Inventera surges 17.14% after Phase 3 contrast-agent success

  • Inventera said INV-002 met all primary endpoints in its South Korean Phase 3 trial.
  • 85 patients participated across eight sites, including Seoul National University Bundang Hospital.
  • Inventera plans to submit an MFDS marketing application in the fourth quarter.

Inventera surged to the daily price limit after its INV-002 MRI contrast agent met all primary endpoints with statistically significant improvements in a South Korean Phase 3 trial. The study enrolled 85 patients with known or suspected shoulder conditions requiring MR arthrography and compared non-contrast MRI with imaging after INV-002 administration. Independent central readers confirmed improvements in joint distension, contrast and sharpness across all assessed parameters. Inventera received the final clinical study report on September 21 and plans to submit a marketing authorization application to South Korea's Ministry of Food and Drug Safety in the fourth quarter, with revenue targeted from next year if approval is granted. INV-002 uses biocompatible iron-based nanotechnology instead of gadolinium, and no contrast agent is currently approved specifically for MR arthrography. Shares traded at 11,890 won, up 17.14%, as of 3:13 p.m., after reaching the 13,190-won daily limit. Regulatory approval remains uncertain. South Korea's contrast-agent market is estimated at 500 billion won, while the global market is projected to grow from 13.156 trillion won in 2022 to 17.4174 trillion won by 2031.

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