PVLA news

Palvella Therapeutics announced FDA acceptance of its QTORIN rapamycin application with a focused launch plan ahead of a February 28, 2027 priority review deadline. The development progress increases the likelihood of a first-ever therapy for a rare disease, though no data on sales figures or immedi…

Palvella Therapeutics announced FDA acceptance and Priority Review for its rapamycin NDA, with a PDUFA date set for February 2027. The breakthrough therapy designation and strong Phase 3 efficacy results suggest a potential first-in-market approval for rare vascular anomalies.

Palvella Therapeutics amended its 2024 Equity Incentive Plan to increase available shares for issuance to 4,090,639 shares, approved by stockholders on June 10, 2026. The increase addresses anticipated future equity compensation needs for employee retention and incentives.

Palvella Therapeutics announced clinical trial results showing 100% of SELVA participants aged 6-11 years improved on primary endpoint, with QTORIN rapamycin demonstrating potential as first FDA-approved therapy for microcystic lymphatic malformations and cutaneous venous malformations. The data sup…