In SELVA Phase 3 study, 100% of participants (13/13) aged 6–11 years were rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) scale at Week 24, with a mean improvement of +2.46 (p<0.001)

87% of participants (20/23) in SELVA with moderate or worse leaking/bleeding at baseline were rated as "Much Improved" (+2) or "Very Much Improved" (+3) on the mLM-IGA Leaking/Bleeding at Week 24, with a mean improvement of +2.48 (p<0.001)

100% of SELVA participants who completed the efficacy evaluation period (43/43) were at least somewhat satisfied with QTORIN™ rapamycin on the TSQM-9 overall satisfaction item at Week 24, with 84% reporting extremely satisfied, very satisfied, or satisfied

Blinded independent review demonstrated pre-treatment stability during the 8-week run-in period, followed by marked improvement on QTORIN™ rapamycin, supporting SELVA's single-arm, baseline-controlled design

TOIVA Phase 2 study demonstrated statistically significant improvements in both cVM-MCSS Height and cVM-MCSS Appearance at all measured time points, with increasing clinical response observed with longer duration of QTORIN™ rapamycin therapy

QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for microcystic lymphatic malformations and cutaneous venous malformations

WAYNE, Pa., May 20, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or "the Company") (NASDAQ:PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced new clinical data from the Phase 3 SELVA and Phase 2 TOIVA studies were reported at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 in Philadelphia, PA.