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Verastem Oncology (NASDAQ: VSTM) is a clinical-stage biopharmaceutical company pioneering targeted therapies for cancer treatment, with a specialized focus on inhibiting RAF/MEK and FAK signaling pathways. This dedicated news hub provides investors and industry observers with timely updates on the company's progress in developing innovative solutions for treatment-resistant cancers.
Access comprehensive coverage of Verastem's latest developments including clinical trial milestones, regulatory updates, strategic partnerships, and financial results. Our curated news collection serves as an essential resource for tracking advancements in cancer stem cell research and precision oncology programs.
Find authoritative reporting on key initiatives such as VS-6766 (RAF/MEK inhibitor) developments, combination therapy trials, and intellectual property updates. The page consolidates earnings announcements, research publications, and management commentary for efficient due diligence.
Bookmark this page for direct access to verified information about Verastem's pipeline progress and corporate developments. Check regularly for new updates on therapeutic candidates moving through clinical evaluation and their potential implications for cancer care innovation.
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.
Verastem Oncology (VSTM) has completed its rolling New Drug Application (NDA) to the FDA for avutometinib plus defactinib combination therapy for adults with recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). The company is seeking accelerated approval and priority review, with a potential FDA approval decision by mid-2025. The Phase 2 RAMP 201 study showed promising results with a 44% confirmed overall response rate, 22 months median progression-free survival, and 70% disease control rate at 6 months in KRAS mutant LGSOC patients. If approved, this would be the first FDA-approved treatment specifically for this rare cancer type.
Verastem Oncology (Nasdaq: VSTM) has announced its management team's upcoming participation in two major investor conferences. The company will attend the 2024 Truist Securities BioPharma Symposium on November 7 and participate in a fireside chat at the 2024 Guggenheim Healthcare Innovation Conference on November 13 at 9:00 am EDT.
The fireside chat will be accessible via live webcast in the Events & Presentations section of Verastem's website, with a replay available for approximately 90 days post-presentation.
Verastem Oncology presented updated data from the Phase 2 RAMP 201 trial evaluating avutometinib and defactinib combination in recurrent low-grade serous ovarian cancer (LGSOC) at the IGCS 2024 Annual Meeting. Key findings include:
- 31% overall response rate (44% in KRAS mutant, 17% in KRAS wild-type)
- Median progression-free survival of 12.9 months (22 months in KRAS mutant)
- Disease control rate at 6+ months: 61% overall (70% KRAS mutant, 50% KRAS wild-type)
- Generally well-tolerated with 10% discontinuation rate due to adverse events
Verastem plans to complete NDA submission in October 2024 for adult patients with recurrent KRAS mutant LGSOC, seeking Accelerated Approval and Priority Review from the FDA. The company aims to bring the first FDA-approved treatment for this specific indication to market in 2025.
Verastem Oncology (Nasdaq: VSTM) announced details for its late-breaking presentation of mature data from the ongoing Phase 2 RAMP 201 clinical trial at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting in Dublin, Ireland. The presentation, scheduled for October 17, 2024, at 11:42 AM ET, will include updated safety and efficacy data on the combination of avutometinib and defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC).
The company will host an investor conference call and webcast on the same day at 4:30 PM EDT to review the trial data. The presentation will cover overall response rate, progression-free survival, and duration of response. Professor Susana N. Banerjee, the global lead investigator, will present the findings.
