Verastem, Inc. Files 8-K Report

Ticker: VSTM · Form: 8-K · Filed: May 24, 2024 · CIK: 1526119

Verastem, INC. 8-K Filing Summary
FieldDetail
CompanyVerastem, INC. (VSTM)
Form Type8-K
Filed DateMay 24, 2024
Risk Levellow
Pages9
Reading Time11 min
Key Dollar Amounts$0.0001
Sentimentneutral

Sentiment: neutral

Topics: corporate-update, 8-K

Related Tickers: VSTM

TL;DR

VSTM filed an 8-K updating corporate info. Stock still on Nasdaq.

AI Summary

On May 24, 2024, Verastem, Inc. (VSTM) filed an 8-K report. The filing indicates the company's principal executive offices are located at 117 Kendrick Street, Suite 500, Needham, MA 02494. Verastem, Inc. is registered in Delaware and its common stock trades on The Nasdaq Capital Market under the symbol VSTM.

Why It Matters

This 8-K filing provides an update on Verastem, Inc.'s corporate information, including its principal executive offices and stock exchange listing.

Risk Assessment

Risk Level: low — This filing is a routine corporate update and does not contain material financial or operational news.

Key Players & Entities

FAQ

What is the primary purpose of this 8-K filing?

The primary purpose of this 8-K filing is to report current information as required by the Securities Exchange Act of 1934, specifically updating the company's principal executive offices and confirming its stock listing.

When was the earliest event reported in this filing?

The earliest event reported in this filing occurred on May 24, 2024.

Where are Verastem, Inc.'s principal executive offices located?

Verastem, Inc.'s principal executive offices are located at 117 Kendrick Street, Suite 500, Needham, MA 02494.

On which exchange is Verastem, Inc.'s common stock traded?

Verastem, Inc.'s common stock is traded on The Nasdaq Capital Market.

What is the trading symbol for Verastem, Inc.'s common stock?

The trading symbol for Verastem, Inc.'s common stock is VSTM.

Filing Stats: 2,692 words · 11 min read · ~9 pages · Grade level 19.2 · Accepted 2024-05-24 07:01:58

Key Financial Figures

Filing Documents

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On May 24, 2024, Verastem, Inc. (the "Company" or "Verastem") issued a press release announcing the initiation of a rolling submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for Accelerated Approval of the combination of avutometinib and defactinib for adult patients with recurrent KRAS mutant ("KRAS mt") low-grade serious ovarian cancer ("LGSOC"); A copy of the press release is furnished hereto as Exhibit 99.1 to this Current Report on Form 8-K. On May 24, 2024, the Company also posted its corporate presentation on its website, a copy of which is furnished hereto as Exhibit 99.2 to this Current Report on Form 8-K.

01 Other Events

Item 8.01 Other Events. Recent Developments RAMP-201 (ENGOTov60/GOG3052) The Company recently announced that it has initiated the rolling submission of an NDA to the FDA seeking accelerated approval of the combination of avutometinib and defactinib for patients with recurrent KRAS mt 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 nonclinical and quality sections. Based on discussions with the FDA, the primary efficacy analysis will be based on the RAMP 201 study with 12 months of follow up and that the proposed indication for final submission of the clinical module can be expanded in the event the Company provides data that would be considered a substantial improvement over available therapy in the KRAS wildtype ("KRAS wt") population. 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. In the RAMP 201 trial, 115 patients with recurrent LGSOC were treated with the combination of avutometinib and defactinib, of which 109 patients had measurable tumor masses at baseline and were eligible for formal efficacy evaluation as of the data cutoff (February 2024). As of the data cutoff, all patients had a minimum follow-up of five months since enrollment. Confirmed objective response rates by blinded independent central review for patients evaluable for efficacy were 27% in all patients, and 37% and 15% in KRAS mt (n=57) and KRAS wt (n=52) LGSOC, respectively. Of the 32 patients who remained on s

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: May 24, 2024 By: /s/ Da niel W. Paterson Daniel W. Paterson President and Chief Executive Officer

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