Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • The company is initiating four to five potentially registrational programs for IMVT - 1402 by March 31, 2025, and trials in ten indications by March 31, 2026.
  • Added the requirement for a valid transfer mechanism for personal information transfers, impacting operations.
  • The FDA approved VYVGART (efgartigimod alfa and hyaluronidase-qvfc) for gMG treatment.
  • Increased risks due to severe ransomware attacks and potential interruptions in operations.
  • The FDA accepted for priority review a supplemental BLA for VYVGART Hytrulo for CIDP.
  • Enhanced cybersecurity risks due to increased cyberattacks following hostilities, posing threats to data.
  • The FDA approved RYSTIGGO (rozanolixizumab-noli) for gMG treatment in adults.
  • Expanded risks related to dependence on third parties for manufacturing capabilities and product commercialization.
  • The FDA accepted for priority review a supplemental BLA for VYVGART Hytrulo for CIDP.
  • Added potential tax obligations increase due to the adoption of Pillar Two proposal.
  • The FDA approved ULTOMIRIS (ravulizumab-cwvz) for gMG treatment in April 2022.
  • The FDA approved ZILBRYSQ (zilucoplan) for gMG treatment in October 2023.

Full Text Changes in Most Recent 10-K

Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.

To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1764013&owner=exclude

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