MoonLake Immunotherapeutics (MLTX) FDA Approvals $18.19 0.00 (0.00%) Closing price 05/22/2026 04:00 PM EasternExtended Trading$18.15 -0.04 (-0.24%) As of 05/22/2026 07:44 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock MoonLake Immunotherapeutics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by MoonLake Immunotherapeutics (MLTX). Over the past two years, MoonLake Immunotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Sonelokimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Sonelokimab FDA Regulatory Timeline and Events Sonelokimab is a drug developed by MoonLake Immunotherapeutics for the following indication: Moderate-to-severe hidradenitis suppurativa. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Results - March 28,2026Results Phase 3Drug: SonelokimabAnnounced Date: March 28, 2026Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics announces long-term Week 40 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS and confirms the presentation of the data at the 2026 American Academy of Dermatology (AAD) Annual Meeting later today.AI SummaryMoonLake Immunotherapeutics announced long-term Week 40 results from its Phase 3 VELA-1 and VELA-2 trials in moderate-to-severe hidradenitis suppurativa (HS) and confirmed the data will be presented today at the 2026 American Academy of Dermatology Annual Meeting. At Week 40, 62% of patients on sonelokimab (SLK) reached a HiSCR75 response, a level the company says sets a new standard for long-term lesion control. For context, approved IL‑17A inhibitors and IL‑17A/F inhibitors have reported HiSCR75 rates near 40% and 60%, respectively, at one year in pooled pivotal-trial analyses. The safety profile of SLK in the VELA trials remained consistent with no new safety signals. Prof. Alexa Kimball will present the findings (S034 Late-Breaking Research: Session 2) on March 28, 2026, 4:00–4:12 pm ET (2:00–2:12 pm MT). Key upcoming milestones include Q2 2026 52-week VELA data, mid-2026 IZAR-1 PsA readout, and H2 2026 plans for a BLA submission in HS and the IZAR-2 PsA readout.Read AnnouncementTop-line results - February 21,2026Top-Line Results Phase 2Drug: SonelokimabAnnounced Date: February 21, 2026Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics announces topline results from the S-OLARIS Phase 2 trial of SLK in patients with radiographic and non-radiographic axSpA and announces its financial results for the fourth quarter and year ended December 31, 2025.AI SummaryMoonLake Immunotherapeutics announced topline positive results from the S-OLARIS Phase 2 trial of SLK (sonelokimab) in patients with radiographic and non-radiographic axial spondyloarthritis (axSpA). Company statements said the data further strengthen SLK’s potential across a range of inflammatory diseases and mark the fifth indication with positive Phase 2 or Phase 3 data for the IL‑17A and F Nanobody®. Sonelokimab is being evaluated in several programs, including VELA‑TEEN Phase 3 for adolescent hidradenitis suppurativa (HS), and ongoing Phase 2 S‑OLARIS and P‑OLARIS trials for axSpA and psoriatic arthritis (PsA). MoonLake noted these trials combine traditional clinical outcomes with cellular imaging to better characterize drug effects. MoonLake also announced its financial results for the fourth quarter and year ended December 31, 2025, and said the positive S‑OLARIS topline supports continued development and upcoming clinical milestones across its pipeline.Read AnnouncementDesignation Grant - February 2,2026Designation Grant Fast TrackDrug: SonelokimabAnnounced Date: February 2, 2026Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics announces that the FDA has granted Fast Track designation for sonelokimab for the treatment of moderate‑to‑severe PPP. MoonLake had submitted a request for Fast Track designation on December 1, 2025.AI SummaryMoonLake Immunotherapeutics announced that the FDA has granted Fast Track designation for sonelokimab to treat moderate-to-severe palmoplantar pustulosis (PPP). MoonLake submitted its Fast Track request on December 1, 2025. The designation recognizes the serious burden of PPP and the absence of approved treatments, and is meant to help streamline the drug’s development. Fast Track status provides benefits such as more frequent FDA meetings and written feedback on trial design and biomarker use, potential eligibility for Accelerated Approval and Priority Review if criteria are met, and Rolling Review so completed BLA sections can be submitted as they are ready. These tools are intended to speed collection of the data needed to support approval and could shorten timelines for patients with this unmet medical need. MoonLake will continue clinical development of sonelokimab across dermatology and rheumatology indications.Read AnnouncementProvided Update - January 8,2026Provided Update Drug: SonelokimabAnnounced Date: January 8, 2026Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics provided an update following the positive feedback received from the U.S. Food and Drug Administration (FDA) regarding the clinical evidence strategy for SLK in HS, based on the Type B meeting requested by MoonLake.AI SummaryMoonLake Immunotherapeutics requested a Type B meeting with the U.S. Food and Drug Administration to discuss the clinical evidence strategy for submitting a Biologic License Application (BLA) for sonelokimab (SLK) in hidradenitis suppurativa (HS). The FDA provided positive written feedback on that strategy. The FDA indicated MoonLake may establish substantial evidence of effectiveness (SEE) for SLK in HS without running new HS trials, using data from the existing MIRA, VELA-1 and VELA-2 studies. The agency specifically advised including the MIRA results in the BLA and stated VELA-2 should be submitted to inform SLK’s safety profile, even if it is not relied on to establish SEE. The FDA also said mechanistic evidence combined with a single clinical trial cannot serve as confirmatory evidence to establish SEE. Based on the meeting records, MoonLake will proceed with BLA preparations, aiming for submission in H2 2026, and will hold an Investor Day on February 23, 2026 to discuss the feedback and new data.Read AnnouncementProvided Update - October 1,2025Provided Update Drug: SonelokimabAnnounced Date: October 1, 2025Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics nnounced disastrous VELA-2 trial results for sonelokimab, its highly anticipated treatment for patients with skin disease (hidradenitis suppurative or "HS").AI SummaryMoonLake Immunotherapeutics shares plunged 90% after the company announced that its VELA-2 trial for sonelokimab failed to meet its week-16 primary endpoint in patients with hidradenitis suppurativa. The highly anticipated treatment showed only a 9% improvement over placebo, far below the expected 20%. The trial was affected by more intercurrent events in the placebo arm than predicted, which prevented statistical significance in the composite HiSCR75 measure. Analysts called the outcome “arguably the worst‐case scenario” for a late-stage study. National firm Hagens Berman has launched an investigation into whether MoonLake misled investors about the trial design, planning for intercurrent events, and the likelihood of achieving key efficacy targets. Before the results, MoonLake had expressed strong confidence that sonelokimab could become the “gold standard.” Investors who suffered substantial losses and whistleblowers with relevant information are encouraged to contact Hagens Berman to participate in the ongoing probe.Read AnnouncementClinical Update - February 26,2025Clinical Update Drug: SonelokimabAnnounced Date: February 26, 2025Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics Provides clinical updatesAI SummaryMoonLake Immunotherapeutics has provided clinical updates on its progress with the Nanobody® sonelokimab. The company advanced its Phase 3 VELA program, which targets moderate-to-severe hidradenitis suppurativa (HS) in adult patients, and it has launched the Phase 3 IZAR program for patients with active psoriatic arthritis (PsA). In addition, new trials are set to begin in early 2025, including the Phase 3 VELA-TEEN trial for adolescents with HS, a Phase 2 LEDA trial for palmoplantar pustulosis (PPP), and a Phase 2 S-OLARIS trial for axial spondyloarthritis (axSpA). MoonLake’s CEO highlighted the company’s commitment to data-rich developments in 2025, with pivotal HS data expected by mid‐2025 and plans to update the market during their Capital Markets Update in Q2 of 2025.Read AnnouncementPositive Feedback - June 10,2024Positive Feedback Phase 2Drug: SonelokimabAnnounced Date: June 10, 2024Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics announced the successful outcome of its end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), as well as positive feedback from its interactions with the E.U. European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake's proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab in psoriatic arthritis (PsA).AI SummaryMoonLake Immunotherapeutics announced that both the U.S. FDA and the E.U. EMA have given positive regulatory feedback on its Phase 3 program for its Nanobody® sonelokimab in psoriatic arthritis (PsA). The agencies unanimously supported MoonLake’s proposed approach, paving the way for the upcoming IZAR program. This program is designed to include two global, randomized, double-blind, placebo-controlled trials that will examine the safety and efficacy of sonelokimab over one year, including assessments of radiographic progression in biologic naive patients and comparison with an active reference for TNF-inhibitor experienced patients. The program plans to test both 60mg and 120mg doses of sonelokimab in a total population of approximately 1,500 patients, with key trial endpoints set to be evaluated at week 16 and primary endpoint readout expected at the end of 2026.Read Announcement MoonLake Immunotherapeutics FDA Events - Frequently Asked Questions Has MoonLake Immunotherapeutics received FDA approval? As of now, MoonLake Immunotherapeutics (MLTX) has not received any FDA approvals for its therapy in the last two years. What drugs has MoonLake Immunotherapeutics submitted to the FDA? In the past two years, MoonLake Immunotherapeutics (MLTX) has reported FDA regulatory activity for Sonelokimab. What is the most recent FDA event for MoonLake Immunotherapeutics? The most recent FDA-related event for MoonLake Immunotherapeutics occurred on March 28, 2026, involving Sonelokimab. The update was categorized as "Results," with the company reporting: "MoonLake Immunotherapeutics announces long-term Week 40 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS and confirms the presentation of the data at the 2026 American Academy of Dermatology (AAD) Annual Meeting later today." What conditions do MoonLake Immunotherapeutics' current drugs treat? Currently, MoonLake Immunotherapeutics has one therapy (Sonelokimab) targeting the following condition: Moderate-to-severe hidradenitis suppurativa. 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FDA EventsAgenus FDA EventsAdagio Medical FDA EventsAktis Oncology FDA EventsAkari Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies CRISPR Therapeutics FDA Events MANE FDA Events Kiniksa Pharmaceuticals International FDA Events NewAmsterdam Pharma FDA Events Travere Therapeutics FDA Events Catalyst Pharmaceuticals FDA Events Crinetics Pharmaceuticals FDA Events Organon & Co. FDA Events ACADIA Pharmaceuticals FDA Events Oruka Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:MLTX last updated on 3/30/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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Results - March 28,2026Results Phase 3Drug: SonelokimabAnnounced Date: March 28, 2026Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics announces long-term Week 40 results of the Phase 3 VELA-1 and VELA-2 clinical trials of its registrational global program in patients with moderate-to-severe HS and confirms the presentation of the data at the 2026 American Academy of Dermatology (AAD) Annual Meeting later today.AI SummaryMoonLake Immunotherapeutics announced long-term Week 40 results from its Phase 3 VELA-1 and VELA-2 trials in moderate-to-severe hidradenitis suppurativa (HS) and confirmed the data will be presented today at the 2026 American Academy of Dermatology Annual Meeting. At Week 40, 62% of patients on sonelokimab (SLK) reached a HiSCR75 response, a level the company says sets a new standard for long-term lesion control. For context, approved IL‑17A inhibitors and IL‑17A/F inhibitors have reported HiSCR75 rates near 40% and 60%, respectively, at one year in pooled pivotal-trial analyses. The safety profile of SLK in the VELA trials remained consistent with no new safety signals. Prof. Alexa Kimball will present the findings (S034 Late-Breaking Research: Session 2) on March 28, 2026, 4:00–4:12 pm ET (2:00–2:12 pm MT). Key upcoming milestones include Q2 2026 52-week VELA data, mid-2026 IZAR-1 PsA readout, and H2 2026 plans for a BLA submission in HS and the IZAR-2 PsA readout.Read Announcement
Top-line results - February 21,2026Top-Line Results Phase 2Drug: SonelokimabAnnounced Date: February 21, 2026Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics announces topline results from the S-OLARIS Phase 2 trial of SLK in patients with radiographic and non-radiographic axSpA and announces its financial results for the fourth quarter and year ended December 31, 2025.AI SummaryMoonLake Immunotherapeutics announced topline positive results from the S-OLARIS Phase 2 trial of SLK (sonelokimab) in patients with radiographic and non-radiographic axial spondyloarthritis (axSpA). Company statements said the data further strengthen SLK’s potential across a range of inflammatory diseases and mark the fifth indication with positive Phase 2 or Phase 3 data for the IL‑17A and F Nanobody®. Sonelokimab is being evaluated in several programs, including VELA‑TEEN Phase 3 for adolescent hidradenitis suppurativa (HS), and ongoing Phase 2 S‑OLARIS and P‑OLARIS trials for axSpA and psoriatic arthritis (PsA). MoonLake noted these trials combine traditional clinical outcomes with cellular imaging to better characterize drug effects. MoonLake also announced its financial results for the fourth quarter and year ended December 31, 2025, and said the positive S‑OLARIS topline supports continued development and upcoming clinical milestones across its pipeline.Read Announcement
Designation Grant - February 2,2026Designation Grant Fast TrackDrug: SonelokimabAnnounced Date: February 2, 2026Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics announces that the FDA has granted Fast Track designation for sonelokimab for the treatment of moderate‑to‑severe PPP. MoonLake had submitted a request for Fast Track designation on December 1, 2025.AI SummaryMoonLake Immunotherapeutics announced that the FDA has granted Fast Track designation for sonelokimab to treat moderate-to-severe palmoplantar pustulosis (PPP). MoonLake submitted its Fast Track request on December 1, 2025. The designation recognizes the serious burden of PPP and the absence of approved treatments, and is meant to help streamline the drug’s development. Fast Track status provides benefits such as more frequent FDA meetings and written feedback on trial design and biomarker use, potential eligibility for Accelerated Approval and Priority Review if criteria are met, and Rolling Review so completed BLA sections can be submitted as they are ready. These tools are intended to speed collection of the data needed to support approval and could shorten timelines for patients with this unmet medical need. MoonLake will continue clinical development of sonelokimab across dermatology and rheumatology indications.Read Announcement
Provided Update - January 8,2026Provided Update Drug: SonelokimabAnnounced Date: January 8, 2026Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics provided an update following the positive feedback received from the U.S. Food and Drug Administration (FDA) regarding the clinical evidence strategy for SLK in HS, based on the Type B meeting requested by MoonLake.AI SummaryMoonLake Immunotherapeutics requested a Type B meeting with the U.S. Food and Drug Administration to discuss the clinical evidence strategy for submitting a Biologic License Application (BLA) for sonelokimab (SLK) in hidradenitis suppurativa (HS). The FDA provided positive written feedback on that strategy. The FDA indicated MoonLake may establish substantial evidence of effectiveness (SEE) for SLK in HS without running new HS trials, using data from the existing MIRA, VELA-1 and VELA-2 studies. The agency specifically advised including the MIRA results in the BLA and stated VELA-2 should be submitted to inform SLK’s safety profile, even if it is not relied on to establish SEE. The FDA also said mechanistic evidence combined with a single clinical trial cannot serve as confirmatory evidence to establish SEE. Based on the meeting records, MoonLake will proceed with BLA preparations, aiming for submission in H2 2026, and will hold an Investor Day on February 23, 2026 to discuss the feedback and new data.Read Announcement
Provided Update - October 1,2025Provided Update Drug: SonelokimabAnnounced Date: October 1, 2025Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics nnounced disastrous VELA-2 trial results for sonelokimab, its highly anticipated treatment for patients with skin disease (hidradenitis suppurative or "HS").AI SummaryMoonLake Immunotherapeutics shares plunged 90% after the company announced that its VELA-2 trial for sonelokimab failed to meet its week-16 primary endpoint in patients with hidradenitis suppurativa. The highly anticipated treatment showed only a 9% improvement over placebo, far below the expected 20%. The trial was affected by more intercurrent events in the placebo arm than predicted, which prevented statistical significance in the composite HiSCR75 measure. Analysts called the outcome “arguably the worst‐case scenario” for a late-stage study. National firm Hagens Berman has launched an investigation into whether MoonLake misled investors about the trial design, planning for intercurrent events, and the likelihood of achieving key efficacy targets. Before the results, MoonLake had expressed strong confidence that sonelokimab could become the “gold standard.” Investors who suffered substantial losses and whistleblowers with relevant information are encouraged to contact Hagens Berman to participate in the ongoing probe.Read Announcement
Clinical Update - February 26,2025Clinical Update Drug: SonelokimabAnnounced Date: February 26, 2025Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics Provides clinical updatesAI SummaryMoonLake Immunotherapeutics has provided clinical updates on its progress with the Nanobody® sonelokimab. The company advanced its Phase 3 VELA program, which targets moderate-to-severe hidradenitis suppurativa (HS) in adult patients, and it has launched the Phase 3 IZAR program for patients with active psoriatic arthritis (PsA). In addition, new trials are set to begin in early 2025, including the Phase 3 VELA-TEEN trial for adolescents with HS, a Phase 2 LEDA trial for palmoplantar pustulosis (PPP), and a Phase 2 S-OLARIS trial for axial spondyloarthritis (axSpA). MoonLake’s CEO highlighted the company’s commitment to data-rich developments in 2025, with pivotal HS data expected by mid‐2025 and plans to update the market during their Capital Markets Update in Q2 of 2025.Read Announcement
Positive Feedback - June 10,2024Positive Feedback Phase 2Drug: SonelokimabAnnounced Date: June 10, 2024Indication: Moderate-to-severe hidradenitis suppurativaAnnouncementMoonLake Immunotherapeutics announced the successful outcome of its end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), as well as positive feedback from its interactions with the E.U. European Medicines Agency (EMA), with both regulatory bodies unanimously supporting MoonLake's proposed approach for advancing its Phase 3 program of the Nanobody® sonelokimab in psoriatic arthritis (PsA).AI SummaryMoonLake Immunotherapeutics announced that both the U.S. FDA and the E.U. EMA have given positive regulatory feedback on its Phase 3 program for its Nanobody® sonelokimab in psoriatic arthritis (PsA). The agencies unanimously supported MoonLake’s proposed approach, paving the way for the upcoming IZAR program. This program is designed to include two global, randomized, double-blind, placebo-controlled trials that will examine the safety and efficacy of sonelokimab over one year, including assessments of radiographic progression in biologic naive patients and comparison with an active reference for TNF-inhibitor experienced patients. The program plans to test both 60mg and 120mg doses of sonelokimab in a total population of approximately 1,500 patients, with key trial endpoints set to be evaluated at week 16 and primary endpoint readout expected at the end of 2026.Read Announcement
