[Edaily Reporter SONG YOUNG-DOO ] While domestic pharmaceutical and biotech stocks were generally weak, JWPHARMACEUTICAL(001060)and Olix Pharmaceuticals, Inc.(226950)drew attention. JWPHARMACEUTICAL surged more than 16% as the successful completion of a multinational Phase 3 clinical trial for its gout treatment “Efamynurad” coincided with improved financial performance. In contrast, Olix Pharmaceuticals, Inc. plummeted 14% despite releasing positive research results demonstrating the potential to deliver short interfering RNA (siRNA) to the brain via subcutaneous injection alone. Market analysts suggest that concerns over potential selling pressure—as the conversion period for the convertible preferred shares (CPS) issued last year approaches—contributed to the decline.

JW Chungwa Surpasses Facebook’s Sostart… Stock Price Driven by Phase 3 Success and Earnings

According to KG Zeroin MP Doctor (MP Doctor, formerly Marketpoint) on the 12th, JWPHARMACEUTICAL closed at 30,150 won, up 14.86% (3,900 won) from the previous trading day.

The sharp rise in JWPHARMACEUTICAL’s stock price was driven by the success of the multinational Phase 3 clinical trial for its gout treatment candidate, Epaminurad (URC102). Epaminurad is an oral uricosuric agent that selectively inhibits the human uric acid transporter (hURAT1) to block the reabsorption of uric acid in the kidneys and promote its excretion. It is being developed for patients with hyperuricemia—a condition characterized by abnormally high blood uric acid levels—and gout.

This clinical trial was conducted at 52 institutions across five Asian countries—including South Korea, Taiwan, Thailand, Malaysia, and Singapore—and involved 612 patients with gout. The efficacy and safety of Epaminurad at doses of 6 mg and 9 mg were compared with those of febuxostat, the current standard of care.

Significant results were observed at the primary development dose of 6 mg. For the primary efficacy endpoint—the proportion of patients achieving serum uric acid levels below 6 mg/dL in the last three measurements of the main study period—the 6 mg efaminurad group recorded 50.0%, which was higher than the 38.3% observed in the 40 mg febuxostat group.

The difference in response rates between the two groups was 12.0 percentage points, meeting the non-inferiority criteria and demonstrating statistical superiority. In terms of safety, the incidence rates of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) during the treatment period were similar to those in the febuxostat group. It is particularly noteworthy that febuxostat 40 mg, the comparator drug, is a leading product in the domestic gout treatment market.

According to the pharmaceutical market research firm Ubiest, the domestic gout treatment market was valued at approximately 41.1 billion won last year. Of this, products containing febuxostat accounted for 34.7 billion won, or 84.4% of the market. Prescription sales of febuxostat 40 mg alone totaled approximately 26.0 billion won, representing more than 63% of the total market.

However, the high-dose 9 mg epaminurad failed to meet the statistical non-inferiority criteria for the primary endpoint when compared to 80 mg febuxostat. The rate of achieving serum uric acid levels below 6 mg/dL was 59.6% for 9 mg epaminurad and 63.3% for 80 mg febuxostat.

JWPHARMACEUTICAL plans to proceed with the approval process focusing on the 6 mg dose, which is the primary dose under development. The company is preparing a New Drug Application (NDA) with the goal of obtaining domestic marketing authorization in 2027. In July, it also held two pre-NDA meetings with the Ministry of Food and Drug Safety.

Improved financial performance is also believed to have influenced investor sentiment. JWPHARMACEUTICAL explained that the rise in its stock price that day was attributed to the success of the Phase 3 clinical trial for Efaminurad, as well as the market’s positive reception of its recent financial results.

Ultimately, analysts believe that investor sentiment was stimulated by the fact that the value of the new drug candidate has moved beyond expectations in the preclinical or early clinical stages to a phase where the actual likelihood of approval is being assessed.

Olix Pharmaceuticals, Inc. Falls 14% Despite Announcement of Subcutaneous Injection for Brain Gene Suppression

Although Olix Pharmaceuticals, Inc. announced positive R&D results today, its stock price plummeted. It closed at 113,400 won, down 14.03% (180,500 won) from the previous day.

The company released preclinical study results for its second-generation “OASIS-CNS” platform, which targets central nervous system (CNS) disorders. OASIS-CNS is a technology that uses siRNA to suppress target genes associated with CNS disorders. Olix Pharmaceuticals, Inc. is developing this second-generation platform by combining the technology with a shuttle capable of crossing the blood-brain barrier (BBB), enabling administration via subcutaneous (SC) or intravenous (IV) routes instead of the conventional intrathecal administration. Simply put, it is a technology that delivers RNA therapeutics to the brain via the bloodstream using a standard subcutaneous injection method, rather than administering the drug directly around the brain.

When Olix Pharmaceuticals, Inc. administered the substance subcutaneously and intravenously to mice, suppression of the target gene was confirmed in various brain regions, including deep areas such as the striatum and hippocampus. In some cases, the suppression rate exceeded 70–80%. This represents a significant step forward beyond simply demonstrating that siRNA reached the brain. This is because the company has secured an initial proof of concept (PoC) demonstrating that siRNA crossed the blood-brain barrier (BBB) and actually suppressed the expression of target genes in brain tissue.

However, the stock price moved in the opposite direction of the research results. Olix Pharmaceuticals, Inc. explained that, regarding the day’s stock price decline, no specific adverse events related to the company’s business or R&D process have been identified, and that it understands concerns are being raised in some market circles regarding the timing of the conversion of the CPS issued last year into common stock.

CPS are preferred shares that can be converted into common stock upon meeting certain conditions. If they are actually converted into common stock, the number of outstanding shares will increase, potentially diluting the equity value of existing shareholders; furthermore, if the converted shares are sold on the market, this could create short-term supply-and-demand pressure.

It is important to note that even if the conversion period for the CPS arrives, this does not necessarily mean that the corresponding shares will immediately flood the market. Whether conversion actually occurs, the timing of such conversion, and whether investors choose to hold or sell the shares after conversion are separate issues.

Therefore, it is difficult to conclusively attribute today’s sharp drop in Olix Pharmaceuticals, Inc.’s stock price to the CPS. However, the company explains that it is possible the market perceived the potential volume of shares that could be converted into common stock in the future as an “overhang” (a potential large-scale supply of shares for sale), which may have weighed on investor sentiment.