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Calliditas Therapeutics submitted a New Drug Application (NDA) for Nefecon to the FDA, receiving Priority Review with a PDUFA goal date of September 15, 2021. The NDA follows successful outcomes in the Phase 3 NefIgArd trial. In Q1 2021, no net sales were reported, with an operating loss of SEK 150.8 million, contrasting with SEK 72.3 million in Q1 2020. The company bolstered its US team to prepare for potential commercialization in Q4 2021 if approved. Additionally, the EMA granted accelerated assessment for the NDA in April 2021.
Calliditas Therapeutics AB (Nasdaq: CALT) announces the availability of its 2020 Annual Report on its website. This report provides insights into the company's financial performance and strategic direction, particularly focusing on its lead product, Nefecon, aimed at treating IgA nephropathy. Calliditas is conducting a global Phase 3 study for Nefecon with the intent to commercialize it in the U.S. The announcement complies with the Securities Markets Act, highlighting the company's commitment to transparency.
Calliditas Therapeutics is holding its annual general meeting on May 27, 2021, exclusively via advance voting to reduce Covid-19 transmission risk. Shareholders must vote in advance by May 26, 2021. The agenda includes electing board members, approving financial statements, and introducing long-term incentive programs, including performance-based share awards for board members. Proposed share awards are capped at 32,000 shares, with a maximum dilution of 8.1%. No dividends will be paid for the 2020 financial year.
Calliditas Therapeutics announced that its lead candidate, Nefecon, received an accelerated assessment by the EMA's CHMP for treating primary IgA Nephropathy (IgAN). This designation, recognizing the product's major public health significance, shortens the marketing authorization application review period from 210 to 150 days. Calliditas plans to submit the application in Q2 2021 and, if approved, Nefecon could be available in Europe by H1 2022, marking a significant advancement in treatment options for IgAN.
Calliditas Therapeutics announced the appointment of three new leaders in its US organization: Warren Brooks as VP of US Medical Affairs, Teona Johnson as Head of US Marketing, and David Ferraro as Head of US Sales. This strategic move aims to enhance Calliditas’ efforts towards the potential commercialization of its lead product, Nefecon, an innovative treatment for IgA nephropathy. The appointments reflect Calliditas' commitment to building a robust commercial presence in the US, focusing on orphan drug commercialization to meet significant unmet medical needs.
Calliditas Therapeutics announced the completion of the last visit of the 200th patient in Part A of the pivotal NefIgArd Phase 3 study, evaluating Nefecon for IgA nephropathy. The trial, involving 150 sites across 19 countries, follows the successful Phase 2b NEFIGAN study. With recruitment finished, topline data is expected in Q4 2020, and if positive, Calliditas plans to file for regulatory approval in the US and Europe in H1 2021. The CEO expressed excitement over this milestone, emphasizing the focus on timely data analysis.
Calliditas Therapeutics announced the enrollment of the first patient in China into the confirmatory part of the NefIgArd Phase 3 trial, conducted by Everest Medicines. This trial follows prior IND approval by NMPA in December 2019. Calliditas previously completed recruitment of 200 patients for regulatory submission and is targeting topline data for Q4 2020. The trial aims to validate proteinuria as a surrogate marker. Successful outcomes may lead to regulatory approval in the US and Europe, addressing a significant unmet medical need in Asia.
Calliditas Therapeutics AB announced the appointment of Jonathan Schur as Group General Counsel, effective October 1, 2020. Schur brings over 30 years of legal experience, focusing on the pharmaceutical sector, with expertise in U.S. and European legal and regulatory frameworks. This strategic hire is aimed at supporting the company’s growth and advancing its lead product candidate, Nefecon, towards registration. CEO Renée Aguiar-Lucander emphasized the critical role of an experienced legal resource as the company prepares for its next developmental stage.
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