Calliditas Therapeutics AB American Depositary Shares - CALT STOCK NEWS

Calliditas Therapeutics AB (Nasdaq: CALT) announced the promotion of Andrew Udell to President, North America, effective immediately. Udell, who has been with the company since 2019, will manage US activities, including sales and marketing. The move comes as the FDA has accepted the New Drug Application for Calliditas' product candidate, Nefecon, for IgA nephropathy, with a PDUFA goal date of September 15, 2021. This positions Calliditas for potential commercialization of Nefecon, addressing a significant medical need.

Calliditas Therapeutics announced that the FDA has accepted its New Drug Application for Nefecon, aimed at treating IgA nephropathy, granting it Priority Review. The FDA set a goal date of September 15, 2021 for the application. Nefecon, based on successful Phase 3 trial data, seeks to provide the first approved medication for IgAN patients. The company has also applied for accelerated approval, pending positive clinical data and market launch in the US around Q4 2021, subject to regulatory approval.

Calliditas Therapeutics AB (Nasdaq: CALT) has announced a change in its financial calendar, moving the publication of its interim report for Q1 2021 from May 13, 2021, to May 18, 2021. This shift is due to the overlap with Ascension Day. Calliditas is developing Nefecon, an oral formulation of budesonide for treating IgA nephropathy, targeting a high unmet medical need. The company is undertaking a global Phase 3 study and aims to commercialize the treatment in the U.S.

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.

On March 15, 2021, Calliditas Therapeutics AB (CALT) announced the submission of a New Drug Application (NDA) for Nefecon to the FDA. This oral formulation targets down regulation of IgA1 for treating primary IgA Nephropathy (IgAN). Calliditas seeks accelerated approval under Subpart H based on data from successful Phase 3 and Phase 2b trials, which met primary and key secondary endpoints, including significant proteinuria reduction. If approved, Nefecon could be the first therapy specifically designed for IgAN.

Calliditas Therapeutics has appointed three experienced professionals: 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 is part of Calliditas' effort to enhance its US organization in anticipation of commercializing its lead drug candidate, Nefecon, aimed at treating IgA nephropathy. Each appointee brings extensive industry experience, with a focus on orphan drug commercialization and a commitment to addressing significant unmet medical needs.

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.