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Biotech Stocks Facing FDA Decision In September 2021

BeiGene Ltd
BeiGene Ltd

BeiGene Ltd.’s (BGNE) supplemental new drug application for Brukinsa is under priority review by the FDA, with a decision expected on September 19.

The company is seeking approval of Brukinsa for additional use in the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy.

Marginal zone lymphoma refers to a group of slow-growing, non-Hodgkin's B-cell lymphomas, arising from B-lymphocytes in the marginal zone of lymphoid tissue.

AbbVie and Johnson & Johnson's Imbruvica is the first drug to have been approved for marginal zone lymphoma and that was in the year 2017. TG Therapeutics’ Ukoniq, approved in Feb.2021, and Bristol Myers Squibb’s Revlimid, approved in 2019, are some of the other drugs for the treatment of marginal zone lymphoma.

Brukinsa was granted accelerated approval by the FDA for the treatment of mantle cell lymphoma in adult patients who have received at least one prior therapy in November 2019.

In its first full year on the market, i.e., 2020, the drug brought home sales of $41.7 million for the company.

BGNE closed Friday’s trading at $281.98, down 0.30%.