GI Innovation (358570) shares closed 5% higher at 8,380 won, approximately $6.1, on Aug. 26 after the FDA granted Fast Track designation to GI-101A for patients with locally advanced or metastatic urothelial cancer who have previously received immuno-oncology treatment. The company is conducting a randomized Phase 2 trial of GI-101A in combination with Keytruda (pembrolizumab), with enrollment ongoing since the first patient was dosed in May. Fast Track status provides more frequent FDA interactions and may support priority review or accelerated approval, potentially reducing the review period to as little as six months if clinical data are sufficient. Phase 1 results presented at the ASCO annual meeting showed a 50% objective response rate and 75% disease control rate among four previously treated patients. Of two patients with partial responses, one remained on treatment for more than two years and the other for more than seven months. CEO Jang Myung-ho said the designation was granted in two weeks, compared with the FDA’s typical 60-day decision period, and would help accelerate development.