positive results could support converting the accelerated approval into traditional approval in the U.S., while the company pursues regulatory filings in Europe and Japan.

Verastem shares have risen 4.9 percent year to date, trailing the 10.2 percent gain for its industry group, and carry a Zacks Rank #3 (Hold). Better-ranked oncology peers such as Precigen, AC Immune and Aldeyra Therapeutics have drawn more favorable analyst ratings, underscoring the competition for investor capital in the sector. The October readout and the year-end FDA meeting are the near-term events that will determine whether the three-month surge extends or stalls. A setback in any of the three tumor types would expose the stock to sharp downside given how much of the rally rests on VS-7375's promise.

This article is for informational purposes only and does not constitute investment advice.