IFRX

#3730
InflaRx N.V. - Common Stock
2.2 6 USD
+0.06%
Market Price
Settore: Salute
Base: USD
Valuta di Profitto: USD
Intervallo Giornaliero
2.22
2.26
Intervallo Annuale
0.80
2.94
Variazione giornaliera
+6.10%
Variazione Mensile
+34.52%
Variazione di 6 mesi
+153.93%
Variazione Annuale
+34.52%
Chiusura Precedente
2.1 3
Open
2.2 2
Minimo
2.2 2
Massimo
2.2 6
Volume
116
Apri il grafico completo

Financials

Panoramica Estratto Conto Statistiche Documents

2026

Current report, Q3 FY2026
Inflarx N.V. current report, Q3 FY2026
6-K
Current report, Q2 FY2026
Inflarx N.V. current report, Q2 FY2026
6-K
Current report, Q2 FY2026
Inflarx N.V. current report, Q2 FY2026
6-K
Current report, Q2 FY2026
Inflarx N.V. current report, Q2 FY2026
6-K
Current report, Q2 FY2026
Inflarx N.V. current report, Q2 FY2026
6-K
Current report, Q2 FY2026
Inflarx N.V. current report, Q2 FY2026
6-K
Current report, Q2 FY2026
Inflarx N.V. current report, Q2 FY2026
6-K
Current report, Q2 FY2026
Inflarx N.V. current report, Q2 FY2026
6-K
Current report, Q2 FY2026
Inflarx N.V. current report, Q2 FY2026
6-K
Current report, Q1 FY2026
Inflarx N.V. current report, Q1 FY2026
6-K

Inflarx N.V. current report, Q4 FY2024

Full document

Business Context and Reporting Period

This Form 6-K filing by InflaRx N.V. covers the period ending November 15, 2024. The report discloses a significant regulatory milestone regarding the Company's lead product candidate, vilobelimab (GOHIBIC®).

Key Financial Metrics

The filing text does not provide a clear value for revenue, profit, cash flow, margins, debt, or liquidity. This report focuses exclusively on a regulatory update and does not contain financial statements or operational metrics.

Material Changes

The primary material event is the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The opinion recommends marketing authorization for vilobelimab under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids and invasive mechanical ventilation.

Outlook, Risks, and Management Commentary

  • Regulatory Status: The positive CHMP opinion is a prerequisite for the European Commission to grant marketing authorization.
  • Indication: The approval is specific to ARDS caused by SARS-CoV-2 in patients on mechanical ventilation.
  • Conditions: Authorization is recommended under "exceptional circumstances," which may imply specific post-authorization obligations or limitations compared to standard approvals.
  • Risks: The filing does not explicitly detail new risks, though reliance on a single product candidate and the "exceptional circumstances" designation are inherent considerations.

Investor Verification Checklist

  • Verify the final decision by the European Commission following the positive CHMP opinion.
  • Confirm the specific terms and limitations associated with the "exceptional circumstances" marketing authorization.
  • Assess the commercial potential of the specific patient population (SARS-CoV-2-induced ARDS on mechanical ventilation) in the current market environment.
  • Review the attached press release (Exhibit 99.1) for detailed clinical data supporting the opinion.

Notizie