What's Going On With Alzheimer's-Focused Cassava Sciences On Tuesday?
What's Going On With Alzheimer's-Focused Cassava Sciences On Tuesday?
The firm expressed that this decision allows it to concentrate on simufilam's development without ongoing distractions from regulatory issues.Last month, Cassava Sciences Inc. (NASDAQ:SAVA) agreed to pay over $40 million to resolve SEC charges over misleading statements related to a Phase 2 trial of the company's controversial Alzheimer's drug, simufilam.
上個月，木薯科學公司（納斯達克股票代碼：SAVA）同意支付超過4000萬美元，以解決美國證券交易委員會對該公司備受爭議的阿爾茨海默氏症藥物simufilam的第二階段試驗有關的誤導性言論的指控。
The SEC also charged Hoau-Yan Wang, a consultant and co-developer of the drug, with manipulating trial results.
美國證券交易委員會還指控該藥物的顧問兼共同開發者Hoau-Yan Wang操縱試驗結果。
In an open letter, Cassava President and CEO Rick Barry emphasized that the settlement, though financially significant, was necessary for the company to refocus its efforts.
Cassava總裁兼首席執行官裏克·巴里在一封公開信中強調，儘管該和解協議財務意義重大，但對於公司重新調整工作重點是必要的。
The firm expressed that this decision allows it to concentrate on simufilam's development without ongoing distractions from regulatory issues.
該公司表示，這一決定使其能夠專注於simufilam的發展，而不會持續分散對監管問題的注意力。
The SEC's investigation found that in September 2020, Cassava disclosed manipulated data from the trial, which falsely suggested dramatic improvements in Alzheimer's biomarkers like total tau and phosphorylated tau.
美國證券交易委員會的調查發現，2020年9月，木薯披露了該試驗中經過操縱的數據，這些數據錯誤地表明總tau和磷酸化tau等阿爾茨海默氏症生物標誌物的顯著改善。
The CEO added, "In sum, we have been able to put the SEC's three-year investigation of Cassava behind us by agreeing to settle a charge of negligently making inaccurate disclosures related to our 2020 Phase 2b clinical study and paying a $40 million monetary penalty. In addition, we do not anticipate that the Department of Justice will charge the company or seek a resolution from us."
這位首席執行官補充說：「總而言之，我們同意解決一項指控，即疏忽地披露了與我們的2020年第20期臨床研究相關的不準確信息，並支付了4000萬美元的罰款，從而得以將美國證券交易委員會對木薯的三年調查拋在腦後。此外，我們預計司法部不會起訴該公司或尋求我們的解決方案。」
With the update, HC Wainwright has upgraded Cassava Sciences' stock from Neutral to Buy, with a price target of $116, an upside of over 290%.
通過此次更新，HC Wainwright已將木薯科學的股票從中性上調至買入，目標股價爲116美元，上漲幅度超過290％。
In the letter, Rick highlighted completing the ReTHINK Phase 3 trial, which enrolled 804 patients. Cassava expects to release top-line results before the end of the year.
裏克在信中強調了ReThink三期試驗的完成，該試驗招收了804名患者。Cassava預計將在年底前公佈業績。
Cassava is also preparing for its larger Phase 3 trial, ReFOCUS, to announce results in mid-2025.
木薯還在爲其更大規模的3期試驗ReFocus做準備，該試驗將於2025年中期公佈結果。
The trial will involve 1,125 patients and further examine cerebrospinal fluid and plasma biomarkers, ensuring a comprehensive analysis of simufilam's efficacy.
該試驗將涉及1,125名患者，並進一步檢查腦脊液和血漿生物標誌物，確保對simufilam的療效進行全面分析。
HC Wainwright analyst anticipates that the results from these clinical trials will show simufilam's potential to be the first drug to sustainably alter disease progression over a six-month treatment period in patients with mild-to-moderate Alzheimer's disease. The analyst factors a 65% clinical program probability of success.
HC Wainwright分析師預計，這些臨床試驗的結果將表明，simufilam有可能成爲第一種在六個月治療期內可持續改變輕度至中度阿爾茨海默病患者疾病進展的藥物。分析師考慮了65％的臨床項目成功概率。
Price Action: SAVA stock is up 16.8% at $29.68 at last check Tuesday.
價格走勢：週二最後一次檢查時，SAVA股價上漲16.8％，至29.68美元。
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譯文內容由第三人軟體翻譯。