Biotech Stocks Facing FDA Decision In January 2022

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OPKO Health
OPKO Health

The FDA decision on Somatrogon injection, a long-acting human growth hormone that is intended to be administered once-weekly, for the treatment of pediatric patients with growth hormone deficiency is expected in January.

Somatrogon, a long-acting human growth hormone (hGH) molecule, is being developed by OPKO Health and Pfizer Inc. (PFE).

Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 people.

Because of this disorder, a child's height may be impacted, and puberty may be delayed. He or she will have ongoing growth attenuation, an extremely short adult height, and possibly other health concerns if not treated.

Pfizer's Genotropin, which has been on the market for years for treating growth hormone deficiency, is designed to be injected daily.

Ascendis Pharma's (ASND) SKYTROFA, administered as a subcutaneous injection, which was approved on Aug.25, 2021, for pediatric growth hormone deficiency, is a once-weekly treatment.

If approved, Somatrogon will also serve as a once-weekly treatment option, and could achieve peak sales of over $1 billion, according to analysts.

OPK closed Thursday’s (Dec.23, 2021) trading at $4.77, up 3.47%.