reports
- Jacob Mekhael
Galapagos GLPG3667 phase 2 hits topline in DM, but misses in SLE
Galapagos announced the topline results from 2 phase 2 studies evaluating the efficacy and safety of GLPG3667 (TYK2 inhibitor) in dermatomyositis (DM, GALARISSO study) and active systemic lupus erythematosus (SLE, GALACELA study). The GALARISSO study in DM met its primary endpoint showing a 14.26 delta on the TIS measure at 24 weeks, which compares favourably to brepocitinib (TYK2/JAK1 inhibitor) in our view. In the GALACELA study in SLE patients, primary endpoint at 32 weeks was not met, but fi...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Livio Luyten
- Michiel Declercq
- Thibault Leneeuw
- Wim Lewi
Galapagos Announces Topline Results from Two Phase 3-Enabling Studies ...
Galapagos Announces Topline Results from Two Phase 3-Enabling Studies with Selective TYK2 Inhibitor GLPG3667 in Dermatomyositis and Systemic Lupus Erythematosus GLPG3667 met primary endpoint in dermatomyositis study, demonstrating a statistically significant clinical benefit and meaningful improvements on secondary measures of disease activity compared to placebo In the systemic lupus erythematosus study, GLPG3667 delivered numerical improvements on several secondary endpoints compared to placebo but did not achieve statistical significance in primary endpoint analysis The safety profile ...
Galapagos maakt topline resultaten bekend van twee fase 3-enabling stu...
Galapagos maakt topline resultaten bekend van twee fase 3-enabling studies met selectieve TYK2-remmer GLPG3667 bij dermatomyositis en systemische lupus erythematodes GLPG3667 bereikte het primaire eindpunt in de dermatomyositis-studie en toonde een statistisch significant klinisch voordeel en betekenisvolle verbeteringen aan op secundaire eindpunten van ziekteactiviteit in vergelijking met placebo In de studie naar systemische lupus erythematodes leverde GLPG3667 numerieke verbeteringen op voor verschillende secundaire eindpunten in vergelijking met placebo, maar bereikte het geen statisti...
- Jacob Mekhael
- Thibault Leneeuw
- Jacob Mekhael
MaaT Pharma Final Xervyteg phase 3 data confirm strong survival outcom...
MaaT reported the final results from the phase 3 (ARES) trial of Xervyteg (MaaT013, microbiome therapy, enema formulation) in aGvHD at the American Society of Hematology (ASH) conference, being held 6-9 December 2025. The final OS results from the phase 3 (ARES) trial of MaaT013 coming in at 54% at 1 year confirm the previously reported 54% probability of survival that was shared with the topline readout in January 2025. We believe this brings a significant benefit vs. the 15% 1-year OS reported...
Autolus Therapeutics Presents Updated Clinical Data from the CARLYSLE ...
Autolus Therapeutics Presents Updated Clinical Data from the CARLYSLE Trial in Patients with Severe Refractory Systemic Lupus Erythematosus at the American Society of Hematology (ASH) Annual Meeting 2025 Data show deep, durable responses in the 50 million cell dose level cohort; initial data suggest substantial early improvement in three patients dosed with 100 million cellsAll patients show deep B-cell depletion after infusion, suggesting an immune resetNine patients were evaluable for safety, no ICANS or high-grade CRS were observed LONDON and GAITHERSBURG, Md., Dec. 08, 2025 (GLOBE NE...
Autolus Therapeutics Presents Initial Clinical Data in Pediatric r/r B...
Autolus Therapeutics Presents Initial Clinical Data in Pediatric r/r B-ALL Patients and Other Oncology Data at the American Society of Hematology (ASH) Annual Meeting 2025 Obe-cel demonstrates high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of 95.5%; low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) observed, consistent with obe-cel’s adult safety profile FELIX study data analyses highlight product cell phenotype and level of CAR T persistence at three months as pote...
- Hilde Van Boxstael
- Mathijs Geerts Danau
- Michiel Declercq
- Thomas Couvreur
- Wim Hoste
- Wim Lewi
Galapagos Presented New ATALANTA-1 Cell Therapy Data in MCL at ASH 202...
Galapagos Presented New ATALANTA-1 Cell Therapy Data in MCL at ASH 2025 High complete response rates and minimal residual disease (MRD) negativity, with durable responses, in high-risk mantle cell lymphoma (MCL) with GLPG5101, a fresh, early memory-enriched CAR T-cell therapy with a 7-day vein-to-vein time Mechelen, Belgium; December 8, 2025, 07:30 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announced new and updated Phase 2 data from the ongoing ATALANTA-1 study with its CD19 CAR T-cell therapy candidate, GLPG5101, during an oral presentation (#662) at the 67th American Society of Hematol...
Galapagos presenteerde nieuwe ATALANTA-1 celtherapiedata in MCL op ASH...
Galapagos presenteerde nieuwe ATALANTA-1 celtherapiedata in MCL op ASH 2025 Hoge percentages complete respons en minimale residuele ziekte (MRD)-negativiteit, met duurzame responsen, bij hoog-risico mantelcellymfoom (MCL) met GLPG5101, een verse, early-memory verrijkte CAR T-celtherapie met een vein-to-vein-tijd van 7 dagen Mechelen, België; 8 december 2025, 07:30 CET; Galapagos NV (Euronext & NASDAQ: GLPG) kondigde nieuwe en geüpdatete fase 2-gegevens aan uit de lopende ATALANTA-1-studie met haar CD19 CAR T-celtherapiekandidaat GLPG5101, tijdens een mondelinge presentatie (#662) op de 67s...
- Guy Sips
- Jacob Mekhael
- Wim Lewi
Autolus Therapeutics Appoints Ryan Richardson to Board of Directors
Autolus Therapeutics Appoints Ryan Richardson to Board of Directors LONDON and GAITHERSBURG, Md., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announced the appointment of Ryan Richardson to the Company’s Board of Directors. Mr. Richardson brings more than 20 years of strategy and corporate development experience and in the healthcare and investment banking industries to Autolus’ Board. “Autolus has entered a new pha...
- Jacob Mekhael
Autolus NICE recommends Aucatzyl for r/r adult B-ALL in England and Wa...
Autolus announced that the National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Aucatzyl (obe-cel, CD19 CAR-T) for use in the National Health Service (NHS) in England and Wales as a treatment option for adult patients (=26 years) with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r B-ALL). Aucatzyl will be available through routine commissioning by the NHS, and Autolus intends to launch the product in England and Wales immi...
- Jacob Mekhael
- Kristof Samoy
- Thibault Leneeuw
Galapagos Receives Transparency Notifications from Bank of America
Galapagos Receives Transparency Notifications from Bank of America Mechelen, Belgium; November 26, 2025, 07:30 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) received transparency notifications from Bank of America. Pursuant to Belgian transparency legislation1, Galapagos received transparency notifications on November 18 and November 19, 2025, from Bank of America Corporation indicating that it positively crossed the threshold of 5% of Galapagos’ voting rights on November 12, 2025 following an acquisition of Galapagos’ voting rights and equivalent financial instrumen...
Galapagos ontvangt transparantieverklaringen van Bank of America
Galapagos ontvangt transparantieverklaringen van Bank of America Mechelen, België; 26 november 2025, 07:30 CET; gereglementeerde informatie – Galapagos NV (Euronext & NASDAQ: GLPG) heeft transparantieverklaringen ontvangen van Bank of America. Overeenkomstig de Belgische transparantiewetgeving1 ontving Galapagos op 18 en 19 november 2025 transparantieverklaringen van Bank of America Corporation. Daaruit blijkt dat Bank of America op 12 november 2025 de drempel van 5% van de stemrechten in Galapagos positief heeft overschreden na een verwerving van stemrechten en daarmee gelijkgestelde fin...
NICE Recommends AUCATZYL® (obecabtagene autoleucel) as a Treatment Opt...
NICE Recommends AUCATZYL® (obecabtagene autoleucel) as a Treatment Option for Adult Patients (≥26 years) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)¹ AUCATZYL® will be available through routine commissioning by the UK National Health Service (NHS) LONDON, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the National Institute for Health and Care Excellence (NICE) has pu...
- Jacob Mekhael
- Lynn Hautekeete
- Thomas Couvreur
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
Autolus Upping our Aucatzyl sales estimates in r/r ALL
Last week, Autolus reported 3Q25 results. Autolus reported 3Q25 sales of $21.1m, bringing the total for 9M25 to $51m. In our launch preview published in January 2025, we estimated Aucatzyl could generate $43m in FY25 sales vs. $37m CSS estimate. Ours and CSS initial estimates turned out to be conservative given that Aucatzyl generated $51m in 9M25. As such, we increase our Aucatzyl FY25 sales estimate in the US to $72.5m, and increase our peak market share to 50% (from 40%) supported by strong i...
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