2025-05-19-Jefferies-萨瓦拉公司（SVRA）_2025年美国胸科学会会议Molbreevi有望成为aPAP的一线疗法-生物制品许可申请即将获批_8页_705kb

Savara Inc. Equity Research Summary

• Company Overview: Savara Inc. is a clinical-stage biopharmaceutical company developing inhaled drugs, with its lead candidate, Molbreevi (molgramostim), advancing into registration for a rare lung disease, aPAP. The company has a market cap of $677.5M and is focused on rare lung disease treatments.

• Rating and Price Target: Jefferies Equity Research assigns a "BUY" rating with a price target of $8.50, representing a potential upside of +177% from the current trading price of $3.07. This target is based on an NPV analysis projecting peak annual sales of $400M+ by 2025-2026, suggesting a valuation range of $1.6B-$2.0B.

• BLA Filing and Approval Outlook: Savara expects a Biologics License Application (BLA) acceptance from the FDA on May 26, 2025, with FDA decision anticipated by November 2025 under priority review. This follows no approved US therapies for aPAP, positioning Molbreevi as a potential first-line treatment.

• Key Clinical Data: Phase III IMPALA-2 study results demonstrate strong efficacy. At week 24, Molbreevi showed a +6.0% improvement in Hgb-adjusted DLCO (p=0.0007) compared to placebo. Long-term data confirms durability up to 5 years in select patients, reducing surfactant burden, decreasing whole-lung lavage (WLL) procedures (7% in Molbreevi vs. 13% in placebo), and improving quality-of-life measures such as daily activity and breathing problems (p-values 0.030 and 0.005 at specific weeks). Patient-reported outcomes indicate better HRQoL and lower pain/discomfort.

• Future Development: Follow-up data from the ongoing 96-week open-label extension of IMPALA-2 is expected in 2025-2026. Reducing invasive WLL could enhance payor access, supporting launch in 2025.

• Valuation and Risks: The peak sales estimate could be conservative, with a 4-5x multiple leading to high valuation. Risks include regulatory delays, competition, biosimilar threats, and potential lack of efficacy data. A successful launch could capture significant market share in the rare lung disease space.