reports
- Thomas Vranken
Fagron FIRST LOOK: Deep-dive into Fagron's warning letter
Following a conference call with management and a readthrough of the warning letter regarding Fagron's Wichita site, our assessment confirms that the issues highlighted in the letter refer mainly to observations that were already known to and being addressed by Fagron since last summer. While the language used by the FDA in the letter is strong, we interpret this in a broader context of the regulator raising the bar on quality standards in the pharmaceutical compounding industry. Three topics we...
- Jacob Mekhael
- Thomas Vranken
Sequana Medical FDA approval for alfapump
Sequana receives a nice Christmas present this year as it obtained PMA approval from the FDA for its alfapump system in the treatment of r/r ascites due to liver cirrhosis, ahead of the guided 1Q25 timeline. We see the approval as an important derisking event for the company, which will enable the company to address a market opportunity of $ >2bn (mgmt. estimates) in the US. The commercialisation intends to specifically target 90 liver transplant centres and is expected to launch in 2H25. We not...
- ING Helpdesk
- Hilde Van Boxstael
- Thomas Vranken
- Wim Lewi
Fagron updates on FDA communication regarding the June 2024 inspection...
Fagron updates on FDA communication regarding the June 2024 inspection at Wichita Regulated information – inside informationNazareth (Belgium)/Rotterdam (The Netherlands), 23 Dec 2024 – 7AM CET Fagron updates on FDA communication regarding the June 2024 inspection at Wichita Following the FDA’s routine inspection at Fagron’s Wichita facility conducted in June 2024, the Company received a warning letter from the FDA (Warning Letter) on December 19, 2024. The Warning Letter requires Fagron to enhance processes for investigating discrepancies, and validations of future manufacturing ca...
Fagron verschaft een update over de FDA-communicatie met betrekking to...
Fagron verschaft een update over de FDA-communicatie met betrekking tot de inspectie in Wichita in juni 2024 Gereglementeerde informatie – voorwetenschap Nazareth (België)/Rotterdam (Nederland), 23 december 2024 – 7:00 CET Fagron verschaft een update over de FDA-communicatie met betrekking tot de inspectie in Wichita in juni 2024 Na de routine-inspectie van de FDA van de vestiging in Wichita in juni 2024, ontving de Vennootschap op 19 december 2024 een waarschuwingsbrief van de FDA (Warning Letter). De waarschuwingsbrief verplicht Fagron om de processen voor het onderzoeken van afwi...
- Hilde Van Boxstael
- Jacob Mekhael
- Lynn Hautekeete
- Thomas Vranken
- Wim Hoste
- Wim Lewi
- Thomas Vranken
Onward Medical A long-awaited present underneath the Christmas tree
Right in line with its YE24 guidance, Onward has successfully obtained FDA approval for its non-invasive ARC-EX device. We see the approval as an important inflection point and expect a phased, relatively de-risked launch given the concentrated patient population and Onward's partnership with Lovell. Although home use is not yet included in the label, we believe this could be addressed in 2025 without additional clinical study requirements. We adjust our TP from € 8.7 to € 10.4 and reiterate a B...
ONWARD Medical Receives FDA De Novo Classification and US Market Autho...
ONWARD Medical Receives FDA De Novo Classification and US Market Authorization for World’s First Non-Invasive Spinal Cord Stimulation System for People with Chronic Spinal Cord Injury THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE (7)(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) ARC-EX System is the first and only FDA approved technology shown to improve hand strength and sensation after chronic spinal cord injury ARC-EX System is an FDA Breakthrough Device and 2024 TIME Magazine Best Invention EINDHOVEN, the Netherlands, Dec. 19, 2024 (GLOBE NEWS...
ONWARD® Medical reçoit la classification De Novo de la FDA et l'autori...
ONWARD® Medical reçoit la classification De Novo de la FDA et l'autorisation de mise sur le marché américain pour le premier système non invasif au monde de stimulation de la moelle épinière destiné aux personnes atteintes de lésion chronique de la moelle épinière CE COMMUNIQUÉ DE PRESSE CONTIENT DES INFORMATIONS PRIVÉES AU SENS DE L'ARTICLE (7)(1) DU RÈGLEMENT EUROPÉEN SUR LES ABUS DE MARCHÉ (596/2014) Le système ARC-EX® est la première et unique technologie approuvée par la FDA ayant démontré une amélioration de la force et de la sensation des mains après une lésion chronique de la moell...
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Sharad Kumar S.P
- Thibault Leneeuw
- Thomas Couvreur
- Thomas Vranken
- Wim Hoste
- Wim Lewi
Dynamic Top Pick List How to start 2025?
On this Friday the 13th we select for you 13 stocks to start 2025 with a bang : ABN Amro, Ackermans & van Haaren, Bekaert, D'Ieteren, EVS, Fagron, Fugro, Gimv, Melexis, Shurgard, Sofina, WDP and Xior However, we maintain a defensive stance in our Benelux selection at the start of 2025.. The long anticipated interest rate cuts by central banks are expected to continue their decline into 2025 (see graph above). However, the Trump election victory in the US hits European stocks even before he tak...
HEINEKEN announces proposed changes to its Supervisory Board
HEINEKEN announces proposed changes to its Supervisory Board Peter Wennink to succeed Jean-Marc Huët as Chair of the Supervisory BoardRetirement of Supervisory Board member Maarten DasAppointment of Supervisory Board member Alexander de CarvalhoReappointment of Supervisory Board member Nitin Paranjpe Amsterdam, 13 December 2024 – The Supervisory Board of Heineken N.V. (HEINEKEN) announces that Peter Wennink, the Vice-Chair of the Supervisory Board, will assume the role of Chair of the Supervisory Board as per the Annual General Meeting (AGM) in April 2025. Mr. Wennink joined the Supervis...
ONWARD Medical Ranks in Top 15 Percent Globally for Corporate Sustaina...
ONWARD Medical Ranks in Top 15 Percent Globally for Corporate Sustainability EcoVadis silver medal recognizes Company's environmental and social impact Demonstrates ongoing commitment to integrating sustainable business practices EINDHOVEN, the Netherlands, Dec. 12, 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 it has been awarded a silver medal by EcoVadis, the world’s largest p...
- Guy Sips
- Kristof Samoy
- Michiel Declercq
- Wim Hoste
Local Champions Midcap Conference Book 12.12.2024
This conference book is your guide to our annual Local Champions Mid Cap Conference set to take place on Thursday, 12 December 2024 at our historic building at Grand Place in Brussels. This event offers the possibility to have one-on-one meetings and/or attend small group sessions with the top management and/or IR of the following companies: BARCO | BEKAERT | DECEUNINCK | EKOPAK | EVS | GREENYARD | IBA | JENSEN | ONTEX | RECTICEL | VAN DE VELDE | WHAT'S COOKING? | XFAB
- ING Helpdesk
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Thomas Vranken
- Wim Lewi
- Hilde Van Boxstael
- Jacob Mekhael
- Kristof Samoy
- Lynn Hautekeete
- Michiel Declercq
- Sharad Kumar S.P
- Wim Lewi
- Jacob Mekhael
- Kristof Samoy
- Michiel Declercq
- Sharad Kumar S.P
- Wim Lewi
- Kristof Samoy
CMB.Tech MTO page turned, focus back on platform transformation
We resume coverage following the closure of the reopened MTO on November 21. Only 0.7% of outstanding shares were tendered into the bid bringing the free float to 7% (from 7.7%). When announcing the outcome of the tender, CMB.Tech once more reaffirmed its commitment to maintaining its listing. During the tender the stock nosedived well below its NAV while supply side dynamics in the crude tanker and dry bulk market remain largely supportive. The company has a sound financing plan for its ongoing...
Disclosure of notification received from FMR LLC
Disclosure of notification received from FMR LLC Regulated information Nazareth (Belgium)/Rotterdam (The Netherlands), 26 November 2024 – 6.45 PM CET Disclosure of notification received from FMR LLC Pursuant to the Belgian law of 2 May 2007 regarding the disclosure of major shareholdings in listed companies, Fagron received a notification from FMR LLC. Notification by FMR LLC On 21 November 2024, Fagron received a notification that the shareholding of Fidelity Management & Research Company LLC, a controlled undertaking of FMR LLC, crossed the disclosure threshold of 3% upwards on 18 Nov...
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