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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.
Calliditas Therapeutics AB (publ) is set to be delisted from Nasdaq Stockholm. The stock exchange has made the decision, with the final trading day scheduled for Thursday, October 10, 2024. This significant development was announced on September 16, 2024, at 15:30 CET. For investors and stakeholders seeking more information, Åsa Hillsten, the Head of IR & Sustainability at Calliditas, has been designated as the contact person.
Calliditas Therapeutics has announced an extraordinary general meeting on 30 September 2024 at Advokatfirman Vinge's premises in Stockholm.
Asahi Kasei, which now owns over 90% of Calliditas shares, requested this meeting. Key agenda items include:
- Election and removal of board members
- Changes to board member fees
- Delisting from Nasdaq Stockholm
Shareholders must be recorded in the Euroclear Sweden AB register by 20 September 2024 and give notice of participation by 24 September 2024. There are 54,033,447 shares eligible to vote at the meeting.
Proxy forms and additional documents are available on the company's website.
Calliditas Therapeutics AB (Nasdaq: CALT) has announced several corporate actions following Asahi Kasei 's acquisition of over 90% of its outstanding shares. The Board of Directors has resolved to:
- Apply for delisting of Calliditas' common shares from Nasdaq Stockholm
- Delist American Depositary Shares (ADSs) from Nasdaq Global Select Market
- File Form 25 with the SEC around September 13, 2024
- Deregister ADSs and suspend reporting obligations
- Terminate the depositary agreement and ADS program
An Extraordinary General Meeting is scheduled for September 30, 2024, to elect a new Board of Directors. The delisting of ADSs is expected to become effective around September 23, 2024.
Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) released its interim report for January to June 2024. Key highlights include:
- Net sales for Q2 2024 reached SEK 559.8 million, with TARPEYO® sales at SEK 493.4 million.
- Adjusted operating profit for Q2 2024 was SEK 70.2 million, excluding expenses related to the Asahi Kasei offer and social security contributions.
- Cash position as of June 30, 2024, was SEK 797.3 million.
- Positive data from Nefecon Open Label Phase 3 Extension trial and setanaxib Phase 2 trial in head and neck cancer.
- Commercial launch of Nefecon in China by partner Everest Medicines.
- Full approval recommendation for Kinpeygo® in EU for IgA nephropathy treatment.
- Updated 2024 outlook: Total net sales from Nefecon franchise estimated at USD 165-185 million.
Calliditas Therapeutics (CALT) has announced the upcoming release of its interim report for Q2 2024 (April - June) on Tuesday, August 13, 2024, at 07:00 a.m. CET. The report will be available in both Swedish and English. Following the release, the company will host a combined audio cast and telephone conference at 14:30 p.m. CET on the same day.
The presentation will feature CEO Renée Aguiar-Lucander, CFO Fredrik Johansson, CMO Richard Philipson, and President North America Maria Törnsén. Participants will have the opportunity to ask questions during the event, which will be conducted in English. Interested parties can join via webcast or conference call, with registration required for the latter.
Calliditas Therapeutics AB (Nasdaq: CALT) CEO Renée Aguiar-Lucander will participate in the 2024 Women in Nephrology (WIN) Leadership Conference in Los Angeles on August 9-10. She will join a panel titled 'How to be Efficient as a Leader in Academia and Industry', focusing on female representation and leadership in the nephrology field.
Aguiar-Lucander emphasizes the progress of women in industry leadership but acknowledges that more work is needed. She highlights the importance of celebrating female leaders' successes and improving mentorship to drive innovation, growth, and profitability. The CEO will share her experience in management, building successful organizations, and the impact of women in leadership at Calliditas.
WIN, founded in 1983, aims to provide mentorship and guidance to all nephrologists and scientists, particularly those historically underrepresented in the field.
Calliditas Therapeutics AB (publ) has reported changes in its share structure due to the exercise of warrants under its long-term incentive programs. As of July 31, 2024, the company's total outstanding shares have increased to 59,941,465 ordinary shares, with an equal number of votes. The share capital has risen by SEK 14,455.12, from SEK 2,383,203.48 to SEK 2,397,658.60. These changes result from the exercise of warrants under the ESOP 2020 and LTIP 2021 programs. This information is disclosed in compliance with the Swedish Financial Instruments Trading Act.
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 AB (NASDAQ: CALT) announced positive topline results from its Phase 2b TRANSFORM trial evaluating setanaxib in patients with primary biliary cholangitis (PBC) and elevated liver stiffness. The study met its primary endpoint, showing statistically significant improvement in Alkaline Phosphatase (ALP) for both tested doses versus placebo. Key findings include:
- 19% ALP improvement in the 1600mg arm
- 14% ALP improvement in the 1200mg arm
- Positive trends on liver stiffness at 24 weeks
- Generally well-tolerated treatment
- Efficacy demonstrated in patients already on multiple medications
The company is conducting additional trials with setanaxib, including a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a Phase 2 proof of concept trial in Alport syndrome.
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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