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Biotech Stocks Facing FDA Decision In June 2021

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BridgeBio Pharma
BridgeBio Pharma

BridgeBio Pharma Inc.’s (BBIO) New Drug Application for Infigratinib for the treatment of cholangiocarcinoma is under priority review by the FDA – with a decision expected by June 1, 2021.

Infigratinib is proposed for the treatment of cholangiocarcinoma (CCA), or bile duct cancer, as a second-line or later therapy in patients with advanced and/or metastatic CCA with FGFR2 fusions or translocations.

Cholangiocarcinoma is a rare form of cancer that forms in bile ducts and fibroblast growth factor receptor 2 (FGFR2) fusions have been found in the tumors of approximately 9 to 14 percent of patients with cholangiocarcinoma.

Infigratinib is being reviewed under the Real-Time Oncology Review (RTOR) pilot program. The RTOR enables the FDA to review a large portion of the data before the company submits the NDA/BLA.

Incyte’s (INCY) Pemazyre, which was greenlighted by the FDA last April, is the first and only FDA-approved targeted drug advanced or metastatic cholangiocarcinoma.

Chemotherapy drugs like Gemzar, Cisplatin, 5-FU, Eloxatin and Xeloda are also used to treat cholangiocarcinoma.

The global cholangiocarcinoma market is estimated to be $185.4 million in 2021 and is expected to grow at a CAGR of 12.8% during 2021-2028, according to a report by Coherent Market Insights.

BBIO closed Friday’s (May 21, 2021) trading at $57.90, up 1.19%.