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OPKO (OPK) BLA Review for Growth Hormone Deficiency Drug Delayed

The FDA extends the PDUFA action date for OPKO (OPK)/Pfizer's BLA for somatrogon to treat pediatric patients with growth hormone deficiency. The revie...

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This story originally appeared on Zacks

OPKO Health Inc. OPK announced that the review period for the biologics license application (“BLA”) for somatrogon has received a further extension of three months from the FDA. A decision from the FDA is now expected in January 2022.

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The BLA is seeking approval for somatrogon as a potential treatment for pediatric patients with growth hormone deficiency (“GHD”). GHD or pituitary dwarfism is a rare disease caused by genetic mutations or acquired after birth. It is marked by inadequate secretion of growth hormones from the pituitary gland, affecting a child’s height and even delaying puberty.

The extension in the review period by the FDA is a result of the submission of additional data by Pfizer PFE in addition to the data submitted at the time of filing for original BLA.

OPKO’s shares have declined 5.1% so far this year against the industry’s 13.5% increase.

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We remind investors that somatrogon is being developed in collaboration with Pfizer. Per the agreement terms, Pfizer is responsible for commercialization of the drug while OPKO is accountable for the drug’s clinical development.

Per the company, GHD affects one out of approximately 4,000-10,000 children. Somatrogon is a long-acting recombinant human growth hormone that will be administered once weekly, following approval.

We note that the drug has already received Orphan Drug Designation in the United States and EU for treating both adults as well as children with GHD.

It is to be noted that the FDA approved Novo Nordisk’s NVO Sogroya in August 2020 for the treatment of GHD in adults. It was also approved in the EU in March 2021.

OPKO manages its operations in two reportable segments, namely Diagnostics and Pharmaceuticals. Currently, the company’s only marketable drug in the Pharmaceuticals segment is Rayaldee, an FDA-approved treatment for secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. It earns a major portion of revenues from the Diagnostics segment.

Zacks Rank & Stock to Consider

OPKO currently carries a Zacks Rank #4 (Sell). A better-ranked in the biotech sector is Regeneron Pharmaceuticals REGN, which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates for 2021 have increased from $49.91 to $59.80 in the past 60 days. The same for 2022 has risen from $40.91 to $46.73 over the same period. The stock has rallied 32.3% in the year so far.



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