Palvella jumps after rare disease treatment shows improvement in late-stage study

Shares of drug developer Palvella Therapeutics PVLA.O jump 28.1% to $112 premarket

Co says its experimental topical treatment for patients with a type of rare skin and soft tissue disease met main goal in a late-stage study

Co was testing its experimental therapy, Qtorin rapamycin, to treat microcystic lymphatic malformations

MLMs are rare congenital conditions characterized by clusters of small, fluid-filled cysts in the lymphatic system, often leading to swelling and discomfort

The therapy showed statistically significant improvement in symptoms on the 7-point scale after 24 weeks, with an average gain of +2.13 points

"We see today's result as a best-case scenario win, and would be buying into anticipated strength this morning. We believe Palvella shares remain substantially undervalued for the total market opportunity across Qtorin indications" - Oppenheimer

Palvella plans to submit a marketing application to the U.S. FDA in H2 2026, expecting a potential approval in H1 2027

Stock has been down 16.1% YTD