{"id":965538,"date":"2026-05-20T18:59:38","date_gmt":"2026-05-20T22:59:38","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/palvella-therapeutics-presents-new-selva-and-toiva-data-at-the-2026-international-society-for-the-study-of-vascular-anomalies-world-congress-supporting-qtorin-rapamycin-as-a-potential-first-i\/"},"modified":"2026-05-20T18:59:38","modified_gmt":"2026-05-20T22:59:38","slug":"palvella-therapeutics-presents-new-selva-and-toiva-data-at-the-2026-international-society-for-the-study-of-vascular-anomalies-world-congress-supporting-qtorin-rapamycin-as-a-potential-first-i","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/palvella-therapeutics-presents-new-selva-and-toiva-data-at-the-2026-international-society-for-the-study-of-vascular-anomalies-world-congress-supporting-qtorin-rapamycin-as-a-potential-first-i\/","title":{"rendered":"Palvella Therapeutics Presents New SELVA and TOIVA Data at the 2026 International Society for the Study of Vascular Anomalies World Congress Supporting QTORIN\u2122 Rapamycin as a Potential First-in-Disease Therapy for Multiple Serious, Rare Vascular Malformations"},"content":{"rendered":"
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\n In SELVA Phase 3 study, 100% of participants (13\/13) aged 6\u201311 years were rated as \u201cMuch Improved\u201d (+2) or \u201cVery Much Improved\u201d (+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)<\/em>\n <\/p>\n

\n 87% of participants (20\/23) in SELVA with moderate or worse leaking\/bleeding at baseline were rated as \u201cMuch Improved\u201d (+2) or \u201cVery Much Improved\u201d (+3) on the mLM-IGA Leaking\/Bleeding at Week 24, with a mean improvement of +2.48 (p<0.001)<\/em>\n <\/p>\n

\n 100% of SELVA participants who completed the efficacy evaluation period (43\/43) were at least somewhat satisfied with QTORIN\u2122 rapamycin on the TSQM-9 overall satisfaction item at Week 24, with 84% reporting extremely satisfied, very satisfied, or satisfied<\/em>\n <\/p>\n

\n Blinded independent review demonstrated pre-treatment stability during the 8-week run-in period, followed by marked improvement on QTORIN\u2122 rapamycin, supporting SELVA\u2019s single-arm, baseline-controlled design<\/em>\n <\/p>\n

\n 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\u2122 rapamycin therapy<\/em>\n <\/p>\n

\n QTORIN\u2122 rapamycin has the potential to become the first FDA-approved therapy and standard of care for microcystic lymphatic malformations and cutaneous venous malformations<\/em>\n <\/p>\n

WAYNE, Pa., May 20, 2026 (GLOBE NEWSWIRE) — Palvella Therapeutics, Inc.<\/a> (Palvella or \u201cthe Company\u201d) (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. The presentation, given by James Treat, MD, Professor of Clinical Pediatrics and Dermatology at the Children\u2019s Hospital of Philadelphia, can be found here<\/a>.<\/p>\n

\u201cData presented today at ISSVA further strengthen our conviction that QTORIN\u2122 rapamycin has the potential to become the first FDA-approved therapy for microcystic lymphatic malformations and cutaneous venous malformations,\u201d said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. \u201cAs understanding of the mTOR pathway biology underlying lymphatic and venous malformations has advanced, this pathway has emerged as a key therapeutic target, yet there remain no FDA-approved therapies for microcystic lymphatic malformations or cutaneous venous malformations. We believe these localized, cutaneous diseases are well-suited to QTORIN\u2122 rapamycin\u2019s targeted topical approach as a potential chronic therapy designed to address the underlying mTOR pathway biology directly in the pathogenic tissue of interest while minimizing systemic exposure. Importantly, data presented in younger patients further support the potential role of early intervention in these serious, progressive diseases. We remain on track to file our NDA in the second half of 2026 for microcystic lymphatic malformations, with potential approval targeted in the first half of 2027.\u201d<\/p>\n

\n QTORIN\u2122 rapamycin for Microcystic Lymphatic Malformations: Additional Data from SELVA study<\/strong>\n <\/p>\n

SELVA is a Phase 3, single-arm, baseline-controlled clinical trial of QTORIN\u2122 rapamycin administered topically once daily for a 24-week efficacy evaluation period followed by an open-label extension period, for microcystic lymphatic malformations (microcystic LMs). Palvella previously announced<\/a> positive topline results from this study in February 2026, including achieving statistical significance on the primary endpoint, key secondary endpoint, and all pre-specified secondary efficacy endpoints.<\/p>\n

Additional data presented today highlight:<\/p>\n