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    GLPG   BE0003818359

GALAPAGOS NV

(GLPG)
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Galapagos Announces Positive CHMP Opinion for Jyseleca® for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

09/17/2021 | 07:15am EDT

Galapagos NV announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), a once-daily, oral, JAK1preferential inhibitor for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Following this positive opinion, a final decision from the European Commission is expected later this year. The CHMP positive opinion is based on data from the pivotal Phase 2b/3 SELECTION program, which evaluated filgotinib as an induction and maintenance therapy in adult patients with moderately to severely active UC who have failed conventional therapy or biologics. SELECTION comprised two placebo-controlled induction studies, one in biologic-naive patients and the other in biologic-experienced patients, followed by a 47-week maintenance study for those who responded to filgotinib after 10 weeks. Responders to placebo continued on blinded placebo during the maintenance phase. The trial was recently published in The Lancet.


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Analyst Recommendations on GALAPAGOS NV
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Financials
Sales 2021 520 M 605 M 605 M
Net income 2021 -220 M -256 M -256 M
Net cash 2021 4 040 M 4 701 M 4 701 M
P/E ratio 2021 -15,1x
Yield 2021 -
Capitalization 2 910 M 3 386 M 3 385 M
EV / Sales 2021 -2,18x
EV / Sales 2022 -1,53x
Nbr of Employees 1 397
Free-Float 74,5%
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Mean consensus HOLD
Number of Analysts 10
Last Close Price 44,40 €
Average target price 56,00 €
Spread / Average Target 26,1%
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Managers and Directors
Onno van de Stolpe Chief Executive Officer
Bart Filius President & Chief Operating Officer
Raj Bhikhu Parekh Chairman
Piet Wigerinck Chief Scientific Officer
Walid Abi-Saab Chief Medical Officer
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