SHPT

OPKO Health Reports Third Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Monday, November 6, 2023
Modex, Appetite, Biomedical Advanced Research and Development Authority, Colon, United Kingdom, Operating cost, Epstein–Barr virus, PIN, International, SARS-CoV-2, Obesity, COVID-19 testing, SHPT, Weight loss, Growth hormone therapy, HIV, Absorption, Health, Merck, Intellectual property, BARDA, Short bowel syndrome, Poster, Oxyntomodulin, Chronic kidney disease, Development, Society, Pfizer, MSTAR, COVID-19, Glucagon, GeneDx, OXM, Public, OPKO Health, CKD, Kidney, Therapy, Patient, Nutrient, Vaccine, Pharmaceutical industry, Video game, EU

OPKO Health presented late-breaking clinical data on RAYALDEE extended-release calcifediol in a poster presentation at the American Society of Nephrology Kidney Week.

Key Points: 
  • OPKO Health presented late-breaking clinical data on RAYALDEE extended-release calcifediol in a poster presentation at the American Society of Nephrology Kidney Week.
  • Operating loss was $25.4 million in the third quarter of 2023 compared with $28.3 million in the third quarter of 2022.
  • Operating loss for the third quarter of 2023 was $64.4 million compared with an operating loss of $87.8 million for the 2022 quarter.
  • OPKO’s senior management will provide a business update, discuss third quarter financial results, provide financial guidance and answer questions during a conference call and audio webcast today beginning at 4:30 p.m. Eastern time.

New Clinical Data on OPKO Health’s RAYALDEE® (ER Calcifediol) Presented at Kidney Week 2023

Retrieved on: 
Thursday, November 2, 2023
EGFR, Secondary hyperparathyroidism, SHPT, ERC, Health, Glomerular filtration rate, HIV disease progression rates, Society, American Society of Nephrology, Phosphorus, Chronic kidney disease, Dialysis, Parathyroid hormone, ASN, Serum, OPKO Health, CKD, Patient, Calcium, Pharmaceutical industry

MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) presented late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia today.

Key Points: 
  • MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) presented late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia today.
  • Treatment with RAYALDEE was not associated with clinically meaningful increases in serum calcium or phosphorus.
  • “RAYALDEE is a safe and highly effective treatment for SHPT in patients with stage 3 or 4 CKD.
  • The new data presented today clearly highlight the possibility that raising serum 25-hydroxyvitamin D to a sufficiently high level to achieve consistent iPTH control with RAYALDEE would improve outcomes in CKD patients.”

OPKO Health to Present New Clinical Data on Rayaldee (ER Calcifediol) at Kidney Week 2023

Retrieved on: 
Wednesday, October 25, 2023
Real-World Evidence, FASN, Secondary hyperparathyroidism, Importance, ERC, Health, Poster, Society, American Society of Nephrology, ASN, Calcitriol, Serum, Quality, OPKO Health, CKD, FACP, Paricalcitol, Patient, Calcifediol, Pharmaceutical industry, SHPT

MIAMI, Oct. 25, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) will present late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia on Thursday, November 2, 2023.

Key Points: 
  • MIAMI, Oct. 25, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) will present late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia on Thursday, November 2, 2023.
  • OPKO Health will present two other posters at ASN Kidney Week summarizing additional new clinical data on RAYALDEE.
  • The data demonstrate that effective control of SHPT has been achieved with RAYALDEE treatment in both randomized clinical trials and in a real-world clinical experience trial.
  • Data from these trials support early initiation of SHPT treatment with RAYALDEE in order to delay disease progression.

Pathalys Pharma and Launch Therapeutics Announce First Patient Enrolled Ahead of Schedule in Pivotal Phase 3 Program for Upacicalcet in Patients Receiving Hemodialysis

Retrieved on: 
Wednesday, May 31, 2023
PATH, Hypocalcemia, Serum, Drug, PTH, Dialysis, Kidney disease, RESEARCH, Patient, Risk, CCA, ESKD, FDA, SVP, MPH, Upacicalcet, PARK, Parathyroid hormone, Pharmaceutical industry, Medical device, SHPT, MD

RESEARCH TRIANGLE PARK, N.C. and BOSTON, May 31, 2023 /PRNewswire/ -- Pathalys Pharma, Inc., a private, late-stage biopharma company co-founded by Catalys Pacific and DaVita Venture Group, and Launch Therapeutics (Launch Tx), a clinical development company, today announced that the first patient has been enrolled in the PATH (PTH Attenuation Trial in Hemodialysis) clinical program, consisting of two identical phase 3 trials, to assess upacicalcet for the treatment of secondary hyperparathyroidism (SHPT) in end-stage kidney disease (ESKD) patients on hemodialysis.

Key Points: 
  • The PATH clinical trial program is the output of Pathalys' previously disclosed intent to initiate two identical phase 3 clinical trials to evaluate upacicalcet.
  • "We have enrolled our first patient for this program ahead of schedule.
  • "The combination of Pathalys Pharma and Launch Therapeutics is already demonstrating immense value with respect to the speed and efficiency of this program.
  • Eligible patients will be adults receiving in-center hemodialysis three times weekly and whose iPTH values are 450 pg/mL or greater.

American Kidney Fund Thanks Amgen for its Champion Level 2022 Corporate Membership

Retrieved on: 
Tuesday, December 13, 2022
Dialysis, Kidney disease, Charity, Partnership, Kidney, Platinum, American Kidney Fund, SHPT, Kidney failure, Disease management, Research, AKF, Disease, Risk, Charity Navigator, Patient, Candid (organization), Pharmaceutical industry, Amgen

ROCKVILLE, Md., Dec. 13, 2022 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) today expressed its appreciation for Amgen’s participation in the 2022 class of its Corporate Membership Program as a Champion-level member.

Key Points: 
  • ROCKVILLE, Md., Dec. 13, 2022 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) today expressed its appreciation for Amgen’s participation in the 2022 class of its Corporate Membership Program as a Champion-level member.
  • “We are very grateful that Amgen has continued to be a Champion-level member in the AKF Corporate Membership Program,” said LaVarne A. Burton, AKF President and CEO.
  • Amgen’s membership also supports AKF’s programs for kidney health care professionals, such as AKF’s dietitian roundtable discussions about navigating healthy eating for kidney disease patients.
  • The American Kidney Fund (AKF) fights kidney disease on all fronts as the nation’s leading kidney nonprofit.

Unicycive Completes Enrollment of Pivotal Bioequivalence Study for RENAZORB™ (lanthanum dioxycarbonate), an Investigational Treatment for Hyperphosphatemia in Chronic Kidney Disease (CKD) Patients on Dialysis

Retrieved on: 
Thursday, November 10, 2022
Dialysis, GLOBE, Private Securities Litigation Reform Act, Atherosclerosis, Hyperphosphatemia, LOS, Artery, Osteoporosis, U.S. Securities and Exchange Commission, Fracture, Cardiovascular disease, CKD, Nasdaq, Food, Diabetes, Risk, Chronic kidney disease, Renal osteodystrophy, Bone pain, COVID-19, Mortality, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, ESKD, Bone disease, Kidney, Failure, Coronavirus, Particle-size distribution, Safety, Gastrointestinal tract, Hypertension, Absorption, Biotechnology, Acute kidney injury, Patient, Security (finance), SHPT, RLD, Kidney disease, NDA, FDA, Trial of the century, Pharmaceutical industry, Generic drug

LOS ALTOS, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it has completed the enrollment of subjects in the RENAZORB bioequivalence (BE) study. RENAZORB (lanthanum dioxycarbonate) is an investigational phosphate binding agent utilizing proprietary nanoparticle technology that is being developed to treat hyperphosphatemia in CKD patients on dialysis.

Key Points: 
  • RENAZORB (lanthanum dioxycarbonate) is an investigational phosphate binding agent utilizing proprietary nanoparticle technology that is being developed to treat hyperphosphatemia in CKD patients on dialysis.
  • The study enrolled 40 subjects per treatment arm (a total of 80 subjects enrolled) for 64 evaluable subjects.
  • RENAZORB is an investigational 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.
  • Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis.

Unicycive Reports Key Findings from Independent Renal Dietitian Survey

Retrieved on: 
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.

Unicycive Initiates Pivotal Clinical Bioequivalence Study of Renazorb to Treat Hyperphosphatemia

Retrieved on: 
Thursday, June 2, 2022
Osteoporosis, Absorption, Company, SHPT, Biotechnology, Bone pain, Food, Gastrointestinal tract, Renal osteodystrophy, Artery, Dialysis, Kidney, Hyperphosphatemia, Nasdaq, Chronic kidney disease, Acute kidney injury, Therapy, FDA, Cardiovascular disease, Patient, GLOBE, Pharmacotherapy, Mortality, Risk, Diabetes, Trial of the century, Fracture, Compliance, Kidney disease, Atherosclerosis, Clinical trial, LOS, CKD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Bone disease, Hypertension, ESRD, Pharmaceutical industry, Lanthanum carbonate, Rastogi

LOS ALTOS, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease today announced the initiation of its pivotal clinical bioequivalence (BE) study of Renazorb (lanthanum dioxycarbonate.)

Key Points: 
  • LOS ALTOS, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.(Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease today announced the initiation of its pivotal clinical bioequivalence (BE) study of Renazorb (lanthanum dioxycarbonate.)
  • Renazorb is a novel phosphate binding agent utilizing proprietary nanoparticle technology that is being developed by Unicycive for the treatment of hyperphosphatemia.
  • The study is a randomized, open label, two-way crossover BE study to establish pharmacodynamic bioequivalence between Renazorb and Fosrenol.
  • The Renazorb program is supported by a previously completed clinical trial that studied Renazorb in 32 healthy volunteers.