AM-Pharma Increases Funding to €163m for Phase-III Trial of recAP in SA-AKI

€23m (US$25.5m) equity provided mainly by US-based Cowen Healthcare Investments €24m (US$26.5m) finance facility provided by the European Investment Bank (EIB) Increased funding allows for finalization of all Marketing Authorization Application preparation activities Utrecht, The Netherlands, 31 March 2020 – AM-Pharma B.V. (‘AM-Pharma, the Company’), a clinical stage biopharmaceutical company leading in the development of […]

AM-Pharma vergroot met extra €47 miljoen de financiering voor klinische fase III-registratiestudie met Nederlands kandidaatmedicijn tegen acuut nierfalen tot €163 miljoen

Tegen de aandoening bestaat mondiaal nog geen goedgekeurde therapie (700.000 overlijdens per jaar) €23 miljoen hoofdzakelijk afkomstig van het Amerikaanse Cowen Healthcare Investments €24 miljoen financieringsfaciliteit verstrekt door de Europese Investeringsbank (EIB) Beoogde klinische studie met 1.400 patiënten grootste ooit op zijn gebied (>100 ziekenhuizen, 12 landen) Financiering voldoende tot aan aanvraag van marktgoedkeuring voor […]

AM-Pharma Expands its Senior Team in Preparation for a Pivotal Phase III Trial of recAP in Acute Kidney Injury

Juliane Bernholz has joined as Chief Operating Officer Kristie Bass has joined as VP Clinical Operations Bunnik, The Netherlands, 1 October 2019 – AM-Pharma B.V. (‘AM-Pharma, the Company’), a clinical stage biopharmaceutical company, leading in the development of a treatment for acute kidney injury (AKI) with its innovative recombinant human Alkaline Phosphatase therapeutic (recAP) today […]

AM-Pharma Raises €116m [$133m] to Conduct Pivotal Phase III Trial of recAP in Acute Kidney Injury

Financing co-led by new investors LSP and Andera Partners, with participation of existing investors Forbion, Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures and Gilde Healthcare Proceeds to be used for the 1,400-patient international pivotal Phase III trial of recombinant human Alkaline Phosphatase (recAP) in patients with sepsis-associated acute kidney injury (SA-AKI) AKI […]

AM-Pharma haalt €116 miljoen ($133 miljoen) financiering op voor fase III registratie-studie met kandidaat-medicijn tegen acuut nierfalen (AKI)

Grootste biotech VC financieringsronde ooit in Nederland, geleid door nieuwe investeerders LSP en Andera Partners met deelname van bestaande investeerders Forbion, Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures en Gilde Healthcare Opbrengst bestemd voor internationale Fase III-registratie-studie met ‘recombinant humaan Alkalische Fosfatase’ (recAP) bij 1.400 patiënten met sepsis (bloedvergiftiging) -geassocieerd acuut nierfalen […]

JAMA publishes Phase II recAP data for sepsis-associated Acute Kidney Injury

JAMA paper to be presented at ESICM conference in Paris New data on mode of action to be presented at ASN conference in San Diego Bunnik, The Netherlands, 24th October 2018. AM‐Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, today publishes data in the prestigious Journal of the […]

AM-Pharma announces Phase II study results of recAP in sepsis-associated Acute Kidney Injury

Study shows use of recAP results in greater than 40% relative reduction in mortality Bunnik, The Netherlands, 9th March 2018. AM‐Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, today announced positive results from its adaptive Phase II study in 301 sepsis patients with Acute Kidney Injury […]

AM-Pharma completes patient recruitment of recombinant human Alkaline Phosphatase

AM-Pharma completes patient recruitment of recombinant human Alkaline Phosphatase (recAP) Phase II trial in Acute Kidney Injury Recruitment of 301 patients in STOP-AKI adaptive Phase II trial marks largest ever therapeutic study in AKI Bunnik, The Netherlands, 22 May 2017. AM‐Pharma B.V., a biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase (reCAP) […]

AM-Pharma publishes safety and pharmacokinetic data from Phase I recAP trial

Pharmacokinetic model determines optimal dose regimen for current Phase IIb recAP dose finding clinical study treating sepsis-associated acute kidney injury Bunnik, The Netherlands, 10 May 2016. AM‐Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant human Alkaline Phosphatase), has published data from its Phase I trial of recAP, for the potential treatment […]

AM-Pharma receives FDA fast track designation for recAP in Acute Kidney Injury

AM-Pharma receives FDA fast track designation for recAP in Acute Kidney Injury, and reports completion of first stage in Phase II trial Trial on track and FDA regulatory status may allow accelerated patient access to new drug Bunnik, The Netherlands, 26 April 2016. AM‐Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant […]