Palvella Therapeutics Q3 net loss widens on higher costs
PVLA•Palvella Therapeutics’ third-quarter net loss widened to $24.64 million, with a loss per share of $1.70. The company ended the quarter with $236.7 million in cash, cash equivalents and short-term investments; the FDA accepted its QTORIN rapamycin NDA for priority review, with a February 2027 target action date.
1. Quarterly results
Palvella Therapeutics reported a third-quarter net loss of $24.64 million, or $1.70 per share. Higher research and development expenses reflected increased manufacturing activity, angiokeratoma clinical development, NDA submission costs, and additional headcount and consulting services. General and administrative expenses also rose, driven by headcount and professional services related to operating as a public company.
2. Drug development plans
The FDA accepted the NDA for QTORIN rapamycin and granted priority review, with a February 2027 target action date. Palvella is preparing for a standalone U.S. commercial launch in the first half of 2027 if the drug is approved. A Phase 3 trial for cutaneous venous malformations is expected to begin in the fourth quarter of 2026, and topline Phase 2 LOTU trial results in angiokeratomas are expected in the second half of 2027.
