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Calliditas' (CALT) Tarpeyo Wins FDA Approval for Renal Disease

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Calliditas Therapeutics AB (CALT - Free Report) announced that the FDA has approved Tarpeyo delayed-release capsules.

The drug has been approved 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. 

Tarpeyo is approved under accelerated approval based on achieving its primary endpoint of reduction in proteinuria in Part A of the NeflgArdn study.

The global clinical study, NeflgArd, is an ongoing phase III randomized, double-blind, placebo- controlled, multicenter study to evaluate the efficacy and safety of Tarpeyo 16 mg once daily versus placebo in adult patients with primary IgAN as an addition to optimized RASi therapy. Patients taking Tarpeyo (n=97) showed a statistically significant 34% reduction in proteinuria from baseline versus 5% with RASi alone (n=102) in nine months.

Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory clinical study.

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.  The disease has a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).

Shares are up 39% in after-market trading hours. However, the stock plunged 44.6% in the year compared with the industry’s 19% decline.

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This is the first approved product in the company’s portfolio and the successful commercialization of the drug will boost prospects.

Chinook Therapeutics, Inc. (KDNY - Free Report) is evaluating atrasentan, a phase III endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases.   The European Commission recently granted orphan drug designation to Chinook’s atrasentan to treat primary IgAN. 

BION-1301, an anti-APRIL monoclonal antibody, is being evaluated in a phase Ib trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases.

Calliditas currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Sarepta Therapeutics, Inc. (SRPT - Free Report) and Viking Therapeutics (VKTX - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.78 to $3.61 for 2022 in the past 60 days. SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.

Estimates for Viking Therapeutics have narrowed to a loss per share of $3.16 from $3.55 for 2021 and to $3.47 from $3.63 for 2022 in the past 60 days. VKTX delivered an earnings surprise of 2.06%, on average, in the last four quarters.