Common Stock, $0.001 par value per share
- Symbol
- PVLA
- Exchange
- NASDAQ
- Classification
- COMMON
Current Report · Items 8.01, 9.01 · 8-K
Palvella Therapeutics, Inc.
Other Events
Item 8.01 Other Events. On May 15, 2026, Palvella Therapeutics, Inc. (the “Company”) issued a press release announcing that new data from the Company’s Phase 2 TOIVA trial of QTORIN™ rapamycin in patients with cutaneous venous malformations were presented at the 83rd Annual Meeting of the Society for Investigative Dermatology.…
Company context
We are a clinical-stage biopharmaceutical company whose vision is to become the leading rare disease biopharmaceutical company focused on developing and, if approved, commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases, for which there are no FDA approved therapies. We intend to leverage our versatile QTORIN™ platform to treat these patients. The QTORIN platform is designed to generate new therapies that penetrate the deep layers of the skin to locally treat a broad spectrum of rare, genetic skin diseases. Our lead product candidate, QTORIN 3.9% rapamycin anhydrous topical gel, or “QTORIN rapamycin”, is in clinical development for two of these diseases: microcystic lymphatic malformations, or “microcystic LM”, and cutaneous venous malformations. QTORIN rapamycin contains the active pharmaceutical ingredient rapamycin, also known as sirolimus, which is an inhibitor of mammalian target of rapamycin, or “mTOR”, a kinase that plays a key role in cell growth and proliferation. The QTORIN platform is novel and has only generated one program to date, QTORIN rapamycin, and clinical evidence to support this candidate is preliminary and limited at this time.
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Palvella Therapeutics, Inc. · 8-K · Filed 2026-05-15
Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On May 15, 2026, Palvella Therapeutics, Inc. (the “Company”) issued a press release announcing that new data from the Company’s Phase 2 TOIVA trial of QTORIN™ rapamycin in patients with cutaneous venous malformations were presented at the 83rd Annual Meeting of the Society for Investigative Dermatology. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Filed exhibits (1)
EX-99.1 2 pvla-ex99_1.htm PRESS RELEASE ISSUED BY PALVELLA THERAPEUTICS, INC. ON MAY 15, 2026 EX-99.1 Palvella Therapeutics Announces New Data from the Phase 2 TOIVA Trial of QTORIN™ Rapamycin in Cutaneous Venous Malformations Presented at the 83rd Annual Meeting of the Society for Investigative Dermatology 100% of patients with bleeding at baseline demonstrated a statistically significant improvement on the Cutaneous Venous Malformations Investigator Global Assessment Bleeding scale (cVM-IGA Bleeding) at Week 12 (+2.5 point improvement; p=0.003) 100% of patients with bleeding at baseline reported being "satisfied" or "very satisfied" with QTORIN™ rapamycin on the overall satisfaction item of the Treatment Satisfaction Questionnaire for Medication at Week 12 Baseline qualitative patient interviews underscore the substantial physical, functional, and psychosocial burden of cutaneous venous malformations QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 75,000 individuals with cutaneous venous malformations in the U.S. WAYNE, PA., May 15, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvell…
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