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InflaRx N.V. Secures EU Approval for GOHIBIC®: A Game Changer for ARDS Treatment

$IFRX
Form 6-K
Filed on: 2025-01-15
Source
InflaRx N.V. Secures EU Approval for GOHIBIC®: A Game Changer for ARDS Treatment

Here are the key insights extracted from the provided section of the financial report (Form 6-K) for InflaRx N.V.:

  1. Company Information:
  • Name: InflaRx N.V.
  • Address: Winzerlaer Str. 2, 07745 Jena, Germany.
  • Contact Number: (+49) 3641508180.
  1. Filing Details:
  • Form Type: 6-K (Report of Foreign Private Issuer).
  • Commission File Number: 001-38283.
  • Filing Date: January 15, 2025.
  1. Key Announcement:
  • The European Commission has granted marketing authorization for GOHIBIC® (vilobelimab) for the treatment of SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) in adults.
  • This treatment is notable for being the first and only approved in the European Union for this specific condition.
  1. Conditions for Use:
  • GOHIBIC is intended for patients who are receiving systemic corticosteroids as part of standard care and who are undergoing invasive mechanical ventilation (with or without extracorporeal membrane oxygenation).
  1. Incorporation by Reference:
  • The report mentions that it will be incorporated by reference into the company's registration statements on Form S-8 and Form F-3.
  1. Forward-looking Statements:
  • The report contains forward-looking statements, which are projections regarding the company's future performance or intentions. It includes a caution that these statements are subject to various risks and uncertainties that could lead to actual results differing materially from what is projected.
  1. Press Release Reference:
  • A copy of the press release regarding the European Commission's approval is included as Exhibit 99.1 but is not considered "filed" for legal purposes.
  1. Signature:
  • The report is signed by Niels Riedemann, Chief Executive Officer of InflaRx N.V., confirming its authenticity.

This information highlights significant developments in the company's product offerings and regulatory approvals, which could have implications for its market position and financial performance going forward.