ODD and RPDD granted by the FDA and ODD granted by the European Commission to UCART22 for the treatment of ALL ODD granted by the FDA to CLLS52 (alemtuzumab) for ALL treatment Cash position of $273 million as of June 30, 20241; cash runway projection into 2026 ________________________ NEW YORK, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Cellectis (the "Company") (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and g ...

NEW YORK, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Cellectis (the "Company") (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Cellectis' CLLS52 (alemtuzumab), an Investigational Medicinal Product (IMP) used as part of the lymphodepletion regimen associated with UCART22, evaluated in the ...

NEW YORK, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Cellectis (the "Company") (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Cellectis' CLLS52 (alemtuzumab), an Investigational Medicinal Product (IMP) used as part of the lymphodepletion regimen associated with UCART22, evaluated in the ...

文章核心观点 - 急性淋巴细胞白血病(ALL)占美国白血病病例的10%,进展迅速,如果不治疗通常在几周或几个月内死亡 [1][3] - 对于不适合接受造血干细胞移植或在CD19靶向CAR T细胞治疗和/或造血干细胞移植后复发的ALL患者,迫切需要开发新的治疗方法 [4] - 美国FDA授予UCART22孤儿药物和罕见儿童疾病指定地位,这是开发可随时供所有患者使用的异基因CAR T产品的重要一步 [2][4] 公司概况 - Cellectis是一家临床阶段生物技术公司,利用其开创性的基因编辑平台开发拯救生命的细胞和基因疗法 [8] - Cellectis采用异基因方法进行CAR-T免疫治疗,开创了现成和随时可用的基因编辑CAR T细胞治疗癌症患者的概念 [8] - Cellectis拥有24年以上的基因编辑经验和专业知识,正在利用TALEN基因编辑技术和PulseAgile电穿孔系统开发改变生命的产品候选药物 [8] UCART22项目进展 - UCART22是一种针对CD22的异基因CAR T细胞产品候选药物,正在BALLI-01 I/II期临床试验中评估 [5] - 2023年12月在美国血液学会上公布的最新临床数据显示,UCART22-P2(由Cellectis完全制造)的疗效更佳,Dose Level 2的初步反应率为67%,优于Dose Level 3的UCART22-P1(由外部CDMO制造)的50%反应率 [6] - Cellectis预计将在2024年底前提供BALLI-01试验进展的更新信息 [6] 监管进展 - FDA授予UCART22孤儿药物和罕见儿童疾病指定地位,这可能有助于加快开发、批准和商业化治疗药物的进程,并有机会获得罕见儿童疾病优先审评券 [7]

Cellectis S.A. (CLLS) has been beaten down lately with too much selling pressure. While the stock has lost 22.8% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.How to Determine if a Stock is OversoldWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator ...

NEW YORK, June 28, 2024 (GLOBE NEWSWIRE) -- Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, held today a shareholders general meeting at 2:30 p.m. CET at the Biopark auditorium, 11 rue Watt, 4th floor, 75013 Paris, France. At the meeting, during which approximately 40% of shares were exercised, resolutions 1 through 28 were adopted and resolution 29 was rejected, consistent wit ...

NEW YORK, June 28, 2024 (GLOBE NEWSWIRE) -- Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, held today a shareholders general meeting at 2:30 p.m. CET at the Biopark auditorium, 11 rue Watt, 4th floor, 75013 Paris, France. At the meeting, during which approximately 40% of shares were exercised, resolutions 1 through 28 were adopted and resolution 29 was rejected, consistent wit ...

NEW YORK, June 20, 2024 (GLOBE NEWSWIRE) -- Cellectis (the "Company") (Euronext Growth: ALCLS - NASDAQ:  CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced today the publication of a manuscript in Scientific Reports, demonstrating how three key factors can be determinant for efficient TALE base editing. TALE base editors are a recent and important addition to the gene editing landscape. By design, TALE base edito ...

NEW YORK, June 20, 2024 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ:  CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced today the publication of a manuscript in Scientific Reports, demonstrating how three key factors can be determinant for efficient TALE base editing. TALE base editors are a recent and important addition to the gene editing landscape. By design, TALE base edito ...

Cellectis S.A. (CLLS) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.The power of a chan ...