Biotechnology: Takeaways from our KOL call on Sjögren’s disease (ARGX, AMGN)

研报英文原文证据摘录

Biotechnology: Takeaways from our KOL call on Sjögren’s disease (ARGX, AMGN)

nt change is clinically

meaningful, any stat sig improvement would warrant use. We note the FcRn class pivotal

programs utilize ClinESSDAI while the B cell modulator class’ trials use ESSDAI. On See abbreviations inside

usage, he estimates 15-20% of his Sjögren’s patients would be eligible for therapy.

Real-world data on efgartigimod is an advantage

On ARGX’s efgartigimod (FcRn), our KOL noted the marked CRESS (35% pbo-adj

responder rate) and ClinESSDAI (-3-point pbo-adj) improvements in the ph 2 RHO study,

with particular emphasis on the real-world data of efgar’ in CIDP and gMG. He views the

progression to phase 3 as warranted and notes FcRn’s have potential to be frontline

therapy. He stressed the importance of infection risk given off-label use of rituximab

and steroids in patients, and we think efgar’s FcRn mechanism could demonstrate a

differentiated safety profile compared to B cell modulators. We look for more color on

competitive positioning with ARGX’s phase 3 readouts (2H27 guide). ARGX remains a top

large-cap biotech pick, and we maintain our Buy rating with $1,016/€863 PO.

Dazodalibep clinical effect is modest; safety is a concern

On AMGN’s dazodalibep (CD40L), which is separately assessing systemic (ESSDAI ≥5)

and symptomatic (ESSPRI ≥5) Sjögren’s, he viewed the ph 2 data across systemic (-2.2

pbo-adj on ClinESSDAI) and symptomatic (-1.3 pbo-adj on ESSPRI) patients as modest

and expects to see similar results in the ongoing ph 3 studies, but expects to utilize dazo

if approved. On safety, he noted the AE profile was consistent with his off-label therapy

use and doesn’t view it as a concern for patients. However, he thinks infection risk can