Calliditas Therapeutics AB American Depositary Shares - CALT STOCK NEWS

Calliditas Therapeutics has entered a significant agreement with Viatris to commercialize Nefecon® in Japan, targeting IgA Nephropathy. The deal includes an upfront payment of $20M and potential milestone payments up to $80M. Viatris will also offer mid-teens percentage royalties on net sales. This agreement aims to address the unmet medical needs of patients with IgAN in Japan, a severe autoimmune disease.

Calliditas Therapeutics AB will host a fireside chat with Everest Medicines on December 14, 2022, at 8am ET. The event will feature Everest’s new CEO, Rogers Yongqing Luo, and CMO Zhengying Zhu, who will discuss the IgA nephropathy landscape in China and the NefIgArd clinical trial. Calliditas and Everest's partnership began in 2019 to develop Nefecon for IgAN. Everest's NDA for Nefecon was accepted for review in November 2022. For registration, click here.

Calliditas Therapeutics (CALT) announced that the National Medical Products Administration (NMPA) of China has accepted Everest Medicines' New Drug Application (NDA) for Nefecon. This follows a Breakthrough Therapy Designation recommendation from the NMPA in December 2020, targeting the significant IgAN patient population in China, estimated at around five million. Nefecon is already marketed in the U.S. as TARPEYO and in the E.U. as Kinpeygo. Calliditas, which licensed Nefecon to Everest for Greater China and Singapore, is optimistic about providing a treatment option for IgAN patients.

Calliditas Therapeutics received conditional marketing authorization for Kinpeygo in the EU, making it the first approved treatment for IgA nephropathy. The product will launch in Germany initially, with other European countries to follow. In the US, TARPEYO saw a 94% sales growth quarter-over-quarter, reaching SEK 123.4 million (~$12.1 million) in Q3. Total net sales for the quarter amounted to SEK 260.1 million. The company anticipates continued growth in 2023, driven by increasing familiarity among nephrologists and ongoing clinical developments.

Calliditas Therapeutics is hosting a Key Opinion Leader (KOL) Fireside Chat on November 8, 2022, focusing on the treatment landscape for IgA Nephropathy (IgAN) in the US. KOL Richard Lafayette, M.D. from Stanford Healthcare, will present on proteinuria reduction and findings from the NefIgArd study. A live Q&A will follow. Calliditas, based in Stockholm, is known for its Nefecon product, approved by the FDA as TARPEYO® and launched as KINPEYGO® in the EU. The company's shares are traded as CALT on NASDAQ.

Calliditas Therapeutics AB has announced the composition of its nomination committee for the upcoming 2023 Annual General Meeting (AGM), scheduled for May 17, 2023. The committee, formed under principles established in 2017, includes Patrick Sobocki, Karl Tobieson, Jan Särlvik, and Elmar Schnee as chairman. The committee's responsibilities involve proposing board member elections, committee chairs, auditors, and fee determinations. Shareholders can submit their proposals by March 29, 2023. Further details are available on the company's website.

Calliditas Therapeutics AB (Nasdaq: CALT) announced the publication of successful results from the NefIgArd Part A study in Kidney International. This pivotal Phase 3 trial assessed TARPEYO's efficacy in reducing proteinuria and improving estimated glomerular filtration rate (eGFR) in patients with primary immunoglobulin A nephropathy (IgAN). TARPEYO demonstrated a statistically significant 34% reduction in proteinuria compared to placebo after 9 months. These findings support TARPEYO's potential as a disease-modifying therapy, although further confirmatory trials are necessary.

Calliditas Therapeutics (CALT) announced that its partner, STADA Arzneimittel AG, has launched the first approved treatment for primary immunoglobulin A nephropathy (IgAN) in the EU, starting in Germany. This marks a significant milestone for Calliditas after receiving conditional approval from the European Commission for Nefecon. The treatment addresses the high unmet need in a rare kidney disease, with implications for all EU member states. This launch signifies the introduction of STADA's first orphan medicine, expanding treatment options for patients at risk of rapid disease progression.

Calliditas Therapeutics announced on August 18, 2022 that KINPEYGO® received conditional marketing authorization from the European Commission for treating IgA nephropathy, marking a historic first for this rare disease in Europe. In the U.S., TARPEYO® generated net revenues of SEK 63.6 million ($6.6m) in Q2, reflecting a growth of over 250% from Q1. The company also reported an operating loss of SEK 209.8 million for the quarter, compared to SEK 159.4 million in the same period last year.