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Palvella Receives Second Year of FDA Grant Funding for Phase 3 Qtorin Trial
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Palvella Receives Second Year of FDA Grant Funding for Phase 3 Qtorin Trial
Oct 13, 2025 7:19 AM

10:09 AM EDT, 10/13/2025 (MT Newswires) -- Palvella Therapeutics ( PVLA ) said Monday it has received the second year of funding under its US Food and Drug Administration Office of Orphan Products Development grant, supporting the company's ongoing phase 3 trial evaluating Qtorin 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations.

The grant provides up to $2.6 million over four years, the company said, adding that the 24-week trial exceeded its 40-patient goal, enrolling 51 subjects at US vascular anomaly centers.

The biopharmaceutical company said it is on track to report top-line results in Q1 of 2026 and plans to submit a new drug application to the FDA in the second half of 2026.

Shares of Palvella Therapeutics ( PVLA ) were down more than 3% in recent Monday trading.

Price: 67.49, Change: -2.41, Percent Change: -3.45

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