Verastem Stock Price, News & Analysis

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.

Verastem Oncology (VSTM), a biopharmaceutical company focused on developing treatments for RAS/MAPK pathway-driven cancers, has announced its management team's participation in three upcoming investor conferences in May 2025:

• H.C. Wainwright BioConnect Conference: Fireside chat on May 20 at 12:00 PM ET
• RBC Capital Markets Healthcare Conference: Fireside chat on May 20 at 3:35 PM ET
• A.G.P. Healthcare Company Showcase: Virtual fireside chat on May 21 at 10:20 AM ET

Live webcasts will be available on Verastem's website with replays archived for approximately 90 days.

Verastem Oncology (VSTM) has secured a $75 million private placement through a combination of common stock and pre-funded warrants. The company is offering shares at $7.00 per share for approximately $24 million, and $51 million in pre-funded warrants at $6.9999 per warrant with a $0.0001 exercise price.

The placement was led by RTW Investments, with participation from BVF Partners, Nantahala Capital, Octagon Capital, OrbiMed, and Stonepine Capital Management. The closing is expected around April 28, 2025.

The proceeds will fund:

• Potential launch of avutometinib and defactinib in recurrent low-grade serous ovarian cancer
• Continued clinical development of products including VS-7375
• Working capital and general corporate purposes

Verastem Oncology (VSTM) has received FDA clearance for its Investigational New Drug (IND) application of VS-7375, an oral KRAS G12D inhibitor. The company plans to initiate a Phase 1/2a trial in mid-2025 for advanced solid tumors, including pancreatic, colorectal, and non-small cell lung cancers.

Initial data from partner GenFleet Therapeutics' Phase 1/2 study showed promising results with oral bioavailability and no dose-limiting toxicities across six dose levels, achieving partial responses in pancreatic and advanced lung cancer patients. The upcoming trial's starting dose will be based on GenFleet's efficacy findings to accelerate progress.

GenFleet will present preliminary dose escalation results at the 2025 ASCO Annual Meeting in Chicago (May 30-June 3). The abstract (#3013) is embargoed until May 22, 2025.