S-8 - GALAPAGOS NV (0001421876) (Filer)

6-K - GALAPAGOS NV (0001421876) (Filer)

6-K - GALAPAGOS NV (0001421876) (Filer)

6-K - GALAPAGOS NV (0001421876) (Filer)

6-K - GALAPAGOS NV (0001421876) (Filer)

6-K - GALAPAGOS NV (0001421876) (Filer)

6-K - GALAPAGOS NV (0001421876) (Filer)

6-K - GALAPAGOS NV (0001421876) (Filer)

6-K - GALAPAGOS NV (0001421876) (Filer)

6-K - GALAPAGOS NV (0001421876) (Filer)

New Phase 1/2 data support the potential of our CAR T-cell therapy candidates, GLPG5101 and GLPG5201, in addressing unmet needs for patients with poor prognoses. Our innovative decentralized cell therapy manufacturing platform delivers fresh, fit cells within a median vein-to-vein time of seven days, with potentially encouraging patient outcomes. Three abstracts, including one oral presentation for GLPG5101 in relapsed/refractory non-Hodgkin lymphoma, and a company showcase, will spotlight our cutting-edge cell therapy innovations in blood cancers and solid tumors.  Mechelen, Belgium; November 5, 2024, 22:01 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced that it wi

We are advancing our pipeline and accelerating innovation through focused execution of our Forward, Faster strategy.We are committed to addressing the high unmet needs of patients through a growing cell therapy and small molecule pipeline with breakthrough potential. This includes more than 20 programs, with four assets in clinical development across 11 indications, and more than 15 preclinical programs in oncology and immunology. We achieved a major regulatory milestone with the FDA clearance of the Investigational New Drug (IND) application for the Phase 1/2 ATALANTA-1 study of our CD19 CAR-T candidate, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma (R/R NHL), marking an important s

Mechelen, Belgium; October 7, 2024, 07:00 CET — Galapagos NV ((Euronext &, NASDAQ:GLPG), today announced the appointment by way of co-optation of Oleg Nodelman as Non-Executive Non-Independent Director to its Board of Directors, effective October 7, 2024. Mr. Nodelman replaces Mr. Dan G. Baker who stepped down on October 6, 2024. The addition of Mr. Nodelman marks an important step in Galapagos' ongoing efforts to engage with shareholders and continue to execute on our Forward, Faster strategy to accelerate innovation and create near-and long-term value.  "We are pleased to welcome Oleg Nodelman to the Galapagos Board," said Dr. Paul Stoffels, Galapagos' CEO and Chair of the Board of Direc

Excellos is the first decentralized manufacturing unit (DMU) within the nationwide network of Blood Centers of America to be selected for Good Manufacturing Compliant (GMP) manufacturing for Galapagos' CAR-T hemato-oncology program. Excellos Inc., a cell therapy contract and development manufacturing organization (CDMO) member of Blood Centers of America (BCA), today announced that it has been selected to manufacture Galapagos' CAR-T cell therapy candidate, GLPG5101, for its recently FDA cleared ATALANTA-1 clinical study in patients with relapsed/refractory non-Hodgkin lymphoma in the U.S. Galapagos ((Euronext &, NASDAQ:GLPG) is a clinical stage biotechnology company with operations in Eu

Mechelen, Belgium; 30 September 2024, 22:01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) received a transparency notification from EcoR1 Capital LLC. Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 26 September 2024 on behalf of Mr. Oleg Nodelman and EcoR1 Capital LLC, who notified us that EcoR1 Capital LLC holds 7,094,049 of Galapagos' voting rights, consisting of 6,939,043 ordinary shares and 155,006 American Depository Receipts, further to a conversion of financial instruments and an acquisition of voting securities. EcoR1 Capital LLC, controlled by Mr. Oleg Nodelman, controls investment funds EcoR1 Capital Fun

Mechelen, Belgium; 16 September 2024, 22:01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) received a transparency notification from EcoR1 Capital LLC. Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 13 September 2024 on behalf of Mr. Oleg Nodelman and EcoR1 Capital LLC, who notified that EcoR1 Capital LLC holds 6,713,553 of Galapagos' voting rights, consisting of 839,388 ordinary shares and 5,874,165 American Depository Receipts, further to an acquisition of voting securities and financial instruments that are treated as voting securities. EcoR1 Capital LLC, controlled by Mr. Oleg Nodelman, controls investment

Mechelen, Belgium; 3 September 2024, 22:01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) received a transparency notification from FMR LLC. Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 30 August 2024 from FMR LLC, who notified that it holds 2,687,116 of Galapagos' voting rights, consisting of 2,686,016 ordinary shares and 1,100 equivalent financial instruments. FMR LLC controls investment funds Fidelity Management & Research Company LLC, FIAM LLC, Fidelity Management Trust Company, Strategic Advisers LLC, and FMR Investment Management (UK) Limited, of which Fidelity Management & Research Company LLC decreased its pos

Mechelen, Belgium; August 23, 2024, 07:00 CET; regulated information – inside information – Galapagos NV ((Euronext &, NASDAQ:GLPG) today announced that the U.S. Food and Drug Administration (FDA) has cleared Galapagos' Investigational New Drug (IND) application for ATALANTA-1, a Phase 1/2 multicenter study evaluating the feasibility, safety, and efficacy of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). GLPG5101 is an autologous CD19 CAR-T cell therapy product candidate produced using Galapagos' innovative decentralized cell therapy manufacturing platform with the potential for the administration of fresh, fit cells within a median vein-to-vein time of se

Mechelen, Belgium; 20 August 2024, 22:01 CET; regulated information – Galapagos NV ((Euronext &, NASDAQ:GLPG) received a transparency notification from FMR LLC. Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 16 August 2024 from FMR LLC, who notified that it holds 3,696,750 of Galapagos' voting rights, consisting of 3,693,550 ordinary shares and 3,200 equivalent financial instruments. FMR LLC controls investment funds Fidelity Management & Research Company LLC, FIAM LLC, Fidelity Management Trust Company, Strategic Advisers LLC, Fidelity Institutional Asset Management Trust Company, and FMR Investment Management (UK) Limited, of which Fid

BridGene Eligible to Receive Up to $159 Million in Total Payments SAN JOSE, Calif., Aug. 1, 2024 /PRNewswire/ -- BridGene Biosciences, Inc., a leader in the discovery of small molecule drugs for traditionally "hard-to-drug" targets, today announced an expansion to its strategic collaboration and licensing agreement with Galapagos NV (Euronext: GLPG) (NASDAQ:GLPG). This new collaboration builds upon the partnership initiated in January 2024, focusing on the discovery of a highly selective oral SMARCA2 small molecule proteolysis targeting chimera (PROTAC). Under the expanded agr

Adaptimmune and Galapagos to conduct clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next generation MAGE-A4 TCR T-cell therapy) produced on Galapagos' decentralized manufacturing platform in patients with head & neck cancerUza-cel has shown encouraging results in head & neck cancer with partial responses in four out of five patients to date in a Phase 1 trial using Adaptimmune's centralized manufacturing platformInitial in vitro testing of uza-cel produced on Galapagos' decentralized manufacturing platform has shown encouraging data that support further clinical developmentAdaptimmune to receive initial payments of $100 million, comprising $70 million upfront

BCA's national network of blood centers will provide decentralized manufacturing services for Galapagos' CAR-T product candidates, close to cancer treatment centersCollaboration enables rapid deployment of Galapagos' decentralized CAR-T platform across the U.S., improving patient access to potentially life-saving CAR-T treatmentsImportant milestone for Galapagos' U.S. expansion strategy, supporting upcoming pivotal trials and potential future commercial manufacturing of CAR-T therapiesComplements existing collaborations with Galapagos' other manufacturing partnersMechelen, Belgium; 15 May 2024, 22:01 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) and Blood Centers of America (BCA) today announ

Results from our continuing operationsTotal operating loss from continuing operations for the three months ended 31 March 2024 was €33.1 million, compared to an operating loss of €14.2 million for the three months ended 31 March 2023.Total net revenues for the three months ended 31 March 2024 amounted to €62.4 million, compared to €58.6 million for the three months ended 31 March 2023. The revenue recognition related to the exclusive access rights granted to Gilead for our drug discovery platform amounted to €57.6 million for the first three months of both 2024 and 2023. Our deferred income balance at 31 March 2024 includes €1.2 billion allocated to our drug discovery platform that is recogn

Morgan Stanley analyst Judah Frommer maintains Galapagos (NASDAQ:GLPG) with a Equal-Weight and maintains $38 price target.

Two oral presentations and one poster on encore preliminary data from Phase 1/2 CD19 CAR-T studies in non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) / Richter transformation (RT)  

Bank of America Securities downgrades European drugmaker Galapagos NV (NASDAQ:GLPG) to underperform, citing few catalysts in the near term. Galapagos’ enterprise value has been consistently low, ranging between $1.5 billion and $2 billion, and the analysts don’t anticipate any immediate or medium-term solutions to this.  Additionally, the company’s main programs are entering crowded markets where differentiation is unclear, and there is a lack of significant catalysts to drive growth. Galapagos’ primary cancer pipeline requires 3 to 4 years to reach the market, accompanied by significant cash depletion and uncertain standing in fiercely competitive markets.  Moreover, Galapagos’

B of A Securities analyst Jason Gerberry downgrades Galapagos (NASDAQ:GLPG) from Neutral to Underperform and lowers the price target from $41 to $31.

B of A Securities analyst Jason Gerberry downgrades Galapagos (NASDAQ:GLPG) from Neutral to Underperform and lowers the price target from $41 to $31.

Morgan Stanley analyst Judah Frommer assumes Galapagos (NASDAQ:GLPG) with a Equal-Weight rating and announces Price Target of $38.

We are advancing our pipeline and accelerating innovation through focused execution of our Forward, Faster strategy.We are committed to addressing the high unmet needs of patients through a growing cell therapy and small molecule pipeline with breakthrough potential. This includes more than 20 programs, with four assets in clinical development across 11 indications, and more than 15 preclinical programs in oncology and immunology. We achieved a major regulatory milestone with the FDA clearance of the Investigational New Drug (IND) application for the Phase 1/2 ATALANTA-1 study of our CD19 CAR-T candidate, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma (R/R NHL), marking an important s

Executing on our Forward, Faster strategy with strong progress in a pivotal year, focused on delivering regulatory and clinical milestones, expanding our cell therapy manufacturing capabilities, and advancing our early-stage programs.Submitted IND application to FDA for our Phase 1/2 ATALANTA-1 study of CD19 CAR-T candidate, GLPG5101 in R/R NHL.Submitted CTA to EMA for our Phase 2 study of GLPG5201 in R/R CLL with or without RT.IND filing for our Phase 1/2 EUPLAGIA-1 study of CD19 CAR-T candidate GLPG5201 in R/R CLL with or without RT on track for Q4 2024.Encouraging new Phase 1/2 safety, efficacy, and translational data for GLPG5101 and GLPG5201, evaluating seven-day vein-to-vein, fresh CD1

Adaptimmune and Galapagos to conduct clinical proof-of-concept trial to evaluate the safety and efficacy of uza-cel (next-generation MAGE-A4 TCR T-cell therapy) produced on Galapagos' decentralized manufacturing platform in patients with head & neck cancerUza-cel has shown encouraging results in head & neck cancer with partial responses in four out of five patients to date in a Phase 1 trial using Adaptimmune's centralized manufacturing platform Initial in vitro testing of uza-cel produced on Galapagos' decentralized manufacturing platform has shown encouraging data that support further clinical development Adaptimmune to receive initial payments of $100 million, comprising $70 million upfro

Advanced potentially best-in-class cell therapy and small molecule R&D pipeline comprising four clinical assets and >15 discovery programs in oncology and immunologyExecuted agreements with BridGene Biosciences and Thermo Fisher Scientific, and investment in Frontier MedicinesTransferred Jyseleca® business to Alfasigma S.p.A., freeing up resources to invest in growth areasGroup net revenues in the first quarter of €100 millionCash and current financial investments of €3.6 billion on 31 March 2024Reconfirmed 2024 cash burni guidance of €280 million to €320 million, not including potential business development opportunities  Webcast presentation with management on 3 May 2024, at 1

Full year 2023 key financials: Group net revenues of €783.5 million, including Jyseleca® net sales of €112.3 million Cash and current financial investments of €3.7 billion on 31 December 2023Operational cash burni of €414.8 million, within guidance 2023 and year-to-date key updates: Transferred Jyseleca® business, including approximately 400 positions, to Alfasigma S.p.A.Achieved encouraging data from ongoing Phase 1/2 studies with CD19 CAR-T product candidates, GLPG5101 in rrNHL and GLPG5201, in rrCLL, with or without RTExpanded CAR-T pipeline with start of Phase 1/2 study with BCMA CAR-T product candidate GLPG5301 in rrMMEnrolled first patients in Phase 2 study with TYK2 inhibitor, G

First nine months 2023 key financials: Group revenues of €448.9 million Jyseleca® net sales of €82.1 million Cash and current financial investments of €3.8 billion at 30 September 2023Full year 2023 net Jyseleca® sales guidance of €100-€120 million and cash burn guidance of €380-€420 million reiterated Jyseleca® strategic evaluation completed: signed Letter of Intent to transfer the Jyseleca® (filgotinib) business to Alfasigma, including the European and UK Marketing Authorizations and development activities, and approximately 400 positions in 14 European countries Oncology pipeline: New encouraging data from ongoing CAR-T Phase 1/2 studies in relapsed/refractory chronic lymphocytic leuk

Half-year 2023 key financials Group revenues of €328.8 million Jyseleca® net sales of €54.3 million Cash and current financial investments of €3.9 billion on 30 June 2023 Full year 2023 net sales guidance for Jyseleca® lowered to €100-€120 million – 2023 cash burn guidance of €380-€420 million reiteratedOncology pipeline update – continued progress with point-of-care manufactured CAR-T candidates in hemato-oncology, including approval of the clinical trial application in Europe for BCMA CAR-T candidate in multiple myeloma Immunology pipeline update – start of Phase 3 study with filgotinib in axial spondyloarthritis; start of Phase 2 study with GLPG3667 in dermatomyositis; clinical trial ap

Progress with immunology and oncology pipeline: First patients dosed in pivotal Phase 3 OLINGUITO study with filgotinib in axial spondyloarthritis (AxSpA)Clinical sites opened to start patient recruitment in Phase 2 GALARISSO study with TYK2 inhibitor product candidate, GLPG3667, in dermatomyositis (DM)On track to report topline results from two CAR-T Phase 1/2 studies in hemato-oncology mid-2023Further expanding CAR-T point-of-care network in Europe, with IND filing in the US expected before year-end First quarter 2023 financial highlights: Jyseleca® net sales of €26.7 million (+85% versus Q1 '22)Group revenues of €178.9 millionOperating profit of €22.0 millionCas

Key 2022 and post-period events Dr. Paul Stoffelsi appointed as Chief Executive Officer and Chairman of the Board of DirectorsImplemented new strategic direction to accelerate innovation and time-to-patients: Set-up of new innovation model and fit-for-purpose R&D organizationFocus on key therapeutic areas of immunology and oncologyDiscontinuation of activities in fibrosis and kidney diseaseExpansion of drug modalities beyond small molecules, including biologicals and CAR-T Entered into the field of oncology through the acquisitions of CellPoint and AboundBioPresented encouraging initial safety and efficacy data from two ongoing Phase 1/2 studies in pat

Clear path forward for accelerated growth and value creation Reshape innovation model and build fit-for-purpose organization in key strategic therapeutic areas: immunology and oncologyJyseleca® 2022 net sales guidance further increased to €80-€90 million from €75-€85 million at H1 2022First nine months 2022 financial results: Strong performance of Jyseleca franchise with €60.5 million in net salesGroup revenues of €410.2 millionOperating loss of €135.1 millionCash and current financial investments of €4.4 billion on 30 September R&D and Strategy Webcast presentation at R&D Update tomorrow in New York, 4 November 2022, 13.00 – 15.30 CET / 8 am – 10.30 am EDT, www.glpg.com