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Gilead-Galapagos Report Efficacy & Safety Results on RA Drug

Zacks Equity Research

Gilead Sciences, Inc. GILD and partner Galapagos NV GLPG announced 52-week efficacy and safety results of an investigational, oral, selective JAK1 inhibitor, filgotinib, from FINCH 1 and FINCH 3 studies.

The candidate is being evaluated for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

The FINCH phase III program evaluated the efficacy and safety of 100 mg and 200 mg filgotinib once daily in early-stage to biologic-experienced RA patients. FINCH 1 was a 52 week, randomized, placebo- and Humira-controlled study on filgotinib in combination with methotrexate (MTX) in 1,759 adult patients with moderately-to-severely active RA, who had an inadequate response to only MTX. The trial included a radiographic assessment at weeks 24 and 52. FINCH 3 was a 52 week, randomized study in 1,252 MTX-naïve patients evaluating filgotinib 200 mg alone and filgotinib 100 mg or 200 mg combined with MTX versus MTX alone.

The 52-week data on filgotinib exhibited the same favorable safety profile seen in the first 24 weeks, including similar rates of thrombotic events as previously observed, and persistent efficacy.

We note that a Marketing Authorization Application (MAA) for filgotinib for the treatment of adults with RA is currently under review with the European Medicines Agency (EMA) and a New Drug Application (NDA) for the same has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW). Gilead plans to file an NDA for filgotinib for the treatment of RA in the United States later in the year.

A potential approval of the candidate will broaden Gilead’s portfolio. Notably, Eli Lilly’s LLY Olumiant is also approved for RA.

Gilead’s stock has gained 1.1% so far this year against the industry’s decline of 7.8%.

The company is also looking to diversify its portfolio and focus on therapeutic areas other than HCV. While the HIV portfolio maintains momentum, the company intends to develop drugs for inflammation diseases as well. Meanwhile, Gilead has also collaborated with Novo Nordisk NVO for NASH treatments.

Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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