Penny Stock Kezar Life Sciences Rejects Acquisition Deal From Concentra Biosciences At $1.10/Share, Shelves Mid-Stage Lupus Nephritis Study
Penny Stock Kezar Life Sciences Rejects Acquisition Deal From Concentra Biosciences At $1.10/Share, Shelves Mid-Stage Lupus Nephritis Study
The Independent Data Monitoring Committee (IDMC) overseeing the PORTOLA Phase 2a trial of zetomipzomib in patients with AIH recommended that the trial may proceed without modification.On Thursday, Kezar Life Sciences, Inc (NASDAQ:KZR) decided to terminate the PALIZADE Phase 2b trial in patients with active lupus nephritis (LN) and focus clinical development efforts on zetomipzomib in autoimmune hepatitis (AIH).
週四，kezar life sciences決定終止在活動性狼瘡性腎炎（LN）患者中進行的PALIZADE第20億階段試驗，並將臨床開發工作重點放在自身免疫性肝炎（AIH）的zetomipzomib上。
Last week, the FDA placed a clinical hold on the company's zetomipzomib Investigational New Drug (IND) application for LN following a review of emerging safety data, including an assessment of four Grade 5 (fatal or death) serious adverse events (SAEs) that occurred during the trial in patients enrolled in the Philippines and Argentina.
上週，FDA在審查涉及菲律賓和阿根廷患者的試驗中發生的四起五級（致命或死亡）嚴重不良事件（SAE）評估等新出現的安全數據後，對該公司的zetomipzomib新藥（IND）申請放置了臨床暫停，用於LN。
Kezar will unblind the trial and perform a full investigation into all safety events from the study. As of termination, 84 patients were enrolled, and Kezar will report available data from the PALIZADE study later.
Kezar將揭盲試驗並對研究中所有安全事件進行全面調查。 截至終止時，已有84名患者參加了試驗，Kezar將在稍後報告PALIZADE研究的可用數據。
The Independent Data Monitoring Committee (IDMC) overseeing the PORTOLA Phase 2a trial of zetomipzomib in patients with AIH recommended that the trial may proceed without modification.
負責監督在AIH患者中進行zetomipzomib PORTOLA第2a階段試驗的獨立數據監控委員會（IDMC）建議該試驗可以在不進行修改的情況下繼續進行。
The IDMC examined safety data from all patients enrolled in the trial, including data from patients who completed the blinded treatment period and continued to the open-label extension portion, which includes an additional 24 weeks of treatment.
IDMC審查了所有參與試驗的患者的安全數據，包括那些完成了盲眼治療期並繼續進行開放式延長部分的患者的數據，該部分包括額外的24周治療。
To date, no Grade 4 or 5 serious adverse events (SAEs) have been observed in the PORTOLA trial.
截至目前，PORTOLA試驗中尚未觀察到任何四級或五級嚴重不良事件（SAE）。
Kezar has completed enrollment and plans to report topline data from the PORTOLA trial in the first half of 2025.
Kezar已完成招募，並計劃在2025年上半年報告來自PORTOLA試驗的最新數據。
Earlier on Thursday, Kezar Life Sciences rejected the previously disclosed unsolicited, non-binding proposal from Concentra Biosciences for cash consideration of $1.10 per share, plus a contingent value right that represents the right to receive 80% of the net proceeds from any out-license or disposition of Kezar's development programs or intellectual property.
週四早些時候，Kezar Life Sciences拒絕了Concentra Biosciences此前披露的非約束性提議，提議以每股1.10美元的現金代價加上一項有條件權益，代表有權獲得來自Kezar開發計劃或知識產權任何外部許可或處置淨收益的80%。
"The proposal would result in an implied equity value for Kezar stockholders that is materially below Kezar's available liquidity and fails to provide adequate value to reflect the significant potential of zetomipzomib as a therapeutic candidate," the company said.
該提案將導致對kezar股東的暗含股權價值明顯低於kezar的可用流動性，並未提供足夠的價值來反映zetomipzomib作爲治療候選藥物的重大潛力。該公司表示。
Price Action: KZR stock is down 8.48% at $0.82 at last check Thursday.
股價走勢：KZR股票在上週四最後一次檢查時下跌了8.48%，至0.82美元。
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譯文內容由第三人軟體翻譯。
