Why Calliditas (CALT) Shares Are Surging Today - Calliditas Therapeutics (NASDAQ:CALT)

Calliditas Therapeutics AB CALT announced topline results from the Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (TARPEYO/Kinpeygo (budesonide) delayed-release capsules) versus placebo in patients with primary IgA nephropathy (IgAN).
The trial studied Nefecon on primary IgA nephropathy (IgAN) patients who were also on RAS inhibitor therapy.
The drug demonstrated a "highly statistically significant benefit" over the placebo in two years, with nine months of treatment studying the primary endpoint of estimated glomerular filtration rate (eGFR), a measure of the level of kidney function.
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Supportive 2-year total slope analyses were statistically significant and clinically meaningful, reflecting a sustained treatment benefit.
The eGFR was, on average, 5.05 mL higher with Tarpeyo compared to the placebo (p<0.0001) over two years.
Urine protein-to-creatinine ratio reductions observed were durable, reflecting a long-lasting treatment effect during the 15-month follow-up period off treatment.
Tarpeyo received FDA accelerated approval in December 2021 and conditional marketing authorization from the European Commission in July 2022.
Based on the data, Calliditas plans to file for full approval from the FDA and support a filing for full approval with the EC and UK's MHRA during 2023.
Price Action: CALT shares are up 38.4% at $23.29 on the last check Monday.

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Calliditas Plans To File For Complete FDA Approval For Rare Kidney Disease Drug After Positive Phase 3 Data

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