Core Points - Calliditas Therapeutics announced the issuance of a patent by the USPTO for the use of NOX inhibitors in cancer treatment, specifically for solid tumors resistant to PD-1 inhibitor immunotherapy, with setanaxib as the treatment agent [1] - The patent is set to expire in 2039 and Calliditas has additional patent applications in various global territories, including a pending application in Europe [1] - The CEO of Calliditas expressed optimism about the extended product protection for setanaxib in oncology and plans for geographical expansion [2] - Positive topline results from a Phase 2 trial for head and neck cancer using setanaxib were reported, showing statistically significant improvements in progression-free survival and overall survival [3] Company Overview - Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden, focused on developing treatments for orphan indications with significant unmet medical needs [4] - The company's shares are listed on Nasdaq Stockholm and its American Depositary Shares are listed on the Nasdaq Global Select Market [4]

The patent covers a method of treating a solid tumor presenting resistance to PD-1 inhibitor immunotherapy by administering setanaxib in combination with a PD-1 inhibitor. The patent will have an expiration date in 2039. Calliditas has corresponding applications and patents in several additional territories around the world, including a pending patent application in Europe. Calliditas read out positive topline results of its Phase 2 head and neck cancer trial with setanaxib in May 2024. The analysis showed ...

Core Points - Calliditas Therapeutics held its annual general meeting on June 17, 2024, where several key resolutions were passed regarding board remuneration, share issuance, and incentive programs [9][19][25]. Group 1: Board Remuneration - The board of directors' fees were set at SEK 940,000 for the chairman and SEK 365,000 for other non-employee members, with additional amounts for members residing in the U.S. and Europe [2]. - The remuneration for the audit committee chairman is SEK 200,000, while other members receive SEK 100,000, and for the remuneration committee, the chairman receives SEK 50,000 and other members SEK 25,000 [2]. Group 2: Share Issuance Authorization - The board was authorized to transfer up to 5,908,018 ordinary shares, with the total number of shares transferred not exceeding 20% of the total ordinary shares issued at the time of the resolution [4][12]. - The purpose of this authorization is to finance acquisitions, procure capital for project development, repay loans, or commercialize products [17]. Group 3: Incentive Programs - A new long-term performance-based incentive program was adopted for board members, which includes share awards contingent on performance conditions [13]. - The company also approved a new long-term incentive program for management and key personnel, granting options that allow for share acquisition at a predetermined price after three years [29]. - The terms for previously outstanding long-term incentive programs were amended to include a net share settlement method [23]. Group 4: Financial Resolutions - The annual general meeting resolved that no dividends would be paid for the financial year 2023, with SEK 904,299 thousand to be carried forward [19]. - The income statement and balance sheet for the financial year 2023 were adopted, and the members of the board and CEO were discharged from liability for that year [25]. Group 5: Board Composition and Election - The board of directors was confirmed to consist of six members without deputies, with Elmar Schnee re-elected as chairman [26]. - Ernst & Young AB was re-elected as the auditor for the company for the same period [26]. Group 6: Remuneration Guidelines - Updated guidelines for remuneration to group management and board members were adopted, allowing variable cash remuneration to exceed 80% of the annual fixed cash salary, up from the previous 60% [30].

Before you hire a law firm, you should talk to a lawyer and ask: NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Monteverde & Associates PC (the "M&A Class Action Firm"), has recovered money for shareholders and is recognized as a Top 50 Firm in the 2018-2022 ISS Securities Class Action Services Report. We are headquartered at the Empire State Building in New York City and are investigating Calliditas Therapeutics AB (NASDAQ: CALT), relating to a tender offer from Asahi Kasei Corporation. Under the terms of the ...

Group 1 - Monteverde & Associates PC is investigating Calliditas Therapeutics AB in relation to a tender offer from Asahi Kasei Corporation, which proposes to acquire all outstanding shares of Calliditas stock for SEK 0.04 in cash per ADS [1] - The tender offer from Asahi Kasei Corporation is set to expire on July 18, 2024 [2] - Monteverde & Associates PC has a successful track record in recovering money for shareholders and is recognized as a Top 50 Firm in the 2018-2022 ISS Securities Class Action Services Report [1][2] Group 2 - The firm is headquartered in the Empire State Building, New York City, and operates as a national class action securities firm [2] - Contact information for inquiries regarding the tender offer and shareholder concerns is provided, including an email and telephone number for Juan Monteverde, Esq. [3]

STOCKHOLM, May 30, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of full marketing authorisation for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). Kinpeygo, which was granted conditional marketing authorisation in EU on 15 July 2022, was the ...

STOCKHOLM, May 30, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of full marketing authorisation for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). Kinpeygo, which was granted conditional marketing authorisation in EU on 15 July 2022, was the ...

Core Insights - Calliditas Therapeutics presented additional efficacy analysis of Nefecon (TARPEYO®) and real-world analysis of systemic glucocorticoids (SGC) in IgA nephropathy (IgAN) at ERA 2024 [1][2] Efficacy Analysis - Treatment with Nefecon for 9 months showed a significant estimated glomerular filtration rate (eGFR) benefit compared to continuous treatment with sparsentan [2][4] - The matching-adjusted indirect comparison (MAIC) methodology indicated that Nefecon had favorable effects on eGFR at 9, 12, and 24 months, with mean differences of 5.68 mL/min/1.73 m² (p<0.001), 3.48 mL/min/1.73 m² (p=0.006), and 3.28 mL/min/1.73 m² (p=0.048) respectively [4] Real-World Analysis - The real-world analysis highlighted significant side effects and costs associated with SGC treatment in IgAN patients, including increased incidents of severe infections and healthcare resource utilization [5][6] - The findings emphasized the need for careful consideration of treatment-emergent toxicity before initiating SGC therapy in IgAN patients [5] Company Positioning - Calliditas aims to establish TARPEYO as a cornerstone therapy for IgAN, focusing on treating the underlying autoimmune pathogenesis associated with the disease [3][7] - The company continues to gather evidence supporting the efficacy and safety of TARPEYO in managing IgAN [3]

Core Viewpoint - The Board of Directors of Calliditas Therapeutics AB unanimously recommends that shareholders accept the public tender offer from Asahi Kasei Corporation, which values the company at SEK 11,164 million [1][3][18]. Group 1: Offer Details - Asahi Kasei has proposed a cash offer of SEK 208 per share and SEK 416 per American Depositary Share (ADS), representing a total offer value of SEK 11,164 million [3][14]. - The offer includes a premium of approximately 83% compared to the closing price of SEK 113.6 on May 27, 2024, and a premium of 74% compared to the closing price of USD 22.42 for the ADS on May 24, 2024 [9][14]. - The acceptance period for the offer is expected to start around July 18, 2024, and end around August 30, 2024, subject to extensions [4]. Group 2: Board's Evaluation - The Board has evaluated the offer based on the company's current market position, future opportunities, and associated risks, considering valuation methods typically used for public offers [11][17]. - The Board believes that the combination with Asahi Kasei will enhance Calliditas' product offerings and accelerate revenue growth and pipeline development [12][18]. - The Board has also noted the Irrevocable Undertakings from the three largest securityholders, representing approximately 44.65% of the total shares, to accept the offer [15]. Group 3: Financial Advisory - Lazard AB is acting as the financial advisor to Calliditas and has provided an opinion that the offer consideration is fair from a financial perspective [8][10][31]. - The financial advisory fee is contingent on the size of the offer consideration and whether the offer is completed [31]. Group 4: Strategic Implications - The proposed acquisition aims to address unmet medical needs in IgA nephropathy, focusing on the continued development of Calliditas' first-to-market product in this area [13]. - Asahi Kasei has expressed its commitment to retaining Calliditas' management and employees while potentially integrating operations for efficiency [18].

Core Viewpoint - The Board of Directors of Calliditas Therapeutics AB unanimously recommends that shareholders accept the public tender offer from Asahi Kasei Corporation, which values the company at SEK 11,164 million [1][3][18]. Group 1: Offer Details - Asahi Kasei has proposed a cash offer of SEK 208 per share and SEK 416 per American Depositary Share (ADS), representing a total offer value of SEK 11,164 million [3][34]. - The offer includes a premium of approximately 83% compared to the closing price of SEK 113.6 on May 27, 2024, and a premium of 74% compared to the closing price of USD 22.42 for the ADS on May 24, 2024 [9][14]. - The acceptance period for the offer is expected to start around July 18, 2024, and end around August 30, 2024, subject to extensions [4]. Group 2: Board's Evaluation - The Board has evaluated the offer based on the company's current market position, future opportunities, and associated risks, considering valuation methods typically used for public offers [11][17]. - The Board believes that the combination with Asahi Kasei will enhance Calliditas' product offerings and accelerate revenue growth and pipeline development [12][18]. - The Board has also noted the Irrevocable Undertakings from the three largest securityholders, representing approximately 44.65% of the total shares, to accept the offer [15]. Group 3: Financial Advisory - Lazard AB is acting as the financial advisor to Calliditas and has provided an opinion that the offer consideration is fair from a financial perspective [8][10][31]. - The financial advisory fee is contingent on the size of the offer consideration and whether the offer is completed [31]. Group 4: Strategic Implications - The proposed acquisition aims to address significant unmet medical needs in IgA nephropathy, focusing on the continued development of Calliditas' first-to-market product in this area [13]. - Asahi Kasei has expressed its commitment to integrating Calliditas' management and employees while recognizing their capabilities [18].