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Verastem Oncology develops and commercializes oncology medicines for RAS/MAPK pathway-driven cancers. The company markets AVMAPKI FAKZYNJA CO-PACK in the U.S. for KRAS-mutated recurrent low-grade serous ovarian cancer and reports commercial updates, product revenue, and medical-conference data for the avutometinib and defactinib combination.
Recurring VSTM news also covers the company’s small-molecule pipeline, including RAF/MEK inhibition, FAK inhibition, and VS-7375, an oral KRAS G12D inhibitor studied in KRAS G12D-mutant solid tumors. Company updates commonly include clinical-trial analyses from RAMP studies, preclinical research presentations, FDA-related treatment context, patient advocacy resources for LGSOC, executive and employee equity grants, and quarterly financial results.
Verastem Oncology (Nasdaq: VSTM) has announced positive interim results from the RAMP 201 Phase 2 study evaluating avutometinib combined with defactinib for treating recurrent low-grade serous ovarian cancer (LGSOC). The combination demonstrated a confirmed objective response rate (ORR) of 28%, with a high disease control rate of 93%. The company plans to file for accelerated approval based on mature data and discussions with the FDA. Target enrollment has been achieved, and the safety profile showed no new signals, with most adverse effects being mild to moderate.
Verastem Oncology (Nasdaq: VSTM) announced the grant of 96,700 restricted stock units (RSUs) to four new employees as part of its recruitment strategy. These RSUs, granted under the Nasdaq inducement grant exception, will vest 25% on each employee's one-year anniversary, with the remaining shares vesting quarterly over three years, contingent on continued employment. Verastem focuses on developing novel small molecule drugs targeting critical cancer cell survival pathways, including RAF/MEK and FAK inhibition, aiming to enhance the lives of cancer patients.
Verastem Oncology (Nasdaq: VSTM) has appointed Robert Gagnon to its Board of Directors, effective December 13, 2022. Gagnon, previously Chief Financial Officer at Verastem, brings over 20 years of financial expertise. His role aims to enhance the company's strategic goals, particularly in treating low-grade serous ovarian cancer and RAS-driven tumors. Verastem's investigational drug, avutometinib, is in late-stage development, having received Breakthrough Therapy designation from the FDA for LGSOC treatment, indicating its potential significance in addressing unmet medical needs.
Verastem Oncology (Nasdaq: VSTM) reported its Q3 2022 financial results, highlighting advancements in its RAMP program for Avutometinib (VS-6766) targeting RAS pathway-driven tumors. The RAMP 201 trial showed encouraging interim results, paving the way for a Q4 meeting with the FDA to discuss treatment regimens for low-grade serous ovarian cancer. The company ended the quarter with $104 million in cash and reported a net loss of $18.1 million. Operating expenses increased to $17.7 million due to higher R&D costs, while non-GAAP adjusted net loss was $16.6 million.
Verastem Oncology (Nasdaq: VSTM) has appointed Anil Kapur to its Board of Directors, effective October 20, 2022. Mr. Kapur brings over 25 years of experience in oncology and commercial operations, having held senior roles at Geron Corporation, Actinium Pharmaceuticals, and Bristol-Myers Squibb. His expertise will be pivotal as Verastem advances its lead compound, VS-6766, which is currently in late-stage development for recurrent low-grade serous ovarian cancer. The company is also conducting several clinical trials involving this compound in various cancer types.
Verastem Oncology (Nasdaq: VSTM) announced the granting of stock options for 22,500 shares and 15,000 restricted stock units (RSUs) to a new employee. These awards were issued under the Nasdaq inducement grant exception, aligning with Nasdaq Listing Rule 5635(c)(4). The exercise price of the stock options is $0.87 per share, reflecting the closing stock price on October 3, 2022. The options will vest at 25% after one year, with the remaining shares vesting quarterly over three years, contingent on the employee's continued service.
Verastem Oncology (Nasdaq: VSTM) has announced updates on its RAMP clinical trials. The RAMP 201 trial for recurrent low-grade serous ovarian cancer (LGSOC) shows promising results, prompting an FDA meeting in Q4 to discuss regulatory paths. Conversely, the RAMP 202 trial for KRAS G12V-mutant non-small cell lung cancer (NSCLC) did not meet criteria for continuation, with an overall response rate of only 11%. Ongoing trials RAMP 203 and RAMP 204 are progressing, and newly issued patents extend coverage of VS-6766 and its combinations to 2038 and 2040.
Verastem Oncology (Nasdaq: VSTM) reported interim findings from its RAMP 201 trial for VS-6766 +/- Defactinib in low-grade serous ovarian cancer, displaying encouraging efficacy results and a favorable safety profile. The company has cash reserves of $94.3 million, expected to last until at least 2025. Financial results for Q2 2022 showed a net loss of $22.0 million, with total revenue at $0.0 million. Operating expenses rose to $21.4 million, primarily driven by research and development costs. The company also received a patent extending VS-6766 protection to 2038.
Verastem Oncology (Nasdaq: VSTM) has granted stock options for 120,500 shares and 80,400 restricted stock units (RSUs) to four new employees as an inducement for their employment. The options have an exercise price of $1.13, aligned with the closing stock price on July 1, 2022. Vesting for the stock options and RSUs will commence after one year, followed by quarterly vesting over three years, contingent on continued employment. This move aligns with Nasdaq rules regarding inducement grants.
Verastem Oncology (Nasdaq: VSTM) announced encouraging interim results from its RAMP 201 trial, which is assessing the efficacy of VS-6766 alone and in combination with defactinib for recurrent low-grade serous ovarian cancer (LGSOC). The analysis showed confirmed anti-tumor responses in both KRAS mutant and wild-type tumors, with approximately 80% of patients remaining on therapy. Importantly, no new safety signals were observed. The trial will continue as data maturation is necessary for making further treatment regimen decisions. Full enrollment is anticipated in the second half of the year.