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maumar

02/29/24 7:17 PM

#8331 RE: Fred Kadiddlehopper #8330

Below is a note from MS. Do we know for sure that Halo/Antares are involved with the PFS option?

"Highlights on Vyvgart in MG/CIDP: (1) A pivotal program evaluating Vyvgart in
seronegative MG patients is expected to begin in 2024; (2) On the pre-filled syringe
(PFS), mgt. noted that they aim to make the option available for MG and CIDP - and
that an update on the company's efforts with the bioequivalence & human factors
work required for a filing with the FDA will be provided in 1H24. Argenx aims to
submit these filings this year; (3) In MG, mgt. noted that uptake for Vyvgart Hytrulo
is growing although Vyvgart IV continues to represent the large majority of Vyvgart
use; (4) In CIDP, mgt. noted that the company has gained an increasing level of
conviction in the unmet need with the indication - but regardless continues to
anticipate a measured initial launch curve for Vyvgart Hytrulo (assuming approval)
given the time that will be required for insurance/access to settle and the level of
familiarity patients currently have with IVIG. See our team's prior survey work for
CIDP here."