Hyperphosphatemia

EQS-News: How One Company Plans To Help Battle A Silent Killer Globally Through Its New Kidney Disease Medication

Retrieved on: 
Friday, September 23, 2022
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Most people are surprised to learn that chronic kidney disease (CKD) is the fastest growing, non-communicable disease in the United States.

Key Points: 
  • Most people are surprised to learn that chronic kidney disease (CKD) is the fastest growing, non-communicable disease in the United States.
  • In fact, each year, more people die from this silent killer than from breast or prostate cancer.
  • Hyperphosphatemia (elevated phosphorus levels in the blood) is a common complication of CKD affecting over 80% of dialysis patients.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.

Unicycive Reports Key Findings of UNI-494 Efficacy in Preclinical Animal Model of Acute Kidney Injury (AKI)

Retrieved on: 
Wednesday, September 7, 2022
ADME, Literature, Enzyme, IgG4-related ophthalmic disease, Acute kidney injury, Vance DeGeneres, University, Kidney, Potassium, Safety, Hepatic encephalopathy, Research, Therapy, AKI, Chronic kidney disease, Randomized controlled trial, Hyperphosphatemia, Decision-making, Degenerative disease, Ischemia-reperfusion injury of the appendicular musculoskeletal system, MG, Macular degeneration, KATP, LOS, Kidney disease, RATS, Patent, Alcoholic hepatitis, Liver disease, Animal, GLOBE, Pharmacology, Urine, Nasdaq, Company, Biotechnology, ATP, Nicorandil, AMD, Ischemia, Oxidative stress, Patient, Pharmaceutical industry, Medicine, SUR2B

LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.

Key Points: 
  • LOS ALTOS, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced key findings of UNI-494 efficacy from a preclinical study in rodent model of Acute Kidney Injury.
  • The Company evaluated the effect of UNI-494 on ischemia-reperfusion induced acute kidney injury (IR-AKI) in rats.
  • We are excited to report this key finding from the IR-AKI model showing treatment with UNI-494 significantly reduced this key biomarker of kidney injury that is a well-accepted biomarker of proximal renal tubule damage.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.For more information, please visit www.unicycive.com .

Unicycive Therapeutics to Present at H.C. Wainwright 24th Annual Global Investment Conference

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Tuesday, September 6, 2022
Kidney, Therapy, Hyperphosphatemia, LOS, Acute kidney injury, Kidney disease, GLOBE, Conference, Nasdaq, Biotechnology, Company, Investor, Patient, Pharmaceutical industry

LOS ALTOS, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that Company management will participate at the upcoming H.C. Wainwright 24th Annual Global Investment Conference taking place September 12-14, 2022 in New York City.

Key Points: 
  • LOS ALTOS, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that Company management will participate at the upcoming H.C. Wainwright 24th Annual Global Investment Conference taking place September 12-14, 2022 in New York City.
  • Shalabh Gupta, M.D., Chairman and Chief Executive Officer of Unicycive, will virtually present a corporate overview, which will be available On-Demand beginning at 7:00 am ET on Monday, September 12, 2022 through the end of the conference.
  • Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases.
  • Unicycives lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia.

Tyra Biosciences to Present Preclinical Data on TYRA-300, an FGFR3-selective Inhibitor, at ESMO 2022 Congress

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Monday, September 5, 2022
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"We believe the preclinical results being presented at the ESMO Congress showcase the enhanced anti-tumor activity and selectivity of TYRA-300 as compared to other agents in the class," said Todd Harris, CEO of TYRA.

Key Points: 
  • "We believe the preclinical results being presented at the ESMO Congress showcase the enhanced anti-tumor activity and selectivity of TYRA-300 as compared to other agents in the class," said Todd Harris, CEO of TYRA.
  • Details of the poster presentation are as follows:
    Regular abstracts will be published on the ESMO website on September 5, 2022.
  • The poster presentation on TYRA-300 will be made available on the TYRA website under the "For Investors" section on September 12, 2022.
  • TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements.

Unicycive Announces Multiple Abstracts Selected for Presentation at American Society of Nephrology’s Kidney Week 2022

Retrieved on: 
Wednesday, August 24, 2022
Literature, Enzyme, IgG4-related ophthalmic disease, Vance DeGeneres, COVID-19, Security (finance), Kidney, Safety, Hepatic encephalopathy, ASN, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Chronic kidney disease, Coronavirus, Randomized controlled trial, SUR2, Phosphate binder, Hyperphosphatemia, Decision-making, Degenerative disease, Macular degeneration, Food, KATP, Acute kidney injury, Patent, Alcoholic hepatitis, U.S. Securities and Exchange Commission, Liver disease, FDA, Biotechnology, Nicorandil, Failure, 2021 Essex County Council election, AMD, Private Securities Litigation Reform Act, Oxidative stress, Patient, Pharmaceutical industry

All abstracts for ASNs Kidney Week 2022 will be available via the ASN website ( www.asn-online.org/education/kidneyweek ) by October 14, 2022.

Key Points: 
  • All abstracts for ASNs Kidney Week 2022 will be available via the ASN website ( www.asn-online.org/education/kidneyweek ) by October 14, 2022.
  • Renazorb has been shown to offer unique phosphate binding characteristics, which have the potential to treat hyperphosphatemia in chronic kidney disease patients.
  • Unicycive is preparing a clinical bioequivalence study performed in healthy volunteers in order to submit a 505(b)(2) new drug application to the U.S. Food and Drug Administration.
  • UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.For more information, please visit www.unicycive.com .

Primary Care Providers Report a High Unmet Need for New Therapeutic Treatment Options for Chronic Kidney Disease, Despite Earlier Intervention and Referrals to Nephrologists, Spherix Reports

Retrieved on: 
Wednesday, August 10, 2022
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EXTON, Pa., Aug. 10, 2022 /PRNewswire/ -- Approximately 37 million Americans have chronic kidney disease (CKD)—that is one out of every seven U.S. adults.1 Many of these patients are being managed by primary care physicians (PCPs) but are unaware of their kidney disease. In fact, just 10% of people with chronic kidney disease are aware of their condition.2 As such, referrals to nephrologists often vary and are inconsistent across providers.

Key Points: 
  • In fact, just 10% of people with chronic kidney disease are aware of their condition.2 As such, referrals to nephrologists often vary and are inconsistent across providers.
  • The study found that PCPs are often taking the initial critical steps in disease identification and treatment initiation.
  • This is important, as participating PCPs report their own comfort managing CKD patients wanes drastically as their disease advances.
  • When it comes to treatment, PCPs rank CKD within the top three disease areas that have a "high" unmet need for new therapeutic treatment options.

Unicycive Reports Key Findings from Independent Renal Dietitian Survey

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Tuesday, July 26, 2022
Renal osteodystrophy, Osteoporosis, ESRD, Diabetes, Absorption, Kidney disease, Kidney, GLOBE, CKD, Intelligence, Mortality, Acute kidney injury, Dialysis, Cardiovascular disease, Fracture, Compliance, Hyperphosphatemia, Bone pain, Atherosclerosis, Chronic kidney disease, Risk, Therapy, SHPT, Biotechnology, Artery, Company, Gastrointestinal tract, Patient, Nasdaq, Bone disease, Hypertension, Pharmacotherapy, LOS, Lanthanum carbonate, Pharmaceutical industry, Rastogi

LOS ALTOS, Calif., July 26, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced the results from an independent survey of renal dietitians conducted by Spherix Global Insights, an independent business intelligence firm that leverages its own independent data and expertise to provide strategic guidance. The survey canvassed 100 U.S. renal dietitians regarding a variety of topics related to the treatment of their chronic kidney disease and dialysis patients.

Key Points: 
  • The survey canvassed 100 U.S. renal dietitians regarding a variety of topics related to the treatment of their chronic kidney disease and dialysis patients.
  • Key findings from the Spherix survey:
    As renal dietitians indicate they have high influence on brand selection for phosphate binders, the results of this survey are an important barometer that further support the potential for Renazorb to be the phosphate binder of choice, said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive.
  • The Unicycive team is preparing to capitalize on this substantial opportunity by offering patients and providers an attractive treatment alternative.
  • Unicycive is conducting important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.

Unicycive Reports Key Findings from Market Research with Nephrologists

Retrieved on: 
Wednesday, July 20, 2022
Renal osteodystrophy, Osteoporosis, ESRD, Diabetes, Trademark, Absorption, Kidney disease, Kidney, GLOBE, CKD, Mortality, Acute kidney injury, U.S. Securities and Exchange Commission, Dialysis, Calcium, Research, Fracture, Cardiovascular disease, Compliance, Hyperphosphatemia, Bone pain, Private Securities Litigation Reform Act, Chronic kidney disease, Atherosclerosis, Risk, Failure, Therapy, Safety, COVID-19, Strategic management, SHPT, Nephrology, Biotechnology, Artery, MBA, FDA, Company, Security (finance), Gastrointestinal tract, Patient, Nasdaq, Bone disease, Coronavirus, Hypertension, Sevelamer, Face, LLC, Pharmacotherapy, LOS, Lanthanum carbonate, Pharmaceutical industry, Genzyme, Rastogi

LOS ALTOS, Calif., July 20, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced the results from a primary market research study conducted on behalf of the company by Reason Research, LLC. The study was a discrete-choice model (“conjoint”) analysis in which 100 US-based nephrologists were presented with various phosphate binder attributes, including efficacy, safety/tolerability, pill burden, composition (calcium or non-calcium based), and dose form (chewable or swallowed), in a trade-off methodology to determine comparative prescribing preferences for currently available phosphate binders and Renazorb®, Unicycive’s product under development.

Key Points: 
  • Key findings from the research:
    Nephrologists estimate that they will prescribe Renazorb (pending FDA approval) for a market-leading 34% of their dialysis patients requiring phosphate binder therapy.
  • This market research with nephrologists, the predominant prescribers of phosphate binders, provides strong validation for our belief in the best-in-class potential of the Renazorb product profile, said Doug Jermasek, MBA, Executive Vice President, Corporate Strategy at Unicycive.
  • These survey results give us further confidence in the significant market opportunity for Renazorb.
  • Unicycive is conducting important market research to inform its brand and market access strategy and comprehensive launch plan for Renazorb.

Unicycive Announces Exclusive License and Development Agreement with Lee’s Pharmaceutical Holdings Limited for Renazorb in China and Certain Other Asian Markets

Retrieved on: 
Monday, July 18, 2022
Dermatology, SEHK, Serum, Failure, Artery, Kidney disease, Diabetes, LOS, Company, ESRD, Coronavirus, Hyperphosphatemia, Compliance, Absorption, CKD, Pharming, Atherosclerosis, Renal osteodystrophy, Nasdaq, U.S. Securities and Exchange Commission, Private Securities Litigation Reform Act, Medication, Incidence, Fracture, Physician, Mortality, Health, Pediatrics, Bone pain, PMP, Patient, Security (finance), Hypertension, Safety, Gastrointestinal tract, Bone disease, Kidney, CI, SHPT, COVID-19, Risk, Prevalence, Therapy, Achievement, Cardiovascular disease, Osteoporosis, Dialysis, GLOBE, Obstetrics, Acute kidney injury, Marketing, Drug development, Biotechnology, Degenerative disease, FDA, Chronic kidney disease, Pharmaceutical industry

LOS ALTOS, Calif., July 18, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that the Company has entered into an agreement granting exclusive rights to develop, market and commercialize Renazorb® (lanthanum dioxycarbonate) to Lee's Pharmaceutical (HK) Limited, a wholly-owned subsidiary of Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm”) (SEHK: 950), in Mainland China, Hong Kong, and certain other Asian markets. Renazorb is Unicycive’s novel phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients.

Key Points: 
  • Renazorb is Unicycives novel phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients.
  • Unicycive owns global rights for Renazorb and by partnering Renazorb in select Asian countries, we begin to unlock its value for patients, physicians and for our shareholders.
  • Under the terms of the agreement, Lee Pharm will be responsible for development, registration filing and approval for Renazorb in the licensed territories.
  • Renazorb also provides Lees Pharms commercial team with another product in our portfolio to sell in Asian markets.

High Unmet Needs Remain in Nephrology Despite Newly Approved Treatment Options According to Latest Research from Spherix Global Insights

Retrieved on: 
Thursday, June 30, 2022
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EXTON, Pa., June 30, 2022 /PRNewswire/ -- A survey of 124 US nephrologists, conducted just last week, identifies acute kidney injury (AKI), diabetic kidney disease (DKD), and polycystic kidney disease (PKD) as areas physicians would most like to see new products approved to treat patients under their care. New agents for glomerular diseases, including focal segmental glomerulonephritis (FSGS) and IgA nephropathy (IgAN) are also in high demand.

Key Points: 
  • New agents for glomerular diseases, including focal segmental glomerulonephritis (FSGS) and IgA nephropathy (IgAN) are also in high demand.
  • In prior Spherix research, following the receipt of these CRLs, many nephrologists expressed disappointment about the non-approval of the HIF-PH inhibitors, which are approved in countries outside the US, and tenapanor.
  • Korsuva, for CKD-associated pruritus in hemodialysis patients, is the newest approved renal product that Spherix is tracking.
  • Korsuva was originally approved in August of 2021; however, the product didn't officially launch until this past spring.