Gilead Sciences, Inc. (GILD - Free Report) announced that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use ("CHMP") has issued a positive opinion on the company’s Marketing Authorization Application ("MAA") for CAR T therapy, axicabtagene ciloleucel, as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma ("DLBCL") and primary mediastinal large B-cell lymphoma ("PMBCL"), after two or more lines of systemic therapy.
Axicabtagene ciloleucel, a chimeric antigen receptor T cell (CAR T) therapy, modifies a patient’s own T cells to recognize and attack cancer cells.
The agency had earlier granted PRIME status to axicabtagene ciloleucel in May 2016.
A tentative approval is on the cards as the EMA generally takes the CHMP recommendation into account while reviewing any MAA.
We note that axicabtagene ciloleucel was approved by the FDA in October 2017 as Yescarta.
An approval in Europe will boost the growth prospects of the therapy, given the market potential. Per the information provided by the company, there are an estimated 7,700 patients with DLBCL, who are refractory to or have relapsed after two or more lines of the therapy, and may be eligible for CAR T therapy in Europe.
Concurrently, Novartis (NVS - Free Report) also obtained positive opinion from the CHMP for its CAR-T therapy, Kymriah, for two B-cell malignancies — B-cell acute lymphoblastic leukemia (ALL) and DLBCL.
Gilead’s stock has gained 0.4% in the year so far as against the industry's decline of 6.9%.
We note that Gilead is looking to newer avenues to help its top line by solidifying its presence in the gene therapy space. The initial uptake of Yescarta in the United States is also encouraging. Gilead is also intending to foray into the NASH market.
Gilead’s HCV franchise is experiencing slowdown across key markets, including the United States and Europe, reflecting lower sales of Harvoni and Sovaldi as a result of competitive and pricing pressure. The franchise saw a significant plunge in sales, due to new competition and fewer patient starts. We note that Harvoni, Sovaldi and Epclusa face competition from AbbVie’s (ABBV - Free Report) Viekira Pak and Mayret, and Merck’s (MRK - Free Report) Zepatier, among others. Nevertheless, the HIV franchise continues to maintain momentum.
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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