Palvella Therapeutics, Inc. (PVLA)
NASDAQ:PVLA
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Palvella Therapeutics
(NASDAQ:PVLA)
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Rating:48Neutral
Price Target:
$114.00
▼(-12.31% Downside)
Action:Reiterated
Date:05/21/26
The score is held down primarily by weak financial performance (no revenue, widening losses, and ongoing cash burn). Technicals also lean bearish with the stock below key moving averages and a negative MACD. Offsetting these is a strong set of recent corporate events driven by positive late-stage clinical data and stated progress toward an NDA in 2H 2026, supported by a low-leverage balance sheet.
Positive Factors
Robust late-stage clinical data and regulatory momentum
Pivotal SELVA and supportive TOIVA results, coupled with Breakthrough/Orphan/Fast Track designations and a planned H2 2026 NDA, create a clearer regulatory path. This materially raises the probability of a first-in-disease approval and the potential for durable market exclusivity in niche rare-disease markets.
Negative Factors
No product revenue and widening losses
As a clinical-stage biotech with zero product revenue and escalating net losses, Palvella lacks operating earnings to sustain growth. Long-term value depends on translating clinical success into approved product sales; until then, returns remain negative and the business is financing-dependent.
Read all positive and negative factors
Positive Factors
Negative Factors
Robust late-stage clinical data and regulatory momentum
Pivotal SELVA and supportive TOIVA results, coupled with Breakthrough/Orphan/Fast Track designations and a planned H2 2026 NDA, create a clearer regulatory path. This materially raises the probability of a first-in-disease approval and the potential for durable market exclusivity in niche rare-disease markets.
Read all positive factors
Palvella Therapeutics (PVLA) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.56B
Dividend YieldN/A
Average Volume (3M)224.97K
Price to Earnings (P/E)―
Beta (1Y)-0.03
Revenue GrowthN/A
EPS GrowthN/A
CountryUS
Employees14
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-4.17
Shares Outstanding14,342,844
10 Day Avg. Volume225,272
30 Day Avg. Volume224,970
Financial Highlights & Ratios
PEG Ratio0.54
Price to Book (P/B)42.09
Price to Sales (P/S)0.00
P/FCF Ratio-47.10
Enterprise Value/Market Cap0.77
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/Ebitda-35.60
Forecast
1Y Price Target
$234.89Price Target Upside80.67% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering11
EPS Forecast (FY)-5.55
Revenue Forecast (FY)$26.67K
Palvella Therapeutics Business Overview & Revenue Model
Company Description
Palvella Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on developing and commercializing novel therapies to treat patients serious and rare genetic skin diseases. Its lead product candidate is QTORIN 3.9% rapamycin anhydr...
How the Company Makes Money
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Palvella Therapeutics Financial Statement Overview
Summary
Income Statement
18
Very Negative
Balance Sheet
62
Positive
Cash Flow
24
Negative
| Breakdown | Mar 2026 | Mar 2025 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 25.90M | 31.42M |
| Gross Profit | 0.00 | 0.00 | 0.00 | 23.12M | 29.05M |
| EBITDA | -35.90M | -13.12M | 18.69M | -30.50M | -43.37M |
| Net Income | -41.72M | -17.43M | 18.69M | -33.28M | -45.74M |
Balance Sheet | |||||
| Total Assets | 59.56M | 88.23M | 7.55M | 16.52M | 153.56M |
| Cash, Cash Equivalents and Short-Term Investments | 57.98M | 83.60M | 7.35M | 16.05M | 117.76M |
| Total Debt | 633.00K | 0.00 | 0.00 | 0.00 | 14.89M |
| Total Liabilities | 31.58M | 25.63M | 11.43M | 39.70M | 102.81M |
| Stockholders Equity | 27.98M | 62.61M | -3.88M | -23.17M | 50.76M |
Cash Flow | |||||
| Free Cash Flow | -25.01M | -10.84M | -13.70M | -14.84M | -8.61M |
| Operating Cash Flow | -25.01M | -10.84M | -13.70M | -14.84M | -7.66M |
| Investing Cash Flow | 0.00 | 0.00 | 0.00 | 0.00 | -949.00K |
| Financing Cash Flow | -660.00K | 87.09M | 5.00M | 9.57M | 59.13M |
Palvella Therapeutics Technical Analysis
Negative
130.01
Price Trends
121.04
Negative
112.79
Negative
95.16
Positive
Market Momentum
-2.82
Positive
42.86
Neutral
55.02
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For PVLA, the sentiment is Negative. The current price of 130.01 is above the 20-day moving average (MA) of 115.35, above the 50-day MA of 121.04, and above the 200-day MA of 95.16, indicating a neutral trend. The MACD of -2.82 indicates Positive momentum. The RSI at 42.86 is Neutral, neither overbought nor oversold. The STOCH value of 55.02 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for PVLA.
Palvella Therapeutics Risk Analysis
Palvella Therapeutics disclosed 83 risk factors in its most recent earnings report. Palvella Therapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Palvella Therapeutics Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
70 Outperform | $839.80M | 7.29 | 43.85% | ― | 68.20% | ― | |
53 Neutral | $398.46M | -33.88 | -12.84% | ― | ― | 40.38% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $1.58B | -12.55 | -42.66% | ― | ― | -33.07% | |
48 Neutral | $1.56B | -28.85 | -56.87% | ― | ― | ― | |
46 Neutral | $1.51B | -5.46 | -64.21% | ― | 27.23% | -12.53% |
* Healthcare Sector Average
PVLA
Palvella Therapeutics
108.67
82.04
308.07%
TBPH
Theravance Biopharma
16.29
5.34
48.77%
MNPR
Monopar Therapeutics Inc
59.48
24.85
71.76%
NRIX
Nurix Therapeutics
14.64
2.10
16.75%
TYRA
Tyra Bioscience
26.64
16.38
159.65%
Palvella Therapeutics Corporate Events
Business Operations and StrategyProduct-Related Announcements
Palvella Reports Positive Phase 3 Data for QTORIN
Positive
May 20, 2026
On May 20, 2026, Palvella Therapeutics reported new positive Phase 3 SELVA and Phase 2 TOIVA clinical data for its topical QTORIN rapamycin gel at the International Society for the Study of Vascular Anomalies World Congress 2026 in Philadelphia, u...
Business Operations and StrategyProduct-Related Announcements
Palvella Unveils Promising Phase 2 Data for QTORIN
Positive
May 15, 2026
On May 15, 2026, Palvella Therapeutics reported new data from its Phase 2 TOIVA trial of topical QTORIN rapamycin in cutaneous venous malformations, presented at the 83rd Annual Meeting of the Society for Investigative Dermatology in Chicago. The ...
Delistings and Listing Changes
Palvella Therapeutics Upgrades Listing to Nasdaq Global Market
Positive
May 13, 2026
On May 11, 2026, Palvella Therapeutics, Inc. announced that it had received approval from the Nasdaq Listing Qualifications Department to transfer its common stock listing from the Nasdaq Capital Market to the Nasdaq Global Market. The move, effec...
Business Operations and StrategyExecutive/Board ChangesFinancial DisclosuresPrivate Placements and Financing
Palvella Highlights QTORIN Progress and Financing in Q1 Update
Positive
May 7, 2026
On May 7, 2026, Palvella Therapeutics reported first-quarter 2026 results and a broad corporate update, highlighting positive Phase 3 SELVA data for QTORIN rapamycin in microcystic lymphatic malformations, a granted FDA pre‑NDA meeting in th...
Business Operations and StrategyExecutive/Board Changes
Palvella Therapeutics Adds Independent Dermatology Expert to Board
Positive
Apr 13, 2026
On April 13, 2026, Palvella Therapeutics increased the size of its board of directors from six to seven members and appointed dermatologist and healthcare investment analyst John Doux, M.D., as a Class III director, with his initial term set to ex...
Business Operations and StrategyExecutive/Board ChangesProduct-Related Announcements
Palvella Showcases QTORIN Platform Momentum and Commercial Readiness
Positive
Apr 7, 2026
On April 7, 2026, Palvella Therapeutics, Inc. detailed in a corporate presentation its strategy as a rare disease biopharma company focused on first-in-disease topical therapies for serious, underserved skin and vascular malformation disorders, bu...
Business Operations and StrategyFinancial DisclosuresPrivate Placements and Financing
Palvella Highlights 2025 Results and SELVA Phase 3 Progress
Positive
Mar 31, 2026
On March 31, 2026, Palvella Therapeutics reported its full-year 2025 results and detailed significant clinical and corporate progress, highlighted by positive Phase 3 SELVA data in microcystic lymphatic malformations announced in February 2026 and...
Business Operations and StrategyPrivate Placements and FinancingRegulatory Filings and Compliance
Palvella Therapeutics Announces Underwritten Common Stock Offering
Positive
Feb 27, 2026
On February 25, 2026, Palvella Therapeutics, Inc. entered into an underwriting agreement to issue and sell 1,600,000 shares of common stock at $125.00 per share, with underwriters granted a 30‑day option to purchase up to an additional 240,0...
Business Operations and StrategyProduct-Related Announcements
Palvella Reports Positive Phase 3 Data for QTORIN Gel
Positive
Feb 24, 2026
On February 24, 2026, Palvella Therapeutics presented topline Phase 3 SELVA data for its QTORIN 3.9% rapamycin anhydrous gel in microcystic lymphatic malformations, a serious, progressive condition with no FDA-approved therapies and an estimated 3...
Business Operations and StrategyProduct-Related Announcements
Palvella Reports Positive Phase 3 Data for QTORIN
Positive
Feb 24, 2026
On February 24, 2026, Palvella Therapeutics reported positive topline data from its Phase 3 SELVA study of once-daily QTORIN 3.9% rapamycin gel in patients with microcystic lymphatic malformations, a rare and debilitating genetic disease with no a...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.