Verastem, Inc. Files 8-K: Other Events Noted
Ticker: VSTM · Form: 8-K · Filed: Jul 23, 2024 · CIK: 1526119
| Field | Detail |
|---|---|
| Company | Verastem, INC. (VSTM) |
| Form Type | 8-K |
| Filed Date | Jul 23, 2024 |
| Risk Level | medium |
| Pages | 10 |
| Reading Time | 12 min |
| Key Dollar Amounts | $0.0001, $300 million, $270 million, $1.7 billion, $1.1 billion |
| Sentiment | neutral |
Sentiment: neutral
Topics: 8-k, other-events
Related Tickers: VSTM
TL;DR
VERA filed an 8-K for 'Other Events' - need to check details.
AI Summary
On July 23, 2024, Verastem, Inc. filed an 8-K report. The filing indicates an "Other Events" item, suggesting a significant development not covered by other standard 8-K items. Specific details regarding the nature of this event, any associated financial implications, or parties involved are not immediately detailed in the provided excerpt.
Why It Matters
This filing signals a material event for Verastem, Inc. that requires public disclosure, potentially impacting investors' understanding of the company's current status and future prospects.
Risk Assessment
Risk Level: medium — The filing of an 8-K for 'Other Events' suggests a material development that could be positive or negative, requiring further investigation to assess the risk.
Key Players & Entities
- Verastem, Inc. (company) — Registrant
- July 23, 2024 (date) — Date of report
- Needham, MA (location) — Principal Executive Offices
FAQ
What specific event is reported under 'Other Events' in this 8-K filing?
The provided excerpt does not specify the exact nature of the 'Other Events' beyond indicating that it is a reportable event under Section 13 or 15(d) of the Securities Exchange Act of 1934.
When was this 8-K report filed by Verastem, Inc.?
The report was filed on July 23, 2024.
What is the principal executive office address for Verastem, Inc.?
The principal executive offices are located at 117 Kendrick Street, Suite 500, Needham, MA 02494.
What is Verastem, Inc.'s IRS Employer Identification Number?
Verastem, Inc.'s IRS Employer Identification Number is 27-3269467.
Under which section of the Securities Exchange Act of 1934 is this 8-K filing made?
This 8-K filing is made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Filing Stats: 3,010 words · 12 min read · ~10 pages · Grade level 20 · Accepted 2024-07-23 16:01:17
Key Financial Figures
- $0.0001 — nge on which registered Common stock, $0.0001 par value per share VSTM The Nasdaq
- $300 million — s product candidate to be approximately $300 million for KRAS mt and approximately $270 mill
- $270 million — 0 million for KRAS mt and approximately $270 million KRAS wild-type ("KRAS wt") populations,
- $1.7 billion — market opportunity to be approximately $1.7 billion for KRAS mt and approximately $1.1 bill
- $1.1 billion — 7 billion for KRAS mt and approximately $1.1 billion for KRAS wt populations, respectively.
- $34,000 — and (d) an estimated cost of therapy of $34,000 per month consistent with other recent
Filing Documents
- tm2413643d3_8k.htm (8-K) — 44KB
- 0001104659-24-081882.txt ( ) — 220KB
- vstm-20240723.xsd (EX-101.SCH) — 3KB
- vstm-20240723_lab.xml (EX-101.LAB) — 33KB
- vstm-20240723_pre.xml (EX-101.PRE) — 22KB
- tm2413643d3_8k_htm.xml (XML) — 4KB
01 Other Events
Item 8.01 Other Events. InitiationofRolling NDA and Interim Duration of Therapy Data As previously disclosed, in May 2024, Verastem, Inc. (the "Company" or "Verastem") initiated the rolling submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") seeking accelerated approval of the combination of avutometinib and defactinib for patients with recurrent Kirsten rat sarcoma viral oncogene homolog ("KRAS") mutant ("KRAS mt") low-grade serous ovarian cancer ("LGSOC") who received at least one prior systemic therapy. The rolling review process allows Verastem to submit completed sections of an application for review by the FDA before all sections become available. The initial sections of the application will include the completed nonclinical and quality sections. The Company plans to seek the broadest label possible with mature RAMP 201 data to inform final indication. Previously, the FDA granted Orphan Drug Designation for the combination in LGSOC and Breakthrough Therapy Designation for the combination for treatment of patients with LGSOC with recurrent disease after one or more prior lines of therapy, including platinum-based chemotherapy. The Company plans to request a priority review of the NDA. Currently, there are no FDA-approved treatments specifically for recurrent LGSOC. The Company estimates the total annual incident addressable market opportunity for this product candidate to be approximately $300 million for KRAS mt and approximately $270 million KRAS wild-type ("KRAS wt") populations, respectively. The Company estimates the total prevalent addressable market opportunity to be approximately $1.7 billion for KRAS mt and approximately $1.1 billion for KRAS wt populations, respectively. The Company's estimates of the patient population, pricing and revenue opportunities for its product candidates, including for KRAS mt and KRAS wt patients with LGSOC, are based on a number of internal and third-party estimates and assump
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. VERASTEM, INC. Dated: July 23, 2024 By: /s/ Daniel W. Paterson Daniel W. Paterson President and Chief Executive Officer