WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) reported third-quarter results and detailed an intensifying slate of clinical milestones as its QTORIN platform advances across four rare dermatologic diseases — none of which currently have an FDA-approved therapy. With two late-stage readouts approaching and new programs entering development, the company said it expects the next 18 months to be “catalyst-rich.”
CEO Wes Kaupinen said Palvella’s lead candidate, QTORIN rapamycin, continues to emerge as a “pipeline-in-a-product” for mTOR-driven skin disorders. Top-line data from the fully enrolled Phase 2 TOIVA trial in cutaneous venous malformations remain on track for mid-December, followed by Phase 3 top-line results from the SELVA study in microcystic lymphatic malformations in the first quarter of 2026.
Kaupinen said the results could propel the company toward its first regulatory submission, while additional indication expansion and pre-commercial work move forward in parallel. “As we enter year-end 2025, Palvella is now advancing innovative QTORIN-derived therapies for four serious, rare skin diseases,” he said.
Pipeline Builds Out Across Multiple Unmet Needs
Beyond its lead programs, Palvella expanded QTORIN rapamycin into clinically significant angiokeratomas, a lymphatic malformation newly classified in 2025. A Phase 2 trial is targeted for launch in the second half of 2026. The company also unveiled a new program, QTORIN pitavastatin, for disseminated superficial actinic porokeratosis (DSAP), a chronic, pre-cancerous genetic condition with no approved treatment. A Phase 2 study for DSAP is also expected to begin in the second half of 2026.
New scientific publications further validated Palvella’s development strategy. A peer-reviewed analysis highlighted 26 real-world studies supporting rapamycin’s therapeutic potential for venous malformations, while a separate population study estimated more than 190,000 U.S. patients currently receive off-label treatment for cutaneous venous malformations — underscoring the scale of unmet medical need.
Regulatory and Scientific Momentum Continues
Palvella received year-two funding from the FDA Orphan Products Grant program to support the SELVA Phase 3 study, and the company highlighted progress in patient recruitment across both late-stage trials.
Its scientific leadership also expanded with the appointment of David Osborne as Chief Innovation Officer. Osborne, a veteran of topical dermatology drug development, will oversee early-stage QTORIN pipeline efforts.
Financial Position Supports Long Development Runway
Palvella ended the quarter with $63.6 million in cash and expects its resources to fund operations into the second half of 2027. R&D expenses rose to $6.5 million, reflecting intensified activity in Phase 2 and Phase 3 programs. G&A expenses increased to $3.6 million, driven by higher compensation and public-company costs.
Net loss widened to $11.3 million from $7 million a year earlier, consistent with the company’s growing clinical footprint.
With multiple readouts on deck — including two that could shape the path toward registration — Palvella is positioning its QTORIN platform to potentially deliver the first approved therapies across several rare, debilitating skin diseases.
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