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Celyad Announces Third Quarter 2019 Financial Results and Recent Business Highlights

Tuesday, November 19, 2019 - 6:00am

Completed enrollment in the dose-escalation segment of the alloSHRINK trial with additional results from the trial anticipated during first half 2020.

Key Points: 
  • Completed enrollment in the dose-escalation segment of the alloSHRINK trial with additional results from the trial anticipated during first half 2020.
  • Closed global equity offering with gross proceeds of $20.0 million (approximately 18.2 million) in September 2019.
  • As of September 30, 2019, the Company ended the quarter with a treasury position of 44.6 million ($48.8 million), which includes net proceeds of 17.0 million from the global equity offering in September 2019.
  • Net cash burn over the third quarter of 2019 amounted to 6.1 million, in line with expectations.

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.

MDxHealth Provides Q3-2019 Business Update

Monday, November 11, 2019 - 2:13pm

IRVINE, CA, and HERSTAL, BELGIUM November 11, 2019 MDxHealth SA (Euronext: MDXH.BR), a commercial-stage innovative molecular diagnostics company, today provided a business update for the three and nine months ended September 30, 2019.

Key Points: 
  • IRVINE, CA, and HERSTAL, BELGIUM November 11, 2019 MDxHealth SA (Euronext: MDXH.BR), a commercial-stage innovative molecular diagnostics company, today provided a business update for the three and nine months ended September 30, 2019.
  • Michael McGarrity, CEO of MDxHealth, said: During this transitional period for MDxHealth we have set a foundation that will enable us to drive growth into our best in class menu which provides a pathway for both clinicians and patients screened for prostate cancer.
  • We are confident that our refocused commercial organization, strengthened leadership team, financial operating discipline and clear strategic focus will serve as drivers of revenue growth.
  • We expect SelectMDx billed volumes and revenues to accelerate upon receipt of final LCD coverage decision, expected in H1-2020
    Nine Months Ended September 30,

Celyad Highlights Safety and Clinical Activity of CYAD-101, a First-In-Class, Non-Gene Edited Allogeneic CAR-T Therapy for mCRC, from SITC 34th Annual Meeting

Monday, November 11, 2019 - 6:00am

Results were presented at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting, held in Washington D.C. from November 6-10, 2019.

Key Points: 
  • Results were presented at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting, held in Washington D.C. from November 6-10, 2019.
  • In addition, any host-versus-graft reaction against the allogeneic CAR-T product candidate appears to be controlled by the non-myeloablative FOLFOX chemotherapy.
  • Our confidence in CYAD-101 has continued to build as data from the alloSHRINK trial have emerged over the past year.
  • There is limited data concerning safety and clinical activity following treatment with the CYAD-01, CYAD-101 and CYAD-02 drug product candidates.

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.

Celyad to Present Update to r/r AML and MDS Program at 2019 ASH Annual Meeting

Wednesday, November 6, 2019 - 2:00pm

Celyad will host an event at ASH for investors and analysts on Monday, December 9, 2019, beginning at 8:30 p.m.

Key Points: 
  • Celyad will host an event at ASH for investors and analysts on Monday, December 9, 2019, beginning at 8:30 p.m.
  • ET to review data presented, as well as to provide updates on the companys development program for r/r AML and MDS and its proprietary OptimAb manufacturing process.
  • The event will also be webcast live and can be accessed under Events & Webcasts in the Investors section of the companys website.
  • Following presentation at the meeting, the posters will be available in the library section of Celyads website.

Radisson Hospitality AB’s Q3 2019 report

Wednesday, November 6, 2019 - 6:30am

On a like-for-like basis, including hotels under renovation (LFL&R), Revenue increased as well by MEUR8.5 (3.4%).

Key Points: 
  • On a like-for-like basis, including hotels under renovation (LFL&R), Revenue increased as well by MEUR8.5 (3.4%).
  • The increase is mainly due to the implementation of the new accounting standard IFRS 16 Leases (MEUR11.4) and lower net costs in central activities.
  • EBIT increased by MEUR18.7 (94.4%) to MEUR38.5, where of MEUR4.7 is due to the implementation of IFRS 16 Leases.
  • 9,394 (5,691) rooms were contracted, 3,278 (3,133) rooms opened and 1,404 (604) rooms left the system.

Celyad Highlights Abstracts from mCRC Clinical Program Released for SITC 34th Annual Meeting

Tuesday, November 5, 2019 - 1:00pm

Celyad is a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based product candidates and utilizes its expertise in cell engineering to target cancer.

Key Points: 
  • Celyad is a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based product candidates and utilizes its expertise in cell engineering to target cancer.
  • Celyads CAR-T cell platform has the potential to treat a broad range of solid and hematologic tumors.
  • There is limited data concerning safety and clinical activity following treatment with the CYAD-01, CYAD-101 and CYAD-02 drug product candidates.
  • Prior clinical and preclinical results may not be repeated or observed in ongoing or future clinical studies involving the CYAD-01 and CYAD-101 drug product candidates.