Palvella Therapeutics to Present QTORIN™ Rapamycin Results from Phase 3 SELVA and Phase 2 TOIVA Studies at the International Society for the Study of Vascular Anomalies World Congress 2026
Rhea-AI Summary
Palvella Therapeutics (Nasdaq: PVLA) announced that two late-breaking abstracts reporting results from the Phase 3 SELVA and Phase 2 TOIVA studies of QTORIN™ 3.9% rapamycin anhydrous gel were accepted for presentation at the ISSVA World Congress 2026.
Findings cited include statistically significant, clinically meaningful improvement in microcystic lymphatic malformations (SELVA) and cutaneous venous malformations (TOIVA). The presentations will occur during the late-breaking session on May 20, 2026 at 4:30 p.m. ET, presented by James Treat, MD. Slides will be available at the company website at the session start.
Positive
- Phase 3 SELVA reported statistically significant, clinically meaningful improvement in microcystic lymphatic malformations
- Phase 2 TOIVA showed clinically meaningful improvement in cutaneous venous malformations
- Two late-breaking abstracts accepted for ISSVA World Congress 2026, increasing scientific visibility
Negative
- QTORIN™ has no FDA approval yet and remains investigational
News Market Reaction – PVLA
In the Apr 20 session, PVLA declined 0.52%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 24 | Phase 3 topline data | Positive | +37.1% | Positive topline Phase 3 SELVA results in microcystic lymphatic malformations. |
| Dec 16 | Fast Track designation | Positive | +8.8% | FDA Fast Track designation for QTORIN rapamycin in angiokeratomas. |
| Dec 15 | Phase 2 topline data | Positive | -9.7% | Positive Phase 2 TOIVA data in cutaneous venous malformations with strong responder rates. |
| Sep 15 | Trial enrollment complete | Positive | -3.9% | Completion of enrollment in Phase 2 TOIVA trial for cutaneous venous malformations. |
| Jun 23 | Phase 3 enrollment | Positive | +2.2% | Phase 3 SELVA enrollment completion, exceeding target and outlining NDA plans. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial and designation news for QTORIN™ has often led to sizable moves, with a mix of strong gains and occasional negative reactions despite positive data.
Over the last year, Palvella has repeatedly advanced QTORIN™ 3.9% rapamycin across microcystic lymphatic malformations and cutaneous venous malformations. Positive Phase 3 SELVA topline results on Feb 24, 2026 drove a 37.08% move, while Fast Track designation and positive Phase 2 TOIVA data in late 2025 produced mixed price reactions. Today’s conference presentation announcement fits this ongoing pattern of clinical progress and data dissemination.
Key Terms
phase 3 medical
phase 2 medical
rapamycin medical
microcystic lymphatic malformations medical
cutaneous venous malformations medical
late-breaking abstract technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
James Treat, MD, Professor of Clinical Pediatrics and Dermatology at the Children’s Hospital of Philadelphia to present clinical results on Wednesday, May 20, 2026, at 4:30 p.m. ET
WAYNE, Pa., April 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 that two late-breaking abstracts highlighting results from the Phase 3 SELVA and Phase 2 TOIVA studies of QTORIN™
Presentation title: QTORIN™
Presenter: James Treat, MD, Professor of Clinical Pediatrics and Dermatology at the Children’s Hospital of Philadelphia
Session: Late-Breaking Abstract Session
Date/Time: Wednesday, May 20, 2026 at 4:30 p.m. ET
The presentation will be available at the start of the session on the company’s website at https://palvellatx.com/publications-and-presentations/
About Palvella Therapeutics
Founded and led by rare disease biotech veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is 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 FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases and vascular malformations, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™
QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication.
James Treat, MD, is a paid consultant to Palvella Therapeutics, Inc., and has participated as a site investigator at Children’s Hospital of Philadelphia for portions of the Phase 3 SELVA study.
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from clinical trials, Palvella’s clinical development plans and related anticipated development milestones, Palvella’s plans to pursue Breakthrough Therapy Designation, Palvella’s plans to meet with regulatory authorities, Palvella’s cash, financial resources and expected runway, Palvella’s expectations regarding its programs, including QTORIN™ rapamycin and QTORIN™ pitavastatin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORIN™ rapamycin and QTORIN™ pitavastatin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; Palvella’s limited experience in commercial manufacturing; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.
Contact Information
Investors
Wesley H. Kaupinen
Founder and CEO, Palvella Therapeutics
wes.kaupinen@palvellatx.com
Media
Marcy Nanus
Managing Partner, Trilon Advisors LLC
mnanus@trilonadvisors.com
