FDA Approves Rivfloza For Children ≥9 Years Old And Adults Living With Primary Hyperoxaluria Type 1 (PH1), A Rare Genetic Condition
Portfolio Pulse from Benzinga Newsdesk
Novo Nordisk has received FDA approval for Rivfloza, a treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disease. The approval is based on the results of the phase 2 PHYOXTM2 clinical trial and interim data from the ongoing phase 3 PHYOXTM3 extension study. Rivfloza was developed by Dicerna Pharmaceuticals, which was acquired by Novo Nordisk in 2021. The company plans to make the treatment available for eligible patients in early 2024.

October 02, 2023 | 3:16 pm
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POSITIVE IMPACT
Novo Nordisk's new drug approval could potentially boost its revenues and strengthen its position in the rare disease market. However, the impact on the stock price may not be immediate as the drug will be available in 2024.
The FDA approval of Rivfloza is a positive development for Novo Nordisk as it expands the company's product portfolio and opens up a new revenue stream. However, the drug will only be available in 2024, so the immediate impact on the stock price may be limited. The acquisition of Dicerna Pharmaceuticals, which developed Rivfloza, also demonstrates Novo Nordisk's strategic focus on rare diseases.
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