Rafael Holdings Reports Mixed Phase 3 Results for Trappsol Cyclo; Confirms 2026 NDA Timeline

Key Facts

1Trappsol Cyclo did not achieve statistical significance on the primary endpoint but showed a statistically significant effect in a prespecified subgroup analysis.

2Rafael Holdings remains on track to submit a New Drug Application (NDA) in the fourth quarter of 2026.

Rafael Holdings announced that its drug Trappsol Cyclo did not achieve statistical significance on the primary endpoint of the Phase 3 TransportNPC study for Niemann-Pick Disease Type C. According to a statement released via GlobeNewswire, the treatment did demonstrate a statistically significant effect in a prespecified subgroup analysis despite missing the broader primary goal.

The company remains on track to submit a New Drug Application (NDA) in the fourth quarter of 2026 based on the study findings. Shares of RFL closed at $2.03 on September 29, 2026, having traded between a low of $2 and a high of $2.14 during that session.