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Delphine Brault ... (+2)
  • Delphine Brault
  • Steven Boumans
Delphine Brault ... (+2)
  • Delphine Brault
  • Steven Boumans
Jacob Mekhael ... (+6)
  • Jacob Mekhael
  • Livio Luyten
  • Michiel Declercq
  • Thomas Couvreur
  • Thomas Vranken
  • Wim Hoste

Morning Notes : ARGX BB, BFIT NA, PNL NA, QFG BB, UMI BB, BTLS BB, ONW...

: ARGX BB, BFIT NA, PNL NA, QFG BB, UMI BB, BTLS BB, ONWD BB, JDEP NA

Thomas Vranken
  • Thomas Vranken

Onward Medical FIRST LOOK: ARC-EX filed for home use in US and CE mark...

Onward has submitted two key regulatory applications for its ARC-EX system, a non-invasive neurostimulation device designed to improve hand function after spinal cord injury. Following its US clinic-use approval in December 2024 and initial sales of ten units in Q1 2025, the company has now filed a 510(k) with the FDA to enable home use in the US and a CE mark application under MDR for commercialization in the EU. Onward expects both approvals by YE25. The company remains confident in meeting it...

Thomas Vranken
  • Thomas Vranken

Biotalys The planned Evoca-tion of a first US approval

Biotalys is a Belgian AgTech company developing protein-based biocontrols through its proprietary Agrobody Foundry platform. The company aims to replace traditional chemical pesticides with safer, sustainable alternatives. The company recently guided for market approval in the US for its lead product Evoca by the end of September 2025, which would reflect an important value inflection point for the company. We have updated our model, and taking into account the expected near-term trigger, raise ...

 PRESS RELEASE

ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and...

ONWARD Medical Files 510(k) with US FDA for ARC-EX System Home Use and Submits CE Mark Application FDA 510(k) application submitted to allow marketing of the ARC-EX® System for home use in the United StatesCE Mark application filed with notified body to enable commercialization of the ARC-EX System in the European Union and other countries EINDHOVEN, the Netherlands, July 01, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord ...

Olfa Taamallah ... (+3)
  • Olfa Taamallah
  • Roy Külter
  • Yan Derocles
VIE VEOLIA ENVIRONNEMENT SA
EDEN EDENRED SA
TKA THYSSENKRUPP AG
RR. ROLLS-ROYCE HOLDINGS PLC
MT ARCELORMITTAL SA
CA CARREFOUR SA
BEKB BEKAERT SA
SOP SOPRA STERIA GROUP SA
APAML APERAM SA
OUT1V OUTOKUMPU OYJ
MTX MTU AERO ENGINES AG
ACN ACCENTURE PLC CLASS A
HO THALES SA
SSAB A SSAB AB CLASS A
RXL REXEL SA
INF INFOTEL SA
FGA FIGEAC AERO SA
RHM RHEINMETALL AG
SZG SALZGITTER AG
WHA WERELDHAVE N.V.
SWP SWORD GROUP SE
AUB AUBAY SA
FII LISI SA
GOE GROUPE GORGE SA
ATE ALTEN SA
VOE VOESTALPINE AG
ACX ACERINOX SA
XIOR XIOR STUDENT HOUSING N.V.
SAF SAFRAN S.A.
HEI HEIDELBERGCEMENT AG
AIR AIRBUS SE
ERA ERAMET SA
CAP CAPGEMINI SE
BA. BAE SYSTEMS PLC
COFB COFINIMMO SA
VRNL VERNEUIL PARTICIPATIONS
CTAC CTAC N.V.
TIETO TIETOEVRY OYJ
NDA AURUBIS AG
ANA ACCIONA SA
HM B H&M HENNES & MAURITZ AB CLASS B
COK CANCOM SE
VASTB VASTNED RETAIL BELGIUM NV
BC8 BECHTLE AG
ADN1 ADESSO AG
MONT MONTEA SCA
AED AEDIFICA SA
AMG AMG ADVANCED METALLURGICAL GROUP N.V.
CPINV CARE PROPERTY INVEST SA
VGP VGP NV
BC BRUNELLO CUCINELLI S.P.A.
FACC FACC AG
IDR INDRA SISTEMAS S.A. CLASS A
RIO RIO TINTO PLC
LDO LEONARDO SPA
ECONT ECONOCOM GROUP SE CLASS D
BHP BHP GROUP LTD
REY REPLY S.P.A.
AMAG AMAG AUSTRIA METALL AG
NSI NSI N.V.
AEIN ALLGEIER HOLDING AG
WAVE WAVESTONE SA
PRX PROSUS N.V. CLASS N
HAG HENSOLDT AG
WDP WAREHOUSES DE PAUW SCA
NA9 NAGARRO
AERO MONTANA AEROSPACE AG
ANE CORPORACION ACCIONA ENERGIAS RENOVABLES SA
ECMPA EUROCOMMERCIAL PROPERTIES NV
AM DASSAULT AVIATION
CTPNV CTP NV
SHEL SHELL PLC
IOS IONOS GROUP SE
LAT LATECOERE
R3NK RENK GROUP AG
EXENS EXOSENS
ATO ATOS SE
AAL ANGLO AMERICAN PLC
Olfa Taamallah ... (+3)
  • Olfa Taamallah
  • Roy Külter
  • Yan Derocles
Olfa Taamallah ... (+3)
  • Olfa Taamallah
  • Roy Külter
  • Yan Derocles
VIE VEOLIA ENVIRONNEMENT SA
EDEN EDENRED SA
TKA THYSSENKRUPP AG
RR. ROLLS-ROYCE HOLDINGS PLC
MT ARCELORMITTAL SA
CA CARREFOUR SA
BEKB BEKAERT SA
SOP SOPRA STERIA GROUP SA
APAML APERAM SA
OUT1V OUTOKUMPU OYJ
MTX MTU AERO ENGINES AG
ACN ACCENTURE PLC CLASS A
HO THALES SA
SSAB A SSAB AB CLASS A
RXL REXEL SA
INF INFOTEL SA
FGA FIGEAC AERO SA
RHM RHEINMETALL AG
SZG SALZGITTER AG
WHA WERELDHAVE N.V.
SWP SWORD GROUP SE
AUB AUBAY SA
FII LISI SA
GOE GROUPE GORGE SA
ATE ALTEN SA
VOE VOESTALPINE AG
ACX ACERINOX SA
XIOR XIOR STUDENT HOUSING N.V.
SAF SAFRAN S.A.
HEI HEIDELBERGCEMENT AG
AIR AIRBUS SE
ERA ERAMET SA
CAP CAPGEMINI SE
BA. BAE SYSTEMS PLC
COFB COFINIMMO SA
VRNL VERNEUIL PARTICIPATIONS
CTAC CTAC N.V.
TIETO TIETOEVRY OYJ
NDA AURUBIS AG
ANA ACCIONA SA
HM B H&M HENNES & MAURITZ AB CLASS B
COK CANCOM SE
VASTB VASTNED RETAIL BELGIUM NV
BC8 BECHTLE AG
ADN1 ADESSO AG
MONT MONTEA SCA
AED AEDIFICA SA
AMG AMG ADVANCED METALLURGICAL GROUP N.V.
CPINV CARE PROPERTY INVEST SA
VGP VGP NV
BC BRUNELLO CUCINELLI S.P.A.
FACC FACC AG
IDR INDRA SISTEMAS S.A. CLASS A
RIO RIO TINTO PLC
LDO LEONARDO SPA
ECONT ECONOCOM GROUP SE CLASS D
BHP BHP GROUP LTD
REY REPLY S.P.A.
AMAG AMAG AUSTRIA METALL AG
NSI NSI N.V.
AEIN ALLGEIER HOLDING AG
WAVE WAVESTONE SA
PRX PROSUS N.V. CLASS N
HAG HENSOLDT AG
WDP WAREHOUSES DE PAUW SCA
NA9 NAGARRO
AERO MONTANA AEROSPACE AG
ANE CORPORACION ACCIONA ENERGIAS RENOVABLES SA
ECMPA EUROCOMMERCIAL PROPERTIES NV
AM DASSAULT AVIATION
CTPNV CTP NV
SHEL SHELL PLC
IOS IONOS GROUP SE
LAT LATECOERE
R3NK RENK GROUP AG
EXENS EXOSENS
ATO ATOS SE
AAL ANGLO AMERICAN PLC
Olfa Taamallah ... (+3)
  • Olfa Taamallah
  • Roy Külter
  • Yan Derocles
Guy Sips ... (+5)
  • Guy Sips
  • Kristof Samoy
  • Livio Luyten
  • Thomas Vranken
  • Wim Hoste
Thomas Vranken
  • Thomas Vranken

Onward Medical FIRST LOOK: 1Q25 confirms ARC-EX' initial sales tractio...

Onward's 1Q25 update highlights steady progress across commercial and clinical fronts. The company sold ten ARC-EX systems in its limited US launch, with positive feedback and a target of 30 units for 1H25. It reported € 0.4m revenue and held € 50.5m net cash at the end of the quarter, in line with our expectations. Upcoming regulatory milestones continue to be the anticipated FDA home use label expansion and CE mark approval, as well as IDE approval for the pivotal Empower BP study. €10.4 TP/Bu...

 PRESS RELEASE

ONWARD Medical Builds Commercial Momentum for the ARC-EX System and Re...

ONWARD Medical Builds Commercial Momentum for the ARC-EX System and Reinforces its Brain-Computer Interface Leadership in Q1 2025 EINDHOVEN, the Netherlands, June 17, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and other movement disabilities, today announces its Q1 2025 business update and year-to-date highlights: Commercial traction: Following FDA market authorization, the Company met its Q1 objective for...

 PRESS RELEASE

ONWARD Medical Announces Results of its Annual General Meeting of Shar...

ONWARD Medical Announces Results of its Annual General Meeting of Shareholders THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) Shareholders approve all proposed resolutions EINDHOVEN, The Netherlands, June 11, 2025 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD and US OTCQX: ONWRY), the leading neurotechnology company pioneering therapies to restore movement, function and independence in people with spinal cord injury and other movement disabilities, today announces that that all proposed resol...

Thomas Vranken
  • Thomas Vranken

Biotalys Regulatory update points to end of 3Q25 for Evoca's US approv...

Biotalys announced regulatory progress for its lead biofungicide candidate, Evoca, in both the US and Europe. In the US, the EPA confirmed that Biotalys has met its data requirements and expects to complete its review by September 30, 2025. In Europe, Dutch authorities have positively evaluated Evoca's active ingredient as low risk, paving the way for EU-level peer review with Biotalys expecting a potential decision in 2H26. The update provides greater clarity on regulatory timelines, supporting...

Jacob Mekhael ... (+3)
  • Jacob Mekhael
  • Lynn Hautekeete
  • Thomas Vranken
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