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Gilead (GILD) & Galapagos Discontinue Development of IPF Drug

Zacks Equity Research
·3-min read

Gilead Sciences, Inc. GILD and partner Galapagos NV GLPG announced that they will discontinue phase III program, ISABELA, on investigational candidate, ziritaxestat, in patients with idiopathic pulmonary fibrosis (IPF).

We note that ziritaxestat (GLPG1690) is an investigational autotaxin inhibitor discovered by Galapagos. Gilead in-licensed ex-European rights to ziritaxestat in July 2019 and started sharing the phase III development costs.

The decision to discontinue the above-mentioned studies was based on the recommendations of the Independent Data Monitoring Committee (IDMC). Following a regular review of unblinded data, the IDMC concluded that ziritaxestat’s benefit-risk profile no longer supported continuing these studies.

All clinical trials with ziritaxestat, including the long-term extension of the phase IIa NOVESA trial in systemic sclerosis, will be discontinued.

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Earlier, in December 2020, Gilead announced its decision to not seek approval of filgotinib for the treatment of rheumatoid arthritis (RA) in the United States, as it does not see a viable path for the drug for the same indication.

Consequently, Gilead and Galapagos decided to amend their existing arrangement for the commercialization and development of filgotinib.

Separately, Gilead’s company, Kite, announced findings from a new analysis of the ZUMA-1 trial of CAR T cell therapy, Yescarta (axicabtagene ciloleucel), in adult patients with relapsed or refractory large B-cell lymphoma (LBCL) in an oral session at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).

Data showed that the use of corticosteroids prior to Yescarta infusion has the potential to impact the benefit/risk profile based on data from a cohort of ZUMA-1 patients and the use of prophylactic steroids may play a significant role in reducing the severe side effects of CAR T.

The massive decline in sales of Gilead’s HCV franchise has prompted it to focus on the HIV franchise, Yescarta and other newer avenues.

The company recently reported better-than-expected results for the fourth quarter of 2020 on increased demand for Veklury for the treatment of COVID-19 patients. The strong performance of Biktarvy amid stiff competition from the likes of GlaxoSmithKline GSK was impressive too

However, the core virology business continues to decline due to the coronavirus pandemic.

Gilead’s stock has gained 13.7% in the year so far compared with the industry's growth of 11.9%.

The company expects a gradual recovery in underlying market dynamics starting second-quarter 2021. While Truvada and Atripla sales are expected to continue to decline in first-quarter 2021 and beyond as multiple generics are expected to enter the market starting the second quarter, Biktarvy, Trodelvy, Vemlidy and cell therapy are expected to be key growth drivers in 2021.

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Alexion Pharmaceuticals, Inc. ALXN, which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Earnings estimates for Alexion for 2021 are up by 4 cents in the last thirty days.

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