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Biotech Stocks Facing FDA Decision In April 2021

Mithra Pharmaceuticals
Mithra Pharmaceuticals

The FDA decision on Mithra Pharmaceuticals’ (MITPF.OB) oral contraceptive, Estelle, is expected to be announced in April.

Estelle is a Combined Oral Contraceptive (COC), composed of 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP). E4 is a naturally occurring estrogen that is produced by the human foetal liver during pregnancy.

If approved, Estelle would be the first contraceptive product containing E4 and the first new estrogen introduced in the US for contraceptive use in approximately 50 years.

The company has an agreement with Mayne Pharma Group Limited (MAYNF.OB) for the commercialization of Estelle in the United States.

Estelle was approved in Canada, under the trademark Nextstellis, as recently as Mar.8, 2021.

MITPF.OB closed Friday’s (Mar.26, 2021) trading at $23.90.