1Q26 Reports: Commercial Prep Well Underway Ahead of MOLBREEVI PDUFA Nov 22nd

研报英文原文证据摘录

1Q26 Reports: Commercial Prep Well Underway Ahead of MOLBREEVI PDUFA Nov 22nd

e Pharmacy (private) as their

exclusive US pharmacy for MOLBREEVI, which has a robust track record and experience in the

rare disease space. Accordingly, the use of a single specialty pharmacy should effectively allow

SVRA to provide a "white-glove" approach to efficiently integrate MOLBREEVI use in addition

to providing clear visibility on patient uptake and launch progression (in our view). As an added

bonus, it is crucial to appreciate SVRA has been identifying aPAP patients "line of sight" and is

warehousing them to help support a streamlined initial launch. Altogether, we are confident in

an efficient launch of MOLBREEVI pending approval given the diligent approach SVRA is taking

to their commercial preparations.

MOLBREEVI is expected to have 12-year market exclusivity in the US pending approval.

Further, a key value driver of MOLBREEVI is upon BLA approval the FDA would grant 12-

year market exclusivity in the US. Additionally, from an intellectual property standpoint, SVRA

has pending patent applications for drug formulations of MOLBREEVI where the European

Patent Office notified SVRA they intend to grant the patent. With this, SVRA also has the

worldwide exclusive license to proprietary eFlow Nebulizer System (PARI) for MOLBREEVI in

aPAP and pending joint patent application with PARI for the drug/device combination (European

patent granted; US patent pending). Moreover, SVRA also has a proprietary cell bank. Thus,

MOLBREEVI appears positioned to have robust marketing exclusivity and intellectual property.

SVRA has a strong ATS 2026 presence with new data from Ph3 IMPALA-2. Accordingly, ATS

2026 (May 17-20) will be a significant conference for SVRA where they have 1 oral presentation,