reports
- Guy Sips
- Jacob Mekhael
- Livio Luyten
- Lynn Hautekeete
- Thomas Vranken
- Wim Lewi
- Jacob Mekhael
Hyloris FDA approval for Tranexamic Acid Intravenous Premix RTU
Hyloris announced that its partner Avenacy received FDA approval for its ANDA (generic NDA) of Tranexamic Acid Intravenous Premix Ready-to-Use (RTU), with launch planned for 2H25. This product, approved through the generic ANDA pathway, is non-core for the company, as Hyloris' main focus is on the more valuable reformulation and repurposing 505(b)(2) pathway. Sales of intravenous tranexamic acid reached $ 29.1m in the 12 months up to March 2025, and we estimate Hyloris could receive approx. $ 2m...
- ING Helpdesk
Benelux Morning Notes
Aedifica and Cofinimmo: Agreement reached to create Europe's leading Healthcare REIT. bpost: CMD press release; #Reshape 2029. D'Ieteren: Belgian new car registrations down 11.7% in May, VW down 13.5% Fugro: Meeting with CEO & IR; 2Q25 also has its challenges. UCB: Peer Moonlake held takeover talks with US Merck, FT reports
- Jacob Mekhael
MaaT Pharma Completes EU regulatory submission for MaaT013 in aGvHD
MaaT announced the submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate MaaT013 (microbiome therapy, enema formulation) in aGvHD under the brand name Xervyteg. Potential approval could be granted in 2H26, and MaaT is actively exploring strategic partnerships to commercialise MaaT013 in Europe. We believe the solid phase 3 results and good uptake in the early access program will be supportive of MaaT013's commercial launch ...
- Guy Sips
- Jacob Mekhael
- Lynn Hautekeete
- Michiel Declercq
Autolus Therapeutics to Participate in Upcoming Investor Conferences
Autolus Therapeutics to Participate in Upcoming Investor Conferences LONDON, May 29, 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 upcoming investor conferences. William Blair 45th Annual Growth Stock ConferenceManagement to host investor meetingsDate: June 3, 2025Location: Chicago, IL Jefferies Global Healthcare ConferenceFireside Chat PresentationDate and time: June 5, 2025; 3:10pm E...
Galapagos NV: 1 director
A director at Galapagos NV bought 62,273 shares at 28.810USD and the significance rating of the trade was 100/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years clearly...
Galapagos Creates New Subscription Right Plan
Galapagos Creates New Subscription Right Plan Mechelen, Belgium; May 27, 2025, 22:30 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announced today that its Board of Directors created 925,000 subscription rights under a new subscription right plan. On May 27, 2025, the Board of Directors of Galapagos approved “Subscription Right Plan 2025 (A)”, intended for personnel of the Company, within the framework of the authorized capital. Under this subscription right plan, 925,000 subscription rights were created, subject to acceptance, for senior management compensation p...
Galapagos creëert nieuw inschrijvingsrechtenplan
Galapagos creëert nieuw inschrijvingsrechtenplan Mechelen, België; 27 mei 2025, 22:30 CET; gereglementeerde informatie – Galapagos NV (Euronext & NASDAQ: GLPG) kondigt vandaag aan dat haar Raad van Bestuur 925.000 inschrijvingsrechten heeft gecreëerd onder een nieuw inschrijvingsrechtenplan. De Raad van Bestuur van Galapagos heeft op 27 mei 2025 “Inschrijvingsrechtenplan 2025 (A)”, bestemd voor personeel van de Vennootschap, goedgekeurd binnen het kader van het toegestaan kapitaal. Onder dit inschrijvingsrechtenplan werden 925.000 inschrijvingsrechten gecreëerd in het kader voor beloningen...
Inventiva to Participate in the Upcoming Jefferies Global Healthcare C...
Inventiva to Participate in the Upcoming Jefferies Global Healthcare Conference and UBS Spring Biotech Conference Daix (France), New York City (New York, United States), May 27, 2025 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced that the Company’s Management will participate in two upcoming investor conferences in June 2025. Frédéric Cren, CEO and cofounder of Inventiva, will p...
Inventiva Participera à la « Jefferies Global Healthcare Conference » ...
Inventiva Participera à la « Jefferies Global Healthcare Conference » et à la « UBS Spring Biotech Conference » Daix (France), New York City (New York, Etats-Unis), le 27 mai 2025 – Inventiva (Euronext Paris et Nasdaq : IVA) (« Inventiva » ou la « Société »), société biopharmaceutique spécialisée dans le développement de thérapies orales pour le traitement de la stéatohépatite associée à un dysfonctionnement métabolique (« MASH »), annonce aujourd’hui que son équipe de direction participera à deux conférences investisseurs au cours du mois de juin 2025. Frédéric Cren, directeur général et c...
- Jacob Mekhael
Sequana Medical Extends runway into 1Q26 with additional € 6.3m conver...
Sequana announced that SFPIM and other existing shareholders have invested a further € 6.3m in the 2025 convertible loan announced on 18 March 2025. Sequana's cash runway has now been extended into 1Q26 (previously YE25), which will provide Sequana with more breathing room to demonstrate initial commercial traction during the soft launch phase of the alfapump's US commercialisation in 3Q25. This could trigger additional investor interest to fund the company into the broader launch, which is expe...
- Jacob Mekhael
- Thomas Couvreur
- Guy Sips
- Hilde Van Boxstael
- Jacob Mekhael
- Thomas Vranken
- Wim Hoste
- Wim Lewi
- Jacob Mekhael
Autolus Receives positive CHMP opinion for Aucatzyl in r/r adult ALL i...
Friday during trading hours, Autolus announced the EMA's CHMP issued a positive opinion for Aucatzyl (CD19 CAR-T) in r/r adult ALL. The European Commission is expected to make a decision on marketing approval in the EU within approx. 2 months, and usually follows the CHMP opinion. Commercial launch in Europe is expected to be on a country by country basis, and the company has previously indicated that the initial focus in Europe will be on Germany and the UK. With initial US sales showing solid ...
Autolus Therapeutics Announces Positive CHMP Opinion for Obecabtagene ...
Autolus Therapeutics Announces Positive CHMP Opinion for Obecabtagene Autoleucel for Adult Patients (age 26 and older) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) Positive CHMP opinion based on FELIX clinical trial of obecabtagene autoleucel (obe-cel) in adult patients with r/r B-ALL, demonstrating high and durable response rates and low toxicityOpinion follows FDA approval and MHRA conditional marketing authorisationEuropean Commission (EC) decision on conditional marketing authorization application (MAA) expected within approximately two months L...
- Jacob Mekhael
Inventiva Uneventful 1Q25 results, runway and pipeline timelines reite...
Inventiva reported uneventful 1Q25 results, and confirmed its cash runway guidance, which is until the end of 3Q26. Timeline for the topline readout from the ongoing phase 3 trial of lanifibranor in MASH was also reiterated, with results expected in 2H26. With the funding overhang lifted, a fully recruited phase 3 trial in MASH, as well as competitive phase 2 data, we continue to see Inventiva as significantly undervalued and reiterate our € 7 TP and Buy rating.
Inventiva reports 2025 First Quarter Financial Information¹
Inventiva reports 2025 First Quarter Financial Information¹ Cash and cash equivalents at €67.9 million Daix (France), New York City (New York, United States), May 23, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today reported financial information for the first quarter of 2025, including its cash, cash equivalents and revenues. Key Financial Results Cash, cash equivalents and deposits As of March 3...
Inventiva publie ses informations financières¹ du 1er trimestre 2025
Inventiva publie ses informations financières¹ du 1er trimestre 2025 Trésorerie et équivalents de trésorerie à 67,9 millions d’euros Daix (France), New York City (New York, Etats-Unis), le 23 mai 2025 – Inventiva (Euronext Paris et NASDAQ : IVA) (« Inventiva » ou la « Société »), société biopharmaceutique spécialisée dans le développement de thérapies orales pour le traitement de la stéatohépatite associée à un dysfonctionnement métabolique (« MASH »), publie aujourd’hui ses informations financières du 1er trimestre 2025 dont sa trésorerie, ses équivalents de trésorerie et son chiffre d’af...
Results of the Votes of the Combined Shareholders’ General Meeting of ...
Results of the Votes of the Combined Shareholders’ General Meeting of May 22, 2025 Daix (France), New York City (New York, United States), May 23, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting. The Combined Shareholders' Meeting was held on Thursday May 22, 2025, at 9 a.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 Paris (Fr...
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