Newron provided context on the clinical hold of US sites in the ENIGMA-TRS 2 trial, arguing there is no evidence of a causal relationship and discussing a pathway to file without US patients if the hold persists. The FDA appears focused on risk-mitigation measures rather than fundamentally questioning the program's viability.
Key catalysts include:
1. Topline results ENIGMA-TRS 1 (Q1 2027)
2. Topline results ENIGMA-TRS 2 (Q3 2027)
3. Partnering evenamide in non-core markets (2026/2027)