Verastem Oncology Begins TARGET-D 201 Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 16 2026
0mins
The company states: "Verastem Oncology announced that the first patient has been dosed in the TARGET-D 201 Phase 2 registration-directed trial evaluating VS-7375, an investigational oral KRAS G12D inhibitor with best-in-class potential, to treat patients with KRAS G12D-mutated metastatic pancreatic ductal carcinoma. TARGET-D 201 is a Phase 2, open-label, multi-center study to evaluate VS-7375 at 900 mg once daily both as monotherapy and in combination with full-dose cetuximab in patients with second-line metastatic pancreatic ductal carcinoma. The study is also evaluating VS-7375 900 mg and cetuximab in the first-line mPDAC setting, representing a potential chemotherapy-free frontline regimen. FDA Fast Track Designation was previously granted for VS-7375 for the treatment of KRAS G12D-mutated advanced or metastatic pancreatic cancer in both the first- and second-line treatment settings. In June 2025, Verastem initiated TARGET-D 101, its Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating VS-7375 in patients with advanced KRAS G12D-mutated pancreatic, non-small cell lung, colorectal, and other solid tumor cancers. Enrollment is ongoing with monotherapy dose escalation progressing from 400 mg through 900 mg QD doses without dose-limiting toxicities or major safety concerns observed to date. The study is currently evaluating a 1200 mg QD monotherapy dose and a 900 mg QD dose of VS-7375 in combination with full-dose cetuximab, as well as combinations with either gemcitabine plus nab-paclitaxel or carboplatin/pemetrexed/pembrolizumab."
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Analyst Views on VSTM
Wall Street analysts forecast VSTM stock price to rise
6 Analyst Rating
6 Buy
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Current: 4.100
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14.00
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15.60
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20.00
Current: 4.100
Low
14.00
Averages
15.60
High
20.00
About VSTM
Verastem, Inc. is a late-stage development biopharmaceutical company, which focuses on the development and commercialization of new medicines to improve the lives of patients diagnosed with ras sarcoma (RAS)/ mitogen-activated pathway kinase (MAPK) pathway-driven cancers. Its product candidates include avutometinib and defactinib. Avutometinib is an oral RAF/MEK clamp that inhibits MEK1/2 kinase activities and induces inactive complexes of MEK with A-Raf proto-oncogene, potentially serine/threonine kinase (ARAF), B-Raf proto-oncogene serine/threonine kinase (BRAF) and C-raf proto-oncogene serine/threonine kinase, creating antitumor response through maximal RAS/MAPK pathway inhibition. Defactinib is an oral, selective inhibitor of FAK and proline-rich tyrosine kinase (PYK2), the two members of the focal adhesion kinase family of non-receptor protein tyrosine kinases. FAK and PYK2 integrate signals from integrin and growth factor receptors to regulate cell proliferation.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Verastem Oncology Reports Positive RAMP 205 Trial Results
- Clinical Trial Results: In the RAMP 205 trial, 29 patients received a combination of avutometinib and defactinib with chemotherapy, achieving an 86% overall survival rate at six months, indicating the potential of this combination as a new treatment option for metastatic pancreatic cancer.
- Tumor Shrinkage Rate: Among patients at the recommended dose, 83% experienced tumor shrinkage, demonstrating the effectiveness of the treatment combination in inhibiting tumor growth, which may improve patient prognosis and quality of life.
- Research Support: Verastem received a $3.8 million grant from PanCAN to accelerate the development of this treatment combination, underscoring the commitment to pancreatic cancer research and laying the groundwork for future clinical applications.
- Future Development Directions: Verastem plans to continue evaluating the potential role of this treatment combination in metastatic pancreatic cancer and explore opportunities for strategic collaborations to advance the development and application of new therapies.
See More
Verastem's VS-7375 Receives FDA Fast Track Designation for Lung Cancer Treatment
- FDA Fast Track Approval: Verastem's oral drug VS-7375 has received Fast Track designation from the FDA, aimed at expediting its development as a treatment for advanced non-small cell lung cancer driven by specific genetic mutations, which is expected to significantly reduce patient wait times.
- Significant Market Potential: The KRAS G12D mutation occurs in about 5% of non-small cell lung cancer cases, translating to over 8,000 patients diagnosed annually in the U.S. who currently face poor treatment responses, indicating that the success of VS-7375 could transform their treatment landscape.
- Clinical Trial Progress: Verastem is conducting multiple clinical trials, including a mid-stage registration-directed trial focused on advanced lung cancer patients who have received one or two prior lines of treatment, with early safety and activity data expected in the first half of 2026.
- Investor Sentiment Shift: Following the FDA approval, retail investor sentiment around VSTM stock has shifted from 'bearish' to 'bullish', with message volume on Stocktwits significantly increasing, reflecting market optimism regarding the drug's future potential.
See More
Verastem Receives FDA Fast Track Designation for VS-7375
- Clinical Trial Progress: Verastem is conducting the TARGET-D 101 clinical trial to evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D-mutated tumors, with early data updates expected in the first half of 2026, indicating the drug's potential in treatment.
- FDA Fast Track Designation: The FDA has granted Fast Track Designation to VS-7375 for KRAS G12D-mutated non-small cell lung cancer, highlighting the drug's significant potential to address unmet medical needs and improve patient outcomes.
- Strong Market Demand: Non-small cell lung cancer is the most prevalent type of lung cancer in the U.S., with over 8,000 patients diagnosed with KRAS G12D mutations annually, showcasing the market potential of VS-7375 and its significant impact on patients.
- Multi-Center Study Initiation: The TARGET-D 202 clinical trial has been initiated to evaluate a 900mg once-daily dose of VS-7375, further validating its efficacy in advanced non-small cell lung cancer patients who have received one to two prior lines of therapy, advancing the development of new therapies.
See More
Verastem Oncology Appoints New Board Member
- New Board Member: Verastem Oncology has appointed Michael P. Bailey to its Board of Directors, bringing over three decades of experience in global pharmaceuticals and biotechnology, which is expected to significantly support the company's future growth.
- Strategic Development Focus: Bailey's appointment comes as Verastem enters a new phase with AVMAPKI® FAKZYNJA® CO-PACK and VS-7375, a potential best-in-class oral KRAS G12D inhibitor aimed at improving the quality of life for patients with rare cancers lacking effective treatments.
- Rich Leadership Experience: Currently the CEO of AVEO Pharmaceuticals, Bailey has held executive roles in several pharmaceutical companies, notably launching ERBITUX® during his tenure at ImClone Systems, providing valuable insights for Verastem's innovative pipeline.
- Acknowledgment of Former Director: The company expressed gratitude for Robert Gagnon's contributions during his tenure on the board, highlighting the importance of board member transitions in maintaining competitiveness in the rapidly evolving biopharmaceutical industry.
See More
Verastem Oncology Announces Investor Conference Schedule
- Investor Conference Schedule: Verastem Oncology is set to participate in the HCW 4th Annual BioConnect Investor Conference on May 19, 2026, and the RBC Global Healthcare Conference on May 20, 2026, showcasing advancements in RAS/MAPK pathway-driven cancers, which is expected to attract investor interest and enhance company visibility.
- Webcast Availability: The company will provide live webcasts of the presentations on its website under the 'Events & Presentations' section, with replays available for approximately 90 days post-event, ensuring that investors unable to attend live can still access critical information.
- Product Market Positioning: Verastem Oncology focuses on developing and commercializing new medicines, particularly for patients with RAS/MAPK pathway-driven cancers, with existing products like AVMAPKI® and FAKZYNJA® CO-PACK in the market, indicating the company's potential in the biopharmaceutical sector.
- R&D Pipeline Focus: The company's pipeline emphasizes novel small molecule drugs that inhibit critical signaling pathways promoting cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition, showcasing its innovative capabilities in cancer treatment.
See More
Launch of LGSOC Resource Guide to Support Patients
- Resource Integration: The STAAR Low-Grade Serous Ovarian Cancer Foundation and Verastem Oncology have launched the LGSOC Resource Guide, designed to provide comprehensive educational materials and community resources for patients and caregivers dealing with this rare form of ovarian cancer, thereby addressing significant informational gaps.
- Patient Engagement: The guide's release coincides with World Ovarian Cancer Day, emphasizing the critical role of patients in treatment decision-making, which helps them transition from feeling powerless to becoming active participants in their care, ultimately enhancing their quality of life and treatment confidence.
- FDA Interaction: In 2023, STAAR held its first-ever Externally-led Patient-Focused Drug Development meeting with the FDA, advancing recognition of LGSOC as a distinct disease requiring dedicated treatment approaches, which facilitated the development of the first FDA-approved treatment for KRAS-mutated recurrent LGSOC.
- Mental Health Focus: LGSOC patients face significant mental and physical health challenges, and the resource guide offers support information regarding emotional well-being and fertility, aiming to assist patients and their families in obtaining necessary support and information when confronting the disease.
See More
Verastem Oncology Reports Positive RAMP 205 Trial Results
- Clinical Trial Results: In the RAMP 205 trial, 29 patients received a combination of avutometinib and defactinib with chemotherapy, achieving an 86% overall survival rate at six months, indicating the potential of this combination as a new treatment option for metastatic pancreatic cancer.
- Tumor Shrinkage Rate: Among patients at the recommended dose, 83% experienced tumor shrinkage, demonstrating the effectiveness of the treatment combination in inhibiting tumor growth, which may improve patient prognosis and quality of life.
- Research Support: Verastem received a $3.8 million grant from PanCAN to accelerate the development of this treatment combination, underscoring the commitment to pancreatic cancer research and laying the groundwork for future clinical applications.
- Future Development Directions: Verastem plans to continue evaluating the potential role of this treatment combination in metastatic pancreatic cancer and explore opportunities for strategic collaborations to advance the development and application of new therapies.
See More
Verastem's VS-7375 Receives FDA Fast Track Designation for Lung Cancer Treatment
- FDA Fast Track Approval: Verastem's oral drug VS-7375 has received Fast Track designation from the FDA, aimed at expediting its development as a treatment for advanced non-small cell lung cancer driven by specific genetic mutations, which is expected to significantly reduce patient wait times.
- Significant Market Potential: The KRAS G12D mutation occurs in about 5% of non-small cell lung cancer cases, translating to over 8,000 patients diagnosed annually in the U.S. who currently face poor treatment responses, indicating that the success of VS-7375 could transform their treatment landscape.
- Clinical Trial Progress: Verastem is conducting multiple clinical trials, including a mid-stage registration-directed trial focused on advanced lung cancer patients who have received one or two prior lines of treatment, with early safety and activity data expected in the first half of 2026.
- Investor Sentiment Shift: Following the FDA approval, retail investor sentiment around VSTM stock has shifted from 'bearish' to 'bullish', with message volume on Stocktwits significantly increasing, reflecting market optimism regarding the drug's future potential.
See More
Verastem Receives FDA Fast Track Designation for VS-7375
- Clinical Trial Progress: Verastem is conducting the TARGET-D 101 clinical trial to evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D-mutated tumors, with early data updates expected in the first half of 2026, indicating the drug's potential in treatment.
- FDA Fast Track Designation: The FDA has granted Fast Track Designation to VS-7375 for KRAS G12D-mutated non-small cell lung cancer, highlighting the drug's significant potential to address unmet medical needs and improve patient outcomes.
- Strong Market Demand: Non-small cell lung cancer is the most prevalent type of lung cancer in the U.S., with over 8,000 patients diagnosed with KRAS G12D mutations annually, showcasing the market potential of VS-7375 and its significant impact on patients.
- Multi-Center Study Initiation: The TARGET-D 202 clinical trial has been initiated to evaluate a 900mg once-daily dose of VS-7375, further validating its efficacy in advanced non-small cell lung cancer patients who have received one to two prior lines of therapy, advancing the development of new therapies.
See More
Verastem Oncology Appoints New Board Member
- New Board Member: Verastem Oncology has appointed Michael P. Bailey to its Board of Directors, bringing over three decades of experience in global pharmaceuticals and biotechnology, which is expected to significantly support the company's future growth.
- Strategic Development Focus: Bailey's appointment comes as Verastem enters a new phase with AVMAPKI® FAKZYNJA® CO-PACK and VS-7375, a potential best-in-class oral KRAS G12D inhibitor aimed at improving the quality of life for patients with rare cancers lacking effective treatments.
- Rich Leadership Experience: Currently the CEO of AVEO Pharmaceuticals, Bailey has held executive roles in several pharmaceutical companies, notably launching ERBITUX® during his tenure at ImClone Systems, providing valuable insights for Verastem's innovative pipeline.
- Acknowledgment of Former Director: The company expressed gratitude for Robert Gagnon's contributions during his tenure on the board, highlighting the importance of board member transitions in maintaining competitiveness in the rapidly evolving biopharmaceutical industry.
See More
Verastem Oncology Announces Investor Conference Schedule
- Investor Conference Schedule: Verastem Oncology is set to participate in the HCW 4th Annual BioConnect Investor Conference on May 19, 2026, and the RBC Global Healthcare Conference on May 20, 2026, showcasing advancements in RAS/MAPK pathway-driven cancers, which is expected to attract investor interest and enhance company visibility.
- Webcast Availability: The company will provide live webcasts of the presentations on its website under the 'Events & Presentations' section, with replays available for approximately 90 days post-event, ensuring that investors unable to attend live can still access critical information.
- Product Market Positioning: Verastem Oncology focuses on developing and commercializing new medicines, particularly for patients with RAS/MAPK pathway-driven cancers, with existing products like AVMAPKI® and FAKZYNJA® CO-PACK in the market, indicating the company's potential in the biopharmaceutical sector.
- R&D Pipeline Focus: The company's pipeline emphasizes novel small molecule drugs that inhibit critical signaling pathways promoting cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition, showcasing its innovative capabilities in cancer treatment.
See More
Launch of LGSOC Resource Guide to Support Patients
- Resource Integration: The STAAR Low-Grade Serous Ovarian Cancer Foundation and Verastem Oncology have launched the LGSOC Resource Guide, designed to provide comprehensive educational materials and community resources for patients and caregivers dealing with this rare form of ovarian cancer, thereby addressing significant informational gaps.
- Patient Engagement: The guide's release coincides with World Ovarian Cancer Day, emphasizing the critical role of patients in treatment decision-making, which helps them transition from feeling powerless to becoming active participants in their care, ultimately enhancing their quality of life and treatment confidence.
- FDA Interaction: In 2023, STAAR held its first-ever Externally-led Patient-Focused Drug Development meeting with the FDA, advancing recognition of LGSOC as a distinct disease requiring dedicated treatment approaches, which facilitated the development of the first FDA-approved treatment for KRAS-mutated recurrent LGSOC.
- Mental Health Focus: LGSOC patients face significant mental and physical health challenges, and the resource guide offers support information regarding emotional well-being and fertility, aiming to assist patients and their families in obtaining necessary support and information when confronting the disease.
See More
