Immunoglobulin A

XORTX Submits a New Patent for the Treatment of Chronic Kidney Disease

Retrieved on: 
Wednesday, January 3, 2024
DN, Immunoglobulin A, IgA nephropathy, Kidney disease, Diabetic nephropathy, Uric acid, Trial of the century, Oxipurinol, Therapy, Autosome, Pharmacokinetics, Focal segmental glomerulosclerosis, Patent, Chronic kidney disease, ADPKD, Treating, Study, Polycystic kidney disease, XRX, Safety, Lupus nephritis, XOI, CKD, Pharmaceutical industry

CALGARY, Alberta, Jan. 03, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, announces submission of a new patent for the treatment of chronic kidney disease (“CKD”).

Key Points: 
  • CALGARY, Alberta, Jan. 03, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, announces submission of a new patent for the treatment of chronic kidney disease (“CKD”).
  • This patent is designed to protect new discoveries and strategies for the treatment of individuals with varied degrees of kidney function in the setting of CKD.
  • This patent application is intended to claim new opportunities to enhance how the xanthine oxidase inhibitor class of drugs may be dosed in the future.
  • Importantly, how to further improve the safe and effective administration of this class of drugs, including oxypurinol.”

Travere Completes Successful pre-NDA Meeting for FILSPARI in IgAN; Provides Regulatory Updates for both IgAN and FSGS

Retrieved on: 
Monday, December 4, 2023
Workforce, Depreciation, Food, Nephrology, Immunoglobulin A, Shanda, FDA, SAN, Therapy, Focal segmental glomerulosclerosis, New Drug Application, Proteinuria, HCU, EGFR, Pharmaceutical industry

SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced the completion of a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan) in IgA nephropathy (IgAN). The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. accelerated approval of FILSPARI to full approval. The Company also completed regulatory engagement on focal segmental glomerulosclerosis (FSGS) in which the FDA communicated that the Phase 3 DUPLEX Study results alone are not sufficient to support an sNDA submission for an FSGS indication for sparsentan. As a result, the Company will be conducting additional analyses of FSGS data with plans to re-engage FDA in 2024, and is implementing a strategic reorganization in Q4 2023 to focus near-term resources on the ongoing FILSPARI launch in IgAN and the advancement of pegtibatinase in classical homocystinuria (HCU).

Key Points: 
  • The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. accelerated approval of FILSPARI to full approval.
  • “Following a successful pre-NDA meeting, we are pleased to be moving forward with our planned sNDA submission for full approval of FILSPARI in IgA nephropathy.
  • “Unfortunately, there is uncertainty around a regulatory path forward for FSGS.
  • Together with $634.6 million in cash and cash equivalents as of September 30, 2023, the Company expects to have a cash runway into 2028.

Aurinia Submits IND Application to US Food & Drug Administration for AUR 200

Retrieved on: 
Wednesday, December 20, 2023
Research, FDA, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Research and development, Food, Immunoglobulin A, Autoimmune disease, BAFF, IND, IgA nephropathy, APRIL, Lupus, Mouse, BCMA, Investigational New Drug, Membrane protein, B-cell activating factor, Rheumatology, American College, Safety, B cell, Pharmaceutical industry

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases.

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases.
  • AUR200 is a highly potent and specific Fc-fusion protein containing a modified B cell maturation antigen (BCMA), for enhanced binding to both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand).
  • “Our IND submission for AUR200 is an important step forward for Aurinia’s pipeline and our mission to change the trajectory of autoimmune disease.
  • Aurinia acquired AUR200 as part of a strategy to diversify its development pipeline and leverage existing R&D capabilities to advance innovative therapeutic solutions to help people living with autoimmune diseases.

Molecular Templates, Inc. Reports Third Quarter 2023 Financial Results and Business Update

Retrieved on: 
Monday, November 13, 2023
CD38, Malignancy, PD-L1, Immunomodulatory imide drug, Neck, Bristol Myers Squibb, Research, Head, Alveolar soft part sarcoma, HIV disease progression rates, Patient, Part, ETB (company), TME, Therapy, Immunoglobulin A, Cancer, Symantec Endpoint Protection, BCMA, CMV, CPS, Biology, Pharmaceutical industry, Nursing, Vaccine, Medical imaging, Engineered wood

The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.

Key Points: 
  • The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.
  • Revenues for the third quarter of 2023 were $6.8 million, compared to $4.2 million for the same period in 2022.
  • Total research and development expenses for the third quarter of 2023 were $7.6 million, compared with $22.0 million for the same period in 2022.
  • Total general and administrative expenses for the third quarter of 2023 were $4.3 million, compared with $5.9 million for the same period in 2022.

Alentis Therapeutics Doses First ANCA-Associated Vasculitis Rapidly Progressive Glomerulonephritis Patient in Phase 2 Clinical Trial of Lixudebart (ALE.F02)

Retrieved on: 
Tuesday, December 5, 2023
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Oncology, Principal, Safety, ANCA, Cirrhosis, Disease, Nephritis, RPGN, Clinical trial, Patient, Dialysis, CLDN1, Pharmacokinetics, University of Cambridge, Immunoglobulin A, Kidney, Diabetes, Trial of the century, Lupus, Aarhus University Hospital, Vasculitis, Pharmaceutical industry

The randomized, double-blind, placebo-controlled Phase 2 study ( NCT06047171 ) of lixudebart evaluates the drug’s safety, tolerability, pharmacokinetics, and how well it protects against the loss of kidney function.

Key Points: 
  • The randomized, double-blind, placebo-controlled Phase 2 study ( NCT06047171 ) of lixudebart evaluates the drug’s safety, tolerability, pharmacokinetics, and how well it protects against the loss of kidney function.
  • The study plans to recruit patients with Antineutrophil Cytoplasmic Antibody (ANCA)-associated vasculitis with Rapidly Progressive Glomerulonephritis (RPGN).
  • This disease typically causes a rapid and dramatic loss of kidney function and can result in kidney loss with patients requiring dialysis or a transplant.
  • It is the second clinical trial investigating lixudebart in patients after the initiation of a clinical study in advanced liver fibrosis patients earlier this year,” said Dr. Luigi Manenti, Chief Medical Officer of Alentis.

Alpine Immune Sciences Presents New Translational Data on Povetacicept in Systemic Lupus Erythematosus at American College of Rheumatology Convergence 2023

Retrieved on: 
Wednesday, November 15, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, APRIL, Rheumatology, WT, Patient, TACI, Inflammation, Lupus, American College, Glomerulonephritis, BAFF, SLE, ALPN, Immunoglobulin A, Trial of the century, BCMA, Autoimmunity, IgA nephropathy, Pharmaceutical industry, Vaccine

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced today that the Company presented new translational data for povetacicept (ALPN-303) in systemic lupus erythematosus (SLE) at the American College of Rheumatology Convergence 2023, November 10-15, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced today that the Company presented new translational data for povetacicept (ALPN-303) in systemic lupus erythematosus (SLE) at the American College of Rheumatology Convergence 2023, November 10-15, 2023.
  • In SLE patients, BAFF- and APRIL-related genes (i.e., BAFF, APRIL, TACI, and BCMA) are increased in myeloid lineage cells and B cells compared to healthy adults.
  • Povetacicept, as compared to single BAFF or APRIL pathway inhibitors, more potently downregulates genes associated with activation in B cells.
  • Povetacicept significantly reduces multiple disease parameters in a mouse model of lupus, more effectively than WT TACI-Fc or conventional B cell depletion.

Alpine Immune Sciences Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 14, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Immunoglobulin G, ASN, PMN, UPCR, Investment, Clinical trial, American Society of Nephrology, APRIL, Glomerular filtration rate, Administration, Patient, TACI, Inflammation, Immunoglobulin A, Neonatal Fc receptor, Lupus, Infection, Research program, BAFF, SLE, ALPN, Immunoglobulin M, MD, Development, EGFR, BCMA, Society, NIH Intramural Research Program, Autoimmunity, Proteinuria, AANEM, Pharmaceutical industry, Sewage treatment, Vaccine, Paint, IgA nephropathy, AbbVie, Alpine

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results and company highlights for the third quarter ended September 30, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results and company highlights for the third quarter ended September 30, 2023.
  • “Following our data presentation, we executed a follow-on equity offering of $150 million to bolster our balance sheet.
  • Cash Position and Runway: As of September 30, 2023, Alpine’s cash and investments totaled $227.2 million compared to $273.4 million as of December 31, 2022.
  • The respective increases of $0.8 million and $2.3 million were primarily attributable to increases in personnel and legal costs.

Kira Pharmaceuticals Presents Positive Results of KP104 Phase 2 Study in Complement-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) at the 2023 ASH Annual Meeting

Retrieved on: 
Thursday, December 14, 2023
Safety, Interim, ASH, Cohort, Headache, PD, PNH, Patient, ULN, IgA nephropathy, Week, Microangiopathy, Pharmacokinetics, Immunoglobulin A, COVID19, Common, Society, RBC, LDH, Medical device, Pharmaceutical industry, Fine chemical, Vaccine

The interim results support the advancement of KP104 to Phase 3 studies as an optimal and safe treatment for PNH patients to address currently unmet medical needs.

Key Points: 
  • The interim results support the advancement of KP104 to Phase 3 studies as an optimal and safe treatment for PNH patients to address currently unmet medical needs.
  • The presentation has also been selected to be featured in the 2024 Highlights of ASH.
  • Kira Pharmaceuticals is committed to advancing KP104 as an innovative therapy for patients with PNH and other complement-mediated diseases.
  • Title: KP104, a bifunctional C5 antibody/factor H fusion protein, effectively controls both intravascular and extravascular hemolysis: interim results from a phase 2 study in complement inhibitor-naïve PNH patients

Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®

Retrieved on: 
Monday, December 11, 2023
Capsule, Sustainability, Budesonide, CALT, CET, Orange Book, Immunoglobulin A, Person, Patent, IgA nephropathy, Medical device

STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.

Key Points: 
  • STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.
  • "  This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
  • Calliditas expects the resulting patent will be Orange Book-listable, with an anticipated expiration date in 2043.
  • The patent, when issued, will be Calliditas' second patent for TARPEYO in the United States.

Calliditas Receives Notice of Allowance for United States Patent Application Covering TARPEYO®

Retrieved on: 
Monday, December 11, 2023
Capsule, Sustainability, Budesonide, CALT, CET, Orange Book, Immunoglobulin A, Person, Patent, IgA nephropathy, Medical device

STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.

Key Points: 
  • STOCKHOLM, Dec. 11, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no.
  • "  This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.
  • Calliditas expects the resulting patent will be Orange Book-listable, with an anticipated expiration date in 2043.
  • The patent, when issued, will be Calliditas' second patent for TARPEYO in the United States.