CKD

Gallant Therapeutics Raises Over $15 Million in Series A Funding to Advance Pipeline of "Off-the-Shelf" Stem Cell Therapies for Pets

Retrieved on: 
Monday, January 8, 2024
Pet, Cat, FDA, Conditional sentence, Health, Disease, Microsoft Exchange Server, SAN, Therapy, Dog, Chronic kidney disease, DVM, FCGS, Stem cell, OA, Veterinary medicine, Growth, Gallant, CKD, Pharmaceutical industry

SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Gallant Therapeutics , an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced the successful completion of its Series A financing, securing over $15 million.

Key Points: 
  • SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Gallant Therapeutics , an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced the successful completion of its Series A financing, securing over $15 million.
  • The successful funding round will enable Gallant to accelerate the development of its pipeline of potentially first-in-class allogeneic stem cell therapeutics, focusing on achieving conditional FDA approval for its leading therapeutic candidate targeting FCGS, a deadly disease with a high unmet medical need.
  • “We have made unprecedented progress this past year, hitting significant clinical, regulatory, and manufacturing milestones,” said Linda Black, DVM, Ph.D., CEO of Gallant Therapeutics.
  • This series A funding represents a crucial step toward Gallant’s vision of bringing "off-the-shelf" stem cell therapies to veterinary clinics worldwide.

Mineralys Therapeutics Appoints Minji Kim, Ph.D. as Chief Business Officer

Retrieved on: 
Thursday, January 4, 2024
Seoul National University, Business, National university, Hypertension, Yale School of Management, MBA, License, Min-ji, Aldosterone, Therapy, Chronic kidney disease, Business development, Roche, Doctor of Philosophy, Patient, Corporation, Harvard Medical School, Neurology, Yale school, CKD

Adam Levy will remain in his role as Chief Financial Officer.

Key Points: 
  • Adam Levy will remain in his role as Chief Financial Officer.
  • “With our expanding operations, we have decided to split the functions of Chief Financial Officer and Chief Business Officer into two roles, and we are excited to have Minji join our team.
  • She brings a solid track record of generating value for multiple companies by identifying and executing strategic opportunities,” stated Jon Congleton, Chief Executive Officer of Mineralys.
  • Prior to joining Mineralys, she held the role of Chief Business Officer at Affamed Therapeutics and General Manager at Affamed Digital, and brought multiple products into their pipeline.

Use of SGLT2 Inhibitors Continues to Expand for the Treatment of Chronic Kidney Disease, with Eli Lilly/Boehringer Ingelheim’s Jardiance Making Significant Strides Following Label Expansion

Retrieved on: 
Wednesday, January 3, 2024
Kidney, MRAS, AstraZeneca, Physician, Kidney disease, DMC, Nephrology, Weight loss, Prevalence, BMI, FLOW, Bayer, Diabetic nephropathy, Novo Nordisk, Chronic kidney disease, Proteinuria, Data monitoring committee, Patient, Obesity, MRA, DKD, ACE, SGLT2, Dialysis, CKD, Pharmaceutical industry

As the landscape grows more competitive, their role will be crucial in determining the success of brands like Farxiga and Jardiance.

Key Points: 
  • As the landscape grows more competitive, their role will be crucial in determining the success of brands like Farxiga and Jardiance.
  • This unique positioning compared to other agents was swiftly recognized by nephrologists, prompting them to express a clear preference for the brand.
  • Since the label expansion of Eli Lilly/Boehringer Ingelheim's Jardiance to include CKD, nephrologists have rapidly embraced this drug for both their DKD and non-diabetic CKD patients.
  • Several of these agents, including SGLT2 inhibitors and Kerendia, have demonstrated their effectiveness in slowing the progression of CKD.

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.”

Healis Therapeutics Announces Supply Agreement with CKD Bio to develop CKDB-501 for neuropsychiatric indications

Retrieved on: 
Tuesday, January 2, 2024
Partnership, Post-traumatic stress disorder, Mental health, Depression, Research, WHO, Major depressive disorder, Therapy, PTSD, Bangladesh Technical Education Board, World Health Organization, MDD, Patient, Veterans' affairs, CKD

NEWPORT BEACH, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Healis Therapeutics, a privately held biotechnology company, today announced it has entered into a supply agreement with CKD Bio Corporation (A063160.KS) for CKDB-501, a neuromodulator BoNT/A protein.

Key Points: 
  • NEWPORT BEACH, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Healis Therapeutics, a privately held biotechnology company, today announced it has entered into a supply agreement with CKD Bio Corporation (A063160.KS) for CKDB-501, a neuromodulator BoNT/A protein.
  • CKD Bio is a subsidiary of Chong Kun Dang group based in Seoul, South Korea.
  • Healis Therapeutics intends to develop CKDB-501 for Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD).
  • “Our collaboration with CKD Bio on this new agreement could one day impact over 42 million Americans” said Sebastian De Beurs, Co-Founder of Healis.

Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Date of authorisation: 20/07/2007, Revision: 30, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, Erythropoietin, European Commission, Agency, ESA, Methoxy group, INN, Bone marrow, ATC, Polyethylene, Kidney disease, Hypertension, International, European, Disease, Darbepoetin alfa, Ageing, Blood, Language, Chronic kidney disease, Oxygen, European Medicines Agency, Select, Epoetin alfa, Committee, Iron, Safety, Anatomy, Medicine, Skin, Dialysis, IIA, CHMP, CKD, Medical device

Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Date of authorisation: 20/07/2007, Revision: 30, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Date of authorisation: 20/07/2007, Revision: 30, Status: Authorised

GWM: A Year-Long Streak of Ten Consecutive Months of Sales Growth

Retrieved on: 
Sunday, November 12, 2023
Hydrogen, GWM, Greens–European Free Alliance, Research, Life-cycle assessment, LCA, Growth, Transport, CKD, News, China International Import Expo

Over the first ten months of the year, GWM maintained its impressive growth streak, accumulating total sales of 995,353 vehicles, signifying a 10.29% year-over-year increase.

Key Points: 
  • Over the first ten months of the year, GWM maintained its impressive growth streak, accumulating total sales of 995,353 vehicles, signifying a 10.29% year-over-year increase.
  • Simultaneously, in the first ten months of 2023, overseas sales reached 247,046 units, marking an 86.03% year-over-year growth, while GWM's new energy vehicle sales reached 200,897 units, an extraordinary 86.24% increase from the previous year.
  • October was a pivotal month for GWM as it witnessed record-high monthly sales of both the overseas markets and the new energy.
  • GWM's overseas sales soared to 35,350 units, representing a remarkable year-over-year growth of 67.92%.

Mineralys Therapeutics Announces First Subject Dosed in Launch-HTN, the Second Pivotal Trial of Lorundrostat for the Treatment of Hypertension

Retrieved on: 
Thursday, December 21, 2023
Hypertension, Safety, Chronic kidney disease, Aldosterone, CKD, Therapy, Pharmaceutical industry

RADNOR, Pa., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced that the first subject has been dosed in the Launch-HTN (NCT06153693) pivotal trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), when used as an add-on therapy to prescribed background treatment.

Key Points: 
  • “Initiating this second pivotal trial demonstrates the continued progress we’re making towards introducing a targeted approach to care in hypertension by identifying and profiling potential responders to lorundrostat,” stated Jon Congleton, Chief Executive Officer of Mineralys.
  • This trial is designed to model real world treatment of uHTN and rHTN in the primary care setting.
  • Previously, in May 2023, the Company announced the first subject dosed in the first pivotal trial, Advance-HTN.
  • The Company expects to announce topline data from the Advance-HTN trial in the second half of 2024.

Cara Therapeutics Announces Outcome from Dose-Finding Part A of KIND 1 Study Evaluating Oral Difelikefalin for Moderate-to-Severe Pruritus in Patients with Atopic Dermatitis

Retrieved on: 
Monday, December 18, 2023
Atopic dermatitis, Notalgia paresthetica, Itch, BID, TCS, MD, Therapy, NRS, Week, KIND, Tablet, Patient, Safety, CKD, Pharmaceutical industry

STAMFORD, Conn., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the outcome from the dose-finding Part A of the KIND 1 study evaluating the efficacy and safety of oral difelikefalin as adjunct therapy to topical corticosteroids (TCS) for moderate-to-severe pruritus in adult patients with atopic dermatitis (AD). Oral difelikefalin as adjunct to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone, resulting in the Company’s decision to discontinue its clinical program in pruritus associated with atopic dermatitis.

Key Points: 
  • Oral difelikefalin as adjunct to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone, resulting in the Company’s decision to discontinue its clinical program in pruritus associated with atopic dermatitis.
  • “We are disappointed with the outcome of this study recognizing that comparing the adjunctive use of oral difelikefalin with TCS to TCS alone represented a high clinical bar based on anticipated real-world commercial use.
  • Oral difelikefalin as adjunct therapy to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone.
  • Oral difelikefalin was generally well tolerated with a safety profile similar to prior trials.

Unicycive Therapeutics Announces Enrollment of First Patient in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC) in Patients with Chronic Kidney Disease on Dialysis

Retrieved on: 
Monday, December 18, 2023
Hyperphosphatemia, Quality of life, Physician, OLC, TID, Kidney disease, Trial of the century, NDA, MD, Therapy, Pharmacokinetics, Chronic kidney disease, LOS, Patient, Safety, Dialysis, CKD, Pharmaceutical industry

LOS ALTOS, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).

Key Points: 
  • LOS ALTOS, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).
  • OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
  • “The initiation of patient enrollment in our OLC pivotal clinical trial is a critical milestone as we strive to reduce the pill burden and improve quality of life for individuals with chronic kidney disease on dialysis,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • Once titrated to a clinically effective dose, participants will then be treated for four weeks to evaluate serum phosphate levels.