Savara nagsumite ng BLA para sa MOLBREEVI sa autoimmune PAP

Savara nagsumite ng BLA sa FDA noong Disyembre 2025 para sa MOLBREEVI (molgramostim inhalation solution) para sa autoimmune pulmonary alveolar proteinosis. Ang paghahain ay suportado ng positibong resulta ng Phase 3 IMPALA-2 na nagpapakita ng makabuluhang pagpapabuti sa DLco% sa Linggo 24 at 48 kumpara sa placebo, na may kanais-nais na tolerability at 100% open-label rollover.

Mahahalagang fact

Na-file: Ene 9, 2026, 01:00 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: SVRASavara
Asset: molgramostim
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 d24211dex991.htm EX-99.1 EX-99.1 Corporate Overview Enero 2026 Developing new therapies for rare respiratory diseases Exhibit 99.1 Safe Harbor Statement © Savara Inc. All Rights Reserved. Savara Inc. (“Savara” or the “Company”) cautions you that statements in this presentation that are not a description of historical fact are forward-looking statements which may be identified by the use of words such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements regarding the potential health benefits and risks and projected development timeline of MOLBREEVI; the timing of regulatory submissions; the potential for and impact of regulatory approval; the potential addressable patient population, mar

SEC 8-K