GLOBAL RESEARCH ARCHIVE
MLTX - Investor Day Updates: Robust 52-Week Results Support BIC Potential; BLA Submission End of Sept; Priority Review Is Possible w/ VELA-TEEN; IZAR-1 Data Expected in 3Q26
Research evidence excerpt
MLTX - Investor Day Updates: Robust 52-Week Results Support BIC Potential; BLA Submission End of Sept; Priority Review Is Possible w/ VELA-TEEN; IZAR-1 Data Expected in 3Q26
June 22, 2026
Yatin Suneja yatin.suneja@guggenheimpartners.com MLTX - Investor Day Updates: Robust 52-Week
212 518 9565 Results Support BIC Potential; BLA Submission End
Min Lee, Ph.D.
min.lee@guggenheimpartners.com of Sept; Priority Review Is Possible w/ VELA-TEEN;
212 823 6744 IZAR-1 Data Expected in 3Q26 Eddie Hickman, Ph.D.
eddie.hickman@guggenheimpartners.com
212 518 9904 Key Message: This morning, MLTX hosted an Investor Day, highlighting key updates
Delma Caiati, M.D., Ph.D. throughout the company's ongoing pipeline: (1) 52-week results from VELA studies
delma.caiati@guggenheimpartners.com revealed ~67% HiSCR-75 & ~33.1% HiSCR-100 (~10 ppts up from ~62% HiSCR-75 &
617 859 4606 ~30% HiSCR-100 at 40-weeks disclosed at AAD, exceeding Bimzelx's 62% HiSCR75
& 30% HiSCR100 at 48-weeks; Figure 1). These absolute HiSCR efficacies are highest Iris Gao, Ph.D.
iris.gao@guggenheimpartners.com observed to-date, and we believe SLK has realistic potential to emerge as BIC therapy
212 518 9013 for HS, as the safety profile is significantly differentiated as well; (2) BLA Updates
in HS: Recall that the FDA has confirmed acceptability of MIRA trial to establish
substantial evidence of effectiveness (SEE), as well as inclusion of VELA-TEEN data.
BLA submission is expected for end of Sept, with granting of PDUFA data &
MLTX BUY decisionin the U.S.onisPriorityexpectedReviewfor 3Q27-4Q27expected at(Withend Priorityof Nov Review,2026. SLK'sas earlycommercialas 2Q27);launch(3)
MoonLake Immunotherapeutics Commercialization: Continued growth in real-world data validates HS market potential
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