PALVELLA THERAPEUTICS, INC. - 8-K Filing
Palvella Therapeutics presented new clinical data from its Phase 3 SELVA and Phase 2 TOIVA studies at the ISSVA World Congress, showing QTORIN™ rapamycin achieved statistically significant improvements in microcystic lymphatic malformations (100% of participants aged 6–11 years improved on mLM-IGA scale) and cutaneous venous malformations. The company plans to file an NDA for microcystic LMs by mid-2026, with potential FDA approval in early 2027. (Items: 8.01 Other Events, 9.01 Financial Statements and Exhibits)
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