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PALVELLA THERAPEUTICS, INC. (PVLA)

Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative treatments for patients afflicted with severe and uncommon inherited skin conditions. Central to its pipeline is QTORIN 3.9% rapamycin anhydrous gel (referred to as QTORIN rapamycin), which is currently undergoing Phase 3 clinical trials for microcystic lymphatic malformations. Additionally, this drug is in Phase 2 evaluation for treating cutaneous venous malformations. Beyond these specific indications, Palvella is also advancing QTORIN rapamycin for the treatment of other dermatological diseases driven by the mTOR pathway. The company's headquarters are situated in Wayne, Pennsylvania.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Palvella Therapeutics, Inc. logo

Palvella Therapeutics, Inc.

NASDAQ:PVLAHealthcare
-3.58%$146.15
AH$148.00+1.27%vs close
Mkt Cap$2.11B
Float11.08M
O/S14.41M
Vol
$ Vol
RVOL
Inst Own97.9%
SI21.7%
Earnings
Dilution
Palvella Therapeutics, Inc. logoNASDAQ:PVLA$146.15-3.58%
Upcoming Catalysts
Phase Distribution
19 lead-sponsored trials·5 active·13 completed
Phase 17
Phase 1/22
Phase 25
Phase 2/31
Phase 34

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 3
    Completed

    VALO-2: Study Evaluating the Safety and Efficacy of PTX022 in the Treatment of Adults With Pachyonychia Congenita

    PTX-022

    Pachyonychia Congenita

    Enrollment
    36
    Start
    Sep 2020
    Primary Completion
    Jun 2021
    Completion
    Dec 2022
    NCT04520750
  • Phase 3
    Completed

    A Multicenter, Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Pachyonychia Congenita

    QTORIN 3.9% rapamycin anhydrous gel, Vehicle

    Pachyonychia Congenita

    Enrollment
    87
    Start
    Nov 2021
    Primary Completion
    Jun 2023
    Completion
    Jun 2023
    NCT05180708
  • Phase 3
    Recruiting

    A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita

    PTX-022

    Pachyonychia Congenita

    Enrollment
    45
    Start
    Nov 2022
    Primary Completion
    Oct 2023est.
    Completion
    Nov 2023est.
    NCT05643872
  • Phase 3
    Active, not recruiting

    SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

    QTORIN 3.9% Rapamycin Anhydrous Gel

    Microcystic Lymphatic Malformation

    Enrollment
    51
    Start
    Jul 2024
    Primary Completion
    Jan 2026
    Completion
    Jul 2026est.
    NCT06239480
  • Phase 2/3
    Completed

    Phase 2/3 Study Evaluating the Safety and Efficacy of PTX-022 in Treatment of Adults With Pachyonychia Congenita

    PTX-022, Placebo

    Pachyonychia Congenita

    Enrollment
    73
    Start
    Apr 2019
    Primary Completion
    Sep 2020
    Completion
    Oct 2020
    NCT03920228
  • Phase 2
    Completed

    CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome

    PTX-022, Vehicle comparator

    BCCs in Gorlin Syndrome Patients

    Enrollment
    73
    Start
    May 2021
    Primary Completion
    Mar 2023
    Completion
    Mar 2023
    NCT04893486
  • Phase 2
    Completed

    Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations

    PTX-022

    Microcystic Lymphatic Malformation

    Enrollment
    12
    Start
    Jan 2022
    Primary Completion
    Nov 2022
    Completion
    Dec 2022
    NCT05050149
  • Phase 2
    Active, not recruiting

    Cinrebafusp Alfa in Combination With Ramucirumab and Paclitaxel in HER2-High Gastric or GEJ Adenocarcinoma and in Combination With Tucatinib in HER2-Low Gastric or GEJ Andenocarinoma

    Cinrebafusp alfa (PRS-343) in combination with ramucirumab and paclitaxel, Cinrebafusp alfa (PRS-343) in combination with tucatinib

    HER2-positive Gastric Cancer

    Enrollment
    80
    Start
    Nov 2021
    Primary Completion
    Feb 2023est.
    Completion
    Feb 2023est.
    NCT05190445
  • Phase 2
    Active, not recruiting

    A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations

    QTORIN 3.9% rapamycin anhydrous gel

    Cutaneous Venous Malformations

    Enrollment
    15
    Start
    Dec 2024
    Primary Completion
    Nov 2025
    Completion
    Mar 2026est.
    NCT06653842
  • Phase 2
    Recruiting

    A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Angiokeratomas (LOTU)

    PTX-022

    Angiokeratomas

    Enrollment
    15
    Start
    Apr 2026est.
    Primary Completion
    Aug 2027est.
    Completion
    Sep 2027est.
    NCT07552077
  • Phase 1/2
    Unknown status

    Phase Ib Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients

    PRS-080#022-DP, PRS-080-Placebo#001

    Anemia of Chronic Kidney Disease

    Enrollment
    24
    Start
    Jun 2016
    Primary Completion
    Feb 2017
    Completion
    Dec 2017est.
    NCT02754167
  • Phase 1/2
    Completed

    Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients

    PRS-080#022-DP, PRS-080-Placebo#001

    Anemia of Chronic Kidney Disease

    Enrollment
    11
    Start
    Sep 2017
    Primary Completion
    Mar 2019
    Completion
    Jun 2019
    NCT03325621
  • Phase 1
    Completed

    Study of Angiocal® in Patients With Solid Tumors, Investigating Safety, Tolerability, Blood Concentration of Study Drug

    Angiocal® (PRS-050-PEG40)

    Solid Tumor

    Enrollment
    26
    Start
    May 2010
    Primary Completion
    Sep 2011
    Completion
    Sep 2011
    NCT01141257
  • Phase 1
    Completed

    First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRS-080

    PRS-080#022-DP, PRS-080-Placebo#001

    Healthy

    Enrollment
    48
    Start
    Nov 2014
    Primary Completion
    Jul 2015
    Completion
    Aug 2015
    NCT02340572
  • Phase 1
    Completed

    PRS-343 in HER2-Positive Solid Tumors

    PRS-343

    HER2-positive Breast Cancer, HER2-positive Gastric Cancer +2

    Enrollment
    85
    Start
    Sep 2017
    Primary Completion
    Dec 2023
    Completion
    Dec 2023
    NCT03330561
  • Phase 1
    Completed

    Study of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects

    PRS-060, Placebo

    Healthy Subjects

    Enrollment
    72
    Start
    Dec 2017
    Primary Completion
    Oct 2018
    Completion
    Oct 2018
    NCT03384290
  • Phase 1
    Completed

    Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects With Mild Asthma

    PRS-060, Placebo

    Asthma

    Enrollment
    76
    Start
    Jun 2018
    Primary Completion
    Sep 2020
    Completion
    Sep 2020
    NCT03574805
  • Phase 1
    Completed

    PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors

    PRS-343 in Combination with Atezolizumab

    HER2-positive Breast Cancer, HER2-positive Gastric Cancer +2

    Enrollment
    41
    Start
    Aug 2018
    Primary Completion
    Aug 2022
    Completion
    Aug 2022
    NCT03650348
  • Phase 1
    Completed

    Study of Single and Multiple Doses of PRS-220 Administered by Oral Inhalation in Healthy Subjects

    Placebo, PRS-220

    Healthy

    Enrollment
    64
    Start
    Oct 2022
    Primary Completion
    Aug 2023
    Completion
    Aug 2023
    NCT05473533
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