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Biotech Stocks Facing FDA Decision In September

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The month of August witnessed the FDA approving the first cell-based gene therapy to treat adult and pediatric patients with beta-thalassemia who require regular blood transfusions on Aug.17. This one-time gene therapy by the name Zynteglo, developed by bluebird bio Inc. (BLUE), reportedly carries a price tag of $2.8 million.

Another notable "first" that merits mention is the FDA approval of Daiichi Sankyo's Enhertu on Aug.5. It is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.

Now, the latest on COVID-19 and monkey pox.

The cases of coronavirus as well as hospitalizations have decreased consistently in August. The average number of cases per day in August has fallen to just above 90,000, compared to more than 130,000 average daily cases in mid-July, according to the New York Times. As per the latest data, 1,043,783 people have died in the U.S. due to COVID-19. (Johns Hopkins).

As for the monkeypox, the number of new cases is said to be on the decline in several major U.S. cities. A total of 17,432 monkeypox cases in the U.S. and 47,652 cases globally have been reported, according to latest data available.

Now, let's take a look at the biotech stocks facing FDA decision in September.

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