Mechelen

Galapagos receives transparency notification from Wellington Management Group LLP

Monday, November 18, 2019 - 9:01pm

Mechelen, Belgium; 18 November 2019; 22:01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a new transparency notification from Wellington Management Group LLP.

Key Points: 
  • Mechelen, Belgium; 18 November 2019; 22:01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a new transparency notification from Wellington Management Group LLP.
  • Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 13 November 2019 from Wellington Management Group LLP, who indicated that, following a disposal of ordinary shares, American Depository Receipts and equity swaps, the remaining 3,126,030 Galapagos shares and equivalent financial instruments held by its entirely-controlled subsidiary Wellington Management Company LLP represent 4.84% of the current 64,571,622 outstanding Galapagos shares and thus crossed below the 5% threshold of Galapagos voting rights on 13 November2019.
  • The full transparency notification is available on the Galapagos website.
  • Galapagos ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines.

Transparency notification – Gilead holds 25.10% of Galapagos shares

Wednesday, November 13, 2019 - 9:01pm

Mechelen, Belgium; 13 November 2019; 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from Gilead Sciences, Inc.

Key Points: 
  • Mechelen, Belgium; 13 November 2019; 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from Gilead Sciences, Inc.
    Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 11 November 2019 from Gilead Sciences, Inc. (acting as a parent undertaking or a controlling person), who notified that Gilead Therapeutics A1 Unlimited Company, an indirect subsidiary of Gilead Sciences, Inc., holds 16,207,477 of Galapagos' voting rights, consisting of 16,207,477 shares, as a result of subscribing to a capital increase in the framework of the exercise of the Initial Warrant A and thus receiving 2,617,791 new Galapagos shares on 6 November 2019.
  • Gilead Therapeutics A1 Unlimited Company thus crossed above the 25% threshold of Galapagos' voting rights by acquisition of voting securities on 6 November 2019.
  • The notification specifies furthermore that (i) Gilead Therapeutics A1 Unlimited Company is a direct subsidiary of Gilead Biopharmaceutics Ireland UC, (ii) Gilead Biopharmaceutics Ireland UC is a direct subsidiary of Gilead Sciences, Inc., and (iii) Gilead Sciences, Inc. has no controlling shareholder.
  • The full transparency notification is available on the Galapagos website.

NEW DATA ON FILGOTINIB IN RHEUMATOID ARTHRITIS (RA) DEMONSTRATE DURABLE EFFICACY AND SAFETY PROFILE

Saturday, November 9, 2019 - 9:30pm

The data demonstrate durable efficacy and safety results with filgotinib across multiple RA patient populations, from MTX-nave patients to those who have had an inadequate response to two or more biologic disease-modifying anti-rheumatic drugs (bDMARDs).

Key Points: 
  • The data demonstrate durable efficacy and safety results with filgotinib across multiple RA patient populations, from MTX-nave patients to those who have had an inadequate response to two or more biologic disease-modifying anti-rheumatic drugs (bDMARDs).
  • Filgotinib efficacy was measured by ACR20, and Disease Activity Score 28 (DAS28(CRP)) 3.2 and DAS28(CRP) < 2.6.
  • Results demonstrate that, compared with placebo, filgotinib consistently improved clinical outcomes in bDMARD-IR patients and that treatment efficacy was not impacted by any of these demographic and clinical baseline characteristics.
  • Data comprising 2,203 patient-years of exposure (PYE) with filgotinib from the Phase 2b, open-label extension DARWIN 3 study assessed the long-term safety and efficacy of filgotinib (200 mg or 100 mg) monotherapy and filgotinib plus MTX in 739 patients.

Galapagos increases share capital through warrant exercise by Gilead

Wednesday, November 6, 2019 - 9:50pm

Mechelen, Belgium; 6 November 2019, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from a warrant exercise by Gilead.

Key Points: 
  • Mechelen, Belgium; 6 November 2019, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from a warrant exercise by Gilead.
  • On 1 November 2019, Galapagos NV (the "Company" or "Galapagos") announced that Gilead Therapeutics A1 Unlimited Company, an affiliate of Gilead Sciences, Inc. (NASDAQ: GILD) ("Gilead"), delivered an exercise notice to Galapagos in order to exercise the Initial Warrant A.
  • Initial Warrant A has a term of one year starting as of 22 October 2019.
  • As a result of the exercise of the Initial Warrant A, Gilead subscribed for 2,617,791 shares at 140.59 per share for a total of 368,035,236.69.

Gilead delivers exercise notice to Galapagos for Initial Warrant A to increase ownership to 25.1%

Friday, November 1, 2019 - 8:01pm

This release may contain forward-looking statements with respect to Galapagos, including statements regarding the timing of completion of the exercise of Initial Warrant A by Gilead, the issuance of shares to Gilead, Gileads resulting shareholding in Galapagos and the payment of the aggregate exercise price by Gilead to Galapagos.

Key Points: 
  • This release may contain forward-looking statements with respect to Galapagos, including statements regarding the timing of completion of the exercise of Initial Warrant A by Gilead, the issuance of shares to Gilead, Gileads resulting shareholding in Galapagos and the payment of the aggregate exercise price by Gilead to Galapagos.
  • Galapagos cautions the reader that forward-looking statements are not guarantees of future performance.
  • Among the factors that may result in differences are that the parties may not be able to timely complete the exercise of the Initial Warrant A or at all.
  • Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

GILEAD AND GALAPAGOS TO PRESENT NEW DATA ON FILGOTINIB AT 2019 ACR/ARP ANNUAL MEETING

Thursday, October 31, 2019 - 8:01pm

We are proud to share these latest data at the 2019 ACR/ARP Annual Meeting, said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.

Key Points: 
  • We are proud to share these latest data at the 2019 ACR/ARP Annual Meeting, said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.
  • Presented data will assess the relationship between a series of RA biomarkers and the therapeutic response of filgotinib.
  • For more information, including a complete list of the abstracts being presented at the 2019 ACR/ARP annual meeting, please visit: https://acrabstracts.org .
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

MOR106 clinical development in atopic dermatitis stopped for futility

Monday, October 28, 2019 - 8:45pm

The clinical development program of MOR106 in atopic dermatitis included the two Phase 2 studies IGUANA and GECKO, as well as a Phase 1 bridging study for subcutaneous formulation and a Japanese ethno-bridging study.

Key Points: 
  • The clinical development program of MOR106 in atopic dermatitis included the two Phase 2 studies IGUANA and GECKO, as well as a Phase 1 bridging study for subcutaneous formulation and a Japanese ethno-bridging study.
  • In July 2019, Galapagos and MorphoSys entered into an exclusive worldwide development and commercialization collaboration with Novartis with respect to MOR106.
  • We are obviously disappointed with this result with MOR106 in atopic dermatitis.
  • Unfortunately, the results from the interim analysis for futility do not support the continuation of the current clinical development of MOR106 in atopic dermatitis said Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys.

Galapagos receives transparency notification from Wellington Management Group LLP

Friday, October 25, 2019 - 9:01pm

Mechelen, Belgium; 25 October 2019; 22:01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a new transparency notification from Wellington Management Group LLP.

Key Points: 
  • Mechelen, Belgium; 25 October 2019; 22:01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) received a new transparency notification from Wellington Management Group LLP.
  • Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 22 October 2019 from Wellington Management Group LLP, who indicated that, following a disposal of ordinary shares, the remaining 3,079,573 Galapagos ordinary shares held by its entirely-controlled subsidiary Wellington Management Company LLP represent 4.97% of the current 61,953,831 outstanding Galapagos shares and thus, with the ordinary shares portion of its total position, crossed below the 5% threshold of Galapagos voting rights on 8October2019.
  • In addition, through its wholly owned subsidiary Wellington Management Company LLP, it now also holds 615,676 American Depositary Shares and 8,322 equity swaps with expiration in 2020, bringing the new total number of voting rights for Wellington Management Group to 3,703,571, which represents 5.98% of total outstanding shares.
  • Galapagos ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines.

Solid third quarter 2019 performance with strong balance sheet for continued R&D growth

Thursday, October 24, 2019 - 9:01pm

We realized a net profit of 265.3million for the first nine months of 2019, compared to a net loss of 44.2million for the first nine months of 2018.

Key Points: 
  • We realized a net profit of 265.3million for the first nine months of 2019, compared to a net loss of 44.2million for the first nine months of 2018.
  • We reported an operating profit amounting to 393.0million for the first nine months of 2019, compared to an operating loss of 53.5million for the first nine months of 2018.
  • Our R&D expenditure in the first nine months of 2019 amounted to 298.2million, compared to 231.8million for the first nine months of 2018.
  • To participate in the conference call, please call one of the following numbers ten minutes prior to commencement:

GILEAD AND GALAPAGOS ANNOUNCE EFFICACY AND SAFETY RESULTS OF FILGOTINIB THROUGH 52 WEEKS IN FINCH 1 AND FINCH 3 STUDIES IN RHEUMATOID ARTHRITIS

Thursday, October 10, 2019 - 11:00pm

These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.

Key Points: 
  • These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.
  • Detailed Week 52 results from the FINCH 1 and 3 trials will be submitted for presentation at a future medical conference.
  • Gilead plans to file a New Drug Application (NDA) for filgotinib for the treatment of rheumatoid arthritis in the United States including the FINCH 1 and FINCH 3 Week 52 data later this year.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.