Palvella: Pagsumite ng NDA para sa QTORIN rapamycin sa microcystic LMs ay nakatakda para sa 2H 2026

Nakumpleto na ng Palvella ang pre-NDA meeting at nakatanggap ng rolling review; ang unang module ng NDA ay naisumite na. Inaasahan na ngayon ng kumpanya na makumpleto ang buong pagsumite ng NDA sa 2H 2026, na naglalagay sa produkto para sa potensyal na pag-apruba ng FDA at paglulunsad sa U.S. sa 1H 2027.

Mahahalagang fact

Na-file: Hul 14, 2026, 08:48 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: PVLAPalvella
Asset: QTORIN rapamycin
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Phase 3 SELVA: positibong datos
rate ng completion: 95% (≥6 taon)
Pagpapabuti ng mLM-IGA: +2.13 (p<0.001)

Sipi mula sa source

EX-99.1 2 pvla-ex99_1.htm EX-PALVELLA THERAPEUTICS CORPORATE PRESENTATION - JULY 2026 First-in-disease therapies for patients with rare diseases Corporate Presentation July 2026 Forward Looking Statements This presentation contains forward-looking statements of Palvella Therapeutics, Inc. (“the Company”) within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about th

SEC 8-K