Spotlight Stock: Tai Tsung's Mid-Trial Analysis Misses Market Expectations, Posts Second Consecutive Trading Halt

Tai Tsung (4169-TW) announced on Thursday (23rd) the interim analysis results from the Phase III clinical trial of U101, its investigational drug for preventing recurrent urinary tract infections (rUTI). Although safety was confirmed and the trial will continue as originally planned, the company must complete the full Phase III trial before approval, contrary to market expectations that it could directly apply for regulatory approval. As a result, Tai Tsung's stock plunged again today (27), marking its second consecutive trading halt.

Recently, market sentiment toward Tai Tsung's Phase III trial had been positive, with expectations that the interim analysis would meet the threshold for early unblinding and allow for immediate regulatory submission. Consequently, the stock performed strongly, reaching a peak of NT$290 on Wednesday (22nd).

After Tai Tsung suspended trading on Thursday to announce the interim results—confirming safety but requiring completion of the full Phase III trial—the stock failed to sustain its upward momentum. It plummeted to the daily trading limit on Friday (24th) and again gapped down to hit the limit today, closing at NT$223 with over 1,000 sell orders queued.

Tai Tsung responded to the 'early unblinding' speculation, clarifying that the primary purpose of the interim analysis was to evaluate safety and detect any major anomalies. The threshold for 'early unblinding' was set extremely high.

The company further stated that the Independent Data Monitoring Committee (IDMC) recommendation to continue patient enrollment represents a normal, positive progression in clinical trials—a standard and expected outcome for a Phase III trial proceeding as planned. It emphasized that 'continuing enrollment' should not be misinterpreted as a sign of trial failure.

Tai Tsung noted that the interim analysis showed positive trends and good safety, and it plans to submit an Investigational New Drug (IND) application to the U.S. FDA in the second half of this year to expand into the U.S. and global markets.