Verastem Oncology $VSTM (-1,17 %) (NASDAQ:VSTM) today announced in a press release that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VS-7375. This designation is for the treatment of adult patients with KRAS-G12D-mutated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have already received platinum-based chemotherapy and anti-PD (L)1 antibody therapy. The company's shares, which are currently trading at USD 3.62 and have a market capitalization of USD 315 million, lost more than 10% of their value last week.
The status applies to patients who received the pre-treatments either concurrently or sequentially. VS-7375, an orally administered, selective KRAS-G12D inhibitor in clinical trials, already received FDA fast-track designation in July 2025 for the treatment of advanced or metastatic pancreatic cancer with KRAS-G12D mutation.
Non-small cell lung cancer accounts for approximately 80 % to 85 % of all lung cancers. The KRAS-G12D mutation occurs in 5% of NSCLC cases, affecting more than 8,000 patients annually in the US. To date, there is no FDA-approved therapy that specifically targets KRAS-G12D mutations in cancer.
Verastem has initiated the open-label, multicenter Phase 2 TARGET-D 202 study evaluating VS-7375 at a once-daily oral dose of 900 mg in patients with advanced NSCLC who have received one to two prior lines of therapy. The study also includes the evaluation of VS-7375 in NSCLC patients with asymptomatic, untreated brain metastases.
The company's TARGET-D 101 Phase 1/2 clinical trial, initiated in June 2025, is evaluating VS-7375 in patients with advanced solid tumors harboring a KRAS G12D mutation. Data published in March 2026 from 23 patients treated with once-daily doses of 400 mg, 600 mg and 900 mg showed generally good tolerability of the drug. No drug-related abnormalities in liver function tests or neutropenia of grade higher than 2 were observed by the data cut-off date of January 30, 2026. According to an analysis by InvestingPro the share appears undervalued based on its fair value assessment and the company has a strong current ratio of 3.04. Investors can use the comprehensive Pro Research Reportone of over 1,400 available reports for US stocks.
The trial is currently evaluating a monotherapy with a once-daily dose of 1,200 mg and a combination cohort with cetuximab at a once-daily dose of 900 mg. Verastem has initiated three pivotal Phase 2 trials in pancreatic, lung and colorectal cancer.
As a result, the share price has seen a double-digit post-market reaction. Then I'll stick with it for a while. Let's see what happens tomorrow.
