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Co.'s Shares Gain 27% After FDA Nears Drug Approval
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Shares of Calliditas Therapeutics AB traded higher after the company reported the U.S. FDA granted accelerated approval for its TARPEYO™ (budesonide) to reduce proteinuria in IgA nephropathy.

Commercial-stage biopharmaceutical company Calliditas Therapeutics AB (CALT:NASDAQ ADR), which concentrates its efforts on identifying, developing and commercializing novel treatments for orphan indications in renal and hepatic diseases, yesterday announced that "the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g."

The firm advised that this specific indication was approved by the FDA under accelerated approval program but noted that TARPEYO has not been proven yet whether it is able to slows kidney function decline in patients with IgAN. The company pointed out that completion of a confirmatory clinical trial may be required to continue advancement of TARPEYO.

Calliditas Therapeutics' CEO Renée Aguiar-Lucander stated, "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."

The company stated that FDA authorized the use of TARPEYO under accelerated approval after it successfully met its primary endpoint of reduction in proteinuria in Part A of the NeflgArd pivotal double-blind Phase 3 trial. The ongoing Phase 3 global randomized NeflgArd study enrolled 360 participants to test the efficacy and safety of once-daily TARPEYO 16 mg in adult patients with primary IgAN as an addition to optimized RASi therapy.

The company reported that in Part A of the trial 16 mg TARPEYO successfully achieved a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, versus placebo. The firm listed that "patients taking TARPEYO plus RASi (n=97) showed a statistically significant 34% reduction from baseline vs 5% with RASi alone (n=102) at 9 months, resulting in UPCR reduction of 31% (16% to 42%) p=0.0001."

"IgAN is a tough diagnosis for many patients, and it can progressively lead to the need for dialysis and/or kidney transplantation. The FDA approval of TARPEYO now offers disease-specific treatment for patients with this complicated disease," remarked Richard Lafayette M.D., Professor of Medicine at Stanford University and the Director of the Stanford Glomerular Disease Center.

The company's Chief Medical Officer Dr. Richard Philipson commented, "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."

The firm stated that it anticipates that TARPEYO will be available for sale and distribution in the U.S. in Q1/22. The company advised that it intends to launch a patient support program called TARPEYO Touchpoints™ to provide information and assistance to eligible patients and providers.

The company described TARPEYO as "an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism."

The firm explained that "primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger's Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 are recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney." Left unchecked, IgA nephropathy can cause severe damage to the kidneys and advance towards end-stage renal disease.

Calliditas is a biopharmaceutical firm based in Stockholm, Sweden that is engaged in developing and commercializing novel treatments for orphan diseases with an emphasis on renal and hepatic diseases.

Calliditas Therapeutics began the day with a market cap of around $465.5 million with approximately 24.97 million shares outstanding. CALT ADR shares opened 38% higher today at $25.71 (+$7.07, +37.93%) over yesterday's $18.64 closing price. The stock has traded today between $22.50 and $27.50 per share and is currently trading at $23.70 (+$5.06, +27.15%).


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