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Biotech Stocks Facing FDA Decision In October 2020

Spectrum Pharmaceuticals
Spectrum Pharmaceuticals

The FDA decision on Spectrum Pharmaceuticals Inc.’s (SPPI) Rolontis, proposed for the treatment of chemotherapy induced neutropenia, is expected on October 24, 2020.

Neutropenia is a common and potentially hazardous complication of chemotherapy characterized by an abnormally lower level of white blood cells known as neutrophils, which can expose the patient to serious bacterial infections. Amgen’s Neupogen and Neulasta are popular branded drugs to treat neutropenia, for which a couple of biosimilars have also been approved.

In clinical trials involving early-stage breast cancer patients undergoing chemotherapy, Rolontis, a long-acting granulocyte colony-stimulating factor (G-CSF), provided an absolute risk reduction of severe neutropenia of 6.5% compared to Amgen’s Neulasta in the first cycle of therapy.

The global neutropenia treatment market, valued at $12.6 billion in 2019, is expected to reach $19 billion by 2027, according to a report by ResearchAndMarkets.com.

SPPI closed Friday’s (Sep.25, 2020) trading at $4.30, up 1.77%.