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Palvella Therapeutics Inc/$PVLA

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About Palvella Therapeutics Inc

Palvella Therapeutics Inc is a clinical-stage biopharmaceutical company whose vision is to become the rare disease biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no FDA-approved therapies. Its product candidate, QTORIN 3.9% rapamycin anhydrous gel, is currently in clinical development for microcystic lymphatic malformations and cutaneous venous malformations. It operates in single segment.
Ticker
$PVLA
Sector
Health
Primary listing
NASDAQ
Employees
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PVLA Metrics

BasicAdvanced
$1.7B
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-$4.90
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What the Analysts think about PVLA

Analyst ratings (Buy, Hold, Sell) for Palvella Therapeutics Inc stock.
Analyst projections of the future price of Palvella Therapeutics Inc stock.

Bulls say / Bears say

Phase 3 SELVA met its primary, key secondary and all four other efficacy endpoints, each with p<0.001. Among participants aged six and older who completed the 24-week evaluation, 86% were rated much or very much improved. (GlobeNewswire)
Palvella has completed its NDA submission under the 505(b)(2) pathway, and QTORIN has Breakthrough Therapy, Fast Track and Orphan Drug designations. With no FDA-approved treatment for microcystic lymphatic malformations, approval could give the company a first-in-disease product. (GlobeNewswire)
QTORIN also showed a signal in cutaneous venous malformations: in the Phase 2 TOIVA study, patients with bleeding at baseline had a statistically significant improvement in bleeding scores at week 12. This could broaden the product’s opportunity beyond its lead indication if later development confirms the result. (SEC)
The completed NDA is not an approval, and the company’s planned first-half 2027 launch is conditional on FDA approval. A regulatory setback or delay could push out the first product revenue. (GlobeNewswire)
Palvella is still loss-making and depends on its cash to fund development and launch preparation: its first-half 2026 net loss was $37.6 million, up from $17.7 million a year earlier, and operating cash use nearly doubled. Continued spending before commercial revenue raises the risk that it will need more capital if launch or sales are delayed. (StockTitan)
The venous-malformation programme is less advanced: TOIVA was a single-arm, open-label Phase 2 study, and the FDA did not grant breakthrough designation on the initial 12-week data package. It still needs later-stage evidence and regulatory alignment before it can become a second product opportunity. (GlobeNewswire, The Motley Fool)
Data summarised monthly by Lightyear AI. Last updated on 16 Oct 2026.

PVLA Financial Performance

Revenues and expenses
Income statement
QuarterlyAnnual
Q3 24
QoQ growth
Revenue
Net income
Profit margin

PVLA Earnings Performance

Company profitability
Earnings per share
QuarterlyAnnual
Q4 23
Q1 24
Q2 24
Q3 24
Q4 24
Actual
Expected
Surprise
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