LOS ANGELES, July 22, 2024 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Agenus Inc. ("Agenus" or "the Company") (NASDAQ: AGEN) for violations of the securities laws.The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Agenus is the subject of a Benzinga report published on July 18, 2024. According to the ...

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 ...

Company Overview - Agenus Inc. (AGEN) shares fell 58.8% on July 18 following the FDA's discouragement of the accelerated approval pathway for its immunotherapy combination botensilimab (BOT) and balstilimab (BAL) in treating relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) [1] - The FDA indicated that the objective response rate (ORR) from the phase II study may not translate into a survival benefit [1] Clinical Study Results - Interim data from a phase II study showed that the BOT/BAL combination at a dose of 75 mg BOT and 240 mg BAL achieved an ORR of 19.4%, with 90% of patients alive at this dosage [1] - The FDA has agreed on the dosing regimen for a phase III study, which includes BOT (75 mg) every six weeks for up to four doses and BAL (240 mg) every two weeks for up to two years [2] Future Developments - The FDA has proposed including a BOT monotherapy arm in the phase III study, and Agenus is seeking a partner in the U.S. for this study [2] - Apart from colorectal cancer, the BOT/BAL combination has shown clinical activity in other cancer types, including lung cancer, melanoma, and pancreatic cancers [3] Market Performance - Year-to-date, Agenus shares have declined 55.9%, contrasting with a 1.4% decline in the industry [2]

Core Viewpoint - Agenus Inc. is under investigation for potential securities fraud and unlawful business practices following a significant stock price drop after an unfavorable FDA meeting regarding its immunotherapy combination [1][2]. Group 1: Company Developments - On July 18, 2024, Agenus announced the results of its end-of-Phase 2 meeting with the FDA concerning its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for treating adult patients with relapsed/refractory microsatellite stable colorectal cancer [2]. - The FDA advised against the submission of results for Accelerated Approval, indicating that the objective response rates may not translate to a survival benefit [2]. Group 2: Market Reaction - Following the FDA's announcement, Agenus's stock price fell by $10.43 per share, representing a decline of 58.83%, closing at $7.30 per share on July 18, 2024 [2]. Group 3: Legal Context - Pomerantz LLP is investigating claims on behalf of investors of Agenus, focusing on potential securities fraud or other unlawful business practices by the company and its officers or directors [1].

Agenus (NASDAQ:AGEN) stock is falling hard on Thursday after the clinical-stage biotechnology company provided results from a Phase 2 clinical trial of botensilimab and balstilimab as a colorectal cancer treatment.Specfically, the company met with the Food and Drug Administration (FDA) to conduct an end-of-Phase 2 meeting. During that meeting, the FDA discouraged the company from seeking Accelerated Approval for the treatment.The FDA’s advice was due to the objective response rates from the study not necess ...

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 ...

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) This report details Agenus Inc.'s recent financial announcement and the accompanying exhibit [Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Agenus Inc. announced its first quarter 2024 financial results on May 7, 2024, via a press release furnished as Exhibit 99.1, which is not considered 'filed' under Section 18 of the Securities Exchange Act - Agenus Inc. announced its financial results for the quarter ended March 31, 2024[7](index=7&type=chunk) - The announcement was made on May 7, 2024, through a press release furnished as Exhibit 99.1[7](index=7&type=chunk) - The information is explicitly stated as "furnished" and not "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, which limits its legal liability in certain contexts[7](index=7&type=chunk) [Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the sole exhibit furnished with the Form 8-K report, which is the May 7, 2024 press release containing the company's financial results - The report includes one furnished exhibit: 99.1 Press Release dated May 7, 2024[7](index=7&type=chunk)