Verastem Inc is a biopharmaceutical company focused on developing and commercializing innovative therapies for cancer treatment. The company primarily concentrates on discovering and advancing targeted treatments that address the unmet needs of patients with various types of cancers, particularly those that are known to be difficult to treat. Through its research and development efforts, Verastem aims to provide potentially life-changing treatment options for patients and improve outcomes in cancer care. The company works collaboratively with healthcare professionals and researchers to bring its therapies from concept to market, striving to enhance the quality of life for individuals affected by cancer. Read More
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK-pathway-driven cancers, today announced positive, updated safety and efficacy data and late-breaking presentation details of partner GenFleet Therapeutics’ Phase 1/2 study in China of GFH375, an oral KRAS G12D (ON/OFF) inhibitor, known as VS-7375 outside of China, in advanced non-small cell lung cancer patients with a KRAS G12D mutation. The data will be presented in a mini oral presentation at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer from September 6-9, in Barcelona, Spain.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced business updates and reported financial results for the second quarter ended June 30, 2025.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the Company will host a conference call and webcast to discuss its second quarter 2025 financial results and business updates on Thursday, August 7, 2025, at 4:30 pm ET.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy. Fast Track is a process designed to facilitate the development and expedite the review of new drugs intended to treat or prevent serious conditions and address unmet medical needs.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the primary analysis of the Phase 2 RAMP 201 clinical trial was published online in the Journal of Clinical Oncology (JCO). The data reported in the publication showed that avutometinib plus defactinib demonstrated a confirmed overall response rate (ORR) of 31% in all patients with recurrent low-grade serous ovarian cancer (LGSOC). The full manuscript, titled “Efficacy and Safety of Avutometinib ± Defactinib in Recurrent Low-Grade Serous Ovarian Cancer: Primary Analysis of ENGOT-OV60/GOG-3052/RAMP 201,” will also appear in the print publication of JCO.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the grant of stock options to purchase 45,000 shares of its common stock to four new employees. The awards were granted pursuant to the Nasdaq inducement grant exception as an inducement material to the employee’s acceptance of employment with Verastem Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price equal to $4.29 per share, the closing price of Verastem Oncology’s common stock as reported by Nasdaq on July 1, 2025. The stock options to purchase 45,000 shares of common stock granted to four new employees will vest at a rate of twenty-five percent (25%) on the one-year anniversary of the employee’s date of hire, with the remaining shares vesting quarterly over the next three (3) years in equal quarterly amounts, provided the employee continues to serve as an employee of or other service provider to Verastem Oncology on each such vesting date.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that updated results from the Phase 1/2 FRAME study conducted by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust were published online in Nature Medicine. The full manuscript, titled “Defactinib with avutometinib in patients with solid tumors: the phase 1 FRAME trial,” was the first-in-human study to evaluate the safety, tolerability, and efficacy of avutometinib in combination with defactinib in patients with low-grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC), and other solid tumor types.
PALM BEACH, Fla., July 08, 2025 (GLOBE NEWSWIRE) -- FN Media Group News Commentary - The global oncology market, including breakthrough treatments, is experiencing substantial growth, with revenues projected to reach hundreds of billions of dollars in the coming years. Several factors are driving this expansion, including rising cancer incidence, advancements in therapies like precision medicine and immunotherapy, and increased investment in research and development. A report from Grand View Research said that the global breakthrough therapy designation market size is projected to grow at a CAGR of 14.2% through 2030. It is a process designed to escalate the development and assessment of sanctioning of drugs & biologics that are proposed for treating severe diseases, whereas primary clinical evidence notifies that the drug determines considerable enhancement over existing therapy on a clinically significant endpoint. Furthermore, the BT (Breakthrough) designation lets pharma companies hasten the developmental process by offering additional support and assistance from the FDA and making medications available to the public faster. The report continued: “Apart from breakthrough designation therapy, there are some important tools, all of which have been in place for many years, such as fast-track designation, accelerated approval, and priority review. All of these are inclined toward approving drugs used to treat serious disorders. Although these processes can reduce a drug's time to market, standard clinical testing is required for the development process, which usually involves three phases of large-scale and controlled trials.” Active oncology biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Mustang Bio, Inc. (NASDAQ: MBIO), Verastem Oncology (NASDAQ: VSTM), Cardiff Oncology, Inc. (NASDAQ: CRDF), AstraZeneca PLC (NASDAQ: AZN).
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the first patient has been dosed in VS-7375-101, the U.S. Phase 1/2a clinical trial evaluating VS-7375, a potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, in patients with advanced KRAS G12D mutant solid tumors.
In a study conducted in China, GFH375, also known as VS-7375 in the U.S., showed an overall response rate of 52% in patients with pancreatic ductal adenocarcinoma and 42% in those with non-small cell lung cancer.
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Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced positive updated data from the dose escalation phase of the Phase 1/2 trial of GFH375 (known as VS-7375 in the U.S.). As of May 16, 2025, 23 efficacy-evaluable patients with pancreatic ductal adenocarcinoma (PDAC) and 12 efficacy-evaluable patients with non-small cell lung cancer (NSCLC) achieved an overall response rate (ORR) of 52% and 42%, respectively. The updated data were presented by Verastem’s partner, GenFleet Therapeutics, in a rapid oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2, 2025, in Chicago, IL.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that its management team is scheduled to participate in a fireside chat at the Jefferies Global Healthcare Conference on Wednesday, June 4, 2025, at 4:20 pm ET in New York.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced positive updated safety and efficacy results from the RAMP 205 Phase 1/2 trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the front-line for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). As of April 25, 2025, patients in the dose level 1 cohort, which was selected as the recommended Phase 2 dose (RP2D), achieved an overall response rate (ORR) of 83% (10/12).
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced business updates and reported financial results for the first quarter ended March 31, 2025.
FDA grants accelerated approval to Verastem's Avmapki Fakzynja for KRAS-mutated ovarian cancer; company plans $75 million funding for future developments.
The combination of Avutometinib capsules and Defactinib tablets, under the brand name Avmapki Fakzynja Co-pack, can now be used to treat patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior treatment.
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the U.S. Food and Drug Administration (FDA) has approved AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy. AVMAPKI FAKZYNJA CO-PACK is the first and only FDA-approved medicine for this disease. This indication is approved under accelerated approval based on the tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI plus FAKZYNJA is only commercially available in the U.S. as an oral combination co-pack with the two prescription products, known as “AVMAPKI FAKZYNJA CO-PACK.”
