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Tuesday, March 31, 2026

Palvella Phase 3 rapamycin trial in microcystic lymphatic malformations positive results, backs 1st-line use

 


  • Palvella plans an H2 2026 NDA filing for QTORIN rapamycin in microcystic lymphatic malformations.
  • Positive Phase III CELVA results for QTORIN rapamycin were disclosed during the company's Q4 2025 earnings call.
  • Non-GAAP EPS $-1.08 declined 4% YoY in Q4 2025, missing analyst EPS estimates for the quarter.
  • Q4 2025 revenue was $0, beating analyst revenue estimates for the quarter.
  • Pro forma cash of about $274 million is calculated after a February equity raise.
  • Company reported full-year 2025 results alongside its cash update and QTORIN rapamycin regulatory plans.

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