Calliditas Therapeutics AB (publ) (CALT) stock surged 28.97% in the current trading session at the price of $24.04 following the approval of TARPEYO (budesonide) by the FDA.
Calliditas Therapeutics (CALT) is a biopharmaceutical firm located in Stockholm, Sweden. The company identifies, develops, and commercializes novel therapeutics in orphan indications, focusing on hepatic and renal diseases with unmet medical needs.
FDA Granted Approval For TARPEYO™ (budesonide)
On 15th December 2021, CALT reported the approval of TARPEYO (budesonide) delayed-release capsules by the Food and Drug Administration (FDA). Budesonide reduces proteinuria in adults with immunoglobulin A nephropathy (IgAN). It had not yet confirmed whether TARPEYO lowers kidney failure in patients with IgAN.
The accelerated approval of TARPEYO had based on its capacity of reducing proteinuria in adults. This approval marks the company’s successful transition to a commercial-stage biopharma company. NeflgArd pivotal Phase-III study is an ongoing, double-blind, placebo-controlled, multicenter study conducted to assess the effectiveness and safety of TARPEYO in patients with IgAN.
Chief Executive Officer of CALT, Renée Aguiar-Lucander, remarked that they are very excited to bring the first FDA-approved treatment to market that reduces proteinuria. TARPEYO is the only FDA-approved product that helps patients with a higher risk of disease progression, he added.
Director of the Stanford Glomerular Disease Center, Richard Lafayette M.D., stated that IgAN is a challenging diagnosis for many patients. It can further lead to the need for dialysis or kidney transplantation. The approval of TARPEYO by the FDA now delivers disease-specific treatment to patients with this complex disease, he added.
Chief Medical Officer of CALT, Richard Philipson, added that TARPEYO had devised to target and check the root cause of IgAN. The approval of TARPEYO by the FDA confirms their persistent devotion to patients with IgAN. He thanked the researchers, patients, and clinical attendants who had participated and contributed to the studies of TARPEYO.
CALT Third Quarter 2021 Financial Report
On 18th November 2021, CALT published its interim financial report for the third quarter of 2021. Net sales totaled SEK 198.2 million for the Q3 ended 30th September 2021. Net loss per share amounted to SEK 0.21 for the three months ended on 30th September 2021. The company reported an operating loss of SEK 7.9 million for the third quarter of 2021.