Euronext

argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis

Retrieved on: 
Thursday, January 18, 2024
Patient, Euronext, Steroid, Immunoglobulin G, GMG, MHLW, Autoimmunity, Efgartigimod alfa, Pharmaceutical industry

Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use.

Key Points: 
  • Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use.
  • “Today’s approval of VYVDURA marks a significant milestone for the gMG community in Japan and furthers our commitment to deliver innovative treatments to autoimmune patients globally,” said Hermann Strenger, General Manager, argenx Japan.
  • ADAPT-SC established the efficacy of VYVDURA by demonstrating a reduction in percent change from baseline in total immunoglobulin G (IgG) levels comparable to VYVGART IV in adult gMG patients.
  • ADAPT-SC was a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of VYVGART in Japan in January 2022.

Nyxoah Announces 2024 Strategic Priorities

Retrieved on: 
Wednesday, January 17, 2024
DREAM, ResMed, Patient, Euronext, CCC, Partnership, Mont-Saint-Guibert, AHI, Obstructive sleep apnea, ODI, DTC, Investment, CPAP, OSA, Safety, PMA, Growth, Pharmaceutical industry

Mont-Saint-Guibert, Belgium – January 17, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced, in anticipation of upcoming investor meetings, its strategic priorities for 2024.

Key Points: 
  • Mont-Saint-Guibert, Belgium – January 17, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced, in anticipation of upcoming investor meetings, its strategic priorities for 2024.
  • Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April.
  • Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch.
  • For 2024, we expect continued sales growth driven by an increasing benefit from direct-to-consumer (DTC) initiatives, initial contribution from the ResMed commercial partnership in Germany and geographic expansion.

Cellectis announces the drawdown of the second tranche of €15 million under the credit facility agreement entered with the European Investment Bank (EIB)

Retrieved on: 
Tuesday, January 16, 2024
Euronext, Finance, UCART123, Form, Tranche, Commercial code, EIB, Form 6-K, Exercise, BofA Securities, European Investment Bank, Security (finance)

Tranche B is expected to be disbursed by the EIB by January 25, 2024.

Key Points: 
  • Tranche B is expected to be disbursed by the EIB by January 25, 2024.
  • The Company plans to use the proceeds of Tranche B towards the development of its pipeline of allogeneic CAR T-cell product candidates: UCART22, UCART20x22, and UCART123.
  • The total number of shares issuable upon exercise of the Tranche B Warrants represents circa 2% of the Company’s outstanding share capital as at their issuance date.
  • Tranche B will mature six years from its disbursement date and will accrue interest at a rate of 7% per annum capitalized annually and payable at maturity.

AB Science receives notice of allowance for European patent covering masitinib until 2036 in the treatment of mastocytosis

Retrieved on: 
Monday, January 15, 2024
Masitinib, European Patent Convention, Smouldering, Patient, Depression, Euronext, Itch, Prostate cancer, ALS, Multiple sclerosis, Science, EMA, FDA, NOA, Lancet, Patent, News, Mastocytosis, Pharmaceutical industry

AB Science SA (Euronext - FR0010557264 - AB) today announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis (i.e.

Key Points: 
  • AB Science SA (Euronext - FR0010557264 - AB) today announced that the European Patent Office has issued a Notice of Allowance for a patent relating to methods of treating severe systemic mastocytosis (i.e.
  • This new European patent provides intellectual property protection for masitinib in this indication until October 2036.
  • Masitinib is positioned as a treatment of severely symptomatic systemic mastocytosis patients, including the subvariants of indolent and smoldering systemic mastocytosis, who are unresponsive to optimal symptomatic treatment.
  • The Notice of Allowance (NOA) means that the European Patent Office intends to grant the patent application, EP3359195A1, after the completion of certain formal procedural steps.

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Retrieved on: 
Tuesday, January 9, 2024
DREAM, ResMed, Euronext, Annual report, Partnership, Mont-Saint-Guibert, Obstructive sleep apnea, OSA, FDA, Growth

Mont-Saint-Guibert, Belgium – January 9, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced certain preliminary, unaudited results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Mont-Saint-Guibert, Belgium – January 9, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced certain preliminary, unaudited results for the fourth quarter and full year ended December 31, 2023.
  • Revenue for the fourth quarter of 2023 is anticipated to be approximately €1.8 million, a 40% increase over the fourth quarter of 2022 and an 87% increase over the third quarter of 2023.
  • Revenue for the full year 2023 is anticipated to be approximately €4.3 million, a 41% increase over the full year 2022.
  • “We are excited with the strong preliminary fourth quarter sales, which are anticipated to be nearly double from last quarter.

argenx Highlights 2024 Strategic Priorities

Retrieved on: 
Monday, January 8, 2024
Immunoglobulin therapy, GMG, FDA, PRV, Congenital myasthenic syndrome, ARDA, Research Councils UK, Euronext, Inflammation, Cohort, PGIC, NRDL, Autoimmunity, Efgartigimod alfa, Dermatomyositis, Conference, MuSK protein, IND, CIDP, Pharmacokinetics, MMN, Safety, Therapy, Patient, ALS, Immune system, IL-6, Medicine, International Myeloma Foundation, IIP, FSS, Neonatal Fc receptor, Multifocal motor neuropathy, Growth, Pharmaceutical industry

argenx is planning to reach more patients commercially in 2024 through its multi-dimensional expansion efforts.

Key Points: 
  • argenx is planning to reach more patients commercially in 2024 through its multi-dimensional expansion efforts.
  • In addition, ARGX-119, a muscle-specific kinase (MuSK) agonist, will initiate Phase 1b/2a studies in congenital myasthenic syndrome and amyotrophic lateral sclerosis in 2024.
  • As of December 31, 2023, argenx had approximately $3.2 billion in cash, cash equivalents and current financial assets*.
  • Based on its current operating plans, argenx expects its combined R&D and SG&A expenses in 2024 to be less than $2 billion.

DELFI Diagnostics Appoints Susan Tousi as New Chief Executive Officer

Retrieved on: 
Friday, January 5, 2024
University, Geography, DELFI, Mechanics, Woman, Software, Research, NAE, Acquisition, Lung cancer, Disease, Pennsylvania State University, MBA, Cancer, Kodak, National academy, Genomics, PALO, Engineering, IVD, Informatics, Patient, Corporation, Hewlett-Packard, Euronext, Management

BALTIMORE and PALO ALTO, Calif., Jan. 5, 2024 /PRNewswire/ -- DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, today announced the appointment of Susan Tousi as Chief Executive Officer. Ms. Tousi joins DELFI from Illumina, Inc. where she held multiple leadership roles during a more than 10-year tenure, most recently as Chief Commercial Officer leading global sales, service and support, commercial operations and strategy.

Key Points: 
  • Ms. Tousi joins DELFI from Illumina, Inc. where she held multiple leadership roles during a more than 10-year tenure, most recently as Chief Commercial Officer leading global sales, service and support, commercial operations and strategy.
  • We are excited to welcome her to the team," said Liz Homans, DELFI Board Chair and former CEO of Lyell Immunopharma.
  • "Susan is behind the engineering and launch of several of Illumina's most impactful, globally profitable products.
  • This translatable expertise makes her the right fit to drive DELFI forward and lead the commercial strategy for the FirstLook Lung liquid biopsy test."

Galapagos enters into strategic collaboration agreement with Thermo Fisher Scientific to further expand its decentralized CAR-T manufacturing network in the U.S.

Retrieved on: 
Thursday, January 4, 2024
Technology transfer, Thermo Fisher Scientific, Research, TMO, Galapagos NV, Euronext, GMP, Patient, Pharmaceutical industry

Mechelen, Belgium; 4 January 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it has entered into a strategic collaboration agreement with Thermo Fisher Scientific, Inc. (NYSE: TMO) (“Thermo Fisher”) for the decentralized manufacturing of Galapagos’ point-of-care CAR-T product candidate in the San Francisco area.

Key Points: 
  • Mechelen, Belgium; 4 January 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it has entered into a strategic collaboration agreement with Thermo Fisher Scientific, Inc. (NYSE: TMO) (“Thermo Fisher”) for the decentralized manufacturing of Galapagos’ point-of-care CAR-T product candidate in the San Francisco area.
  • Under the terms of the agreement, Thermo Fisher will provide GMP manufacturing as well as BioServices and Specialty Logistics for Galapagos’ CAR-T hemato-oncology clinical program in the San Francisco area, effective January 2024.
  • Galapagos will initiate the technology transfer to enable Thermo Fisher’s manufacturing activities.
  • This collaboration follows Galapagos’ agreement with Landmark Bio for decentralized CAR-T manufacturing in the Boston area announced in November 2023.

BridGene Biosciences Announces Strategic Collaboration with Galapagos to Discover Small Molecule Drugs for Oncology Targets

Retrieved on: 
Wednesday, January 3, 2024
Galapagos NV, Euronext, Senior, Entrepreneurship, Cancer, Drug discovery, Partnering, SAN, Doctor of Philosophy, Pharmaceutical industry

SAN JOSE, Calif., Jan. 3, 2024 /PRNewswire/ -- BridGene Biosciences, Inc., a leader in the discovery of small molecule drugs for traditional "hard-to-drug" targets, announced today a strategic collaboration and licensing agreement with Galapagos NV (Euronext & NASDAQ: GLPG). Under the collaboration, BridGene will use its chemoproteomics platform, IMTAC™, to discover novel small molecule drug candidates against the collaboration targets. The parties will collaborate to advance the molecules to clinical candidates, which Galapagos has the exclusive rights to develop and commercialize.

Key Points: 
  • SAN JOSE, Calif., Jan. 3, 2024 /PRNewswire/ -- BridGene Biosciences, Inc. , a leader in the discovery of small molecule drugs for traditional "hard-to-drug" targets, announced today a strategic collaboration and licensing agreement with Galapagos NV (Euronext & NASDAQ: GLPG).
  • Under the collaboration, BridGene will use its chemoproteomics platform, IMTAC™, to discover novel small molecule drug candidates against the collaboration targets.
  • The preclinical research collaboration will focus on oncology targets named by Galapagos.
  • "We are excited to collaborate with Galapagos in the discovery of new drugs targeting critical and challenging targets in oncology.

Galapagos establishes strategic collaboration with BridGene Biosciences to expand small molecule drug discovery in oncology

Retrieved on: 
Wednesday, January 3, 2024
Galapagos NV, Euronext, Senior, Cancer, Patient, Drug discovery, Biotechnology, Pharmaceutical industry

Mechelen, Belgium; 3 January 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it has entered into a strategic collaboration and licensing agreement with BridGene Biosciences, Inc. (“Bridgene”), a biotechnology company that uses proprietary chemoproteomics technology to discover novel small molecule drug candidates.

Key Points: 
  • Mechelen, Belgium; 3 January 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced that it has entered into a strategic collaboration and licensing agreement with BridGene Biosciences, Inc. (“Bridgene”), a biotechnology company that uses proprietary chemoproteomics technology to discover novel small molecule drug candidates.
  • Through this collaboration, Galapagos and BridGene aim to discover and develop new precision medicines against clinically validated oncology targets by leveraging Galapagos’ expertise in small molecule drug discovery and translational research along with BridGene’s proprietary IMTAC™ chemoproteomics platform.
  • “We are very pleased to announce this preclinical research collaboration with BridGene, which has a strong track record in small molecule drug discovery for challenging targets.
  • In addition, BridGene will be entitled to receive single-digit tiered royalties on net sales of each product resulting from the collaboration.