Welcome to our dedicated page for Verastem news (Ticker: VSTM), a resource for investors and traders seeking the latest updates and insights on Verastem stock.
Verastem, Inc. (NASDAQ: VSTM) is a pioneering biopharmaceutical company dedicated to discovering and developing innovative drugs that target cancer stem cells. These cells are a significant factor in tumor recurrence and metastasis, posing a substantial challenge in the treatment of various cancers. Verastem's mission is to translate groundbreaking cancer stem cell research into new medicines that address major cancers, including breast cancer.
The core focus of Verastem lies in advancing novel anticancer agents, particularly those inhibiting critical signaling pathways that promote cancer cell survival and tumor growth. This includes the development of RAF/MEK inhibitors and FAK inhibitors. These targeted therapies are designed to intercept the mechanisms that allow cancer cells to thrive and spread, offering hope for more effective treatments.
One of the company's notable projects involves the combination of avutometinib (a RAF/MEK clamp) and defactinib (a FAK inhibitor). This drug combination has shown promising results and has been granted breakthrough therapy designation for treating recurrent low-grade serous ovarian cancer (LGSOC), regardless of KRAS status, after one or more prior lines of therapy, including platinum-based chemotherapy.
Verastem has also entered into a strategic partnership with GenFleet Therapeutics, a clinical-stage biotechnology company. This collaboration aims to advance three oncology programs, with GFH375 being the first selected candidate. GFH375, an oral KRAS G12D inhibitor, targets both the
Verastem Oncology (VSTM), focusing on RAS/MAPK pathway-driven cancer treatments, has announced its upcoming participation in the Guggenheim SMID Cap Biotech Conference. The company's management will engage in a fireside chat scheduled for Wednesday, February 5, 2025, at 1:00 PM EST.
Investors and interested parties can access a live webcast of the presentation through the 'Events & Presentations' section of Verastem's website. The recorded session will remain available for approximately 90 days following the presentation on the company's website at www.verastem.com.
Verastem Oncology announced key 2025 priorities and milestones for its RAS/MAPK pathway-driven cancer pipeline. The FDA granted priority review for avutometinib plus defactinib combination therapy for recurrent KRAS mutant LGSOC, with a PDUFA date of June 30, 2025. The company plans a U.S. commercial launch in mid-2025.
Key developments include: ongoing RAMP 205 trial in metastatic pancreatic cancer with updated data expected in Q1 2025; VS-7375 IND filing planned for Q1 2025 with Phase 1/2a study initiation in mid-2025; and recent financing providing runway beyond potential FDA approval.
The company's 2025 strategic priorities focus on: launching avutometinib plus defactinib in the U.S. for LGSOC; expanding the combination therapy to other solid tumors; and advancing its early-stage pipeline, including VS-7375, a KRAS G12D inhibitor.
Verastem Oncology (VSTM) has appointed Matthew E. Ros as chief operating officer as the company prepares for its transition to a commercial-stage organization. Ros, who brings over 35 years of biopharmaceutical industry experience, will report to CEO Dan Paterson and join the executive leadership team.
The appointment comes as Verastem prepares for a potential mid-2025 product launch of a first-in-class treatment combination for low-grade serous ovarian cancer. Ros's previous experience includes serving as CEO at FORE Biotherapeutics and executive roles at Epizyme, Sanofi-Genzyme, and ARIAD Pharmaceuticals, where he led commercial organizations and secured FDA approvals.
The company focuses on advancing medicines for RAS/MAPK pathway-driven cancers, with their upcoming treatment targeting a rare cancer that currently has no approved specific treatments.
Verastem Oncology (VSTM) has exercised its early option to license VS-7375, a potential best-in-class oral KRAS G12D inhibitor, from GenFleet Therapeutics. The preliminary clinical data from the ongoing Phase 1 study in China shows promising results, with both confirmed and unconfirmed partial responses observed in patients with metastatic pancreatic cancer and advanced non-small cell lung cancer.
The study has cleared six dose cohorts with no dose-limiting toxicities, demonstrating oral bioavailability and plasma levels correlating with efficacious exposures that induced deep tumor regressions in preclinical models. Verastem plans to file a U.S. IND application in Q1 2025 and initiate a Phase 1/2a study by mid-2025.
The license grants Verastem global development and commercialization rights outside China, Hong Kong, Macau, and Taiwan. This agreement stems from an August 2023 collaboration with GenFleet targeting RAS pathway-driven cancers.
Verastem Oncology (VSTM) has secured a new credit facility of up to $150 million and a $7.5 million equity investment from Oberland Capital Management. The company also announced a strategic partnership with IQVIA to support the launch of avutometinib plus defactinib for recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC) planned for mid-2025.
The initial agreement includes $75 million in notes at closing, with potential access to an additional $75 million upon achieving specific milestones. The notes have a six-year interest-only period with floating rates. Oberland Capital will receive 1.0% of the first $100 million in annual net sales of certain products.
The company's cash position was $88.8 million as of December 31, 2024, with a pro forma balance of $128.6 million including the debt refinancing and equity issuance. The FDA has set a PDUFA date of June 30, 2025, for the NDA submission.
Verastem Oncology (VSTM) has announced the granting of stock options to a new employee as part of their inducement compensation package. The grant includes options to purchase 15,000 shares of common stock at an exercise price of $6.49 per share, which matches the company's closing stock price on January 2, 2025.
The stock options will vest over a four-year period, with 25% vesting on the first anniversary of employment, and the remaining shares vesting quarterly over the following three years in equal amounts. The continuation of vesting is contingent upon the employee's continued service with Verastem Oncology. This grant was made under Nasdaq Listing Rule 5635(c)(4) as an inducement for employment.
Verastem Oncology (VSTM) announced FDA acceptance and Priority Review of its New Drug Application (NDA) for avutometinib in combination with defactinib for treating recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). The FDA set a PDUFA target action date of June 30, 2025.
The NDA submission, completed in October 2024, is based on Phase 2 RAMP 201 clinical trial results, which showed substantial overall response rates with durable responses. If approved, this would be the first FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOC. The company is currently conducting RAMP 301, a Phase 3 confirmatory trial, which could potentially support an expanded indication regardless of KRAS mutation status.
Verastem Oncology (VSTM) reported preliminary clinical data for its RAMP 203 Phase 1/2 study, testing a triplet combination therapy in KRAS G12C mutant advanced non-small cell lung cancer (NSCLC). The therapy combines avutometinib, LUMAKRAS™ (sotorasib), and defactinib. No dose-limiting toxicities were observed in the first cohort of three patients previously treated with a G12C inhibitor. Two of these patients showed initial tumor reductions of at least 20% at first scan, with all three remaining on treatment.
The company plans to continue enrollment and present an interim update at a medical meeting in H2 2025. The doublet combination study has completed enrollment (n=28) in the treatment-naïve cohort, while the prior-treated cohort is expected to complete enrollment in early 2025.
Verastem Oncology (Nasdaq: VSTM) announced its management team's upcoming participation in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference. The presentation is scheduled for Tuesday, December 3rd at 11:15 am EST.
The event will be accessible through a live webcast under the 'Events & Presentations' section of Verastem's website. A replay will remain available on the website for approximately 90 days after the presentation.
Verastem Oncology (Nasdaq: VSTM) reported its Q3 2024 financial results and highlighted recent business updates. The company completed the rolling NDA submission for the avutometinib and defactinib combination in recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC) in October 2024. They seek accelerated approval and priority review, with an FDA decision expected by the end of 2024 and potential approval by mid-2025. Verastem presented positive data from the RAMP 201 trial at IGCS 2024, showing robust response rates and low discontinuation due to adverse events. Financially, the company ended Q3 2024 with $113.2 million in cash and equivalents, providing a runway through mid-2025. Total operating expenses were $37.0 million, up from $21.3 million in Q3 2023, driven by increased R&D and SG&A costs. The net loss for Q3 2024 was $24.0 million, or $0.60 per share, compared to $20.0 million, or $0.75 per share, in Q3 2023.
FAQ
What is the current stock price of Verastem (VSTM)?
What is the market cap of Verastem (VSTM)?
What does Verastem, Inc. specialize in?
What are some of Verastem's key projects?
Who are Verastem's partners?
What is GFH375?
What makes Verastem's approach unique?
What are RAF/MEK and FAK inhibitors?
What types of cancer is Verastem targeting?
What recent achievements has Verastem made?
How does Verastem's partnership with GenFleet Therapeutics benefit their research?
Where can I find more information about Verastem, Inc.?
