Calliditas Therapeutics AB Announced That The FDA Approved TARPEYO Delayed Release Capsules To Reduce The Loss Of Kidney Function In Adults With Primary Immunoglobulin A Nephropathy At Risk For Disease Progression
Portfolio Pulse from Benzinga Newsdesk
The FDA has approved Calliditas Therapeutics' TARPEYO delayed release capsules for adults with primary IgAN at risk of disease progression. TARPEYO, also known as NEFECON, showed a statistically significant benefit over placebo in reducing the loss of kidney function over a two-year study period. The treatment resulted in 50% less deterioration of kidney function compared to placebo and is the only FDA-approved treatment for IgAN that targets the production of pathogenic antibodies causing the disease.
December 20, 2023 | 9:35 pm
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POSITIVE IMPACT
Calliditas Therapeutics' TARPEYO has been approved by the FDA for reducing kidney function loss in IgAN patients, marking a significant milestone for the company and its product portfolio.
FDA approval of a new drug is a significant positive catalyst for a pharmaceutical company. It not only validates the efficacy of the drug but also opens up market opportunities and potential revenue streams. Given that TARPEYO is now the only FDA-approved treatment for IgAN that significantly reduces the loss of kidney function, this approval is likely to have a positive impact on Calliditas Therapeutics' stock price in the short term.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100