Lakefront Biotherapeutics NV 6-K, filed Oct 24, 2025
Lakefront Biotherapeutics NV (LKFT)
About this 6-K
Lakefront Biotherapeutics NV filed this 6-K on October 24, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of October 2025
Commission File Number: 001-37384
GALAPAGOS NV
(Translation of registrant's name into English)
Generaal De Wittelaan L11 A3 2800 Mechelen, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
The information contained in this Report on Form 6-K, including Exhibit 99.1, is hereby incorporated by reference into the Company's Registration Statements on Form S-8 (File Nos. 333-204567, 333-208697, 333-211834, 333-215783, 333-218160, 333-225263, 333-231765, 333-249416, 333-260500, 333-268756, 333-275886, and 333-283361).
On October 23, 2025, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
(c) Exhibit 99.1. Press release dated October 23, 2025
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| GALAPAGOS NV | ||
| (Registrant) | ||
| Date: October 24, 2025 | /s/ Annelies Denecker | |
| Annelies Denecker | ||
| Company Secretary | ||
EXHIBIT 99.1
Galapagos to Present In Vitro Data at ACR Convergence 2025 Suggesting Differentiation of GLPG3667 from Other TYK2 Inhibitors
Mechelen, Belgium; October 23, 2025, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it will present new in vitro pharmacological data from its selective TYK2 inhibitor, GLPG3667, currently in two Phase 3-enabling studies in dermatomyositis (DM) and systemic lupus erythematosus (SLE), at the American College of Rheumatology (ACR) Convergence 2025, taking place in Chicago, IL, October 24-29, 2025.
The data show that the in vitro pharmacological profile of GLPG3667 suggests differentiation from other TYK2 inhibitors at their clinical dose regimens.
Key findings from the study include:
- At exposure levels associated with its clinical dose of 150 mg once daily, GLPG3667 showed inhibition of the IFN-α, and IL-23 pathways, comparable to the expected inhibition for the currently approved TYK2 inhibitor at its clinical dose regimens, without a measurable impact on TYK2-independent pathways.
- Inhibition of the IL-12 pathway was more pronounced for GLPG3667 than for the currently approved TYK2 inhibitor. Zasocitinib showed the most sustained inhibition of TYK2-dependent pathways.
- GLPG3667 showed no measurable inhibition of IL-10-mediated signaling up to the highest concentration tested (~10-fold above clinical concentrations) in monocytes, CD4+ T cells and CD19+ B cells, while strong inhibition was observed with two other TYK2 inhibitors at concentrations corresponding to the respective clinical dose regimens.
The abstract details are as follows:
| Abstract title | Authors (Presenter) | Presentation date/time |
| Galapagos-driven original abstract | ||
| In Vitro Pharmacological Profile of GLPG3667 Suggests Differentiation from the TYK2 Inhibitors Deucravacitinib and Zasocitinib at their Clinical Dose Regimens | May-Linda Lepage, Patrick Nolain, Céline Cottereaux, Emilie Lagoutte, Justine Dao, Adrien Cosson, Laetitia Furio, Willem Hettema, Chantal Tasset, Roland Blanqué, Isabelle Parent and René Galien | Poster presentation number: 0653 Date: October 26, 2025 Time: 10:30 am -12:30 pm CT Session: Systemic Lupus Erythematosus – Treatment Poster I Location: McCormick Place, Hall F1 |
About GLPG3667, the GALARISSO (NCT: 05695950) and GALACELA (NCT: 05856448) studies
GLPG3667 is an investigational reversible and selective tyrosine kinase 2 (TYK2) kinase domain inhibitor currently being evaluated in two Phase 3-enabling studies for systemic lupus erythematosus (SLE) and dermatomyositis (DM).
GALACELA is a Phase 3-enabling randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of GLPG3667 in adults with active SLE. Two once-daily oral administration of GLPG3667 (75 mg and 150 mg) or placebo are being investigated in adult patients with SLE for 48 weeks. The primary endpoint is the proportion of patients who achieve the SLE responder index (SRI)-4 response at Week 32. The secondary efficacy endpoints are the proportion of patients who achieve SRI-4 response at Week 48, the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Weeks 32 and 48, proportion of patients with >=50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Weeks 32 and 48, proportion of patients who achieve Lupus Low Disease Activity State (LLDAS) at Weeks 32 and 48 and change from baseline in the 28-joint count for tender, swollen, and tender and swollen (active) joints at Weeks 32 and 48.
GALARISSO is a Phase 3-enabling randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of GLPG3667. A daily oral administration of GLPG3667 150 mg or placebo is being investigated in adult patients with DM over 24 weeks. At Week 24, patients will be offered the possibility to enter a long-term extension study for an additional 24 week period where they will all receive GLPG3667 150 mg daily (once a day). The primary endpoint is the Total Improvement Score (TIS) at Week 24 according to the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) criteria.
For further information, contact Galapagos:
Investor Relations
Glenn Schulman
+1 412 522 6239
ir@glpg.com
Corporate Communications
Marieke Vermeersch
+32 479 490 603
media@glpg.com
Visit us at www.glpg.com or follow us on LinkedIn or X.
Forward-looking statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than present and historical facts and conditions contained in this press release are forward-looking statements that involve substantial risks and uncertainties. When used in this press release, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing, design and readouts of our ongoing and planned preclinical studies and clinical trials, including but not limited to GLPG3667 in SLE and DM, statements relating to interactions with regulatory authorities, and statements related to our endpoint goals and business plans. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: our ability to successfully implement the winding down of our cell therapy business within the expected timeframe or at all, or if implemented, will achieve its anticipated economic benefits; our ability to identify suitable buyers or investors; our ability to successfully pursue new transformational business development transactions; potential litigation associated with the winding down; negative impact of this press release on our stock price, employee retention, business relationships and business generally; the outcome of the consultations with works councils in Belgium and the Netherlands; changes to our capital allocation strategies; our ability to advance product candidates into, and successfully complete, clinical trials; the initiation, timing, progress and results of our preclinical studies and clinical trials and our research and development programs; our ability to identify product candidates that have commercial success and/or are profitable; the timing or likelihood of regulatory filings and approvals; differing interpretations and assessments by regulatory authorities on our clinical trial data; the risk that interim or preliminary data that we report differ from actual final results; risks related to conducting global clinical trials, including the possibility of differing perspectives and requirements by local regulatory authorities; new or changing government regulations; uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; clinical failure at any stage of clinical development; uncertainty inherent to patient enrollment and enrollment rate; our ability to use and expand our drug discovery efforts; competition; side effects caused by our product candidates; delays in obtaining regulatory approval of manufacturing processes and facilities or disruptions in manufacturing processes; the rate and degree of market acceptance of our product candidates if approved by regulatory authorities; our ability to develop sales and marketing capabilities; risks related to the commercialization of our product candidates, if approved; the pricing and reimbursement of our product candidates, if approved; our ability to implement our business model, strategic plans for our business, product candidates and technology; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights and proprietary technology of third parties; regulatory developments in the United States, Europe and other jurisdictions; our ability to enter into strategic arrangements and strategic collaboration agreements; our ability to maintain and establish collaborations or obtain additional grant funding; our ability to attract and retain qualified employees and key personnel; and other factors described under the headings “Special Note Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our latest Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Further, we cannot assess the impact of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement.