Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $65.9352W HIGH $161.38
Volume
49.61 K
Value Traded
21.57 M
Short % Float
25.45%
+2.66%Week
-10.14%1 Month
-6.05%3 Month
+6.99%6 Month
-99.06%5 Year
-99.45%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
1.97 B
EPS (TTM)
-4.28
P/E Ratio
-
Ent. Value
1.71 B
Total Shares
14.41 M
Float Shares
9.14 M
Insiders
36.60%
Institutions
88.35%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
PoA blends historical approval base rates, trial design score and FDA review track record.
PVLA Catalyst Timeline
Dated clinical, regulatory and corporate events for Palvella Therapeutics, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Palvella Therapeutics, Inc.
335Total events
32Upcoming
72Tier-1 (high impact)
2014 to 2027Coverage
Upcoming catalysts 2
Event history 50
▲Grant / FundingCorporate
FDA awards third year of grant funding for QTORIN rapamycin Phase 3 SELVA trial and OLE
microcystic lymphatic malformationssource ↗
●NDA SubmissionRegulatory Filing
Completed rolling submission of NDA to FDA
microcystic lymphatic malformationssource ↗
●NDA SubmissionRegulatory Filing
Submitted first module of rolling NDA
microcystic lymphatic malformationssource ↗
▲First Patient DosedTrial
First patients dosed in LOTU trial
clinically significant angiokeratomassource ↗
▲Oral PresentationPresentation
Presented additional Phase 3 SELVA data at ISSVA
microcystic lymphatic malformationssource ↗
●NDA SubmissionRegulatory Filing
Completion of NDA submission for QTORIN rapamycin
microcystic lymphatic malformationssource ↗
●End Of Phase 2 MeetingFDA Meeting
End-of-Phase 2 meeting planned before Phase 3 initiation
cutaneous venous malformationssource ↗
●Pre NDA MeetingFDA Meeting
Completed pre-NDA meeting with FDA
microcystic lymphatic malformationssource ↗
▲Rolling Submission InitiatedRegulatory Filing
FDA granted Rolling Review for NDA
microcystic lymphatic malformationssource ↗
▲Rolling Submission InitiatedRegulatory Filing
Submitted first module of rolling NDA to FDA
microcystic lymphatic malformationssource ↗
◆Oral PresentationPresentation
Palvella Therapeutics to participate in fireside chat at Goldman Sachs 47th Annual Global Healthcare Conference 2026
▲Pre NDA MeetingFDA Meeting
Completion of FDA pre-NDA meeting for QTORIN rapamycin in microcystic LMs
microcystic lymphatic malformationssource ↗
▲Oral PresentationPresentation
Presented Phase 2 TOIVA data at SID 2026
cutaneous venous malformationssource ↗
▲Patent GrantedIP / Competition
U.S. Patent No. 12,636,273 issued, exclusively licensed from Yale University, covering topical mevalonate pathway inhibition in porokeratosis
porokeratosis (including DSAP)source ↗
◆Oral PresentationPresentation
Presentation of Phase 3 SELVA and Phase 2 TOIVA results at ISSVA 2026
microcystic lymphatic malformations, cutaneous venous malformationssource ↗
▲Poster PresentationPresentation
New data from Phase 2 TOIVA trial presented at SID 2026
cutaneous venous malformationssource ↗
◆Oral PresentationPresentation
Additional data presentation at SID Annual Meeting
cutaneous venous malformationssource ↗
◆Quarterly UpdateCorporate
First Quarter 2026 Financial Results and Corporate Update Conference Call
▲First Patient DosedTrial
First patients dosed in Phase 2 LOTU trial of QTORIN rapamycin for angiokeratomas
clinically significant angiokeratomassource ↗
▲Topline ReadoutClinical Data
Positive topline data from Phase 3 SELVA study reported
microcystic lymphatic malformationssource ↗
▲Patent GrantedIP / Competition
European patent granted for QTORIN rapamycin anhydrous topical compositions
●PublicationPresentation
Publication in Journal of Vascular Anomalies highlighting unmet need in microcystic LMs
microcystic lymphatic malformationssource ↗
▲First Patient DosedTrial
First patients dosed in Phase 2 LOTU trial of QTORIN rapamycin for angiokeratomas
clinically significant angiokeratomassource ↗
▲Oral PresentationPresentation
Presented Phase 2 TOIVA data at SID 2026
cutaneous venous malformationssource ↗
▲Fast Track DesignationDesignation
FDA granted Fast Track Designation for angiokeratomas
Clinically Significant Angiokeratomassource ↗
●PublicationPresentation
Systematic review of real-world evidence for QTORIN pitavastatin in DSAP published
Disseminated Superficial Actinic Porokeratosis (DSAP)source ↗
◆FDA Feedback ReceivedFDA Meeting
Pre-NDA meeting with FDA anticipated in Q2 2026
microcystic lymphatic malformationssource ↗
◆Breakthrough Therapy DesignationDesignation
Application for FDA Breakthrough Therapy Designation submitted for QTORIN rapamycin in cutaneous VMs
cutaneous venous malformationssource ↗
●Trial InitiationTrial
Initiation of Phase 2 trial for angiokeratomas planned
clinically significant angiokeratomassource ↗
◆Pre NDA MeetingFDA Meeting
Pre-NDA meeting granted by FDA; meeting expected Q2 2026
Microcystic Lymphatic Malformationssource ↗
◆Breakthrough Therapy DesignationDesignation
Breakthrough Therapy Designation application expected to be submitted Q2 2026
Cutaneous Venous Malformationssource ↗
◆Pre NDA MeetingFDA Meeting
FDA Pre-NDA meeting granted for QTORIN rapamycin for microcystic LMs
microcystic lymphatic malformationssource ↗
●Pre NDA MeetingFDA Meeting
Completed pre-NDA meeting with FDA for QTORIN rapamycin NDA
microcystic lymphatic malformationssource ↗
▲Rolling Submission InitiatedRegulatory Filing
FDA granted Rolling Review for QTORIN rapamycin NDA
microcystic lymphatic malformationssource ↗
●NDA SubmissionRegulatory Filing
Submitted first module of rolling NDA to FDA
microcystic lymphatic malformationssource ↗
▲First Patient DosedTrial
Dosed first patients in LOTU Phase 2 trial
clinically significant angiokeratomassource ↗
▲Oral PresentationPresentation
Presented additional Phase 3 SELVA data at ISSVA
microcystic lymphatic malformationssource ↗
▲Patent GrantedIP / Competition
Issuance of U.S. Patent No. 12,636,273 covering topical HMG-CoA reductase inhibitors
porokeratosissource ↗
◆Quarterly UpdateCorporate
Full Year 2025 Financial Results and Corporate Update Conference Call
●PublicationPresentation
Publication of review article in Journal of Vascular Anomalies on microcystic and macrocystic lymphatic malformations
▲Primary Endpoint MetClinical Data
QTORIN rapamycin achieved primary endpoint in Phase 3 SELVA trial with highly statistically significant results
microcystic lymphatic malformationssource ↗
▲Poster PresentationPresentation
Poster #76954: QTORIN Rapamycin formulation science and Phase 3 SELVA results
microcystic lymphatic malformationssource ↗
●Poster PresentationPresentation
Poster #76929: Burden of living with porokeratosis patient and caregiver interview study
porokeratosissource ↗
Past FDA Catalysts and PDUFA Decisions
How PVLA actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-05-20 | QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) | Phase 2 data readout | Phase 2 |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
C43 / 100
Pipeline Score
$36M
Pipeline Value
Richly Valued
Valuation Signal
2
Drugs Scored
0.0x
rNPV / MCap
Top 32%
Micro Cap(rank 211 of 658)
Percentile Rank
Palvella Therapeutics, Inc. carries a moderate pipeline score (43/100), with $90M risk-adjusted pipeline value, led by PTX-022 in Angiokeratomas (Phase 2).
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| PTX-022 Small moleculeNCT03920228 | Pachyonychia Congenita | Phase 3 | COMPLETED | 154 | Oct 19, 2020 |
Clinical Trial Results
Readouts, endpoints and source filings for every PVLA program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| QTORIN rapamycin BreakthroughFast TrackOrphan | microcystic lymphatic malformations | Phase 3 | 2026-05-20 | 100% of participants (13/13) aged 6 11 years were rated as Much Improved (+2) or Very Much Improved (+3) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) scale at Week 24; mean improvement of +2.46 (p<0.001); 87% of participants (20/23) in SELVA with moderate or worse leaking/bleeding at baseline were rated as Much Improved (+2) or Very Much Improved (+3) on the mLM-IGA Leaking/Bleeding at Week 24; mean improvement of +2.48 (p<0.001); 100% of SELVA participants who completed the efficacy evaluation period (43/43) were at least somewhat satisfied with QTORIN rapamycin on the TSQM-9 overall satisfaction item at Week 24; 84% reporting extremely satisfied, very satisfied, or satisfiedRead More | ISSUED BY PALVELLA THERAPEUTICS, INC. ON MAY 20, 2026 EX-99.1 Palvella Therapeutics Presents New SELVA and TOIVA Data at the 2026 International Society for the Study of Vascular Anomalies World Congress SupRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Goin KathleenOfficer (Chief Operating Officer) | Option | 2,154 2,154 held | $7.14 | 09/16/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in PVLA
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Frazier Life Sciences Management, L.P. | 2.9 % (3.6 %) | 134.85 M | 882.40 K |
PVLA Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
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Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
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| Last | Vol | OI | Last | Vol | OI | |
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Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How PVLA ranks across every disease it competes in
Competitive Position is a premium feature
See how PVLA ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialPVLA News
PVLAU.S. Food and Drug Administration Awards Additional Funding for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
Palvella Therapeutics has received additional funding from the FDA for QTORIN™ rapamycin, following the successful Phase 3 SELVA trial. The therapy aims to treat microcystic lymphatic malformations, with a potential U.S. launch in early 2027 if approved. The funding supports ongoing trials and highlights the therapy's promise as a first FDA-approved treatment for this condition.
Read more →PVLAPalvella Therapeutics Appoints James R. Treat, M.D., Nationally Recognized Pediatric Dermatologist as Chief Medical Officer
Palvella Therapeutics has appointed Dr. James R. Treat as Chief Medical Officer, effective December 21, 2026. Dr. Treat, a recognized expert in pediatric dermatology, will lead the company's medical strategy as it advances its QTORIN™ rapamycin towards potential approval for treating microcystic lymphatic malformations. His extensive experience and previous collaboration with Palvella are expected to significantly contribute to the company's mission in rare skin diseases.
Read more →PVLAPalvella Therapeutics to Participate in Upcoming Healthcare Investor Conferences
Palvella Therapeutics announced its participation in two upcoming healthcare investor conferences, including the Cantor Global Healthcare Conference and the H.C. Wainwright 28th Annual Global Investment Conference. CEO Wes Kaupinen will represent the company at these events, which will be available via live webcasts. Palvella focuses on developing therapies for rare skin diseases.
Read more →PVLAPalvella Therapeutics Completes Rolling Submission of New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
Palvella Therapeutics has completed the rolling submission of its New Drug Application for QTORIN™ rapamycin, targeting microcystic lymphatic malformations. The drug has received Breakthrough Therapy and Fast Track designations from the FDA, and the NDA includes promising results from the Phase 3 SELVA trial. If approved, QTORIN™ rapamycin could launch commercially in the first half of 2027.
Read more →PVLAPalvella Therapeutics to Participate in the Canaccord Genuity 46th Annual Growth Conference
Palvella Therapeutics will participate in the Canaccord Genuity 46th Annual Growth Conference on August 12, 2026. CEO Wes Kaupinen will lead a fireside chat, which will be available via live webcast. The company focuses on developing therapies for rare skin diseases and vascular malformations, with a pipeline that includes investigational products.
Read more →PVLA▲ +8%on this newsshared move
Palvella Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
Palvella Therapeutics reported its second quarter 2026 financial results, highlighting the submission of the first module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations. The company is preparing for a potential commercial launch in 2027, pending FDA approval. Additionally, Palvella plans to initiate Phase 3 trials for QTORIN™ rapamycin and Phase 2 trials for QTORIN™ pitavastatin later in 2026.
Read more →PVLA▲ +5.3%on this newsshared move
Palvella Therapeutics Chief Scientific Officer Jeff Martini, Ph.D. Selected to Present at Upcoming FDA Public Workshop on Drug Repurposing
Jeffrey Martini, Ph.D., Chief Scientific Officer of Palvella Therapeutics, will present at an FDA public workshop on August 5, 2026, focusing on drug repurposing. The meeting aims to discuss evidence frameworks and regulatory approaches for advancing therapies for serious, rare diseases. This initiative builds on the FDA's efforts to identify new uses for approved medications.
Read more →PVLAPalvella Therapeutics to Host Second Quarter 2026 Financial Results and Corporate Update Conference Call on August 4, 2026
Palvella Therapeutics will report its second quarter 2026 financial results on August 4, 2026. A conference call for investors is scheduled for 8:30 a.m. ET on the same day to discuss the results and provide a corporate update. The company focuses on developing therapies for serious, rare skin diseases.
Read more →PVLAPalvella Therapeutics Appoints Accomplished Rare Disease Biotech Executive and Commercial Leader Matt Pauls, J.D., M.B.A., to Board of Directors
Palvella Therapeutics has appointed Matt Pauls, an experienced executive in rare disease biotech, to its Board of Directors. With over 25 years in the industry, Pauls has held leadership roles in several companies and is expected to contribute significantly to Palvella's upcoming regulatory and commercial advancements. His expertise will be crucial as the company prepares for the potential launch of its lead product, QTORIN™ rapamycin.
Read more →PVLAPalvella Therapeutics Submits First Module of Rolling New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
Palvella Therapeutics has initiated the rolling New Drug Application (NDA) process for QTORIN™ rapamycin, aimed at treating microcystic lymphatic malformations. The FDA has previously granted Breakthrough Therapy and Fast Track designations for this treatment, highlighting its potential to meet a significant medical need. The company plans to complete the NDA submission by the second half of 2026 and is preparing for a potential commercial launch in 2027.
Read more →PVLA▲ +10.3%on this news
Palvella Therapeutics Announces Completion of FDA Pre-NDA Meeting for QTORIN™ Rapamycin in Microcystic Lymphatic Malformations
Palvella Therapeutics has completed its pre-New Drug Application meeting with the FDA for QTORIN™ rapamycin, aimed at treating microcystic lymphatic malformations. The company plans to submit the NDA in the second half of 2026, supported by data from its Phase 3 SELVA study. QTORIN™ rapamycin could become the first FDA-approved therapy for this condition, which affects over 30,000 individuals in the U.S.
Read more →PVLA▼ -7%on this newsshared move
Palvella Therapeutics to Participate in the Goldman Sachs 47th Annual Global Healthcare Conference 2026
Palvella Therapeutics, a clinical-stage biopharmaceutical company, will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on June 9, 2026. CEO Wes Kaupinen will lead a fireside chat, which will be available via live webcast. The company focuses on developing therapies for serious, rare skin diseases and vascular malformations.
Read more →PVLAPalvella Therapeutics Strengthens QTORIN™ Pitavastatin Intellectual Property with Yale-Licensed U.S. Patent Providing Protection into 2043
Palvella Therapeutics announced the issuance of a U.S. patent for QTORIN™ pitavastatin, enhancing its intellectual property for treating disseminated superficial actinic porokeratosis (DSAP). The patent, licensed from Yale University, provides protection until 2043. Palvella aims to begin a Phase 2 clinical trial for this investigational therapy in the latter half of 2026.
Read more →PVLAPalvella Therapeutics Named Healthcare & Life Sciences Company of the Year at the Philadelphia Alliance for Capital and Technologies (PACT) Ecosystem Awards
Palvella Therapeutics has been awarded the Healthcare & Life Sciences Company of the Year at the 2026 PACT Ecosystem Awards. This recognition underscores the company's dedication to developing innovative therapies for serious, rare skin diseases and vascular malformations. CEO Wes Kaupinen emphasized the team's commitment to advancing treatment options for patients without FDA-approved therapies.
Read more →PVLA▲ +5.8%on this newsshared move
Palvella Therapeutics Presents New SELVA and TOIVA Data at the 2026 International Society for the Study of Vascular Anomalies World Congress Supporting QTORIN™ Rapamycin as a Potential First-in-Disease Therapy for Multiple Serious, Rare Vascular Malformations
Palvella Therapeutics Presents New SELVA and TOIVA Data at the 2026 International Society for the Study of Vascular Anomalies World Congress Supporting QTORIN™ Rapamycin as a Potential First-in-Disease Therapy for Multiple Serious, Rare Vascular Malformations
Read more →PVLA▲ +5.8%on this newsshared move
Palvella Therapeutics Presents New SELVA and TOIVA Data at the 2026 International Society for the Study of Vascular Anomalies World Congress Supporting QTORIN Rapamycin as a Potential First-in-Disease Therapy for Multiple Serious, Rare Vascular Malformations
Palvella Therapeutics presented new data from Phase 3 SELVA and Phase 2 TOIVA studies at the ISSVA World Congress, highlighting the efficacy of QTORIN rapamycin for treating microcystic lymphatic malformations and cutaneous venous malformations. The SELVA study reported that all participants aged 6 to 11 years showed improvement on the mLM-IGA scale, while the TOIVA study revealed notable reductions in visual and height scores of cutaneous venous malformations. Palvella plans to submit a New Drug Application to the FDA for QTORIN rapamycin in the latter half of 2026.
Read more →PVLAPalvella 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
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
Read more →PVLAPalvella 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
Palvella Therapeutics announced positive new data from the Phase 2 TOIVA trial of QTORIN rapamycin for cutaneous venous malformations, presented at the 83rd Annual Meeting of the Society for Investigative Dermatology. Notably, 100% of patients with baseline bleeding exhibited significant improvement in symptoms and reported high satisfaction with the treatment. This therapy has potential to be the first FDA-approved treatment for this condition, aiming to address the substantial burden faced by affected individuals. The trial highlights the importance of both clinical and patient-reported outcomes, reinforcing the need for novel treatment options in this area.
Read more →PVLAPalvella Therapeutics Announces Uplisting to the Nasdaq Global Market
Palvella Therapeutics has announced its uplisting to the Nasdaq Global Market, reflecting the company's progress in developing therapies for rare skin diseases and vascular malformations. This transition is effective May 13, 2026, and aims to enhance visibility and support its mission. Palvella continues to comply with Nasdaq listing standards and SEC requirements.
Read more →PVLA▼ -13%on this news
Palvella Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
Palvella Therapeutics has reported its first quarter financial results for 2026, revealing a net loss of $15.8 million. Positive developments include the grant of a Pre-New Drug Application meeting by the FDA for QTORIN rapamycin, aimed at treating microcystic lymphatic malformations, with an NDA submission planned for the second half of 2026. The company also announced successful financing of $230 million to bolster its commercialization strategy. Additionally, advancements in its clinical pipeline were highlighted, including multiple trials scheduled for the second half of 2026.
Read more →About Palvella Therapeutics, Inc.
Headquarters353 W. LANCASTER AVENUE, WAYNE, PA, 19087
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