- Palvella reported Q3 2026 results and said the FDA accepted the NDA for QTORIN rapamycin in microcystic lymphatic malformations with Priority Review.
- The PDUFA target action date is February 28, 2027, and Palvella is preparing a standalone U.S. commercial launch in H1 2027 if approved.
- Palvella reported cash, cash equivalents and short-term investments of $236.7 million as of September 30, 2026.
- Palvella's pipeline includes Phase 2 LOTU trial enrollment for angiokeratomas with topline results expected in H2 2027, and a Phase 3 cutaneous venous malformations trial start on track for Q4 2026.
- Zenas BioPharma reported Q3 2026 results with a PDUFA target action date of May 27, 2027 for obexelimab in IgG4-RD, following FDA acceptance of the BLA in August 2026.
引述
“we believe we are closer than ever to bringing our first therapy to patients”
“Our focus is clear: successfully obtain FDA approval and bring our first therapy to patients”