Humanigen

Humanigen, Inc. is a clinical-stage biopharmaceutical company. engages in the development of cell and gene therapies for the treatment of cancers through novel human granulocyte-macrophage colony-stimulating factor neutralization and gene-knockout platforms. The company was founded by Jeng-Horng Her & Robert F. Balint on March 15, 2000 and is headquartered in Essex County, NJ.

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Humanigen is a biopharmaceutical company that uses its biologic capabilities and its proprietary platform technology to develop first-in-class human antibody therapeutics. It focuses on preventing the serious and potentially life-threatening side-effects associated with chimeric antigen receptor T-cell (CAR-T) therapy. Its pipeline includes programs such as Lenzilumab, Ifabotuzumab, and HGen005.

Humanigen Inc. (NASDAQ:HGEN) shares are trading sharply lower Thursday after the company announced the FDA declined its EUA request for lenzilumab in hospitalized COVID-19 patients. Humanigen was down 51% to $7.43 at time of publication.

Why Did Humanigen's Stock Dump Today And What's Next?

An attempt to earn authorization for lenzilumab hit a wall at the FDA.

Here's Why Humanigen Is Getting Hammered Today

The FDA declined Humanigen Inc's (NASDAQ: HGEN) request for emergency use authorization (EUA) of its lenzilumab drug to treat newly hospitalized COVID-19 patients. The Company filed its application with the FDA for emergency drug use in May, citing late-stage trial data.

See Why Humanigen Stock Is Plunging To 52-Week Low

The FDA declines Humanigen's request for emergency use authorization of lenzilumab to treat newly hospitalized Covid-19 patients.

Humanigen Sinks After FDA Declines Emergency Use Request for Covid Treatment

The stock price of Humanigen, Inc. (Nasdaq: HGEN) fell over 50% pre-market today. This is why it happened.

HGEN Stock: Why It Is Significantly Lower Today

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,' announced today the U.S. FDA has declined its request for emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients. In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential

FDA has declined Humanigen's Emergency Use Authorization (EUA) Request for Lenzilumab in Hospitalized COVID-19 Patients

Investors need to pay close attention to Humanigen (HGEN) stock based on the movements in the options market lately.

Implied Volatility Surging for Humanigen (HGEN) Stock Options

KaloBios Pharmaceuticals Inc. (HGEN) delivered earnings and revenue surprises of -160.87% and -98.27%, respectively, for the quarter ended June 2021. Do the numbers hold clues to what lies ahead for the stock?

KaloBios Pharmaceuticals Inc. (HGEN) Reports Q2 Loss, Misses Revenue Estimates

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called “cytokine storm'” with its lead drug candidate, lenzilumab, today provided a corporate and regulatory update and reported financial results for the second quarter and six months ended June 30, 2021. Update on Status of Emergency Use Authorization (“EUA”) Application On May 28, 2021, Humanigen submitted an

Humanigen Reports Second Quarter 2021 Financial Results

Humanigen Inc (NASDAQ: HGEN) has announced an analysis of results from its Phase 3 LIVE-AIR study of lenzilumab in hospitalized patients with COVID-19. Data suggested that Black and African-American patients having a CRP over 150 mg/L may be the highest responders to treatment, with a nearly 9-fold increase in the likelihood of survival without ventilation (SWOV).

Humanigen's COVID-19 Candidate Shows 2.5 Fold Increase In Survival Without Ventilation

BURLINGAME, Calif.--(BUSINESS WIRE)--Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients

Lenzilumab Treatment May Provide Enhanced Likelihood of Survival Without Ventilation in Hospitalized Black and African-American COVID-19 Patients

BURLINGAME, Calif.--(BUSINESS WIRE)--NIH Advances ACTIV-5/BET-B study to a Phase 2/3 study and modified the primary endpoint to survival without ventilation

NIH Advances ACTIV-5/BET-B Trial Evaluating Lenzilumab from a Phase 2 Exploratory Study to a Phase 2/3 Study for the Treatment of COVID-19

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), today announced its development and commercialization partners for South Korea and the Philippines, Telcon RF Pharmaceutical, Inc. (“Telcon”) and KPM Tech Co., Ltd. (“KPM Tech”), have received approval from South Korea's MFDS (the South Korean equivalent of the U.S. FDA) to conduct a Phase 1 clinical study of lenzilumab, which may support potential use in the treatment of hospitalized COVID-19 patients. The study

Humanigen's Partner in South Korea Receives Ministry of Food and Drug Safety (MFDS) Approval to Conduct Phase 1 Study of Lenzilumab

Is the Options Market Predicting a Spike in Humanigen (HGEN) Stock?

The stock price of Humanigen Inc (NASDAQ: HGEN) increased by over 5% during intraday trading. This is why it happened.

Humanigen Stock Increases Over 5%: Why It Happened

BURLINGAME, Calif.--(BUSINESS WIRE)--UK's MHRA accepts Humanigen's submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review

UK's MHRA accepts Humanigen's submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review

Burlingame, California--(Newsfile Corp. - June 28, 2021) - Humanigen, Inc. (NASDAQ: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called 'cytokine storm', today announced that Humanigen has been added to the Russell 3000® Index at the conclusion of the 2021 Russell indexes annual reconstitution.The event represents the ongoing accomplishments of Humanigen during a transformational year in developing lenzilumab for the treatment of newly hospitalized patients with COVID-19, and its...

Humanigen Inc. Added to Russell 3000(R) Index

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen announced it has initiated a rolling review submission for Marketing Authorization (MA) by the MHRA for its lead drug candidate, lenzilumab

Humanigen Initiates Submission for Lenzilumab Marketing Authorization in COVID-19, to the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA)

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm' with its lead drug candidate, lenzilumab, today announced the appointment of Ken Trbovich to the newly-created role of SVP of Investor Relations, effective immediately, reporting to Timothy E. Morris, COO/CFO of Humanigen. Mr. Trbovich brings to Humanigen 20 years of experience on Wall St

Humanigen Announces Ken Trbovich Appointed as Senior Vice President, Investor Relations

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen announces it will present at the 2021 LD Micro Invitational XI

Humanigen to Present at the 2021 LD Micro Invitational XI

Humanigen Inc (NASDAQ: HGEN) has submitted an application to the FDA seeking Emergency Use Authorization (EUA) for lenzilumab to treat patients hospitalized with COVID-19. The application is based on positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.

Humanigen Files US Emergency Use Application For Lenzilumab For COVID-19

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen announces submission of application to the FDA requesting Emergency Use Authorization for lenzilumab

Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen announces that granulocyte macrophage-colony stimulating factor gene-edited CAR-T data will be presented at the ISCT 2021 Annual Meeting

GM-CSF Gene-Edited CAR-T Data to be Presented at International Society for Cell & Gene Therapy Annual Meeting 2021

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm' with its lead drug candidate, lenzilumab™, today announced that the Company's management team will participate in a fireside chat at the Jefferies Healthcare Conference being held from June 1-4, 2021. Management will discuss its lead product, lenzilumab, which recently completed a Phase 3

Humanigen to Present at Jefferies Healthcare Conference

Humanigen Inc (NASDAQ: HGEN) and Chime Biologics, contract development and manufacturing organization (CDMO), have entered into a manufacturing services agreement to produce Humanigen's lenzilumab bulk drug substance and drug product for commercial sale. It will follow the receipt of the requisite regulatory authorizations or approvals in regions outside of the U.S., including Europe, the U.K., India, and Brazil.

News for Humanigen Stock (HGEN)