Hyloris FIRST LOOK: Maxigesic IV gains FDA approval

Hyloris announced that Maxigesic IV (1000mg paracetamol with 300mg ibuprofen) has been approved by the FDA for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults. This comes as a positive step forward for Hyloris providing validation for the company's business model of bringing products to market in less than 7 years. We note that the US market is key for the commercial success of Maxigesic IV and look forward to the commercial rollout, which is expected in early 2024. With the FDA decision being on investors' radar as an important trigger for the stock, we expect a positive share price reaction today. We reiterate our BUY rating and € 19.5 TP.