CALT - Calliditas jumps 35% on prospects for full approval of kidney disease therapy

2023-03-13 13:15:19 ET

Calliditas Therapeutics ( NASDAQ: CALT ) added 35% on Monday after announcing that its Phase 3 trial for renal disease candidate Nefecon reached the primary endpoint, paving the way for Swedish pharma to seek its full approval.

In Dec. 2021, the U.S. granted accelerated approval for the oral therapy under the trade name Tarpeyo for autoimmune renal disease immunoglobulin A nephropathy.

Citing topline data, Calliditas ( CALT ) said that its NefIgArd Phase 3 clinical trial met the primary endpoint as Nefecon indicated a statistically significant benefit over placebo for estimated glomerular filtration rate (eGFR) over two years.

The analysis included 364 patients with primary IgAN who received Nefecon or a placebo for nine months daily and then underwent 15 months of follow-up.

"…..we believe this dataset supports regulatory filing for full approval based on the Phase 3 study population," Chief Executive of Calliditas ( CALT ), Renée Aguiar-Lucander, remarked.

With the support of this data, the company plans to seek full approval for Nefecon this year in the U.S., U.K., and EU for patients with primary IgAN.

NefIgArd trial is set to end in Q3 2023 after the final 29 patients from China, required for regulatory purposes in that country, complete nine months of treatment and 15 months of observation.

Read: Seeking Alpha contributor predicts Calliditas ( CALT ) can generate better than expected Tarpeyo sales in 2023.

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