- Palvella Therapeutics has received the **second year of funding** from its FDA Office of Orphan Products Development grant, providing up to **$2.6 million** in non-dilutive funding over its **4-year term**.  **[1746473_62ea388412354aaca67898a9d01878ab_0]** 
- This grant supports the ongoing **Phase 3 SELVA trial** of QTORIN™ 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations.  **[1746473_62ea388412354aaca67898a9d01878ab_0]** 
- The SELVA trial has **exceeded its enrollment target**, enrolling **51 subjects**.  **[1746473_62ea388412354aaca67898a9d01878ab_0]** 
- Top-line data from the SELVA trial is expected in the **first quarter of 2026**, with a New Drug Application (NDA) submission planned for the **second half of 2026**.  **[1746473_62ea388412354aaca67898a9d01878ab_0]** 
- QTORIN™ rapamycin has been granted **Breakthrough Therapy, Orphan Drug, and Fast Track designations** by the FDA.  **[1746473_62ea388412354aaca67898a9d01878ab_1]**

PLIANT THERAPEUTICS (PLRX)