MLTX

DEFA14A - MoonLake Immunotherapeutics (0001821586) (Filer)

DEF 14A - MoonLake Immunotherapeutics (0001821586) (Filer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

SCHEDULE 13D/A - MoonLake Immunotherapeutics (0001821586) (Subject)

144 - MoonLake Immunotherapeutics (0001821586) (Subject)

Results from the Phase 3 VELA clinical trials in adults with moderate-to-severe hidradenitis suppurativa (HS) show that clinical responses continue to improve to Week 40, with 62% of patients treated with sonelokimab (SLK) achieving HiSCR75 and up to 32% of patients achieving HiSCR100 An analysis of different hallmark lesions of HS shows that up to 25% of patients achieved inflammatory remission at Week 40, defined as a 100% reduction in abscesses (A100), nodules (N100) and draining tunnels (DT100)Patients treated with SLK also showed substantial improvements in HiSQOL items at week 40 versus baseline, ranging from 41% (pain), to 54% (walking, getting dressed) to 62% (down or depressed)Up to

Wolfe Research upgraded MoonLake Immunotherapeutics from Underperform to Outperform and set a new price target of $24.00

Rothschild & Co Redburn upgraded MoonLake Immunotherapeutics from Neutral to Buy and set a new price target of $40.00

10-K - MoonLake Immunotherapeutics (0001821586) (Filer)

8-K - MoonLake Immunotherapeutics (0001821586) (Filer)

In the Phase 2 S-OLARIS clinical trial in axial spondyloarthritis (axSpA), sonelokimab (SLK) demonstrated clinically meaningful benefit with 80+% of patients achieving ASAS40 by Week 12Consistently, other clinical and imaging scores also showed improvements of 80+% by week 12 for patients treated with SLK, including ASDAS-CRP and SPARCC MRIaxSpA is a disease driven by inflammation leading to irreversible ossification (via osteoblast activity) and ultimately to irreversible restriction of mobility – objective PET/MRI imaging data further showed a significant reduction in inflammation and osteoblast activity deep in affected joints, already by week 12, suggesting potential for disease modifica

SCHEDULE 13G - MoonLake Immunotherapeutics (0001821586) (Subject)

Brings 20+ years of clinical development experience in autoimmune and inflammatory diseases, including OX40/OX40L program leadership Will build and lead Imagene's clinical organization and drive completion of the Phase 2b ADAPTIVE trial in atopic dermatitis Will expand Phase 2b trial footprint with planned international sites including in the UK and Europe SAN DIEGO, Feb. 10, 2026 (GLOBE NEWSWIRE) -- ImageneBio, Inc. (NASDAQ:IMA, "Imagene, " or the "Company")), today announced the appointment of Dr. Ben Porter-Brown, a seasoned autoimmune and inflammatory drug developer with experience in the OX40 receptor-ligand (OX40-OX40L) inhibition field, as its Chief Medical Officer. He will be fo

The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by positive results from the Phase 2 LEDA trialThe upcoming Phase 3 program will therefore be expected to benefit from earlier and more frequent interactions with the FDA under the Fast Track program, potentially enabling a more efficient development pathway This regulatory decision follows the recent clear guidance from the FDA, in which the Company confirmed its clinical evidence strategy for the planned submission of a Biologic License Application (BLA) in H2 2026 for SLK in hidradenitis suppurativa (H

Goldman downgraded MoonLake Immunotherapeutics from Neutral to Sell and set a new price target of $10.00

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

BTIG Research upgraded MoonLake Immunotherapeutics from Neutral to Buy and set a new price target of $24.00

DENVER, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Markets head into the session with a familiar but powerful theme in focus: enabling technologies that quietly unlock the next wave of growth. From satellite connectivity at cruising altitude to biologics edging closer to regulatory milestones, and from AI-driven diagnostics to advanced biomaterials, today's news flow highlights companies pushing infrastructure, science, and scale forward at the same time. Connectivity Takes Flight: flyExclusive Embraces Starlink flyExclusive (NYSE:FLYX) is setting a new benchmark in private aviation after being named an authorized Starlink Aviation dealer and installer. The move brings high-speed, low-latency sat

8-K - MoonLake Immunotherapeutics (0001821586) (Filer)

MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS)FDA feedback confirms that the Company may establish substantial evidence of effectiveness (SEE), without additional clinical trials in HS, with a BLA consisting of data from its existing VELA-1, VELA-2 and MIRA trials The FDA specifically advised the Company to include the results of the MIRA trial in the submission and to submit the results of the VELA-2 trial for the marketing application to inform the safety profile of SLK, re