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Calliditas Therapeutics AB (publ) - CALT STOCK NEWS

Welcome to our dedicated page for Calliditas Therapeutics AB (publ) news (Ticker: CALT), a resource for investors and traders seeking the latest updates and insights on Calliditas Therapeutics AB (publ) stock.

Calliditas Therapeutics AB (NASDAQ: CALT, Nasdaq Stockholm: CALTX) is a clinical and commercial-stage biopharmaceutical company dedicated to identifying, developing, and commercializing novel treatments specifically targeting orphan indications with significant unmet medical needs, particularly in renal and hepatic diseases. Headquartered in Stockholm, Sweden, Calliditas is pioneering therapies aimed at addressing complex conditions with limited treatment options.

The company's lead product, TARPEYO® (also known as Nefecon outside the United States), is an innovative medication designed to reduce proteinuria in patients suffering from IgA nephropathy (IgAN), a progressive autoimmune disease affecting the kidneys. TARPEYO® has received full approval from the U.S. FDA and conditional marketing authorization in the EU, marking a significant milestone in the treatment landscape for IgAN. Recent data from the ongoing global Phase 3 NefIgArd study and its Open Label Extension (OLE) demonstrate the drug's consistent efficacy and safety profile over an extended period.

Besides TARPEYO®, Calliditas' robust pipeline includes setanaxib, a NOX enzyme inhibitor showing promise in various indications, including squamous cell carcinoma of the head and neck (SCCHN). Recent Phase 2 trial results indicated statistically significant improvements in progression-free survival and overall survival, thus reinforcing the potential of setanaxib in oncological applications.

Calliditas is also expanding its market presence through strategic global partnerships. A notable achievement is the commercial launch of Nefecon in China by its partner, Everest Medicines. This launch is a critical step in addressing the high prevalence and unmet medical needs of IgAN patients in Asia.

Financially, Calliditas continues to strengthen its position, driven by ongoing commercial efforts and strategic equity initiatives. The company remains committed to enhancing shareholder value through advancements in its pipeline, strategic collaborations, and robust operational execution.

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Calliditas Therapeutics (NASDAQ: CALT) has announced that its partner, Viatris Pharmaceutical Japan, initiated a Phase 3 clinical trial in Japan with Nefecon, branded as VR-205. This trial focuses on Japanese patients with IgA nephropathy (IgAN), a condition affecting an estimated 33,000 people in Japan. The trial is a bridging study, similar to the global NefIgArd trial, requiring a number of participants. This initiative follows a license agreement enabling Viatris to register and commercialize Nefecon in Japan, addressing the treatment options available for IgAN patients.

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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.

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The annual general meeting of Calliditas Therapeutics AB, held on June 17, 2024, in Stockholm, resulted in several key resolutions. The income statement and balance sheet for the financial year 2023 were adopted, and no dividends will be paid out, with SEK 904.3 million carried forward. The board of directors, comprising six members, was re-elected, including chairman Elmar Schnee. Ernst & Young was re-appointed as the auditor. An authorization was granted to the board for issuing new shares, warrants, and convertibles, up to 20% of the current share capital, to increase financial flexibility. Additionally, a long-term incentive program for the board and management was approved, including equity-based awards. The meeting also amended terms for previous incentive programs and updated remuneration guidelines for the management and board.

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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.

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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.

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On May 28, 2024, the Board of Directors of Calliditas Therapeutics recommended shareholders accept Asahi Kasei 's public cash offer to acquire all shares and American Depositary Shares (ADS) of Calliditas. The offer values each share at SEK 208 and each ADS at SEK 416, representing a premium of 83% over the closing price and the 30-day volume-weighted average price of Calliditas shares. The offer, valued at SEK 11,164 million, is contingent upon Asahi Kasei acquiring more than 90% of Calliditas shares and securing necessary approvals. The acceptance period for the offer is expected to commence around July 18, 2024, and conclude around August 30, 2024. Major shareholders, holding about 44.65% of shares, have agreed to the offer. The board believes the transaction will benefit Calliditas by leveraging Asahi Kasei's resources and expertise, particularly in rare disease drug development.

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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.

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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.

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Calliditas Therapeutics announced the release of its interim report for Q1 2024 on May 23, 2024, at 07:00 CET. The company will hold a combined audio cast and telephone conference at 14:30 CET the same day, featuring CEO Renée Aguiar-Lucander, CFO Fredrik Johansson, CMO Richard Philipson, and President North America Maria Törnsén. Stakeholders can participate via a webcast or register for the conference call to ask questions. The presentation will be in English, and further details can be obtained from Calliditas's Head of IR & Sustainability, Åsa Hillsten.

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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.

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FAQ

What does Calliditas Therapeutics AB specialize in?

Calliditas specializes in identifying, developing, and commercializing novel treatments for orphan indications, particularly focusing on renal and hepatic diseases with significant unmet medical needs.

What is TARPEYO?

TARPEYO® is a medication developed by Calliditas Therapeutics designed to reduce proteinuria in patients with IgA nephropathy (IgAN). It has received full approval from the U.S. FDA and conditional marketing authorization in the EU.

Where is Calliditas Therapeutics headquartered?

Calliditas Therapeutics is headquartered in Stockholm, Sweden.

Who are some of Calliditas' partners?

Calliditas partners with Everest Medicines for the commercial launch of Nefecon in China and collaborates globally to expand its market presence.

What recent advancements has Calliditas made?

Recent advancements include positive Phase 3 study results for TARPEYO, the commercial launch of Nefecon in China, and promising Phase 2 trial results for setanaxib in treating squamous cell carcinoma of the head and neck.

What is setanaxib?

Setanaxib is a NOX enzyme inhibitor in Calliditas' pipeline, showing significant improvements in progression-free survival and overall survival in a Phase 2 trial for squamous cell carcinoma of the head and neck.

How is Calliditas maintaining financial health?

Calliditas strengthens its financial position through ongoing commercial efforts, strategic global partnerships, and equity initiatives, ensuring robust operational execution and shareholder value enhancement.

What are the key highlights of the OLE study in the NefIgArd trial?

The Open Label Extension (OLE) study in the NefIgArd trial showed consistent treatment response in reducing proteinuria and stabilizing eGFR at 9 months, irrespective of previous treatments, confirming the safety and efficacy of Nefecon.

How does TARPEYO work?

TARPEYO is an oral delayed-release budesonide formulation targeting mucosal B-cells in the ileum, which are responsible for producing galactose-deficient IgA1 antibodies that cause IgA nephropathy.

What are the upcoming milestones for Calliditas?

Upcoming milestones for Calliditas include further clinical data readouts from ongoing trials, regulatory submissions for full approvals, and expanding market reach through strategic partnerships.

Calliditas Therapeutics AB (publ)

Nasdaq:CALT

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1.06B
59.58M
3.3%
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