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    HYL   BE0974363955

HYLORIS PHARMACEUTICALS SA

(HYL)
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Real-time Euronext Bruxelles  -  05/17 07:42:06 am EDT
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Hyloris Announces Earlier than Expected PDUFA Date for Maxigesic? IV

11/15/2021 | 01:00am EDT

Hyloris Pharmaceuticals SA announces that the U.S. Food and Drug Administration (FDA) has set the Prescription Drug User Fee Act date (PDUFA) for the New Drug Application (NDA) for Maxigesic? IV on 30 June 2022. The PDUFA date is the date by which the FDA must respond to an NDA. Maxigesic IV is a novel, unique combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion, indicated for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics, where an intravenous route of administration is considered clinically necessary. Maxigesic IV has been developed under the collaboration agreement between Hyloris and AFT Pharmaceuticals and is currently licensed in over 100 countries across the globe, has been registered in 28 countries and is now launched in 5 countries. Maxigesic IV is protected by several granted patents and pending patent applications. The NDA for Maxigesic IV was based on positive data from two Phase 3 studies of Maxigesic IV: i) a randomised, double-blind, placebo-controlled efficacy trial in 276 patients following bunionectomy surgery; and ii) an open-label, multi-centre, single arm, multiple dose safety study in 232 patients undergoing general, orthopaedic, or plastic surgery. As previously reported, treatment with Maxigesic IV was well-tolerated, had a faster onset of action and offered higher pain relief compared to ibuprofen IV or paracetamol IV alone in the same doses. Moreover, the superior analgesic effect of Maxigesic IV was supported by a range of secondary endpoints, including reduced opioid usage rates compared to the paracetamol IV, ibuprofen IV, and placebo treatment groups (P


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Financials
Sales 2021 2,65 M 2,76 M 2,76 M
Net income 2021 -13,0 M -13,5 M -13,5 M
Net cash 2021 42,0 M 43,7 M 43,7 M
P/E ratio 2021 -29,8x
Yield 2021 -
Capitalization 423 M 441 M 441 M
EV / Sales 2021 144x
EV / Sales 2022 39,6x
Nbr of Employees 8
Free-Float 41,0%
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Number of Analysts 2
Last Close Price 15,80 €
Average target price 20,25 €
Spread / Average Target 28,2%
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Managers and Directors
Stijn van Rompay Chief Executive Officer & Executive Director
Jean-Luc Vandebroek Chief Financial Officer
Stefan Yee Chairman
Dietmar Aichhorn Chief Operating Officer
Marc Foidart Independent Director
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