PVLA
Palvella Therapeutics, Inc.96.81
+7.83+8.8%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
1.15BP/E (TTM)
-Basic EPS (TTM)
-2.92Dividend Yield
0%Recent Filings
8-K
10-Q
8-K
New DSAP therapy candidate announced
Palvella Therapeutics unveiled QTORIN pitavastatin, a topical candidate targeting the mevalonate pathway in disseminated superficial actinic porokeratosis (DSAP), a rare premalignant skin disease affecting over 50,000 U.S. patients with no FDA-approved therapies. Leveraging its QTORIN platform for dermal penetration and stability, the company plans an FDA meeting in early 2026 followed by Phase 2 trial start in late 2026. This expands Palvella's pipeline in rare dermatology. Risks include clinical trial uncertainties.
8-K
QTORIN launch accelerates
Palvella Therapeutics posted a corporate presentation on September 3, 2025, outlining accelerated U.S. launch plans for QTORIN rapamycin 3.9% gel in microcystic lymphatic malformations, targeting H2 2026 NDA submission after Phase 3 SELVA study. The company hired Ashley Kline as Chief Commercial Officer in May 2025 to lead commercialization and David Osborne as Chief Innovation Officer in September 2025 to advance the R&D pipeline, including a third indication announcement this month expanding the addressable patient pool over 10x. Market research shows strong physician intent to prescribe as first-line therapy. Full enrollment in the Phase 2 TOIVA study for cutaneous venous malformations nears, with topline data due December 2025.
8-K
Palvella advances QTORIN trials
Palvella Therapeutics completed enrollment in its Phase 3 SELVA trial for QTORIN rapamycin in microcystic lymphatic malformations, surpassing the target by over 25% with 51 subjects; top-line results remain on track for Q1 2026. The Phase 2 TOIVA trial in cutaneous venous malformations advances toward Q4 2025 data, while plans for a third indication and new platform candidate emerge by year-end. Cash stands at $70.4 million, funding operations into 2H 2027. Momentum builds, yet trial outcomes carry risks.
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