1Q26 - Pre-BLA Update Reaffirms a Clear Regulatory Path Forward in HS. SLK in HS BLA Submission On Track for End of September 2026. Reiterate BUY.

研报英文原文证据摘录

1Q26 - Pre-BLA Update Reaffirms a Clear Regulatory Path Forward in HS. SLK in HS BLA Submission On Track for End of September 2026. Reiterate BUY.

May 11, 2026 MoonLake Immunotherapeutics

(MLTX, Buy, $30 PT)

Julian Harrison

1Q26 - Pre-BLA Update Reaffirms a Clear Regulatory Path Forward in (617) 345-4055 jharrison@btig.com

HS. SLK in HS BLA Submission On Track for End of September 2026. Andrew Kassin

Reiterate BUY. (617) 345-4042 akassin@btig.com

Company DataBIOTECHNOLOGY WHAT YOU SHOULD KNOW: Mgmt. provided a positive update on their latest Closing Price $17.06

interactions with the FDA regarding submission plans and label strategy ahead of Price Target $30.00

SLK's BLA submission for HS. The Agency is aligned on including the acceptability of

Market Cap (M) $1,255.88 MIRA (Phase 2 trial of SLK in HS) to establish substantial evidence of effectiveness,

Enterprise Value (M) $996.98EQUITY the full inclusion of VELA-TEEN trial data for a label that could include patients

aged 12yrs and older, and the inclusion of safety data across MIRA and VELA trials Shares Out (M) 73.62

- all consistent with the scenario presented at the February 2026 investor day. SLK's Avg Daily Vol-3 Months (M) 1.09

proposed label is expected to include MIRA's ~43% absolute and 29% pbo-adjusted Revisions

12wk HiSCR75, which are best-in-class results on a standalone basis. There are no

Previous Current remaining gaps or meetings planned between the FDA and MLTX, which includes topics

Rating Buy BuyRESEARCH of CMC regulations, non-clinical studies, and proposed safety pools and analyses. MLTX

has communicated that the pre-BLA process is now complete, with the remaining Price Target $30.00 $30.00

gating steps being BLA submission at the end of September 2026 and potential FY26E NI (264.93) (287.30)