Key Points:
- Calliditas stock price surged 45.1% on FDA’s approval of TARPEYO.
- The company is yet to complete the phase 3 trial of TARPEYO, but the phase 3 clinical study met its primary endpoint.
- TARPEYO is the only drug that treats primary immunoglobulin A nephropathy (IgAN) in adults.
The Calliditas Therapeutics ADR (NASDAQ: CALT) stock price surged 45.1% after the US Food & Drug Administration (FDA) approved its TARPEYO (budesonide) delayed-release capsules for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults.
The FDA gave the drug accelerated approval since it is the first and only treatment for IgAN despite not confirming whether TARPEYO slows kidney function decline in patients with IgAN.
TARPEYO was approved after the drug met its primary endpoint of reducing proteinuria in Part A of the NeflgArd pivotal Phase 3 study, which is still ongoing.
The study was conducted to evaluate the efficacy and safety of TARPEYO 16 mg administered once daily vs placebo in adult patients with primary IgAN.
Renée Aguiar-Lucander, Calliditas Therapeiutics’ CEO, said: “We are very excited to bring the first and only FDA-approved treatment to reduce proteinuria in IgAN to market. TARPEYO represents an FDA approved product to help these patients who are at risk of rapid disease progression.”
Richard Philipson, Calliditas Chief Medical Officer, added, “TARPEYO was developed to target a root cause of IgAN. The FDA’s approval of TARPEYO demonstrates our unwavering dedication to patients suffering from IgAN. We would like to thank the patients, researchers and clinical staff who participated in the studies of TARPEYO.”
Bonnie Schneider, Director and Co-Founder of the IGA Nephropathy Foundation of America, commented,” It has been a difficult journey not only for our family but for all the IgA nephropathy patients we serve. Having this disease-specific option has our community very excited.”
Investors cheered the news as the company plans to make the drug available in the US during the first quarter of 2022.
*This is not investment advice. Always do your due diligence before making investment decisions.
Calliditas Therapeutics stock price.
Calliditas Therapeutics stock price spiked 45.12% higher to trade at $27.05, rising from Wednesday’s closing price of $18.64.
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