PALVELLA THERAPEUTICS, INC. 8-K

What Happened
Palvella Therapeutics, Inc. (PVLA) announced on February 24, 2026, that the Phase 3 SELVA study of QTORIN™ 3.9% rapamycin anhydrous gel produced positive topline results for the treatment of microcystic lymphatic malformations. The company filed a press release reporting these results as Exhibit 99.1 to its Form 8‑K (Item 8.01). The report was signed by CFO Matthew Korenberg.

Key Details

• Filing date: February 24, 2026 (Form 8‑K, Item 8.01 and Item 9.01).
• Study: Phase 3 SELVA study of QTORIN™ 3.9% rapamycin anhydrous gel.
• Indication: Treatment of microcystic lymphatic malformations.
• Press release: Positive topline results announced and filed as Exhibit 99.1; the 8‑K does not include detailed efficacy or safety data.

Why It Matters
Positive Phase 3 topline results are a material clinical milestone for a development‑stage therapy—this news can be a catalyst for future regulatory filings, more detailed data releases, and potential commercialization plans. However, the 8‑K only reports topline results and the press release is the source of the announcement; investors should watch for the full dataset, detailed safety/efficacy metrics, regulatory strategy, and any timelines the company provides before making investment decisions.