Calliditas Therapeutics (Formerly known as Pharmalink)
108 articles with Calliditas Therapeutics (Formerly known as Pharmalink)
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 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.
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 Therapeutics AB announced that former Head of North America Commercial, Andrew Udell, has been promoted to President, North America, effective immediately.
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 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 (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.
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.
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
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 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
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.
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.
Calliditas Therapeutics AB announced that the first patient has been dosed in the global open-label extension of the Phase 3 NefIgArd study.
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 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 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
Calliditas Therapeutics AB announced it will provide information on the near-term clinical development plans for setanaxib in primary biliary cholangitis and oncology.
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.
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.