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Galapagos (GLPG) Filgotinib In Phase III For Crohn's Disease

Published 11/22/2016, 08:24 PM
Updated 07/09/2023, 06:31 AM

Galapagos NV (NASDAQ:GLPG) announced that it has dosed the first patient in a phase III study – DIVERSITY – on filgotinib for the treatment of Crohn’s disease. This triggered a milestone payment worth $50 million from Gilead Sciences Inc. (NASDAQ:GILD) .

The study will evaluate the safety and efficacy of once-daily filgotinib (100 mg and 200 mg), compared to placebo, in patients with moderately-to-severely active Crohn’s disease, including those who failed previous biological therapy.

We remind investors that in Dec 2015, Galapagos signed a collaboration agreement with Gilead for the development and commercialization of filgotinib for inflammatory indications including rheumatoid arthritis (RA), Crohn’s disease and ulcerative colitis.

In Aug 2016, Gilead initiated a phase III program (FINCH) on filgotinib in RA. The FINCH program comprises three studies that will evaluate the safety and efficacy of once-daily filgotinib (100 mg and 200 mg) in patients from early stage to biologic-experienced.

Moreover, Gilead expects to start a phase II/III study for the treatment of ulcerative colitis later in the quarter.

Meanwhile, Galapagos continues to progress on its cystic fibrosis programs, with partner AbbVie Inc. (NYSE:ABBV) conducting several phase I and II studies.

Going forward, we expect investor focus to remain on further pipeline updates from the company.

Currently, Galapagos carries a Zacks Rank #3 (Hold).

Stock to Consider

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Vanda’s loss estimates narrowed from 68 cents per share to 56 cents for 2016 over the last 60 days, while its earnings estimates increased from 16 cents per share to 17 cents for 2017. The company posted a positive earnings surprise in three of the last four quarters with an average beat of 56.65%. Its share price has surged 80% year to date.

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