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Calliditas Therapeutics AB (symbol: CALTX) is a biopharmaceutical company based in Stockholm, Sweden, dedicated to identifying, developing, and commercializing innovative treatments for rare diseases with unmet medical needs. The company recently announced positive results from the Phase 2 trial evaluating setanaxib, its lead NOX enzyme inhibitor, in combination with pembrolizumab for squamous cell carcinoma of the head and neck. The trial demonstrated statistically significant improvements in progression-free survival and overall survival, along with changes in tumor biology supporting the mechanism of action of setanaxib. Calliditas is also engaged in ongoing clinical trials in other indications, such as primary biliary cholangitis and idiopathic pulmonary fibrosis, showing promising results. The company focuses on anti-fibrotic effects and the development of its first-in-class NOX platform.
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) announced that the European Commission has granted full marketing authorization for Kinpeygo® to treat adults with primary immunoglobulin A nephropathy (IgAN). This approval significantly broadens the label, now covering patients with urine protein excretion (UPCR) ≥ 0.8g/g, based on the two-year data from the Phase 3 NefIgArd clinical trial. The approval triggers a €10 million milestone payment to Calliditas, recognizable as revenue in Q3. Kinpeygo, marketed exclusively by STADA Arzneimittel AG in the EU and UK, now has orphan drug status with 10-year market exclusivity until 2032.
Calliditas Therapeutics announced that the USPTO has issued a patent for setanaxib, used in combination with PD-1 inhibitors to treat solid tumors resistant to PD-1 immunotherapy. The patent will expire in 2039 and complements corresponding applications in other regions, including Europe.
CEO Renee Aguiar-Lucander expressed optimism over the extended product protection and plans for geographical expansion.
Additionally, Calliditas shared positive results from a Phase 2 head and neck cancer trial in May 2024, showing statistically significant improvements in progression-free survival (PFS) and overall survival (OS), aligning with setanaxib's mechanism of action.
Calliditas Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Kinpeygo, recommending full marketing authorisation in treating adults with primary immunoglobulin A nephropathy (IgAN). Kinpeygo, which received conditional marketing authorisation in July 2022, now has a broader treatment label, moving from a urine protein excretion limitation of >1.5g/g to ≥0.8g/g. The positive opinion will be forwarded to the European Commission (EC) for final approval, expected in August 2024. STADA Arzneimittel AG will market Kinpeygo in the EU and UK.
Calliditas Therapeutics presented new data at the 61st European Renal Association Congress, including an additional efficacy analysis of Nefecon (TARPEYO®) and a real-world analysis of systemic glucocorticoids (SGC) in IgA nephropathy (IgAN).
Results showed that treatment with Nefecon for 9 months significantly improved estimated glomerular filtration rate (eGFR) compared to continuous sparsentan treatment. Another study highlighted the severe side effects and costs associated with SGC treatment in IgAN patients.
The presented data emphasized the potential of TARPEYO as a cornerstone therapy for IgAN, showcasing better eGFR outcomes over time compared to sparsentan, and underlined the risks of using systemic glucocorticoids, which involve significant healthcare resource utilization and side effects.
Calliditas Therapeutics reported significant growth in Q1 2024 compared to Q1 2023. Net sales increased to SEK 295.5 million, with TARPEYO® contributing SEK 278.3 million. The company faced an operating loss of SEK 203.8 million and a loss per share of SEK 4.59. Cash reserves decreased to SEK 810.3 million from SEK 1,013.6 million. Key achievements include a 27% increase in enrollments, a new TARPEYO patent valid until 2043, and FDA's orphan drug exclusivity until 2030. Despite a USD 4.7 million revenue impact due to a cyberattack, future revenue is expected to remain stable. Upcoming events include European Commission decisions and Phase 2 trial results.
Calliditas Therapeutics announced an in-person and virtual R&D day on May 30, 2024. The event will feature presentations on the anti-fibrotic effects of Setanaxib and the mode of action of TARPEYO (Nefecon) in treating IgA nephropathy, supported by preclinical and clinical data. Keynote speakers include Gareth J. Thomas, PhD, and Jonathan Barratt, PhD, FRCP. The program will cover supportive preclinical data and a Phase 2 POC trial for Setanaxib in squamous cell carcinoma of the head and neck (SCCHN), as well as a review of upcoming clinical data from the NOX platform. The event will also include a live Q&A session.
Calliditas Therapeutics announced its participation in the 61st European Renal Association (ERA) Congress in Stockholm, Sweden, from May 23 to 26, 2024. The company will present data on Nefecon (TARPEYO® (budesonide) delayed-release capsules) for primary immunoglobulin A nephropathy (IgAN) and real-world challenges with systemic glucocorticoids (SGC) in IgAN. Key presentations include an efficacy analysis of Nefecon and a real-world analysis of SGC challenges. The company will also host a symposium discussing clinical markers in IgAN.
Calliditas Therapeutics (Nasdaq: CALT) announced that its partner, Everest Medicines, has launched Nefecon® in China. China has up to 5 million patients with IgA nephropathy (IgAN), a progressive autoimmune disease. IgAN accounts for 35% to 50% of primary glomerular diseases, with over 100,000 new cases yearly. The Phase 3 NefIgArd trial showed a 66% reduction in kidney function loss in Chinese patients treated with Nefecon, outperforming global results.
Nefecon received conditional approval from China’s National Medical Products Administration (NMPA) in November 2023 and has since been launched in Macau, Hong Kong, and Singapore. The drug is also under review in Taiwan and South Korea.
Calliditas Therapeutics AB (CALT) announced positive results from a Phase 2 trial of setanaxib in combination with pembrolizumab for head and neck cancer treatment. The trial demonstrated significant improvements in progression-free survival and overall survival compared to placebo, with a positive impact on tumor biology. The treatment was well-tolerated, showing an increase in CD8+ T-cells in tumor tissue, indicating enhanced immunological activity. The company plans to present more data at an upcoming R&D day in Stockholm.
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