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 PRESS RELEASE

Inventiva announces filing of its 2024 Universal Registration Document...

Inventiva announces filing of its 2024 Universal Registration Document and 2024 Annual Report on Form 20-F Daix (France), New York City (New York, United States), April 15, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and other diseases with significant unmet medical needs, today announced that it had filed its 2024 Universal Registration Document for the year ended December ...

 PRESS RELEASE

Inventiva annonce le dépôt de son Document d’Enregistrement Universel ...

Inventiva annonce le dépôt de son Document d’Enregistrement Universel 2024 et de son Rapport Annuel 2024 (« Form 20-F ») Daix (France), New York City (New York, États-Unis), le 15 avril 2025 - Inventiva (Euronext Paris et Nasdaq : IVA) (« Inventiva » ou la « Société »), société biopharmaceutique spécialisée dans le développement clinique de petites molécules administrées par voie orale pour le traitement de la stéatohépatite associée à un dysfonctionnement métabolique (« MASH ») et d'autres maladies avec un besoin médical non satisfait, annonce aujourd’hui avoir déposé son Document d’Enreg...

 PRESS RELEASE

Galapagos Announces Departure of Thad Huston, CFO and COO, as of Augus...

Galapagos Announces Departure of Thad Huston, CFO and COO, as of August 1, 2025 Mechelen, Belgium; April 15, 2025, 07:30 CET; regulated information – inside information – Galapagos NV (Euronext & NASDAQ: GLPG), a global biotechnology company dedicated to transforming patient outcomes through life-changing science and innovation, today announced the departure of its CFO and COO, Thad Huston, effective as of August 1, 2025. Mr. Huston has decided to leave the company and return to the U.S. for personal and professional reasons. Mr. Huston joined Galapagos NV in 2023 from Kite Pharma, Inc., t...

 PRESS RELEASE

Galapagos kondigt het vertrek van haar CFO en COO, Thad Huston, aan pe...

Galapagos kondigt het vertrek van haar CFO en COO, Thad Huston, aan per 1 augustus 2025 Mechelen, België; 15 april 2025, 07:30 CET; gereglementeerde informatie - voorwetenschap – Galapagos NV (Euronext & NASDAQ: GLPG), een wereldwijd biotechnologiebedrijf dat zich toelegt op het transformeren van patiëntresultaten door middel van levensveranderende wetenschap en innovatie, heeft vandaag het vertrek van haar CFO en COO, Thad Huston, aangekondigd per 1 augustus 2025. De heer Huston heeft besloten om Galapagos te verlaten en terug te keren naar de U.S. voor persoonlijke en professionele rede...

Guy Sips ... (+7)
  • Guy Sips
  • Hilde Van Boxstael
  • Jacob Mekhael
  • Kristof Samoy
  • Thomas Couvreur
  • Thomas Vranken
  • Wim Lewi
Jacob Mekhael
  • Jacob Mekhael

Sequana Medical CMS proposes NTAP top up payment for the alfapump

Sequana announced that the Centers for Medicare and Medicaid Services (CMS) recommends that alfapump system cases be eligible for incremental payment via a new technology add-on payment (NTAP). This proposal could bring an NTAP top-up payment of up to $ 19,500 on top of the existing DRG payments, boosting the device's reimbursement position, and could make the alfapump procedure profitable for hospitals, which is likely to help drive adoption. With center training due to be completed by the end ...

Guy Sips ... (+11)
  • Guy Sips
  • Jacob Mekhael
  • Kristof Samoy
  • Lynn Hautekeete
  • Michiel Declercq
  • Sharad Kumar S.P
  • Thibault Leneeuw
  • Thomas Couvreur
  • Thomas Vranken
  • Wim Hoste
  • Wim Lewi

US Tariffs Navigating the impact on Benelux equities

Trumps reciprocal tariffs caused a massive blow to equity markets, following a pressured period of escalating trade wars. Retaliatory measures can further heavily damage market confidence, as seen Friday when China announced their 34% tarrif of US goods. International trade policies have never moved this erratic and untransparant, with uncertainty and volatility being the baseline for now. In this report we highlight the key stocks in our coverage relevant to this discussion.

Jacob Mekhael
  • Jacob Mekhael

MaaT Pharma Positive DSMB safety analysis for MaaT033 phase 2 in allo-...

MaaT announced the positive outcome of a key DSMB safety interim analysis for the phase 2b trial (PHOEBUS), which compares the efficacy and safety of MaaT033 (microbiome therapy, oral capsule) to placebo in patients undergoing an allogeneic hematopoietic stem cell transplantation (allo-HSCT). We are encouraged by the DSMB outcome, particularly in the context that allo-HSCT is a high risk patient population, and see this as supportive of MaaT033´s good safety profile. We note that MaaT033 is next...

ING Helpdesk
  • ING Helpdesk

Benelux Morning Notes

Ackermans & van Haaren: Nextensa acquiring the “Proximus Towers” landmark project. Avantium: Called to account. Proximus: Finalizes sale of its old HQ to Nextensa and the development of its new one. UCB: No tariffs on pharmaceutical products, at least for now

 PRESS RELEASE

Autolus Therapeutics to Participate in the 24th Annual Needham Virtual...

Autolus Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference LONDON, April 02, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the Company will participate in the 24th Annual Needham Virtual Healthcare Conference. Autolus Chief Executive Officer Dr. Christian Itin will present in a Fireside Chat on Wednesday, April 9, 2025 at 9:30am EDT / 14:30pm BST. A webcast of the fireside chat will ...

Guy Sips ... (+7)
  • Guy Sips
  • Jacob Mekhael
  • Lynn Hautekeete
  • Michiel Declercq
  • Sharad Kumar S.P
  • Thomas Couvreur
  • Wim Hoste

Morning Notes : ACKB BB, AGFB BB, COLR BB, IBAB BB, IVA FP, ONTEX BB, ...

: ACKB BB, AGFB BB, COLR BB, IBAB BB, IVA FP, ONTEX BB, WHATS BB, SHUR BB, EKOP BB, ARG FP

Jacob Mekhael
  • Jacob Mekhael

Inventiva FIRST LOOK: Completes NATiV3 enrolment, topline results pinn...

Inventiva announced the completion of patient enrolment in its phase 3 (NATiV3) trial of lanifibranor (pan-PPAR agonist) in MASH. This is a key milestone, particularly in the context of the difficulties associated with MASH trial recruitment. As a result, the timeline for the topline readout is now pinned to 2H26 taking into account the 72 weeks treatment period. Subject to the second tranche of ~€ 116m from the financing announced in October 2024, which is expected to be triggered in 2Q25, Inve...

 PRESS RELEASE

Inventiva announces completion of enrollment in the Phase 3 NATiV3 cli...

Inventiva announces completion of enrollment in the Phase 3 NATiV3 clinical trial of lanifibranor in patients with MASH and advanced fibrosis Target enrollment exceeded with 1009 patients randomized in the main cohort and 410 patients in the exploratory cohort Topline results from NATiV3 projected in the second half of 2026 and, if positive, expected to be the basis for submission for regulatory approval Daix (France), New York City (New York, United States), April 1, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical compan...

 PRESS RELEASE

Inventiva annonce la fin du recrutement de l’étude clinique de Phase 3...

Inventiva annonce la fin du recrutement de l’étude clinique de Phase 3 NATiV3 évaluant lanifibranor chez les patients atteints de MASH et de fibrose avancée Objectifs de recrutement dépassés avec 1.009 patients randomisés dans la cohorte principale et 411 dans la cohorte exploratoirePrincipaux résultats de NATiV3 attendus au deuxième semestre 2026 et, si positifs, ils supporteront les demandes règlementaires d’autorisation de mise sur le marché    Daix (France), New York City (New York, États-Unis), le 1 avril 2025 - Inventiva (Euronext Paris et Nasdaq : IVA) (« Inventiva » ou la « Sociét...

 PRESS RELEASE

Autolus Therapeutics to Host R&D Investor Event on Wednesday, April 23...

Autolus Therapeutics to Host R&D Investor Event on Wednesday, April 23, 2025 LONDON, April 01, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announced that the Company will host an R&D investor event on Wednesday, April 23, 2025 at 8:30am EDT / 13:30pm BST. Autolus will present an update on clinical pipeline programs, including plans to expand the obe-cel opportunity. The Company expects to report initial data in six patients from...

Jacob Mekhael
  • Jacob Mekhael

MaaT Pharma To present preclinical data on MaaT034 at AACR

MaaT will present new non-clinical data on MaaT034 (donor independent microbiome therapy) at the American Association for Cancer Research (AACR) conference, taking place on 25-30 April. The results demonstrate MaaT034's potential as a combination therapy to improve responses to checkpoint inhibitors in solid tumours. Being co-cultured means MaaT034 is donor-independent, which offers the scale required for the larger solid tumour market. Initial data from the phase 2 placebo-controlled trial of l...

Guy Sips ... (+4)
  • Guy Sips
  • Jacob Mekhael
  • Thomas Vranken
  • Wim Hoste
Thomas Vranken
  • Thomas Vranken

Onward Medical 2024 was a transformational year, 2025 to scale commerc...

Onward reported its FY24 business update, which underlined a lot of progress yet no major new surprises, and it reaffirms its outlook of main catalysts. Mgmt. confirmed demand is strong, but no commercial outlook was given yet. We look forward to an FDA label expansion for home use in 2025, while we also expect the pivotal Empower BP trial in blood pressure control to kick off. FY24 topline (€ 1.7m) and net result (€ -35.7m) came in line with our expectations, and with a € 60m cash position we b...

 PRESS RELEASE

ONWARD Medical Reports Full Year 2024 Financial and Operating Results ...

ONWARD Medical Reports Full Year 2024 Financial and Operating Results and Shares 2025 Year-to-Date Highlights Received FDA authorization and recorded first commercial sales of ARC-EX System Secured strategic investment from Ottobock and extended cash runway for two years Gained exclusive rights to premier brain-computer interface technology EINDHOVEN, The Netherlands, April 01, 2025 (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 ...

 PRESS RELEASE

ONWARD Medical publie ses résultats financiers et opérationnels pour l...

ONWARD Medical publie ses résultats financiers et opérationnels pour l’exercice 2024 et partage ses faits marquants du début de l’année 2025 Obtention de l’autorisation de la FDA et premières ventes commerciales du système ARC-EX Investissement stratégique d’Ottobock et extension de la visibilité financière sur deux ans Obtention de droits exclusifs sur une technologie de pointe d’interface cerveau-machine EINDHOVEN, Pays-Bas, 01 avr. 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext : ONWD), société de technologie médicale développant des thérapies innovantes po...

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