Inventera (0007J0) surged to its daily price limit after saying its magnetic resonance imaging joint contrast agent met the primary efficacy endpoint in a Phase 3 trial. The company said it plans to file for product approval with the Ministry of Food and Drug Safety based on the results, and expectations for commercialization drove the stock higher.
Inventera traded at 11,890 won as of 3:13 p.m. on the 21st, up 1,740 won, or 17.14%, from the previous session, according to the Korea Exchange. The stock opened at 10,090 won and at one point jumped to 13,190 won, its upper daily limit. Trading value exceeded 47 billion won.
The rally was triggered by clinical trial results released during the session. Inventera disclosed that it had received the final clinical study report for INV-002 (NEMO-103), a contrast agent it developed specifically for magnetic resonance arthrography. The trial enrolled 85 patients with known or suspected shoulder joint disorders who required MR arthrography, and was conducted at eight institutions in Korea including Seoul National University Bundang Hospital.
The trial was designed to determine how much MR arthrography using NEMO-103 improves image quality compared with MRI performed without a contrast agent. Independent central readers assessed three measures — joint distension, contrast and sharpness — and found statistically significant improvement in all three after NEMO-103 was administered. The company said the trial therefore met its primary efficacy objective.
Inventera plans to move the results into the commercialization process. The company said it will file a new drug application for NEMO-103 with the Ministry of Food and Drug Safety based on the final trial results. Investor expectations grew as the company confirmed the main efficacy measures in the Phase 3 trial and brought the approval process into view.
Inventera noted, however, that uncertainty remains over whether the investigational drug will ultimately win approval. Some analysts said clinical results do not automatically translate into product approval, and that the ministry's review and its approval decision will determine the stock's next direction.
