Palvella Phase 3 SELVA study of QTORIN rapamycin meets primary endpoint with p<0.001; NDA planned H2 2026

PALVELLA THERAPEUTICS, INC.

Primary endpoint achieved: mean +2.13 improvement on mLM-IGA (p<0.001); all secondary endpoints met (p<0.001).
86% of completers rated 'Much Improved' or better; 95% improved at least 1 point.
Well-tolerated: no drug-related SAEs; systemic rapamycin levels <2 ng/mL at all timepoints.
NDA submission to FDA planned H2 2026; potential approval H1 2027 for first approved therapy for microcystic LMs.
98% of eligible participants chose to continue in extension period.

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