STOCKHOLM, April 18, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced additional data analyses from the 2-year Phase 3 NeflgArd trial evaluating Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN), were presented at the ISN World Congress of Nephrology in Buenos Aires, Argentina on April 13-16, 2024. "We were pleased to share additional analyses from the 2-year Phase 3 NeflgArd tria ...

公司活动 - Calliditas Therapeutics AB将参加多个投资者和行业会议[1] - 公司管理层将出席多个会议并参与不同的讨论和主持[2] - 公司代表将就未来商业模式和知识产权尽职调查等议题进行讨论[3]

STOCKHOLM, April 8, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced upcoming data presentations, as well as a sponsored symposium at the International Society of Nephrology's World Congress of Nephrology.  The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.Investigators will deliver additional analyses from the 2-year Phase 3 NeflgArd trial with Nefecon (TARPEYO® (budesonide) delayed release ...

合作伙伴关系 - Everest Medicines的合作伙伴Calliditas Therapeutics AB宣布，美国FDA授予Nefecon®孤儿药七年的市场独家权[1] 产品批准 - Nefecon®获得全面批准后，适用于成年原发性免疫球蛋白A肾病（IgAN）患者，旨在减少肾功能损失[2] 市场拓展 - Nefecon®在中国获得NDA批准并在澳门成功商业化后，即将在中国大陆进行商业推出，以尽快为500万IgAN患者提供药物[4]

STOCKHOLM, March 6, 2024 /PRNewswire/ --  Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas') today announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. Following full approval in December 2023, TARPEYO® (budesonide) is indicated 'to reduce the loss of kidney function in adults with primary immunoglobulin A nephro ...

STOCKHOLM, March 1, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) and (Nasdaq Stockholm: CALTX) ("Calliditas"), a commercial biopharma company focused on rare diseases today announced that Renee Aguiar-Lucander, CEO of Calliditas will participate in the following March 2024 conferences.  Carnegie Healthcare Seminar, Wednesday, March 6, 2024.  Fireside chat will be held at 10:20 - 10:50 am CET and one-on-one meetings will be available. Jefferies Biotech on the Bay Summit, Wednesday, March 13 ...

财务数据和关键指标变化 - 2023年第四季度总收入为4.52亿瑞典克朗,其中TARPEYO产品销售收入为3.47亿瑞典克朗,同比增长108% [28][29] - 2023年全年总收入为12.07亿瑞典克朗,TARPEYO全年产品销售收入为10.75亿瑞典克朗,同比增长189% [28][29] - 公司在第四季度实现了正的经营活动现金流,这是公司在2023年设定的目标 [31] - 公司在第四季度完成了信贷融资,使得利息支付期延长至2026年底 [31] - 公司在第四季度末拥有9.74亿瑞典克朗(约9360万美元)的现金余额 [31] - 公司预计2024年总销售额将在1.5亿美元至1.8亿美元之间 [32] 各条业务线数据和关键指标变化 - 第四季度TARPEYO新增处方医生数量增长超过50%,新增患者登记量增长51% [22][23] - 公司在第三季度扩大了TARPEYO的商业和医疗团队,目前拥有约100名现场员工 [23][24] 各个市场数据和关键指标变化 - 公司在中国获得了Nefecon的有条件批准,这为公司在中国这个大市场提供了机会 [5] - 公司正期待其合作伙伴Everest Medicines在2024年第二季度在中国启动Nefecon的商业化推广 [5] - 公司在欧洲的合作伙伴STADA正在推动Kinpeygo在其他欧洲国家的上市 [12] 公司战略和发展方向及行业竞争 - 公司获得TARPEYO在美国的全面批准,新适应症反映了该药物对肾功能损失的减少作用,适用于所有有疾病进展风险的IgA肾病患者 [4] - 公司认为TARPEYO的疾病修饰特性将继续推动肾脏专科医生的需求,成为IgA肾病标准治疗的基础 [11][35] - 公司正在关注KDIGO指南的更新,预计其可能会扩大TARPEYO的适应症人群 [26] - 公司正在关注其他在研药物(如APRIL/BLyS抑制剂)的临床进展,但认为它们与TARPEYO的作用机制不同,两者可能会互补 [49][50] 管理层对经营环境和未来前景的评论 - 公司预计在2024年上半年,新标签与现有支付规则之间可能存在一些不匹配,需要一定时间进行调整 [10] - 公司认为2024年第一季度可能会受到季节性影响,但预计下半年将会更强劲 [39][40] - 公司对TARPEYO在IgA肾病治疗中的地位和未来发展前景保持乐观 [11][35] 问答环节重要的提问和回答 问题1 **Maurice Raycroft 提问** 对2024年收入指引的假设和主要驱动因素是什么,以及第四季度的555例新患者登记如何影响指引 [38][39][40] **Renee Aguiar-Lucander 回答** - 预计上半年可能会受到一些市场准入障碍的影响,需要一定时间让支付政策与新标签相匹配 - 下半年预计会更强劲 - 还考虑了KDIGO指南更新时间的不确定性 - 参考了其他肾脏药物的上市情况和预期 [39][40] 问题2 **Vamil Divan 提问** 对IgA肾病市场规模的最新看法,以及对APRIL/BLyS抑制剂等新兴竞争药物的影响 [47][48] **Renee Aguiar-Lucander 和 Richard Philipson 回答** - IgA肾病患者群体中,目前很多患者可能没有得到积极治疗,随着更多临床数据的积累,预计市场会逐步发展 - APRIL/BLyS抑制剂等新药与TARPEYO的作用机制不同,两者可能会互补,具体影响还需进一步了解新药的临床数据和安全性 [49][50] 问题3 **Annabel Samimy 提问** 新处方医生和老处方医生在推动患者登记方面的差异,以及KDIGO指南更新对销售的潜在影响 [70][71][72] **Renee Aguiar-Lucander 回答** - 新老处方医生在推动患者登记方面的差异不太清楚 - KDIGO指南如果将高风险人群定义降低,例如从1.5克/日降到0.75克/日或0.5克/日,将显著扩大TARPEYO的适应症人群 [72]

STOCKHOLM, Feb. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the United States Patent and Trademark Office (USPTO) issued patent no. 11896719, entitled "New Pharmaceutical Compositions, on January 24, 2024 with validity as of today, February 13, 2024.  This is Calliditas' second patent for TARPEYO in the United States, and provides product protection until 2043. The patent covers a method of treating IgA nephropathy with a co ...

STOCKHOLM, Jan. 7, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that management will present at and participate in the 42nd Annual J.P. Morgan Healthcare Conference, which is taking place January 8-11, 2024, in San Francisco, California. Calliditas will present an update on the company at 7:30 am PT on Tuesday 9th January.For further information, please contact:Åsa Hillsten, Head of IR & Sustainability, CalliditasTel.: +46 76 403 35 ...

SHANGHAI, Dec. 20, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced that the U.S. Food and Drug Administration (FDA) had approved Nefecon® delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Nefecon® was first approved in December 2021 under the FDA accelerated a ...