BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • BCI
    • Ebola outbreak
    • Hantavirus
    • Trump administration impacts
    • Med-tech outlook 2026
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Sunday, July 12, 2026
See today's BioWorld
Home » FDA puts Protagonist blood drug on clinical hold after mice develop tumors
To read the full story, subscribe or sign in.

FDA puts Protagonist blood drug on clinical hold after mice develop tumors

Sep. 17, 2021
By Michael Fitzhugh
Shares of Protagonist Therapeutics Inc. (NASDAQ:PTGX) fell 62% to $17.53 on Sept. 17 after it reported finding malignant skin tumors in a mouse model test of its most advanced candidate, rusfertide for blood disorders. After the company notified the FDA, the regulator put the program on a clinical hold, leading dosing of patients in all ongoing trials of rusfertide to be halted for now. The development could impact Protagonist's ability to start phase III testing of the candidate in polycythemia vera (PV) early in 2022, as well as efforts to expand its development to a third indication beyond PV and hereditary hemochromatosis (HH) by the end of this year, as it has planned.
BioWorld Clinical Regulatory Hematologic FDA

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 10, 2026.
  • Wainua autoinjector

    Ionis, AZ shares down on unexpected Wainua flop in cardiomyopathy

    BioWorld
    News of the unexpected phase III failure of the gene silencing drug Wainua (eplontersen) in the treatment of transthyretin-mediated amyloid cardiomyopathy sent...
  • Art concept for medical research

    FENS 2026: Shedding light on the sheddome

    BioWorld
    At the recently opened FENS Forum 2026 in Barcelona – the Federation of European Neuroscience Societies’ flagship congress and Europe’s largest neuroscience...
  • Silhouette with keyhole

    FENS 2026: Next-gen biologics take on brain disease

    BioWorld
    Whether by fine-tuning neurotransmitter signaling or silencing disease-associated genes, emerging biologic therapies are reshaping neuroscience drug development,...
  • Liver with hepatitis viruses, blood cells

    Recombinant vaccine inhibits HBV-associated HCC growth

    BioWorld Science
    Chronic liver disease and hepatocellular carcinoma (HCC) associated with chronic hepatitis B virus (HBV) are serious health problems in highly endemic areas....
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing