Report
Onward Medical FIRST LOOK: Regulatory submission ARC-EX
Onward announced that it has filed a De Novo application with the FDA for ARCEX to restore upper extremity function. The filing is supported by data from the pivotal Up-LIFT trial, which demonstrated a 72% response rate in 65 patients. With an expected review time of 5-9 months (KBCSe), we deem an approval by YE24 to be well feasible, in line with company guidance. As such, we maintain our € 9.3 TP and Buy rating.
Underlying
ONWARD MEDICAL NV
Provider
KBC Securities
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Thomas Vranken
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