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

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

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

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

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

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

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

424B5 - MoonLake Immunotherapeutics (0001821586) (Filer)

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

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

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

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

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

H.C. Wainwright upgraded MoonLake Immunotherapeutics from Neutral to Buy and set a new price target of $30.00

H.C. Wainwright downgraded MoonLake Immunotherapeutics from Buy to Neutral

Goldman downgraded MoonLake Immunotherapeutics from Buy to Neutral and set a new price target of $7.00

Wolfe Research downgraded MoonLake Immunotherapeutics from Outperform to Underperform and set a new price target of $2.00

Citigroup downgraded MoonLake Immunotherapeutics from Buy to Neutral and set a new price target of $5.00

Jefferies downgraded MoonLake Immunotherapeutics from Buy to Hold and set a new price target of $8.00

BTIG Research downgraded MoonLake Immunotherapeutics from Buy to Neutral

RBC Capital Mkts downgraded MoonLake Immunotherapeutics from Outperform to Sector Perform and set a new price target of $10.00

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

4 - MoonLake Immunotherapeutics (0001821586) (Issuer)

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

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

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

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

NEW YORK, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Cepton, Inc. (NASDAQ:CPTN) and MoonLake Immunotherapeutics (NASDAQ:MLTX). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided. MoonLake Immunotherapeutics (NASDAQ:MLTX) Class Period: March 10, 2024 to September 29, 2025Lead Plaintiff Deadline: December 15, 2025The suit alleges that MoonLake Immunotherapeutics misled investors about its sole drug candidate, sonelokima

Ended the third quarter with $380.5 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from a previously announced debt-facility, are expected to provide runway into the second half of 2027Reported results of its Phase 2 LEDA clinical trial in Palmoplantar Pustulosis (PPP) where sonelokimab (SLK) demonstrated clinically meaningful and statistically significant benefitReported an interim analysis of the long-term data from the VELA-1 and VELA-2 clinical trials in adults with Hidradenitis Suppurativa (HS), as well as an interim analysis of its VELA-TEEN clinical trial in adolescent HS, demonstrating the potential and competitive benefit of SL

VELA-1 and VELA-2 are two identical trials to evaluate the efficacy and safety of sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (HS) and the first Phase 3 program using the higher clinical response level of HS Clinical Response (HiSCR) 75 as primary endpoint at week 16Data was analyzed, as per protocol and in accordance with regulatory agency feedback, using a composite strategy as the primary analysis and a treatment policy strategy to test the robustness of the results: difference between the two methods relates to the statistical handling of intercurrent eventsIn the combined VELA program, patients treated with sonelokimab experienced a clinically

Phase 3 VELA program in hidradenitis suppurativa (HS) on track for an expected primary endpoint readout around September 2025 and an expected submission of a Biologic License Application (BLA) in the United States in mid-2026Other clinical trials of sonelokimab in palmoplantar pustulosis (PPP), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and adolescent HS progressing well and expected to support a catalyst-rich roadmap over the next 12 monthsEnded the second quarter with $425.1 million in cash, cash equivalents and short-term marketable debt securities with up to an additional $425 million in non-dilutive funds remaining accessible through previously announced debt-facility Z

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

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

Ended the third quarter with $380.5 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from a previously announced debt-facility, are expected to provide runway into the second half of 2027Reported results of its Phase 2 LEDA clinical trial in Palmoplantar Pustulosis (PPP) where sonelokimab (SLK) demonstrated clinically meaningful and statistically significant benefitReported an interim analysis of the long-term data from the VELA-1 and VELA-2 clinical trials in adults with Hidradenitis Suppurativa (HS), as well as an interim analysis of its VELA-TEEN clinical trial in adolescent HS, demonstrating the potential and competitive benefit of SL

Phase 3 VELA program in hidradenitis suppurativa (HS) on track for an expected primary endpoint readout around September 2025 and an expected submission of a Biologic License Application (BLA) in the United States in mid-2026Other clinical trials of sonelokimab in palmoplantar pustulosis (PPP), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and adolescent HS progressing well and expected to support a catalyst-rich roadmap over the next 12 monthsEnded the second quarter with $425.1 million in cash, cash equivalents and short-term marketable debt securities with up to an additional $425 million in non-dilutive funds remaining accessible through previously announced debt-facility Z

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

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

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

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

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

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

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

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

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

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

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