FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials For Potential Diabetes Candidate
FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials For Potential Diabetes Candidate
In June, the FDA placed a clinical hold on Friday, the FDA lifted the clinical hold on Biomea Fusion, Inc.'s (NASDAQ:BMEA) ongoing Phase 1/2 clinical trials of the company's investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively.
週五，FDA取消了對Biomea Fusion, Inc.（納斯達克:BMEA）正在進行的公司BMF-219協變性甲醰脲類蛋白酶抑制劑在2型和1型糖尿病中的初期/2期臨床試驗（COVALENt-111和COVALENt-112）的臨床暫停。
"The in-depth review of the clinical data to date reconfirms our confidence in BMF-219 as a novel, first-in-class agent for the treatment of diabetes," stated Thomas Butler, Biomea Fusion's CEO and Chairman.
「迄今爲止對臨床數據進行的深入審查再次確認了我們對BMF-219作爲糖尿病治療的一種新穎，首創的劑量的信心，」Biomea Fusion的CEO兼董事長托馬斯·巴特勒表示。
"We are encouraged from the safety review of the ongoing Phase 2b Expansion Study, where the concerning safety signals seen in the Phase 2a Escalation Study did not translate over to the larger Expansion Study. And most importantly, none of the elevated lab values translated to confirmed serious liver injury or liver impairment," Butler said.
「我們從正在進行的第20億擴展研究的安全審查中獲得了鼓舞，該研究沒有將在第2a逐步上升研究中觀察到的令人擔憂的安全信號轉化爲更大的擴展研究。更重要的是，沒有任何升高的實驗室值轉化爲已確認的嚴重肝損傷或肝功能受損，」巴特勒說。
In June, the FDA placed a clinical hold on Biomea Fusion's Phase 1/2 trials for BMF-219.
6月，FDA對Biomea Fusion的BMF-219初期/2期試驗進行了臨床暫停。
The FDA's decision was driven by concerns over potential drug-induced hepatotoxicity observed during the Dose Escalation Phase of the trials. Elevated liver enzyme levels were noted, although most adverse events were mild to moderate, with no severe reactions reported.
FDA的決定是由於對試驗中劑量遞增階段觀察到的潛在藥物誘導性肝毒性的擔憂而做出的。儘管注意到升高的肝酶水平，大部分不良事件輕度至中度，沒有報告嚴重反應。
During its second-quarter earnings release, the company said data readout from COVALENT-111 Phase 2b and COVALENT-112 Phase 2a trials were on track for the fourth quarter of 2024.
在第二季度收益發布中，該公司表示，COVALENt-111第20億階段和COVALENt-112第2a階段的數據結果預計將於2024年第四季度出爐。
Biomea Fusion Stock Prediction For 2024
2024年Biomea Fusion股票預測
Equity research analysts on and off Wall Street typically use earnings growth and fundamental research as a form of valuation and forecasting. But many in trading turn to technical analysis as a way to form predictive models for share price trajectory.
華爾街內外的股票研究分析師通常使用盈利增長和基本面研究進行估值和預測。但是，許多交易人員則通過技術面分析來制定股票價格走勢的預測模型。
Some investors look to trends to help forecast where they believe a stock could trade at a certain point in the future. Looking at Biomea Fusion, an investor could make an assessment about a stock's long term prospects using a moving average and trend line. If they believe a stock will remain above the moving average, which many believe is a bullish signal, they can extrapolate that trend into the future using a trend line. For Biomea Fusion, the 200-day moving average sits at $11.19, according to Benzinga Pro, which is above the current price of $9.93. For more on charts and trend lines, see a description here.
一些投資者會尋求趨勢的幫助來預測他們認爲股票在未來某一特定時間點可能交易的價格。觀察Biomea Fusion，投資者可以使用移動平均線和趨勢線對股票的長期前景進行評估。如果他們相信股票將保持在移動平均線之上，許多人認爲這是一個看好的信號，他們可以使用趨勢線將這種趨勢推演到未來。對於Biomea Fusion來說，根據Benzinga Pro的數據，200日移動平均線爲11.19美元，高於當前價格9.93美元。有關圖表和趨勢線的更多信息，請見此處描述。
Traders believe that when a stock is above its moving average, it is a generally bullish signal, and when it crosses below, it is a more negative signal. Investors could use trend lines to make an educated guess about where a stock could trade at a later date if conditions remain stable.
交易員認爲，當股票位於其移動平均線上方時，這是一個普遍的看漲信號，當它跨越下方時，這是一個更消極的信號。如果條件保持穩定，投資者可以使用趨勢線來做出關於股票將在稍後時間交易的猜測。
Price Action: BMEA stock is up 3.97% at $9.95 at the last check on Friday.
股價走勢：BMEA股票在上週五最後一次查詢時上漲了3.97%，報價9.95美元。
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譯文內容由第三人軟體翻譯。
