文章核心观点 - 公司Agenus Inc.因在其免疫疗法组合产品临床试验中未能获得FDA加速批准而遭受股价大跌[1][2] - FDA认为公司的临床试验结果可能无法转化为生存获益,因此不建议公司提交申请加速批准[2] 公司相关 - 公司名称为Agenus Inc.,股票代码为NASDAQ: AGEN[1][2] - 公司正在开发免疫疗法组合产品,包括botensilimab(BOT)和balstilimab(BAL),用于治疗复发/难治性微卫星稳定型结直肠癌(r/r MSS CRC)[2] - 公司最近与FDA进行了临床试验结果的沟通会议,但FDA不建议公司提交申请加速批准[2] 股价影响 - 公司股价在消息公布后下跌近59%[2] - 这可能导致投资者遭受损失,引发了股东诉讼[1][3]

Loading...Loading...Thursday, Agenus Inc. AGEN announced the results of its end-of-Phase 2 meeting with the FDA to advance its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for adult patients with relapsed/refractory microsatellite-stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM).The FDA discouraged the accelerated approval pathway and advised against submitting these results to support an Accelerated Approval based on its view that objective response rates ...

Shares of Agenus Inc. (AGEN) plunged 58.8% on Jul 18 after the company announced the outcome of its end-of-phase II (EOP2) meeting with the FDA regarding the accelerated development of its immunotherapy combination botensilimab (BOT) and balstilimab (BAL).The BOT/BAL combination is being studied for the treatment of adult patients with relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) with no active liver metastases.The FDA discouraged the accelerated approval pathway for the BOT/BAL ...

NEW YORK, July 18, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Agenus Inc. ("Agenus" or the "Company") (NASDAQ: AGEN). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.The investigation concerns whether Agenus and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action]On July 18, 2024, Agenus issued a ...

文章核心观点 - 生物制药公司Agenus的一项针对结直肠癌的二期临床试验未能达到预期目标,FDA建议公司不要申请加速审批[1][2][3] - FDA的建议是因为试验结果的客观反应率未必能转化为生存获益,这将延缓该结直肠癌治疗候选药物的开发和审评[3] - 公司首席医疗官表示,尽管如此,公司仍将寻求所有可能的途径让该疗法惠及患者,包括在美国寻找合作伙伴以成功进行三期试验[4] 公司相关 - Agenus是一家临床阶段的生物制药公司[1] - 公司正在开发一种名为botensilimab和balstilimab的结直肠癌治疗方案[1][2] - 公司与FDA进行了二期临床试验的终点会议,FDA建议公司不要申请加速审批[2] 股票相关 - 由于FDA不建议加速审批,Agenus股价大跌54.5%,成交量大幅增加至5.2百万股,远高于日均763,000股[5] - 投资者对此反应强烈,对公司未来发展前景表示担忧[5]

Human life expectancy has doubled since the 1900s, mostly attributed to advancements in lifestyle, living standards and medicine. Thanks to biotech companies that produce transformative drugs and treatments, we now have the collective ability to combat diseases that used to bring entire nations down. And it’s getting better all the time. So, it’s no surprise that investors are looking at biotech stocks to buy. A lot of money is to be made, especially if their prices skyrocket. However, investing in biotech ...

Small-cap stocks could get a boost from the central bank's anticipated rate cuts in 2025. These three stocks may be a great way to get ahead of this catalyst.Small-cap and mid-cap stocks tend to be interest rate sensitive. The core reason is that many of these companies are dependent on debt instruments to meet their long-term financial obligations. Although the Federal Reserve is wobbling on a possible rate reduction this year due to sticky inflation, the central bank is widely expected to slash rates no l ...

Agenus Inc. (NASDAQ:AGEN) Q1 2024 Earnings Conference Call May 7, 2024 8:30 AM ET Company Participants Zack Armen - Head of Investor Relations Garo Armen - Chairman & Chief Executive Officer Steven O’Day - Chief Medical Officer Robin Taylor - Chief Commercial Officer Christine Klaskin - Vice President of Finance & Principal Financial and Accounting Officer Conference Call Participants Emily Bodnar - H.C. Wainright Mayank Mamtani - B. Riley Securities Matthew Phipps - William Blair Operator Thank you for sta ...

Agenus (AGEN) came out with a quarterly loss of $3.04 per share versus the Zacks Consensus Estimate of a loss of $3.58. This compares to loss of $4.40 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 15.08%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.40 per share when it actually produced a loss of $2.60, delivering a surprise of -550%.Over the last four quarters, the company has surp ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 07, 2024 AGENUS INC. (Exact name of Registrant as Specified in Its Charter) Delaware 000-29089 06-1562417 (State or Other Jurisdiction (Commission File Number) (IRS Employer of Incorporation) Identification No .) 3 Forbes Road Lexington, Massachusetts 02421 (Address of Principal Executive O ...