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Verastem Inc (NASDAQ: VSTM) opened nearly 70% down this morning even though the pharmaceutical firm reported positive interim data for its combination therapy as a treatment of pancreatic cancer. Here's what is hitting $VSTM today The oncology company commenced a regulatory submission aimed at U.S. approval for avutometinib and defactinib as well on Friday.
Verastem (NASDAQ: VSTM ) stock is falling hard on Friday following the release of new clinical trial data for its metastatic pancreatic cancer treatment. The company is conducting a Phase 1/2 clinical trial of avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel.
BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that it has 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, a RAF/MEK clamp, and defactinib, a selective FAK inhibitor, for adult patients with recurrent KRAS mutant (KRAS mt) low-grade serous ovarian can.
Shares of Verastem VSTM, +2.53% rose late Thursday after interim data from the company's trial evaluating a combination therapies to treat pancreatic cancer showed a high overall response rate.
BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced the initial interim safety and efficacy results from the ongoing RAMP 205 Phase 1/2 clinical trial evaluating avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel in the first-line in patients with metastatic pancreatic cancer. As of May 14, 2024, patients receiving the combination of avutometinib and def.
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Rolling NDA submission of avutometinib + defactinib for the treatment of patients with low-grade serous ovarian cancer is expected in the 1st half of 2024, with possible commercialization in 2025. Results from two studies, RAMP-203 and RAMP-204, each using avutometinib with two different types of KRAS G12C inhibitors for the treatment of KRAS G12C NSCLC, expected mid-2024. The global non-small cell lung cancer market is expected to reach $38.8 billion by 2030; About 13% of NSCLC patients have the KRAS G12C mutation.
Verastem's (VSTM) avutometinib/Lumakras combination therapy gets the FDA's Fast Track designation to treat KRAS G12C-mutant metastatic NSCLC patients. The stock gains 8% in response.
Verastem (VSTM) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
An application for Accelerated Approval of avutometinib + defactinib for low-grade serous ovarian cancer patients is expected in the first half of 2024. The ongoing RAMP-301 study is being done to keep avutometinib + defactinib for LGSC on the market or to convert Accelerated Approval to Full Approval. Company entered into a collaboration agreement with GenFleet Therapeutics to expand its pipeline and strengthen its position in the RAS driven cancer pathway space.