Euronext

Galapagos appoints Andrew Dickinson as Non-Executive Non-Independent Director to its Board

Retrieved on: 
Tuesday, March 26, 2024
CFO, Lazard, Patient, Sutter Health, Euronext, Galapagos NV, Management

Andrew Dickinson is Gilead's Chief Financial Officer (CFO) and replaces Daniel O’Day, Gilead’s Chairman and Chief Executive Officer (CEO), who was a member of the Galapagos Board of Directors from 22 October 2019 to 26 March 2024.

Key Points: 
  • Andrew Dickinson is Gilead's Chief Financial Officer (CFO) and replaces Daniel O’Day, Gilead’s Chairman and Chief Executive Officer (CEO), who was a member of the Galapagos Board of Directors from 22 October 2019 to 26 March 2024.
  • Mr. Dickinson is also a member of the Board of Directors of Sutter Health.
  • “On behalf of the Galapagos Board of Directors, I am very pleased to welcome Andy to our Board,” said Dr. Paul Stoffels1, CEO and Chairman of Galapagos.
  • The Board and I also want to sincerely thank Dan for his valuable contributions to the Galapagos Board of Directors.”
    “I am honored to step into Dan’s role as a member of the Galapagos Board of Directors,” said Mr. Dickinson.

argenx Announces Annual General Meeting of Shareholders on May 7, 2024

Retrieved on: 
Tuesday, March 26, 2024
Annual, Annual report, Proxy, Euronext, Person

The shareholders and all other persons with meeting rights are invited to attend the Annual General Meeting of shareholders.

Key Points: 
  • The shareholders and all other persons with meeting rights are invited to attend the Annual General Meeting of shareholders.
  • The company’s annual report for the financial year ended December 31, 2023 is now available on its website www.argenx.com/investors/financial-reports .
  • The full agenda for the meeting as well as all ancillary documents relevant for the meeting are available via the argenx website and are also available for inspection at the argenx offices.
  • argenx would like to encourage shareholders to use the voting by (electronic) proxy option as referred to in the convocation.

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

Retrieved on: 
Tuesday, March 26, 2024
Diagnosis, Blood pressure, Efgartigimod alfa, System, Urination, Urinary tract infection, MHLW, Chest pain, Rituximab, Allergy, Disease, Infection, Risk, Headache, Patient, Sore throat, IWG, History, ITP, Chills, Quality of life, Cough, Euronext, Rash, Respiratory tract infection, Splenectomy, Medicine, Skin, Fever, Antibody, Wheeze, Back pain, Shivering, Safety, Pain, Fatigue, Phlegm, Swelling, Food, Autoimmune disease, Nursing

“argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
  • ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.

ONWARD® Medical Publishes Closing of Accelerated Bookbuild Offering and Public Offering in France

Retrieved on: 
Monday, March 25, 2024
Offerings, Private, Brussels Stock Exchange, Euronext, DSM-IV codes, NOT, Euronext Amsterdam, Movement, SCI, Security (finance)

EINDHOVEN, the Netherlands, March 25, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD) (the “Company” or “ONWARD Medical”), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disorders, announces today the closing of its previously announced private placement with institutional investors, certain founders, certain members of management, and certain members of the Board of Directors (the “Private Placement”) and of its separate public offering via the PrimaryBid platform with retail investors in France (the “Public Offer” and together with the Private Placement the “Offerings”).  The gross proceeds from the Offerings amount to €20 million. 

Key Points: 
  • OTHER RESTRICTIONS ARE APPLICABLE.
  • PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
  • As of today, the new shares issued pursuant to the Offerings are admitted to listing and trading on Euronext Brussels and Euronext Amsterdam.
  • This press release does not constitute, contain, or form part of an offering of securities in any jurisdiction.

Nyxoah Advances Patient Access Strategy through Partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation

Retrieved on: 
Monday, March 25, 2024
OSA, Growth, Otorhinolaryngology, Partnership, Patient, Mont-Saint-Guibert, Insurance, Euronext, AAO, Obstructive sleep apnea, CMS, Corporation, Pharmaceutical industry

Nyxoah is the first medical device company to partner with the AAO-HNSF at this level.

Key Points: 
  • Nyxoah is the first medical device company to partner with the AAO-HNSF at this level.
  • The AAO-HNSF is committed to identifying and combating harmful coverage policies that threaten access to quality otolaryngology-head and neck services.
  • The Academy’s Advocacy team, in collaboration with its dedicated members and strategic industry partners like Nyxoah, actively engage with payers to achieve this goal.
  • “Nyxoah and the AAO-HNSF share the common goal of putting patients first and making sure they have access to HGNS therapy.

ONWARD® Medical Publishes Prospectus for Listing of New Shares

Retrieved on: 
Thursday, March 21, 2024
EUR, Offerings, AFM, Euronext, Prospectus, DSM-IV codes, Market, NOT, Movement, SCI

EINDHOVEN, the Netherlands, March 21, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD) (the “Company” or “ONWARD Medical”), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disorders, announces today that it has published a prospectus for the admission to listing of 4,444,444 ordinary shares in the Company’s share capital, with a nominal value of EUR 0.12 each, issued through a private placement with institutional investors, certain founders and certain members of management, and certain members of the Board of Directors (the “Private Placement”) and in a separate public offering via the PrimaryBid platform with retail investors in France (the “Public Offer”), for which pricing and allocation have occurred prior to trading on March 21, 2024 (the “Offerings”). In connection with the listing of the shares placed in the Offerings, a listing prospectus was published today. The prospectus was approved by the Netherlands Authority for the Financial Markets (AFM) on March 21, 2024 and can be downloaded via ir.onwd.com/shareholder-information.

Key Points: 
  • PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
  • In connection with the listing of the shares placed in the Offerings, a listing prospectus was published today.
  • The prospectus was approved by the Netherlands Authority for the Financial Markets (AFM) on March 21, 2024 and can be downloaded via ir.onwd.com/shareholder-information .
  • This press release does not constitute, contain, or form part of an offering of securities in any jurisdiction.

ONWARD® Medical Successfully Raises €20 Million in a Capital Increase by Way of an Accelerated Bookbuild Offering and by Way of a Public Offering in France

Retrieved on: 
Thursday, March 21, 2024
Offerings, Public, Private, Brussels Stock Exchange, KBC, Euronext, DSM-IV codes, CSO, Euronext Amsterdam, NOT, SCI, Movement, Hand, Security (finance)

PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.

Key Points: 
  • PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
  • “We are delighted to announce the successful capital raise of €20 million, including a fully subscribed upsize option despite challenging market conditions,” said Dave Marver, CEO of ONWARD Medical.
  • Existing shareholders participated in the deal with an aggregate of 333,333 shares and 333,333 shares respectively allocated to INKEF Capital and EQT Life Sciences.
  • Following the Offerings, INKEF Capital and EQT Life Sciences will respectively hold 11.5% and 11.2% of the Company’s share capital.

ONWARD® Medical Launches Capital Increase by Way of an Accelerated Bookbuild Offering and of a Public Offering in France for an Indicative Amount of EUR 15 Million, with an Up to EUR 5 Million Upsize Option

Retrieved on: 
Wednesday, March 20, 2024
Brussels Stock Exchange, SCI, Public, Private, KBC, VWAP, ARC, Hand, Acceleration, Regulation, DSM-IV codes, CSO, Movement, EUR, Private placement, BCI, Offerings, Public offering, Equity carve-out, Euronext, Issue, Euronext Amsterdam, Security (finance)

The final number of New Shares placed and the issue price per New Share (the “Issue Price”) will be announced after pricing of the Offerings.

Key Points: 
  • The final number of New Shares placed and the issue price per New Share (the “Issue Price”) will be announced after pricing of the Offerings.
  • The New Shares will be issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights.
  • “It is the Company’s intention to raise gross proceeds of indicatively EUR 15 million from the Offerings, with an up to EUR 5 million upsize option.
  • A separate announcement will be made shortly regarding the Public Offer in France via the PrimaryBid platform and its terms.

Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints

Retrieved on: 
Tuesday, March 19, 2024
DREAM, OSA, Annual report, ODI, Patient, PSG, Mont-Saint-Guibert, IDE, AHI, Euronext, ITT, Oxygen, Obstructive sleep apnea, Pharmaceutical industry

The DREAM study is a pivotal trial, being conducted under an investigational device exemption (IDE) and is designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States.

Key Points: 
  • The DREAM study is a pivotal trial, being conducted under an investigational device exemption (IDE) and is designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States.
  • Study participants entered the DREAM study with a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5.
  • “DREAM is a pivotal, multicenter, international study of Genio, a next generation HGNS technology offering patients bi-lateral stimulation with a non-implanted battery solution powered and controlled by a wearable.
  • A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: DREAM Results Webcast .

ONWARD® Medical Successfully Completes Benchmark Testing on Path to Commercialize ARC-EX® System

Retrieved on: 
Monday, March 18, 2024
BCI, Paralysis, Euronext, ARC, Movement, SCI, Medical device

  EINDHOVEN, the Netherlands, March 18, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces receipt of a positive report from a leading US-based medical equipment testing laboratory confirming its investigational ARC-EX System conforms to prevailing electrical standards, a requirement for commercial launch.  

Key Points: 
  • Last year, the Company announced its decision to update the ARC-EX printed circuit board assembly.
  • With the positive testing report, the Company moves closer to meeting regulatory obligations for market launch.
  • The ONWARD ARC-EX System is designed to improve upper extremity movement after paralysis caused by spinal cord injury.
  • “The positive tests are an important milestone on our path to commercialize the external, non-invasive ARC-EX System in the US later this year,” said ONWARD Medical CEO Dave Marver.