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Highlights
- Calliditas Therapeutics was up over 41% in pre-market trading Thursday, December 16.
- The company provided an update on its delayed-release capsules, TARPEYO, on December 15.
- The firm focuses on renal and hepatic disorders.
The stocks of Calliditas Therapeutics AB (NASDAQ:CALT) were trending on Wall Street Thursday, a day after the US Food and Drug Administration (FDA) approved its delayed-release capsules, TARPEYO (budesonide). The stocks of the company were up over 41% in pre-market trading on December 16.
Calliditas is a clinical-stage biopharma firm that specializes in the identification, development, and commercialization of novel treatments in orphan indications. It primarily focuses on renal and hepatic disorders that are unmet with significant medical requirements. It is based in Sweden.
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The company has announced that the US Food and Drug Administration (FDA) has approved its delayed-release capsules, TARPEYO (budesonide), that are used to decrease the proteinuria in adults having primary immunoglobulin A nephropathy (IgAN), who is at risk of rapid disease progression. In general, the disorder is urine protein-to-creatinine ratio (UPCR) ≥1.5g/g.
The FDA has approved it under accelerated approval. Notably, continued approval may be dependent on verifying and describing the clinical benefits in a probative clinical trial.
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The approval has marked a successful transition for Calliditas Therapeutics as a commercial-stage biopharmaceutical firm.
TARPEYO has been approved by the FDA under accelerated approval, considering the achievement of its primary endpoint in reducing proteinuria in Part A of the NeflgArd pivotal Phase 3 study, which is an ongoing, randomized, and multicenter study that was done to assess the efficacy and safety of TARPEYO 16 mg once daily, versus placebo in adult patients with primary IgAN.
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The efficacy of TARPEYO has been evaluated in patients with biopsy-proven IgAN, eGFR ≥35 mL/min/1.73 m square, and proteinuria, who were on a stable dose of maximally-tolerated RAS inhibitor therapy.
Chief Executive Officer of Calliditas Renée Aguiar-Lucander said that they are excited to achieve the "first and only FDA-approved treatment" that may decrease proteinuria in IgAN.
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Stock performance & highlights of Calliditas Therapeutics AB (NASDAQ:CALT)
The CALT stock was priced at US$26.31 at 8:43 am ET on December 16, up 41.15% from its previous closing price, when it closed at US$18.64. The Sweden-based firm has a market cap of US$487.82 million.
The CALT stocks saw the highest price of US$34.75 and the lowest price of US$14.22 in the last 52 weeks. Its trading volume on December 15 was 1,490,569.
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The company's net sales were SEK 198.2 million (US$21.98 million) in Q3, FY21. Meanwhile, no net sales were recognized in the third quarter of fiscal 2020. For the period, its operating profit was SEK 7.9 million (US$0.88 million), against a loss of SEK 104.9 million (US$11.63 million) in Q3, FY20.
Bottom line:
The overall healthcare sector grew in recent quarters, as the industry has become one of the prime focuses of traders, especially after the Covid-19 pandemic. The S&P 500 healthcare sector surged 21.25% YTD while increasing 8.18% QTD.
