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Humanigen, Inc. - HGEN STOCK NEWS

Welcome to our dedicated page for Humanigen news (Ticker: HGEN), a resource for investors and traders seeking the latest updates and insights on Humanigen stock.

Humanigen, Inc. (OTC Pink: HGEN) is a clinical-stage biopharmaceutical company with a focus on developing innovative therapies to enhance patient outcomes. At the core of the company's mission is the development of lenzilumab, a first-in-class monoclonal antibody designed to neutralize granulocyte-macrophage colony-stimulating factor (GM-CSF), a key cytokine involved in inflammatory responses.

The company's leading product, lenzilumab, is currently being investigated in multiple clinical trials. One of the major studies is the RATinG (Risk Adapted Therapy in Acute GvHD) trial, which aims to explore lenzilumab's efficacy in treating acute Graft versus Host Disease (aGvHD). This condition affects a significant proportion of patients who undergo allogeneic stem cell transplants, with high rates of morbidity and mortality. The Phase 2/3 study is conducted in collaboration with the UK-based IMPACT partnership and is poised to enroll patients across 18 treatment centers.

In addition to aGvHD, lenzilumab is also being tested as a treatment for chronic myelomonocytic leukemia and to mitigate toxicities associated with CAR-T therapy through investigator-initiated trials. The company's expertise in antibody development extends beyond lenzilumab, as demonstrated by the development of an antibody drug conjugate (ADC) utilizing its EphA-3 targeted monoclonal antibody ifabotuzumab for the treatment of solid tumors.

Humanigen’s pipeline is fortified by state-of-the-art antibody customization technologies designed to optimize therapeutic effects while minimizing undesired side effects. The company’s research and development efforts are supported by extensive partnerships with leading institutions such as the University of Birmingham's Cancer Research UK Clinical Trials Unit and the British Society of Blood and Marrow Transplantation.

Despite being at a pre-commercial stage, Humanigen demonstrates resilience and strategic focus, advancing its therapeutic candidates through critical clinical milestones. Financial and market challenges remain, but the company is actively exploring strategic options, including potential restructuring to maintain its innovative edge and ongoing operations.

For more detailed information, including the latest updates and news, visit www.humanigen.com and follow Humanigen on Twitter.

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Humanigen, Inc. has announced the successful dosing of the first participant in the RATinG trial of lenzilumab for the early treatment of acute Graft versus Host Disease (aGvHD). The trial aims to evaluate the efficacy of lenzilumab in improving non-relapse mortality in patients with high-risk aGvHD following allogeneic stem cell transplant. aGvHD affects 40%-70% of all HSCT patients and has a mortality rate of 70%-75%. Lenzilumab neutralizes the immune signaling of GM-CSF, which may initiate the inflammatory cascade that drives aGvHD.
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Humanigen (NASDAQ: HGEN) reported a net loss of $30.1 million for Q2 2022, a significant improvement from $70.8 million in Q2 2021. Total cash and cash equivalents as of June 30, 2022, were approximately $47.0 million. The company has made strides in its clinical studies, increasing sites for the PREACH-M study in Australia and preparing to enroll in the RATinG study in the UK. Humanigen is also evaluating lenzilumab for various applications in oncology and COVID-19, aiming to accelerate development despite deemphasizing COVID-related efforts.

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Humanigen, Inc. (Nasdaq: HGEN) announced preliminary topline results from NIAID's ACTIV-5/BET-B trial evaluating lenzilumab with remdesivir for hospitalized COVID-19 patients. The trial did not achieve statistical significance for its primary endpoint—patients alive and off mechanical ventilation by Day 29. There was a non-significant trend toward reduced mortality (HR 0.72). No new safety concerns related to lenzilumab were noted. CEO Cameron Durrant emphasized the need for further studies on treatments amid the ongoing COVID-19 challenges.

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Humanigen, Inc. (HGEN) announced significant findings from the Phase 3 LIVE-AIR study of lenzilumab, highlighting its effectiveness in treating COVID-19 patients with elevated C-reactive protein (CRP) levels. Patients with baseline CRP <150 mg/L showed a 62% reduction in the risk of invasive mechanical ventilation or death when treated with lenzilumab compared to placebo. The likelihood of surviving without mechanical ventilation was 90% for those on lenzilumab, versus 79% for those receiving placebo. These results may support future Emergency Use Authorization from the FDA for lenzilumab.

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Humanigen, Inc. (Nasdaq: HGEN) announced that the National Institute of Allergy and Infectious Diseases has completed the database lock for the Big Effect Trial of its lead drug candidate, lenzilumab, as part of the NIH's COVID-19 therapeutic initiative. This milestone allows for the completion of topline analysis, with results expected in July. Lenzilumab is being tested as a treatment for COVID-19 and is not yet approved. The study involves hospitalized patients and evaluates lenzilumab's safety and efficacy alongside remdesivir.

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Humanigen, Inc. (NASDAQ: HGEN) has entered into an agreement with PCI Pharma Services to facilitate the importation and commercialization of lenzilumab in the UK, pending Conditional Marketing Authorization for COVID-19 treatment. PCI will purchase the drug for resale, enhancing Humanigen's supply chain readiness. Lenzilumab could save the National Health Service over £10,000 per patient and aims to address the ongoing COVID-19 hospitalizations in the UK, which exceed 235,000 this year. Further studies are planned to explore lenzilumab's efficacy in other conditions.

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Humanigen, Inc. (NASDAQ: HGEN), a biopharmaceutical company, announced participation in various investor conferences in June 2022. Ken Trbovich, SVP Investor Relations, will present at the LD Micro Invitational XII on June 7, 2022. Cameron Durrant, CEO, will present at the Jefferies Global Healthcare Conference on June 10, 2022, and will join a virtual fireside chat at the Lytham Partners Summer 2022 Conference on June 21, 2022. The company focuses on lenzilumab for treating cytokine storm and various inflammatory conditions, continuing its development amidst ongoing clinical trials.

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Humanigen, Inc. (NASDAQ: HGEN) announced that CEO Cameron Durrant will present at the H.C. Wainwright Global Investment Conference on May 23-26, 2022, in Miami, FL, at 11:00 am EDT. The presentation will update on the topline data release for ACTIV-5/BET-B and the company's plans for 2022. With over 1 million COVID-19 hospitalizations and 173,738 deaths in the U.S. this year, Humanigen emphasizes the need for additional therapeutics. A webcast of the event will be available on Humanigen's investor relations website for 90 days.

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Humanigen, Inc. (NASDAQ: HGEN) provides an update on its lead drug candidate, lenzilumab, aimed at treating cytokine storm in COVID-19 patients. Key highlights include the completion of enrollment in the ACTIV-5/BET-B study and positive FDA feedback regarding an EUA amendment. Hospitalizations remain steady, with an average of 2,072 new cases daily. Financially, the company reported a net loss of $21.3 million for Q1 2022, a significant decrease from $65.6 million in Q1 2021, primarily due to reduced R&D expenses.

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FAQ

What is the market cap of Humanigen (HGEN)?

The market cap of Humanigen (HGEN) is approximately 23.8K.

What does Humanigen, Inc. specialize in?

Humanigen, Inc. specializes in developing innovative therapies, including lenzilumab, a monoclonal antibody aimed at neutralizing GM-CSF to treat conditions such as acute Graft versus Host Disease (aGvHD).

What is lenzilumab?

Lenzilumab is a first-in-class monoclonal antibody developed by Humanigen to neutralize granulocyte-macrophage colony-stimulating factor (GM-CSF), thereby potentially improving outcomes in conditions like aGvHD.

What is the RATinG trial?

The RATinG trial is a Phase 2/3 clinical study investigating the efficacy of lenzilumab in treating high-risk acute Graft versus Host Disease (aGvHD) in patients who have undergone allogeneic stem cell transplants.

What are the key partnerships supporting Humanigen's research?

Humanigen collaborates with prestigious institutions like the University of Birmingham's Cancer Research UK Clinical Trials Unit and the British Society of Blood and Marrow Transplantation.

What other conditions is lenzilumab being investigated for?

Besides aGvHD, lenzilumab is being explored as a treatment for chronic myelomonocytic leukemia and to prevent toxicities associated with CAR-T therapy.

What is ifabotuzumab?

Ifabotuzumab is an antibody drug conjugate (ADC) targeting EphA-3, developed by Humanigen, currently being investigated for the treatment of solid tumors.

Is Humanigen a publicly traded company?

Yes, Humanigen, Inc. is publicly traded under the symbol HGEN on OTC Pink.

How can I stay updated with Humanigen's latest news?

You can stay updated by visiting their official website at www.humanigen.com and following their official Twitter account.

What challenges does Humanigen face?

Humanigen faces financial and market challenges typical of clinical-stage biopharmaceutical companies, including the need for additional capital and strategic restructuring.

What is Humanigen's approach to antibody development?

Humanigen employs advanced customization technologies to develop antibodies that enhance desired therapeutic effects while reducing potential side effects.

Humanigen, Inc.

OTC:HGEN

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23.82k
110.48M
10.35%
0.49%
3.48%
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