Opko Health, Inc. OPK shares are trading higher Wednesday after the FDA approved NGENLA treatment for pediatric growth hormone deficiency, produced in partnership with Pfizer PFE.
What To Know: The approval was suppoerted by results from a multi-center, randomized, open-label, active-controlled Phase 3 study evaluating the safety and efficacy of NGENLA when administered once-weekly compared to once-daily somatropin.
"Throughout our collaboration with Pfizer, we have worked tirelessly toward our shared goal of helping children living with growth hormone disease and their families," said Phillip Frost, Chairman and CEO, OPKO Health.
"We are proud of the clinical development program that supported the FDA approval of NGENLA and are excited about its potential for these patients and their families as it becomes available in the United States."
The once-weekly, human growth hormone analog is expected to become available for U.S. prescribing in August 2023 and is already approved for the treatment of pediatric GHD in more than 40 markets.
Related Link: Why Eton Pharmaceuticals Shares Are Trading Lower By Over 15%? Here Are Other Stocks Moving In Wednesday's Mid-Day Session
OPK Price Action: Shares of OPK were up 1.81% at $1.69 at the time of publication, according to Benzinga Pro.
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