| Symbol | PVLA |
|---|---|
| Name | PALVELLA THERAPEUTICS, INC. |
| Sector | HEALTH CARE |
| Region | North America |
| Industry | Biotechnology: Pharmaceutical Preparations |
| Address | 353 W. LANCASTER AVE,SUITE 200, WAYNE, Pennsylvania, 19087, United States |
| Telephone | +1 484 - 253-1461 |
| Fax | — |
| — | |
| Website | https://www.palvellatx.com |
| Incorporation | UNDEFINED |
| Incorporated On | — |
| Employees | — |
| Fiscal Year | — |
| Public Since | — |
| Exchanges | NASDAQ |
| Auditor | — |
| Audit Status | NOT PROVIDED |
| Reporting Status | — |
| CIK | 0001583648 |
| Description | Palvella Therapeutics, Inc., formerly Pieris Pharmaceuticals, Inc., is a clinical-stage biopharmaceutical company. The Company is focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases. The Company is developing a pipeline of product candidates based on its patented QTORIN platform, with an initial focus on serious, rare genetic skin diseases. Its lead product candidate, QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin), is in the Phase III SELVA clinical trial in microcystic lymphatic malformations (microcystic LMs) and a Phase II trial in cutaneous venous malformations. It is also engaged in developing treatment for other serious, functionally debilitating skin diseases driven by the overactivation of the mammalian target of rapamycin (mTOR) pathway. Additional info from NASDAQ: |
Director Pauls Matthew 🟢 acquired 6.0K shares (1 derivative) of PALVELLA THERAPEUTICS, INC. (PVLA) at $154.84 Transaction Date: Jun 29, 2026 | Filing ID: 079865
Read moreNew Form 3 - PALVELLA THERAPEUTICS, INC. <b>Filed:</b> 2026-07-01 <b>AccNo:</b> 0001104659-26-079863 <b>Size:</b> 8 KB
Read more(70% Positive) PALVELLA THERAPEUTICS, INC. (PVLA) Announces New Board Appointment
Read morePalvella Therapeutics Appoints Accomplished Rare Disease Biotech Executive and Commercial Leader Matt Pauls, J.D., M.B.A., to Board of Directors
Read morePalvella Therapeutics Submits First Module of Rolling New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
Read moreGoin Kathleen 🟡 adjusted position in 4.3K shares (2 derivative) of PALVELLA THERAPEUTICS, INC. (PVLA) at $112.23 Transaction Date: Jun 17, 2026 | Filing ID: 076460
Read moreFDA Grants Rolling Review of Palvella’s QTORIN™ Rapamycin NDA for Microcystic Lymphatic Malformations
Read more📋 Goin Kathleen (Officer) plans to sell 4K shares of PALVELLA THERAPEUTICS, INC. (at $110.73 each, total $476K) Filed: Jun 17, 2026 | ID: 000032
Read moreKorenberg Matthew E 🟡 adjusted position in 0 shares (1 derivative) of PALVELLA THERAPEUTICS, INC. (PVLA) at $13.60 Transaction Date: Jun 12, 2026 | Filing ID: 074574
Read more(99% Neutral) PALVELLA THERAPEUTICS, INC. (PVLA) Announces Executive Changes
Read more| Trial ID | Title | Phase | Indication | Status | Start Date | Completion Date | Source |
|---|---|---|---|---|---|---|---|
| NCT07552077 | A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-… | Phase2 | Angiokeratomas | Recruiting | 2026-04-01 | 2027-09-01 | ClinicalTrials.gov |
| NCT06653842 | A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-… | Phase2 | Cutaneous Venous Malformations | Active_Not_Recruiting | 2024-12-20 | 2026-03-01 | ClinicalTrials.gov |
| NCT06239480 | SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Tr… | Phase3 | Microcystic Lymphatic Malformation | Active_Not_Recruiting | 2024-07-31 | 2026-07-01 | ClinicalTrials.gov |
| NCT05643872 | A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anh… | Phase3 | Pachyonychia Congenita | Recruiting | 2022-11-15 | 2023-11-01 | ClinicalTrials.gov |
| NCT05050149 | Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the T… | Phase2 | Microcystic Lymphatic Malformation | Completed | 2022-01-13 | 2022-12-15 | ClinicalTrials.gov |
| NCT05180708 | A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evalu… | Phase3 | Pachyonychia Congenita | Completed | 2021-11-29 | 2023-06-30 | ClinicalTrials.gov |
| NCT04893486 | CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topic… | Phase2 | BCCs in Gorlin Syndrome Patients | Completed | 2021-05-06 | 2023-03-13 | ClinicalTrials.gov |
| NCT04520750 | VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of … | Phase3 | Pachyonychia Congenita | Completed | 2020-09-01 | 2022-12-15 | ClinicalTrials.gov |
| NCT03920228 | Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of A… | Phase2 | Pachyonychia Congenita | Completed | 2019-04-01 | 2020-10-19 | ClinicalTrials.gov |
| Product Name | Type | Development Stage | Therapeutic Area | Study Status | Trial ID |
|---|---|---|---|---|---|
| PTX-022 | Other | Phase PHASE3 | Pachyonychia Congenita | RECRUITING | NCT05643872 |
| Vehicle | Other | Phase PHASE3 | Pachyonychia Congenita | COMPLETED | NCT05180708 |
| QTORIN 3.9% rapamycin anhydrous gel | Other | Phase PHASE3 | Pachyonychia Congenita | COMPLETED | NCT05180708 |
| Vehicle comparator | Other | Phase PHASE2 | BCCs in Gorlin Syndrome Patients | COMPLETED | NCT04893486 |
| PTX-022 | Other | Phase PHASE2 | BCCs in Gorlin Syndrome Patients | COMPLETED | NCT04893486 |
| PTX-022 | Other | Phase PHASE3 | Pachyonychia Congenita | COMPLETED | NCT04520750 |
| Placebo | Other | Phase PHASE2 | Pachyonychia Congenita | COMPLETED | NCT03920228 |
| PTX-022 | Other | Phase PHASE2 | Pachyonychia Congenita | COMPLETED | NCT03920228 |
| PTX-022 | Other | Phase PHASE2 | Microcystic Lymphatic Malformation | COMPLETED | NCT05050149 |
| QTORIN 3.9% rapamycin anhydrous gel | Other | Phase PHASE2 | Cutaneous Venous Malformations | ACTIVE_NOT_RECRUITING | NCT06653842 |
| QTORIN 3.9% Rapamycin Anhydrous Gel | Other | Phase PHASE3 | Microcystic Lymphatic Malformation | ACTIVE_NOT_RECRUITING | NCT06239480 |
| PTX-022 | Other | Phase PHASE2 | Angiokeratomas | RECRUITING | NCT07552077 |
| PTX-022 | Other | Phase PHASE2 | Angiokeratomas | RECRUITING | NCT07552077 |
| PTX-022 | Other | Phase PHASE2 | Angiokeratomas | RECRUITING | NCT07552077 |
| PTX-022 | Other | Phase PHASE2 | Angiokeratomas | RECRUITING | NCT07552077 |
| PTX-022 | Other | Phase PHASE2 | Angiokeratomas | RECRUITING | NCT07552077 |
| PTX-022 | Other | Phase PHASE2 | Angiokeratomas | RECRUITING | NCT07552077 |
| PTX-022 | Other | Phase PHASE2 | Angiokeratomas | RECRUITING | NCT07552077 |
| PTX-022 | Other | Phase PHASE2 | Angiokeratomas | RECRUITING | NCT07552077 |
| QTORIN 3.9% Rapamycin Anhydrous Gel | DRUG | Phase PHASE3 | Microcystic Lymphatic Malformation | ACTIVE_NOT_RECRUITING | NCT06239480 |
| Vehicle | DRUG | Phase PHASE3 | Pachyonychia Congenita | COMPLETED | NCT05180708 |
| QTORIN 3.9% rapamycin anhydrous gel | DRUG | Phase PHASE2 | Cutaneous Venous Malformations | ACTIVE_NOT_RECRUITING | NCT06653842 |
| Vehicle comparator | DRUG | Phase PHASE2 | BCCs in Gorlin Syndrome Patients | COMPLETED | NCT04893486 |
| Placebo | DRUG | Phase PHASE2 | Pachyonychia Congenita | COMPLETED | NCT03920228 |
| PTX-022 | DRUG | Phase PHASE3 | Pachyonychia Congenita | RECRUITING | NCT05643872 |