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.
納斯達克的Verastem, Inc. (股票代碼: VSTM) 在收到監管部門的重要認可後，股價出現顯著上漲。該股在美國股票圖表上呈現看好的趨勢，在週一盤後交易中上漲6.57%至2.92美元。隨着這一增長，該股在美股盤中的下跌7.43%得到了回覆。
Table of Contents
目錄
- FDA Approves Orphan Drug Status
- Positive Interim Results and Future Prospects for Verastem
- FDA批准孤兒藥品地位
- Verastem 公司的正面中期結果和未來前景
FDA Approves Orphan Drug Status
FDA批准孤兒藥品地位
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，美國食品藥品監督管理局（FDA）已將擬合相因子信號調節活化酪氨酸激酶（FAk）選擇性抑制劑 Defactinib 與 RAF/MEK clamp 抑制劑 Avutometinib 組合授予孤兒藥品認定（ODD），用於胰腺癌治療。該分類涉及胰腺癌療法的顯著未滿足的醫療需求。這一承認突顯了該領域有效療法的重要性。
Positive Interim Results and Future Prospects for Verastem
Verastem 公司的正面中期結果和未來前景
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年度會議上，Verastem公司介紹了正在進行的RAMP 205試驗的初步中期結果。該試驗評估avutometinib和defactinib與標準化療結合治療一線轉移性胰腺癌的療效。積極的中期結果突顯了這種治療方法提供一種新的治療策略應對這種具有挑戰性的疾病的潛力。
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 預計在2025年第一季度發佈來自 RAMP 205 試驗各劑量組的最新數據。截至2024年5月14日，已有41名患者在四個劑量組中接受了治療，劑量組1的患者顯示出了有希望的結果。具體而言，該劑量組83% 的患者在超過六個月的隨訪期內達成了確認的部分緩解。
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劑量水平的研究中注意到有一種劑量限制性毒性，隨着更多患者的參與，該毒性得以解決。在所有組中接受了初始掃描的26名患者中，21名報告了目標病變整體直徑的縮小。
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.
美國食品藥品監督管理局（FDA）的孤兒藥品認定爲治療罕見疾病、影響美國200,000人以下的治療措施獲得7年的市場獨家銷售權提供了可能，同時對符合條件的臨床試驗和豁免某些 FDA 用戶費用提供稅收優惠。