Welcome to our dedicated page for Calliditas Therapeutics Ab news (Ticker: CALT), a resource for investors and traders seeking the latest updates and insights on Calliditas Therapeutics Ab stock.
Company Overview
Calliditas Therapeutics AB is a clinical-stage biopharmaceutical company devoted to developing and commercializing novel therapeutic treatments in orphan indications. With a primary focus on addressing the significant unmet medical needs in renal and hepatic diseases, the company is renowned for its cutting-edge approach in designing therapies aimed at conditions such as immunoglobulin A nephropathy (IgAN) and other rare disorders. As a pioneer in targeted therapies, Calliditas leverages an innovative platform that includes the development of controlled-release drug formulations and NOX enzyme inhibitors, making its research a significant force in rare disease treatment.
Core Business Areas
At its core, Calliditas Therapeutics AB is engaged in the identification, development, and commercialization of treatments for diseases that have limited therapeutic options. The company’s strategy is centered on the following areas:
- Renal Therapy: With an emphasis on IgA nephropathy, the company has developed a targeted treatment regimen that aims to reduce kidney function decline, as evidenced by data from global Phase 3 clinical studies.
- Hepatic Therapy: Recognizing the unmet needs in liver diseases, Calliditas is advancing novel treatments for conditions such as primary biliary cholangitis by refining drug formulations and treatment protocols.
- Oncology Research: Exploration into the anti-fibrotic properties of its NOX enzyme inhibitors extends into oncological applications, addressing treatment resistance in solid tumors and expanding the company’s therapeutic reach.
Innovative Pipeline & Clinical Trials
Calliditas is distinguished by its rigorous clinical research program. The company has executed multiple clinical trials, including the landmark NefIgArd Phase 3 study, which supported full regulatory approval in key jurisdictions. The clinical development program extends into additional studies evaluating NOX enzyme inhibitors such as setanaxib in areas ranging from head and neck cancers to fibrotic liver diseases. These studies are designed to deliver robust clinical outcomes that underline the company’s focus on measurable and meaningful improvements in patient health metrics.
Regulatory Milestones & Global Collaborations
Demonstrating its commitment to clinical excellence and patient safety, Calliditas Therapeutics has achieved multiple significant regulatory milestones. The company’s therapies have received conditional approvals and are in advanced stages of regulatory review in various international markets, including top-tier jurisdictions. Strategic partnerships with global entities, such as commercial collaborations to launch innovative treatments in China and licensing agreements in Europe and Japan, further validate the company’s scientific approach and commercial potential.
Market Position & Strategic Value
Calliditas Therapeutics operates within a competitive landscape marked by the increasing demand for therapies in orphan indications. Its unique focus on rare renal and hepatic diseases allows it to address niche markets that have historically been underserved. Through focused molecular research and well-structured clinical trials, the company has established itself as a specialized entity, leveraging expertise in immunomodulation and anti-fibrotic therapies. This nuanced approach not only underscores its scientific credibility but also its ability to deliver therapeutic solutions that resonate with both healthcare providers and regulatory authorities.
Commitment to Scientific Excellence
Expertise, Experience, and Trustworthiness are evident in every aspect of Calliditas’ operations. The company’s publications in leading medical journals and its participation in prominent scientific symposia underline its dedication to advancing medical knowledge. Its strategic orientation, built on strong partnerships and an unwavering commitment to research excellence, confirms its role as an innovator in the biopharmaceutical landscape.
This comprehensive overview is crafted to provide stakeholders, analysts, and potential investors with an in-depth understanding of Calliditas Therapeutics AB, highlighting its research-driven approach, strategic market positioning, and the rigorous clinical programs that are paving the way for novel treatment paradigms in rare diseases.
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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