Gilead (GILD) Files NDA With FDA For RA Candidate Filgotinib

Gilead Sciences, Inc. (NASDAQ:GILD) announced that it has submitted a new drug application (NDA) to the FDA for JAK inhibitor candidate, filgotinib, for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA which should shorten the anticipated time for review. .

Shares of Gilead have gained 4.4% so far this year compared with the industry’s growth of 7.8%.

The NDA includes data from the phase III clinical program, FINCH, which comprises three studies. The data from the FINCH studies showed that filgotinib met its primary endpoints and demonstrated durable efficacy and safety results across multiple RA patient populations, including people with prior inadequate response to methotrexate treatment (MTX), those who were intolerant to one or more biologic treatments and those who were MTX treatment-naive. The safety results were consistent across the studies. These studies demonstrated an efficacy and tolerability profile of filgotinib that may offer meaningful improvements in RA treatment response for patients with this chronic disease.

In August, Gilead and partner Galapagos (NASDAQ:GLPG) announced that the European Medicines Agency (EMA) accepted their marketing authorization application (MAA) for filgotinib as a treatment for RA. The company has also filed a regulatory application in Japan for the same.

Notably, a potential approval of the candidate for RA and successful development in other inflammation indications are expected to favorably impact Gilead’s revenues, as the targeted indication has a significant market opportunity. However, filgotinib is likely to face competition from Eli Lilly’s (NYSE:LLY) Olumiant, which is already approved as a treatment for RA. Several other pharma companies are also developing drugs for inflammation indications, including RA.

Gilead Sciences, Inc. Price

Zacks Rank & A Stock to Consider

Gilead currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the biotech sector is Alkermes Plc. (NASDAQ:ALKS) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.

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