Alport

Calliditas Interim Report January - September 2023

Retrieved on: 
Tuesday, November 7, 2023
International Symposium on Endovascular Therapy, FDA, Operating cost, PDUFA, SEK, Nephrology, Magazine, ASN, NOX, USD, CMO, IgA nephropathy, Alport syndrome, Rare-earth element, Cryptocurrency, Pharmaceutical industry, Alport, EU, Lancet

Operating loss amounted to SEK 159.6 million and SEK 36.2 million for the three months ended September 30, 2023, and 2022, respectively.

Key Points: 
  • Operating loss amounted to SEK 159.6 million and SEK 36.2 million for the three months ended September 30, 2023, and 2022, respectively.
  • Significant Events in Q3 2023, in Summary
    On July 13 Calliditas announced supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib.
  • Calliditas invites investors, analysts and press to a presentation of the Quarterly Report 2023 at 14:30 pm.
  • Calliditas' CEO Renee Aguiar-Lucander will present the report together with CFO Fredrik Johansson, CMO Richard Philipson and President North America Andrew Udell.

Calliditas Interim Report January - September 2023

Retrieved on: 
Tuesday, November 7, 2023
International Symposium on Endovascular Therapy, FDA, Operating cost, PDUFA, SEK, Nephrology, Magazine, ASN, NOX, USD, CMO, IgA nephropathy, Alport syndrome, Rare-earth element, Cryptocurrency, Pharmaceutical industry, Alport, EU, Lancet

Operating loss amounted to SEK 159.6 million and SEK 36.2 million for the three months ended September 30, 2023, and 2022, respectively.

Key Points: 
  • Operating loss amounted to SEK 159.6 million and SEK 36.2 million for the three months ended September 30, 2023, and 2022, respectively.
  • Significant Events in Q3 2023, in Summary
    On July 13 Calliditas announced supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib.
  • Calliditas invites investors, analysts and press to a presentation of the Quarterly Report 2023 at 14:30 pm.
  • Calliditas' CEO Renee Aguiar-Lucander will present the report together with CFO Fredrik Johansson, CMO Richard Philipson and President North America Andrew Udell.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Tuesday, November 7, 2023
Science, Glomerulosclerosis, B-cell activating factor, DSM-IV codes, Ramipril, Biomarker, Rare, Budesonide, EGFR, Kidney, Person, CD23, Fibrosis, GALT, ACE, Protein, Society, American Society of Nephrology, BAFF, CD30, Urine, ASN, Record, Serum, CET, NOX, Immunoglobulin A, CALT, Histology, Patient, CD27, Alport syndrome, Pharmaceutical industry, Vaccine, IgA nephropathy, Publication, Alport

The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.

Key Points: 
  • The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.
  • The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug.
  • Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points.
  • Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Tuesday, November 7, 2023
Science, Glomerulosclerosis, B-cell activating factor, DSM-IV codes, Ramipril, Biomarker, Rare, Budesonide, EGFR, Kidney, Person, CD23, Fibrosis, GALT, ACE, Protein, Society, American Society of Nephrology, BAFF, CD30, Urine, ASN, Record, Serum, CET, NOX, Immunoglobulin A, CALT, Histology, Patient, CD27, Alport syndrome, Pharmaceutical industry, Vaccine, IgA nephropathy, Publication, Alport

The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.

Key Points: 
  • The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.
  • The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug.
  • Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points.
  • Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation.

Calliditas Therapeutics to Present Seven Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Thursday, October 19, 2023
Kidney, Pregnancy, Adrenal insufficiency, Biomarker, EGFR, Vaccine, Glaucoma, Budesonide, American Society of Nephrology, Diabetes, Infection, Ritonavir, CYP3A4, Ciclosporin, Disease, Risk, Capsule, Itraconazole, UPCR, Parasitism, Hypersensitivity, Proteinuria, Alport syndrome, Saquinavir, Measles, Prediabetes, Miscarriage, Immune system, HPA, Ketoconazole, Fetus, CALT, Patient, Anaphylaxis, Tropical ulcer, IgA nephropathy, Indinavir, BAFF, Contraindication, Serum, Cataract, Birth, Administration, Society, Liver, Erythromycin, ASN, Hypertension, Osteoporosis, Immunoglobulin A, Drug interaction, Immunosuppression, Pharmaceutical industry, Dietary supplement, Alport

STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.

Key Points: 
  • STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.
  • Poster presentation details are below and will be available on the Presentation and Publication page on the Calliditas' corporate website following the meeting.
  • It has not been established whether TARPEYO slows kidney function decline in patients with IgAN.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.

Calliditas Therapeutics to Present Seven Abstracts at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Thursday, October 19, 2023
Kidney, Pregnancy, Adrenal insufficiency, Biomarker, EGFR, Vaccine, Glaucoma, Budesonide, American Society of Nephrology, Diabetes, Infection, Ritonavir, CYP3A4, Ciclosporin, Disease, Risk, Capsule, Itraconazole, UPCR, Parasitism, Hypersensitivity, Proteinuria, Alport syndrome, Saquinavir, Measles, Prediabetes, Miscarriage, Immune system, HPA, Ketoconazole, Fetus, CALT, Patient, Anaphylaxis, Tropical ulcer, IgA nephropathy, Indinavir, BAFF, Contraindication, Serum, Cataract, Birth, Administration, Society, Liver, Erythromycin, ASN, Hypertension, Osteoporosis, Immunoglobulin A, Drug interaction, Immunosuppression, Pharmaceutical industry, Dietary supplement, Alport

STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.

Key Points: 
  • STOCKHOLM, Oct. 19, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas"), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.
  • Poster presentation details are below and will be available on the Presentation and Publication page on the Calliditas' corporate website following the meeting.
  • It has not been established whether TARPEYO slows kidney function decline in patients with IgAN.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.

Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib

Retrieved on: 
Wednesday, September 27, 2023
Kidney disease, ESRD, US Foods, IR, Chronic kidney disease, PBC, ODD, Cochlea, SCCHN, Head, Alport syndrome, Neck, Trial of the century, Hypertension, Proteinuria, Internet, Primary biliary cholangitis, Sustainability, Genetic disorder, Patient, Huber loss, CALT, FDA, SA, IPF, CKD, Gene, Idiopathic pulmonary fibrosis, Food, Pharmaceutical industry, Satellite navigation device, GFR, Alport

STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.

Key Points: 
  • STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.
  • Based on supportive pre-clinical work, Calliditas plans to initiate a randomized, placebo-controlled phase 2 clinical study in Alport syndrome with around 20 patients in the fourth quarter of 2023.
  • "We are excited to start another clinical program in the renal space targeting an orphan indication where today there are no approved products," said CEO Renée Aguiar-Lucander.
  • Alport syndrome is a genetic disorder arising from the mutations in the genes that code for type 4 collagen.

Calliditas Therapeutics granted orphan drug designation by the FDA for the treatment of Alport syndrome with setanaxib

Retrieved on: 
Wednesday, September 27, 2023
Kidney disease, ESRD, US Foods, IR, Chronic kidney disease, PBC, ODD, Cochlea, SCCHN, Head, Alport syndrome, Neck, Trial of the century, Hypertension, Proteinuria, Internet, Primary biliary cholangitis, Sustainability, Genetic disorder, Patient, Huber loss, CALT, FDA, SA, IPF, CKD, Gene, Idiopathic pulmonary fibrosis, Food, Pharmaceutical industry, Satellite navigation device, GFR, Alport

STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.

Key Points: 
  • STOCKHOLM, Sept. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.
  • Based on supportive pre-clinical work, Calliditas plans to initiate a randomized, placebo-controlled phase 2 clinical study in Alport syndrome with around 20 patients in the fourth quarter of 2023.
  • "We are excited to start another clinical program in the renal space targeting an orphan indication where today there are no approved products," said CEO Renée Aguiar-Lucander.
  • Alport syndrome is a genetic disorder arising from the mutations in the genes that code for type 4 collagen.

Eloxx Pharmaceuticals Announces $2 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

Retrieved on: 
Tuesday, September 19, 2023
Park Avenue, Regulation D, RNA, Alport syndrome, Sale, 3rd Floor, Form, Security (finance), Rare, Alport

In a concurrent private placement, Eloxx has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 380,590 of its shares of common stock.

Key Points: 
  • In a concurrent private placement, Eloxx has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 380,590 of its shares of common stock.
  • The offering is expected to close on or about September 20, 2023, subject to the satisfaction of customary closing conditions.
  • The gross proceeds to Eloxx from the offering are expected to be approximately $2 million, before deducting the placement agent’s fees and other offering expenses payable by Eloxx.
  • The offering of the shares of common stock (or common stock equivalents) to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement.

Eloxx Pharmaceuticals Reports Independent Confirmation of Positive Biopsy Results in All Patients Treated with ELX-02 in Phase 2 Clinical Study for Alport Syndrome

Retrieved on: 
Monday, September 18, 2023
Drug discovery, Food and Drug Administration, Breakthrough therapy, TEM, RNA, Alport syndrome, Patient, Proteinuria, Investigational New Drug, Rare, FDA, IND, Food, UPCR, Disease, Pharmaceutical industry, Medical imaging, Alport

WATERTOWN, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today reported additional independent confirmation on the positive TEM assessment results from its proof-of-concept Phase 2 open-label clinical trial (NCT05448755) of ELX-02 for the treatment of Alport syndrome after eight weeks of treatment. Visual assessment of TEM images from kidney biopsies showed an improvement in foot process effacement in all three treated patients consistent with disease regression. Alport syndrome is a rare genetic kidney disorder caused by mutations in COL4A3/4/5 genes, characterized by podocyte injury and impaired kidney filter function leading to proteinuria.

Key Points: 
  • Visual assessment of TEM images from kidney biopsies showed an improvement in foot process effacement in all three treated patients consistent with disease regression.
  • Alport syndrome is a rare genetic kidney disorder caused by mutations in COL4A3/4/5 genes, characterized by podocyte injury and impaired kidney filter function leading to proteinuria.
  • Eloxx recently submitted an Investigational New Drug application (IND) to the FDA for ELX-02 for the treatment of Alport syndrome with nonsense mutations.
  • The IND, if allowed, would enable the inclusion of U.S.-based sites in the planned pivotal trial.