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

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$2.2B
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-$4.90
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Bulls say / Bears say

The February 24, 2026 Phase 3 SELVA study for QTORIN™ rapamycin met its primary endpoint with statistically significant improvements across all pre-specified secondary endpoints and reported no drug-related serious adverse events, underscoring a strong efficacy and safety profile. (Reuters)
On June 22, 2026, the FDA granted rolling review for Palvella’s QTORIN™ rapamycin NDA for microcystic lymphatic malformations, allowing the Agency to begin evaluating completed sections of the application as they become available, which could accelerate regulatory approval. (Reuters)
Palvella’s common stock was approved for transfer to the Nasdaq Global Market effective May 13, 2026, reflecting compliance with higher listing standards and likely broadening the company’s visibility and appeal to institutional investors. (Reuters)
Palvella posted a Q2 net loss of $21.9 million, or $1.52 per share, up from $9.5 million a year earlier as R&D expenses more than doubled to $12.5 million, accelerating cash burn and increasing dilution risk. (Reuters)
The Phase 2 TOIVA trial’s bleeding cohort included only four patients, limiting statistical robustness and raising uncertainty over whether these results will translate to larger pivotal studies. (Reuters via Investing.com)
QTORIN™ pitavastatin for DSAP remains in early development with Phase 2 initiation not expected until H2 2026, offering no clinical efficacy data to de-risk the program and potentially diverting resources. (Reuters)
Data summarised monthly by Lightyear AI. Last updated on 7 Sept 2026.
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