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

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

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

DEFA14A - MoonLake Immunotherapeutics (0001821586) (Filer)

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

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

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

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

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

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

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

MoonLake Immunotherapeutics Reports First Quarter 2025 Financial Results and Provides a Business Update Continued to make significant progress with the development of the Nanobody® sonelokimab across portfolio of indications, including Phase 3 studies in hidradenitis suppurativa (HS), psoriatic Arthritis (PsA) and adolescent HS, as well as Phase 2 studies in palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA)Announced completion of enrollment of patients in the Phase 3 program in HS (the VELA program) and disclosed baseline characteristics, replicating the Phase 2 MIRA trialPresented an interim readout of the Phase 2 LEDA study in PPP, highlighting the potential of sonelokimab

Initiated the Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS) and the Phase 3 IZAR program in patients with active psoriatic arthritis (PsA) following positive FDA and EMA regulatory feedback, continuing to support a potential best-in-class profile across two key indicationsInitiated three new trials in the beginning of 2025 with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar pustulosis (PPP) and Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA)Signed a three-year technology partnership with Komodo Health to advance research on inflam

MoonLake Immunotherapeutics Reports Third Quarter 2024 Financial Results and Provides a Business Update Ended the third quarter with $493.9 million in cash, cash equivalents and short-term marketable debt securities, expected to support a roadmap rich in potential catalysts and a cash runway to the end of 2026Strong market performance of other IL-17 inhibitors in hidradenitis suppurativa (HS) and other inflammatory indications validating large market opportunity for sonelokimabPhase 3 clinical program in HS is progressing as per plan with primary endpoint readout anticipated as of mid-2025Preparations for Phase 3 clinical program in psoriatic arthritis (PsA) completed with patient enrollmen

MoonLake Immunotherapeutics Reports Second Quarter 2024 Financial Results and Announces a Capital Markets Update for September 11 Initiated Phase 3 VELA program of the Nanobody® sonelokimab in hidradenitis suppurativa ("HS"), with topline results anticipated as of mid-2025Secured positive feedback from both U.S. Food and Drug Administration ("FDA") and the E.U. European Medicines Agency ("EMA") on the regulatory path for the Phase 3 program of the Nanobody® sonelokimab in psoriatic arthritis ("PsA") and outlined the clinical plan with topline results anticipated in end-2026Ended the quarter with $519.8 million in cash, cash equivalents and short-term marketable debt securities, expected to

MoonLake Immunotherapeutics Reports First Quarter 2024 Financial Results and Provides a Business Update Announced positive feedback from both FDA and EMA on the regulatory path for the Phase 3 program of the Nanobody® sonelokimab in hidradenitis suppurativa (HS) and outlined the development plan with topline results anticipated in mid-2025Reported significant improvements observed across all key outcomes with sonelokimab over 24 weeks in the ARGO Phase 2 trial in active psoriatic arthritis (PsA) including unprecedented multi-domain responses across joints, skin and other domains, supporting potential best-in-class profile of sonelokimabAnnounced the imminent commencement of four additional

MoonLake Immunotherapeutics Reports Full Year 2023 Financial Results, Recent Business Highlights and Announces an R&D Day on March 10 A successful year including the announcements of positive data from two Phase 2 trials of sonelokimab in hidradenitis suppurativa (HS), at 12 and 24 weeks, and active psoriatic arthritis (PsA), at 12 weeks, supporting a potential best-in-class profile across two key indications Phase 3 preparation for sonelokimab in HS nearing completion, following positive feedback from both FDA and EMAYear-end cash, cash equivalents and short-term marketable debt securities of $511.0 million, expected to support a roadmap rich in potential catalysts whilst providing a cash

MoonLake Immunotherapeutics Reports Third Quarter 2023 Financial Results and Provides a Business Update Announced positive full 24-week data from the global Phase 2 MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and differentiated therapeutic solution for hidradenitis suppurativa Presented positive 12-week data from the global Phase 2 MIRA clinical trial for sonelokimab in hidradenitis suppurativa at a late-breaking session during the European Academy of Dermatology and Venereology Congress Announced landmark top-line 12-week data from the global Phase 2 ARGO clinical trial evaluating the efficacy and safety of sonelokimab in patients with active psoriatic

MoonLake Immunotherapeutics Reports Fourth Quarter and Year-End 2022 Financial Results and Provides a Business Update Strong financial position: year-end cash, cash equivalents and short-term marketable debt securities of $72.1 million, expected to provide runway well into 2H 2024 and at least 12 months beyond expected key data readoutsRecent clinical data announced at the 81st Annual Meeting of the American Academy of Dermatology on the novel IL-17A and IL-17F inhibition further reinforces MoonLake's competitive position with sonelokimab in the Hidradenitis Suppurativa ("HS") landscapePatient enrollment and randomization completed ahead of schedule in a global Phase 2 trial of sonelokimab

MoonLake Immunotherapeutics Reports Third Quarter 2022 Financial Results and Provides Recent Business Update Global trial of sonelokimab in Hidradenitis Suppurativa (HS) has continued to meet recruitment targets with an expected primary endpoint readout in mid-2023Global Psoriatic Arthritis (PsA) trial received FDA clearance and US central IRB approvalQuarter-end position of $83.5 million in cash, cash equivalents and short-term marketable debt securities, providing cash runway into 2H2024 and at least 12 months beyond expected key readouts ZUG, Switzerland, November 14, 2022 – MoonLake Immunotherapeutics (NASDAQ:MLTX) ("MoonLake"), a clinical-stage biotechnology company focused on creatin

MoonLake Immunotherapeutics Reports First Quarter 2025 Financial Results and Provides a Business Update Continued to make significant progress with the development of the Nanobody® sonelokimab across portfolio of indications, including Phase 3 studies in hidradenitis suppurativa (HS), psoriatic Arthritis (PsA) and adolescent HS, as well as Phase 2 studies in palmoplantar pustulosis (PPP) and axial spondyloarthritis (axSpA)Announced completion of enrollment of patients in the Phase 3 program in HS (the VELA program) and disclosed baseline characteristics, replicating the Phase 2 MIRA trialPresented an interim readout of the Phase 2 LEDA study in PPP, highlighting the potential of sonelokimab

MoonLake Immunotherapeutics to host a Capital Markets Day on Tuesday, April 29 Zug, Switzerland, April 25, 2025 – MoonLake Immunotherapeutics (NASDAQ:MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, will host a virtual Capital Markets Day for investors and analysts on Tuesday, April 29, 2025. The event will highlight recent financial and clinical milestones and provide future strategic updates. The webcast, streamed live from New York, will start at 8:30 AM EST (2:30 PM CET) and is expected to last one hour. A recording will be made available post event. Webcast Access: https://edge.media-server.com/mmc/p/sgz7i4x9 MoonLake'

Agreement with Hercules Capital significantly increases financial and operational strength, provides up to $500 million in capital with no dilution to shareholders, an attractive cost of capital and low operational and strategic incumbrances, and sets a new standard for the quantum of a nondilutive facility for a development-stage therapeutics company.Facility adds to the $448 million cash position disclosed in previously filed 10-K and provides funding for the next steps of the Company's growth, including the expected launch of sonelokimab in 2027, additional clinical trials and further investments for growth.The Company will hold an in-person and virtual Capital Markets Update on Tuesday,

Initiated the Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS) and the Phase 3 IZAR program in patients with active psoriatic arthritis (PsA) following positive FDA and EMA regulatory feedback, continuing to support a potential best-in-class profile across two key indicationsInitiated three new trials in the beginning of 2025 with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar pustulosis (PPP) and Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA)Signed a three-year technology partnership with Komodo Health to advance research on inflam

New trials in three new indications have been initiated with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar pustulosis (PPP) and Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA)MoonLake now independently running seven trials in 2025 across large dermatology and rheumatology indications: adult HS, adolescent HS, psoriatic arthritis (PsA), PPP and axSpAPhase 2 and Phase 3 data read-outs across all target indications expected in 2025 (adult HS, and PPP) and 2026 (adolescent HS, PsA and axSpA)Data from the Phase 3 VELA-TEEN trial may be combined with the Phase 3 VELA program in adults with moderate-t

Comprehensive Biotechnology sector market analysis and investment insights complement recently launched Disruptive Technology and Energy Transition franchises Clear Street, ("Clear Street", "the Company") a cloud-native financial technology firm on a mission to modernize the brokerage ecosystem, today announced the expansion of its recently launched equity research offering with the addition of Healthcare, initially focused on the biotechnology sector. The expanded research offering complements Clear Street's leading prime brokerage and clearing solutions for its rapidly growing client base of asset managers, institutions and professional traders across equities, fixed income, derivatives

MoonLake Immunotherapeutics starts Phase 3 IZAR program of the Nanobody® sonelokimab in patients with active psoriatic arthritis Two trials for active psoriatic arthritis (PsA) with one focusing on biologic-naïve patients and including evaluation of radiographic progression (IZAR-1), and the other focusing on TNF-IR patients while being the first trial to include risankizumab as an active reference arm (IZAR-2)Program will evaluate sonelokimab for a total of 52 weeks, across IZAR-1 and IZAR-2, at sites in the United States, Europe and Latin America, using a design informed by the Phase 2 ARGO trialThe IZAR program builds upon the Phase 3 VELA program for sonelokimab in hidradenitis suppurat

MoonLake Immunotherapeutics Reports Third Quarter 2024 Financial Results and Provides a Business Update Ended the third quarter with $493.9 million in cash, cash equivalents and short-term marketable debt securities, expected to support a roadmap rich in potential catalysts and a cash runway to the end of 2026Strong market performance of other IL-17 inhibitors in hidradenitis suppurativa (HS) and other inflammatory indications validating large market opportunity for sonelokimabPhase 3 clinical program in HS is progressing as per plan with primary endpoint readout anticipated as of mid-2025Preparations for Phase 3 clinical program in psoriatic arthritis (PsA) completed with patient enrollmen

MoonLake Immunotherapeutics to host a Capital Markets Updateon Wednesday, September 11 ZUG, Switzerland, September 9, 2024 – MoonLake Immunotherapeutics AG (("MoonLake", NASDAQ:MLTX), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, will host a Capital Markets Update for investors and analysts live from New York on Wednesday, September 11 from 2024, from 9:00 – 10:30 EST/06:00 – 08:30 PST/14:00 – 16:30 CETThe event will provide business updates from MoonLake's CEO Jorge Santos da Silva, CSO Kristian Reich and CFO Matthias Bodenstedt and include details on the Phase 3 programs for our investigational Nanobody® sonelokimab (SLK) in hid

MoonLake Immunotherapeutics Reports Second Quarter 2024 Financial Results and Announces a Capital Markets Update for September 11 Initiated Phase 3 VELA program of the Nanobody® sonelokimab in hidradenitis suppurativa ("HS"), with topline results anticipated as of mid-2025Secured positive feedback from both U.S. Food and Drug Administration ("FDA") and the E.U. European Medicines Agency ("EMA") on the regulatory path for the Phase 3 program of the Nanobody® sonelokimab in psoriatic arthritis ("PsA") and outlined the clinical plan with topline results anticipated in end-2026Ended the quarter with $519.8 million in cash, cash equivalents and short-term marketable debt securities, expected to

RBC Capital Mkts initiated coverage of MoonLake Immunotherapeutics with a rating of Outperform and set a new price target of $67.00

Goldman upgraded MoonLake Immunotherapeutics from Neutral to Buy and set a new price target of $82.00 from $62.00 previously

Wedbush resumed coverage of MoonLake Immunotherapeutics with a rating of Outperform and set a new price target of $73.00 from $92.00 previously

Wolfe Research downgraded MoonLake Immunotherapeutics from Outperform to Peer Perform

Oppenheimer initiated coverage of MoonLake Immunotherapeutics with a rating of Outperform and set a new price target of $104.00

Goldman initiated coverage of MoonLake Immunotherapeutics with a rating of Neutral and set a new price target of $62.00

Wolfe Research initiated coverage of MoonLake Immunotherapeutics with a rating of Outperform and set a new price target of $77.00

Citigroup initiated coverage of MoonLake Immunotherapeutics with a rating of Buy and set a new price target of $72.00

Stifel initiated coverage of MoonLake Immunotherapeutics with a rating of Buy and set a new price target of $74.00

Bryan Garnier downgraded MoonLake Immunotherapeutics from Buy to Neutral