PVLA - Quick Take - ISSVA Update: New Data Underscore Clinically Meaningful Efficacy of QTORIN Rapamycin

研报英文原文证据摘录

PVLA - Quick Take - ISSVA Update: New Data Underscore Clinically Meaningful Efficacy of QTORIN Rapamycin

Truist Securities

Equity Research Report May 20, 2026

HEALTHCARE: Biotech Palvella Therapeutics, Inc. (PVLA)

PVLA - Quick Take - ISSVA Update: New Data Underscore Danielle Brill, Pharm.D.

212-303-4110 Clinically Meaningful Efficacy of QTORIN Rapamycin

Danielle.Brill@truist.com

Alex Nackenoff, Ph.D. PVLA shared new data today at ISSVA from its QTORIN rapamycin studies in microcystic

212-590-0908 lymphatic malformations (mLMs; SELVA Phase 3) and cutaneous venous malformations

Alex.Nackenoff@truist.com (cVMs; TOIVA Phase 2). Broadly, the data demonstrate 1) greater improvement in pediatric

patients and those with bleeding manifestations in mLMs and 2) deepening response in

lesion height and improved appearance in cVMs following continued treatment.

Current Price (May 20, $115.50 The SELVA Ph3 trial was previously shown to meet the primary endpoint, with a 2.13

2026) increase (p<0.001) in mLM-IGA at week 24. New subgroup analysis shows pediatric patients

Stock Rating BUY (6-11 yrs) had a greater mean response in MLM-IGA than those >11 yrs. Furthermore, 100% (13/13) of pediatric patients were rated as "much improved" or "very much improved" at 24 Unchanged

weeks post-treatment. In further subpopulation analysis, patients with moderate or worse

Price Target $210.00 leaking/bleeding at baseline achieved a greater response; 87% (20/23) of patients with

Unchanged moderate+ leaking/bleeding at baseline achieved "much improved" or "very much improved"

status at 24 weeks.

Patient satisfaction was also high overall, with the satisfaction questionnaire showing 100%

of patients were at least "somewhat satisfied" with the overall treatment, and 84% were 6 Page Document