Bullish Trend For Verastem (VSTM) Stock Following Orphan Drug Designation
Bullish Trend For Verastem (VSTM) Stock Following Orphan Drug Designation
Verastem, Inc. (NASDAQ: VSTM) experienced a notable increase in its share value following the receipt of a significant designation from regulatory authorities. The stock demonstrated a bullish trend on US stock charts, climbing by 6.57% to $2.92 during the after-market session on Monday. With this increase, the -7.43% loss during regular trading hours was recovered.
纳斯达克的Verastem, Inc. (股票代码: VSTM) 在收到监管部门的重要认可后，股价出现显著上涨。该股在美国股票图表上呈现看好的趋势，在周一盘后交易中上涨6.57%至2.92美元。随着这一增长，该股在美股盘中的下跌7.43%得到了回复。
Table of Contents
目录
- FDA Approves Orphan Drug Status
- Positive Interim Results and Future Prospects for Verastem
- FDA批准孤儿药品地位
- Verastem 公司的正面中期结果和未来前景
FDA Approves Orphan Drug Status
FDA批准孤儿药品地位
Verastem stated that, when combined with defactinib, a selective FAK inhibitor, avutometinib, an RAF/MEK clamp, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA). This classification relates to pancreatic cancer therapy. The acknowledgement highlights the significant unfulfilled medical need for efficient therapies in this area.
Verastem 公司表示，美国食品药品监督管理局（FDA）已将拟合相因子信号调节活化酪氨酸激酶（FAk）选择性抑制剂 Defactinib 与 RAF/MEK clamp 抑制剂 Avutometinib 组合授予孤儿药品认定（ODD），用于胰腺癌治疗。该分类涉及胰腺癌疗法的显著未满足的医疗需求。这一承认突显了该领域有效疗法的重要性。
Positive Interim Results and Future Prospects for Verastem
Verastem 公司的正面中期结果和未来前景
At the ASCO 2024 Annual Meeting, Verastem presented preliminary interim findings from the ongoing RAMP 205 trial. This trial is assessing the efficacy of the combination of avutometinib and defactinib alongside standard chemotherapy in first-line metastatic pancreatic cancer. The positive interim results highlight the potential of this therapeutic approach to offer a novel treatment strategy for this challenging disease.
在 ASCO 2024 年度会议上，Verastem 公司介绍了 ongoing RAMP 205 试验的初步中期发现。该试验正在评估 avutometinib 和 defactinib 与标准化疗在一线转移性胰腺癌中的疗效。正面的中期结果突显了这种治疗方法为这种具有挑战性的疾病提供新的治疗策略的潜力。
VSTM anticipates releasing updated data from various dose cohorts of the RAMP 205 trial in the first quarter of 2025. As of May 14, 2024, 41 patients had been administered treatment across four dose cohorts, with those in dose cohort 1 showing promising results. Specifically, 83% of patients in this cohort achieved a confirmed partial response with over six months of follow-up.
VSTm 预计在2025年第一季度发布来自 RAMP 205 试验各剂量组的最新数据。截至2024年5月14日，已有41名患者在四个剂量组中接受了治疗，剂量组1的患者显示出了有希望的结果。具体而言，该剂量组83% 的患者在超过六个月的随访期内达成了确认的部分缓解。
Furthermore, one dose-limiting toxicity was noted in the dose level 1 cohort, which was subsequently resolved upon the inclusion of additional patients. Of the 26 patients in all groups who had their initial scans, 21 reported a reduction in the target lesions' overall diameter.
此外，第1剂量水平的研究中注意到有一种剂量限制性毒性，随着更多患者的参与，该毒性得以解决。在所有组中接受了初始扫描的26名患者中，21名报告了目标病变整体直径的缩小。
The FDA's Orphan Drug Designation offers the possibility of a seven-year market exclusivity following approval for treatments addressing rare diseases affecting fewer than 200,000 people in the US, as well as tax credits for qualifying clinical trials and waivers of certain FDA user fees.
美国食品药品监督管理局（FDA）的孤儿药品认定为治疗罕见疾病、影响美国200,000人以下的治疗措施获得7年的市场独家销售权提供了可能，同时对符合条件的临床试验和豁免某些 FDA 用户费用提供税收优惠。