Calliditas Therapeutics (Formerly known as Pharmalink)

108 articles with Calliditas Therapeutics (Formerly known as Pharmalink)

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  Calliditas is Getting to the Heart of Berger’s Disease

  6/2/2021

  Calliditas is developing Nefecon, a down regulator of IgA1 and proprietary, novel oral formulation of budesonide – a potent and established immunosuppressant – for the treatment of IgAN.

• Calliditas Therapeutics to Present at Jefferies Virtual Healthcare Conference - May 28, 2021

  5/28/2021

  Calliditas Therapeutics AB announced that management will present at the Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 2:30 pm CET/8:30 am ET. Calliditas will also host 1x1 meetings during the conference.

• Interim Report Q1, 2021

  5/18/2021

  Following the positive top line readout of our pivotal Phase 3 trial NefIgArd, which met both the primary and key secondary endpoints with results being statistically significant and clinically relevant we commenced the regulatory filing process which ultimately resulted in the timely filing of the submission to the FDA in Q1 as planned.

• Calliditas promotes Andrew Udell to President, North America

  5/3/2021

  Calliditas Therapeutics AB announced that former Head of North America Commercial, Andrew Udell, has been promoted to President, North America, effective immediately.

• FDA grants priority review for Nefecon, for patients with IgA nephropathy

  4/28/2021

  Calliditas Therapeutics AB announced that the U.S. Food and Drug Administration has accepted the submission and granted Priority Review for the New Drug Application for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy The FDA has set a Prescription Drug User Fee Act goal date of September 15, 2021.

• Calliditas Therapeutics' 2020 Annual Report Published

  4/27/2021

  Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2020 now is available at the company's website: www.calliditas.com.

• Calliditas Therapeutics AB: Change in financial calendar

  4/27/2021

  Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) announces today that the Board has decided that the interim report for the first quarter 2021 will be published on May 18, 2021 . The previously planned date for publication was May 13, 2021 , which is the Ascension Day.

• Notice of annual general meeting of Calliditas Therapeutics AB (publ) - Apr 26, 2021

  4/26/2021

  The shareholders of Calliditas Therapeutics AB, Reg. No. 556659-9766, with registered office in Stockholm, are summoned to the annual general meeting on Thursday 27 May 2021.

• EMA Grants Accelerated Assessment Procedure for Nefecon for the Treatment of IgA Nephropathy

  4/23/2021

  Calliditas Therapeutics AB announced that its lead product candidate Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy, has been granted accelerated assessment procedure by the European Medicine Agency's Committee for Human Medicinal Products.

• Calliditas Announces Submission of New Drug Application to U.S. FDA for Nefecon in Patients with Primary IgA Nephropathy

  3/15/2021

  Calliditas Therapeutics AB announced the submission of a New Drug Application to the U.S. Food and Drug Administration for Nefecon, a novel oral formulation targeting down regulation of IgA1 for the treatment of primary IgA Nephropathy.

• Calliditas strengthens its US Commercial and Medical Affairs Organization

  3/8/2021

  Calliditas Therapeutics AB announced the appointment of three industry veterans: Warren Brooks, PhD, as Vice President of US Medical Affairs, Teona Johnson as Head of US Marketing and David Ferraro as Head of US Sales.

• Calliditas Therapeutics to Host Key Opinion Leader Perspectives Webinar on the Pathophysiology and Treatment of IgA Nephropathy in Clinical Practice

  3/4/2021

  Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it will host a Key Opinion Leader (KOL) Perspectives webinar on the Pathophysiology and Treatment of IgA Nephropathy in Clinical Practice on Wednesday, March 10, 2021 at 10:00am Eastern Time.

• Calliditas Therapeutics: Year-End Report, 2020

  2/18/2021

  On November 8, 2020, we announced positive topline readout of Part A of our Phase 3 pivotal trial, NefIgArd. The results were statistically significant and clinically relevant: proteinuria showed a 31% reduction versus baseline, a stronger effect than what was seen in the Phase 2b, which is generally not expected when moving from Phase 2 to Phase 3.

• First Patient Dosed in NefIgArd Open Label Extension Study

  2/4/2021

  Calliditas Therapeutics AB announced that the first patient has been dosed in the global open-label extension of the Phase 3 NefIgArd study.

• Calliditas announces termination of the proposed global offering

  1/28/2021

  Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; Nasdaq - CALT) today announced that despite significant interest, it will not pursue the previously announced proposed global offering due to deterioration in market conditions. "This was an opportunistic capital raise against the backdrop of a strong overall ma

• Calliditas Therapeutics launches proposed global offering

  1/26/2021

  Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX: CALTX) (Nasdaq: CALT) will today launch a proposed public offering of American Depositary Shares ("ADSs"), in the United States for trading on The Nasdaq Global Select Market in the United States (the "U.S. Offering")

• Calliditas Announces Full Enrollment of the Phase 3 NefIgArd Trial

  1/21/2021

  Calliditas Therapeutics AB announced that all 360 patients have been enrolled for the global Phase 3 clinical trial NefIgArd, which investigates the effect of Nefecon® versus placebo in patients with primary IgA nephropathy.

• Calliditas announces clinical development plan for setanaxib and comments on data from Part A of NefIgArd study at today´s R&D Day

  1/20/2021

  Calliditas Therapeutics AB announced it will provide information on the near-term clinical development plans for setanaxib in primary biliary cholangitis and oncology.

• Positive Phase 1 results in high-dose setanaxib trial

  1/18/2021

  Genkyotex SA, a subsidiary of Calliditas Therapeutics AB, announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex's lead asset.

• Agenda for Calliditas virtual R&D Day on January 20, 2021

  1/15/2021

  Calliditas Therapeutics AB announced the program for the upcoming virtual R&D Day for investors, analysts and journalists on January 20, 2021, which will take place between 1pm and 5pm CET.