Verastem - VSTM STOCK NEWS

Verastem Oncology (VSTM) has received FDA clearance for its Investigational New Drug (IND) application of VS-7375, an oral KRAS G12D inhibitor. The company plans to initiate a Phase 1/2a trial in mid-2025 for advanced solid tumors, including pancreatic, colorectal, and non-small cell lung cancers.

Initial data from partner GenFleet Therapeutics' Phase 1/2 study showed promising results with oral bioavailability and no dose-limiting toxicities across six dose levels, achieving partial responses in pancreatic and advanced lung cancer patients. The upcoming trial's starting dose will be based on GenFleet's efficacy findings to accelerate progress.

GenFleet will present preliminary dose escalation results at the 2025 ASCO Annual Meeting in Chicago (May 30-June 3). The abstract (#3013) is embargoed until May 22, 2025.

Verastem Oncology (VSTM) has announced new equity compensation grants to fifteen employees. The company granted stock options to purchase 164,500 shares of common stock to fourteen new employees at an exercise price of $5.82 per share, matching the closing price on April 1, 2025. Additionally, one new employee received 83,333 restricted stock units.

The grants were made under Nasdaq's inducement grant exception (Rule 5635(c)(4)). The stock options and 50,000 RSUs will vest 25% after one year, with remaining shares vesting quarterly over three years. The additional 33,333 RSUs will vest based on sales milestone achievements. All vestings are contingent on continued employment with Verastem Oncology.

Verastem Oncology (VSTM) announced multiple presentations at the upcoming AACR Annual Meeting 2025, showcasing significant developments in their cancer treatment pipeline. VS-7375, their oral KRAS G12D inhibitor, demonstrated superior potency compared to other KRAS G12D inhibitors in preclinical models. When combined with cetuximab, it achieved complete responses in colorectal cancer models.

The company reported that their FAK inhibitor, when combined with avutometinib, enhanced tumor regression in LGSOC xenograft models by inhibiting MAPK, PI3K, and YAP/TEAD signaling pathways. Additionally, the combination of avutometinib (RAF/MEK clamp) with a pan-RAF inhibitor showed strong tumor regressions in NRAS- and BRAF-driven tumor models.

Verastem Oncology (VSTM) reported its Q4 and full-year 2024 financial results, highlighting significant pipeline progress. The FDA granted priority review for avutometinib plus defactinib combination in KRAS mutant recurrent LGSOC, with a PDUFA date of June 30, 2025.

The company ended Q4 2024 with $88.8 million in cash and investments, with pro forma cash of $151.3 million including debt refinancing and equity issuance. Q4 operating expenses were $31.6 million, with a net loss of $64.6 million ($1.33 per share).

Key developments include filing an IND for VS-7375 (KRAS G12D inhibitor), progress in the RAMP 205 pancreatic cancer trial, and strategic agreements with Oberland Capital and IQVIA to support commercialization efforts. The company expects its cash runway to extend through potential product launch into Q4 2025.

Verastem Oncology (VSTM) announced multiple presentations at the upcoming Society of Gynecologic Oncology 2025 Annual Meeting. The key highlight is an oral presentation of additional analyses from the Phase 2 RAMP 201 trial, which evaluates avutometinib plus defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC). This data served as the basis for their NDA currently under FDA Priority Review.

The presentations include subgroup analyses by KRAS mutational status, an investigator-sponsored study of the same drug combination in gynecologic mesonephric cancer, and a preclinical poster on treatment resistance. The company will also maintain an exhibition booth (#622) at the conference, which takes place March 14-17 in Seattle.

Verastem Oncology (VSTM), focusing on RAS/MAPK pathway-driven cancer treatments, has announced its upcoming participation in the Guggenheim SMID Cap Biotech Conference. The company's management will engage in a fireside chat scheduled for Wednesday, February 5, 2025, at 1:00 PM EST.

Investors and interested parties can access a live webcast of the presentation through the 'Events & Presentations' section of Verastem's website. The recorded session will remain available for approximately 90 days following the presentation on the company's website at www.verastem.com.

Verastem Oncology announced key 2025 priorities and milestones for its RAS/MAPK pathway-driven cancer pipeline. The FDA granted priority review for avutometinib plus defactinib combination therapy for recurrent KRAS mutant LGSOC, with a PDUFA date of June 30, 2025. The company plans a U.S. commercial launch in mid-2025.

Key developments include: ongoing RAMP 205 trial in metastatic pancreatic cancer with updated data expected in Q1 2025; VS-7375 IND filing planned for Q1 2025 with Phase 1/2a study initiation in mid-2025; and recent financing providing runway beyond potential FDA approval.

The company's 2025 strategic priorities focus on: launching avutometinib plus defactinib in the U.S. for LGSOC; expanding the combination therapy to other solid tumors; and advancing its early-stage pipeline, including VS-7375, a KRAS G12D inhibitor.

Verastem Oncology (VSTM) has appointed Matthew E. Ros as chief operating officer as the company prepares for its transition to a commercial-stage organization. Ros, who brings over 35 years of biopharmaceutical industry experience, will report to CEO Dan Paterson and join the executive leadership team.

The appointment comes as Verastem prepares for a potential mid-2025 product launch of a first-in-class treatment combination for low-grade serous ovarian cancer. Ros's previous experience includes serving as CEO at FORE Biotherapeutics and executive roles at Epizyme, Sanofi-Genzyme, and ARIAD Pharmaceuticals, where he led commercial organizations and secured FDA approvals.

The company focuses on advancing medicines for RAS/MAPK pathway-driven cancers, with their upcoming treatment targeting a rare cancer that currently has no approved specific treatments.

Verastem Oncology (VSTM) has exercised its early option to license VS-7375, a potential best-in-class oral KRAS G12D inhibitor, from GenFleet Therapeutics. The preliminary clinical data from the ongoing Phase 1 study in China shows promising results, with both confirmed and unconfirmed partial responses observed in patients with metastatic pancreatic cancer and advanced non-small cell lung cancer.

The study has cleared six dose cohorts with no dose-limiting toxicities, demonstrating oral bioavailability and plasma levels correlating with efficacious exposures that induced deep tumor regressions in preclinical models. Verastem plans to file a U.S. IND application in Q1 2025 and initiate a Phase 1/2a study by mid-2025.

The license grants Verastem global development and commercialization rights outside China, Hong Kong, Macau, and Taiwan. This agreement stems from an August 2023 collaboration with GenFleet targeting RAS pathway-driven cancers.