Verastem Stock Price, News & Analysis

Verastem, Inc. (Verastem Oncology, Nasdaq: VSTM) is a late-stage development biopharmaceutical company focused on developing and commercializing new medicines for patients diagnosed with RAS/MAPK pathway-driven cancers. According to multiple company disclosures, Verastem Oncology is committed to advancing novel small molecule drugs that inhibit signaling pathways in cancer that promote tumor cell survival and growth, with particular emphasis on RAF/MEK inhibition, FAK inhibition, and KRAS G12D inhibition.

Verastem trades on The Nasdaq Capital Market under the ticker symbol VSTM, as noted in its SEC filings. The company describes itself as a late-stage development biopharmaceutical organization, reflecting its combination of an approved commercial product and an active pipeline of clinical-stage candidates targeting genetically and pathway-defined solid tumors.

Core commercial product: AVMAPKI FAKZYNJA CO-PACK

A central element of Verastem’s business is the U.S. commercialization of AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets). Company communications state that Verastem markets AVMAPKI FAKZYNJA CO-PACK in the United States for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication was granted accelerated approval by the U.S. Food and Drug Administration (FDA) based on tumor response rate and duration of response, with continued approval potentially contingent on verification and description of clinical benefit in a confirmatory trial.

AVMAPKI FAKZYNJA CO-PACK combines two targeted agents:

• AVMAPKI (avutometinib), described as an oral RAF/MEK “clamp” that inhibits MEK kinase activity and blocks compensatory reactivation of MEK by upstream RAF within the RAS/RAF/MEK/ERK (MAPK) pathway.
• FAKZYNJA (defactinib), a focal adhesion kinase (FAK) inhibitor intended to counteract FAK activation, which is characterized as a key mediator of drug resistance.

According to the company, the combination of avutometinib and defactinib is designed to provide a more complete blockade of signaling that drives growth and drug resistance in RAS/MAPK pathway-dependent tumors. AVMAPKI FAKZYNJA CO-PACK is not approved by the FDA or other regulators for uses beyond the specified LGSOC indication, and neither avutometinib nor defactinib is approved on a stand-alone basis for any indication.

Pipeline focus: RAS/MAPK pathway and KRAS G12D

Beyond its commercial product, Verastem’s pipeline is focused on novel small molecule drugs targeting critical signaling pathways in cancer. Company descriptions highlight three main mechanistic areas:

• RAF/MEK inhibition through avutometinib, aimed at blocking key kinases in the MAPK pathway.
• FAK inhibition through defactinib, intended to address mechanisms of drug resistance.
• KRAS G12D inhibition, centered on the oral small molecule VS-7375, described as a potential best-in-class KRAS G12D (ON/OFF) inhibitor.

VS-7375 is identified as the lead program from Verastem Oncology’s discovery and development collaboration with GenFleet Therapeutics. SEC filings and press releases state that Verastem’s U.S. Investigational New Drug (IND) application for VS-7375 was cleared and that the company initiated a Phase 1/2a clinical trial in patients with advanced KRAS G12D mutant solid tumors, including pancreatic ductal adenocarcinoma and non-small cell lung cancer. Verastem holds development and commercialization rights to VS-7375 outside GenFleet’s specified markets.

Key clinical development programs

Verastem describes several ongoing or planned clinical trials built around its targeted agents:

• RAMP 301: An international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy in recurrent LGSOC with and without a KRAS mutation. This study is intended to serve as a confirmatory trial for the accelerated approval indication and may support potential expansion of the indication.
• RAMP 205: A trial assessing avutometinib plus defactinib with standard-of-care chemotherapy as a potential first-line treatment for patients with advanced pancreatic cancer.
• RAMP 203: A Phase 1/2 trial, conducted in collaboration with Amgen, evaluating avutometinib and LUMAKRAS (sotorasib) as a doublet, and avutometinib plus defactinib with LUMAKRAS as a triplet, in patients with advanced KRAS G12C-mutated non-small cell lung cancer (NSCLC). Verastem has reported interim data and later announced its decision to discontinue RAMP 203 in order to focus resources on VS-7375 and other priority programs.
• VS-7375-101 Phase 1/2a study: A dose-escalation and expansion trial in the U.S. evaluating VS-7375 as monotherapy and in combination with other standard-of-care treatments, including cetuximab, in advanced KRAS G12D mutant solid tumors such as pancreatic, colorectal, and NSCLC.

In addition, Verastem has cited updated data from GenFleet’s Phase 1/2 studies of VS-7375 (GFH375) in China, including results in advanced pancreatic ductal adenocarcinoma and NSCLC, to support further development planning.

Business model and stage

Company statements describe Verastem Oncology as both a commercial-stage and late-stage development biopharmaceutical company. The business model centers on:

• Commercialization of AVMAPKI FAKZYNJA CO-PACK in the U.S. for KRAS-mutated recurrent LGSOC.
• Clinical development of avutometinib and defactinib combinations in multiple solid tumors, including ovarian and pancreatic cancers and NSCLC.
• Early- to mid-stage development of VS-7375 as an oral KRAS G12D inhibitor in collaboration with GenFleet.

Verastem has also used public equity offerings and pre-funded warrants, as detailed in its Form 8-K filings, to raise capital for commercial activities related to AVMAPKI FAKZYNJA CO-PACK and for continued research and development of its product candidates, including VS-7375.

Regulatory and safety considerations

Because AVMAPKI FAKZYNJA CO-PACK is an FDA-approved therapy, Verastem’s public materials include detailed Important Safety Information. These disclosures highlight key warnings and precautions, such as:

• Ocular toxicities, including visual impairment and vitreoretinal disorders, with recommendations for baseline and periodic ophthalmic evaluations and guidance on dose interruption or discontinuation for severe events.
• Serious skin toxicities, including photosensitivity and severe cutaneous adverse reactions, with instructions to monitor and adjust dosing based on severity and duration.
• Hepatotoxicity, with recommendations for regular liver function monitoring and dose modification as needed.
• Rhabdomyolysis, with guidance on monitoring creatine phosphokinase and managing suspected cases.
• Embryo-fetal toxicity, including advice that the therapy can cause fetal harm and that effective contraception should be used.

The company also lists common adverse reactions (including laboratory abnormalities) observed at a frequency of 25% or greater, and provides information on drug interactions, such as avoiding strong or moderate CYP3A4 inhibitors or inducers, warfarin, and certain gastric acid-reducing agents when co-administered with AVMAPKI FAKZYNJA CO-PACK.

Sector and classification

Based on the provided industry classification, Verastem, Inc. operates within Pharmaceutical Preparation Manufacturing in the broader Manufacturing sector. Its activities, as described in company and regulatory documents, are characteristic of a biopharmaceutical issuer with a focus on oncology drug development, targeted small molecules, and regulatory approval pathways such as accelerated approval with confirmatory requirements.

Status and trading

Recent SEC filings, including multiple Forms 8-K, identify Verastem, Inc. as a registrant with common stock listed on The Nasdaq Capital Market under the symbol VSTM. These filings do not indicate delisting, deregistration, or bankruptcy events. Instead, they describe ongoing capital markets activity, clinical updates, and corporate communications, consistent with an actively operating public biopharmaceutical company.

FAQs about Verastem, Inc. (VSTM)

• What does Verastem, Inc. do?
  

  Verastem, Inc., also known as Verastem Oncology, is a biopharmaceutical company that develops and commercializes medicines for patients with RAS/MAPK pathway-driven cancers. It focuses on small molecule drugs that inhibit key signaling pathways in cancer, including RAF/MEK, FAK, and KRAS G12D.

• What is AVMAPKI FAKZYNJA CO-PACK?
  

  AVMAPKI FAKZYNJA CO-PACK is a combination of avutometinib capsules and defactinib tablets marketed by Verastem in the U.S. It is indicated for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy, under an FDA accelerated approval based on tumor response rate and duration of response.

• How does AVMAPKI FAKZYNJA CO-PACK work?
  

  According to Verastem, AVMAPKI (avutometinib) inhibits MEK kinase activity and blocks compensatory reactivation of MEK by RAF in the RAS/RAF/MEK/ERK (MAPK) pathway, while FAKZYNJA (defactinib) inhibits focal adhesion kinase (FAK), a mediator of drug resistance. Together, the combination is designed to more completely block signaling that drives growth and drug resistance in RAS/MAPK pathway-dependent tumors.

• What cancers is Verastem targeting with its pipeline?
  

  Company materials indicate that Verastem is targeting cancers driven by RAS/MAPK pathway alterations, including KRAS-mutated recurrent low-grade serous ovarian cancer, advanced pancreatic ductal adenocarcinoma, non-small cell lung cancer, and other KRAS G12D mutant solid tumors. Clinical trials such as RAMP 301, RAMP 205, RAMP 203, and VS-7375-101 reflect this focus.

• What is VS-7375?
  

  VS-7375 is described by Verastem as a potential best-in-class, potent, and selective oral KRAS G12D (ON/OFF) inhibitor. It is the lead program from Verastem’s collaboration with GenFleet Therapeutics and is being evaluated in a Phase 1/2a clinical trial in patients with advanced KRAS G12D mutant solid tumors, both as monotherapy and in combination with other treatments such as cetuximab.

• On which exchange does Verastem trade and what is its ticker?
  

  Verastem’s common stock is listed on The Nasdaq Capital Market under the ticker symbol VSTM, as disclosed in the company’s Form 8-K filings.

• Is Verastem considered a late-stage or early-stage company?
  

  Verastem describes itself as a late-stage development biopharmaceutical company. It has an FDA-approved product, AVMAPKI FAKZYNJA CO-PACK, on the market in the U.S., and it is conducting late-stage trials such as the Phase 3 RAMP 301 confirmatory study, alongside earlier-stage development of pipeline candidates like VS-7375.

• How does Verastem fund its operations?
  

  According to its SEC filings and press releases, Verastem funds its operations through product revenue from AVMAPKI FAKZYNJA CO-PACK and through capital raised in public offerings of common stock and pre-funded warrants. The company has used shelf registration statements on Form S-3 to support these offerings.

• What are some key safety considerations for AVMAPKI FAKZYNJA CO-PACK?
  

  Important Safety Information disclosed by Verastem highlights risks such as ocular toxicities, serious skin toxicities, hepatotoxicity, rhabdomyolysis, and embryo-fetal toxicity. The company recommends specific monitoring, dose interruptions, reductions, or discontinuation depending on the severity and persistence of adverse events.

• Is AVMAPKI FAKZYNJA CO-PACK approved outside its LGSOC indication?
  

  No. Verastem states that AVMAPKI FAKZYNJA CO-PACK is indicated for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy. Avutometinib and defactinib, alone or in combination with other therapies, are not approved by the FDA or other regulatory authorities for any other uses.