CKD

Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA

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星期一, 三月 11, 2024

THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.

Key Points: 
  • THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD).
  • The resubmission is planned for mid-year, with an anticipated six-month regulatory review period.
  • “We have remained steadfast in our support of sotagliflozin in type 1 diabetes and have worked diligently to identify a regulatory path forward for what we believe will be an important new therapy,” said Lonnel Coats, Director and Chief Executive Officer.
  • Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance in order to engage in discussions regarding a path forward for resubmission and potential approval of the NDA.

Unicycive Therapeutics Completes Enrollment in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC)

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星期四, 三月 7, 2024

LOS ALTOS, Calif., March 07, 2024 (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 enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).

Key Points: 
  • LOS ALTOS, Calif., March 07, 2024 (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 enrollment has been completed in the 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 to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
  • “The completion of enrollment in our pivotal OLC clinical trial is a critical achievement for Unicycive as we strive to bring an improved therapy to chronic kidney disease patients struggling with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • “Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).

ProKidney to Participate in Jefferies Biotech on the Bay Summit

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星期四, 二月 29, 2024

WINSTON-SALEM, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the Jefferies Biotech on the Bay Summit being held in Miami on March 12 – 13, 2024.

Key Points: 
  • WINSTON-SALEM, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced that senior members of the management team will be participating in the Jefferies Biotech on the Bay Summit being held in Miami on March 12 – 13, 2024.
  • The ProKidney management team will host one-on-one meetings during the event.
  • Interested investors should contact their Jefferies representative to schedule meetings.

Healis Therapeutics' asset CKDB-501A shares Phase III topline results for glabellar injections from CKD Bio in South Korea

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星期二, 二月 27, 2024

The study results demonstrated that CKDB-501A is non-inferior compared to the active-controlled BOTOX® by AbbVie (NYSE: ABBV) in improving moderate-to-severe glabellar lines.

Key Points: 
  • The study results demonstrated that CKDB-501A is non-inferior compared to the active-controlled BOTOX® by AbbVie (NYSE: ABBV) in improving moderate-to-severe glabellar lines.
  • A randomized, double-blind, active-controlled, multi-center Phase 3 trial to investigate the efficacy and safety of CKDB-501A in subjects with moderate-to-severe glabellar lines was completed in South Korea on November 20, 2023 (NCT05804656).
  • “This is clinically promising to see Healis’ lead protein, CKDB-501A, pass safety and efficacy in South Korea,” said Dr. Eric Finzi, Co-Founder of Healis Therapeutics.
  • Healis Therapeutics announced a strategic partnership with CKD Bio in 2024 to develop CKDB-501A for CNS indications.

FibroGen Regains All Rights to Roxadustat from AstraZeneca in the United States and Other AstraZeneca Territories, Except China and South Korea

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星期一, 二月 26, 2024

SAN FRANCISCO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced today that FibroGen and AstraZeneca have agreed to terminate the U.S./RoW roxadustat collaboration agreement entered into on July 30, 2013, under which AstraZeneca held development and commercialization rights in the United States and other territories outside of China not licensed to Astellas Pharma Inc. Pursuant to a termination and transition agreement entered into between the parties, AstraZeneca is returning all U.S./RoW roxadustat rights to FibroGen (with the exception of South Korea) and providing certain assistance during a transition period. FibroGen’s collaboration agreement with AstraZeneca for roxadustat in China remains in place and roxadustat remains the leader in China by brand value share in the chronic kidney disease (CKD) anemia category. In the event FibroGen subsequently monetizes or commercializes roxadustat in the territories formerly licensed under the U.S./RoW collaboration agreement, FibroGen will have certain financial obligations to AstraZeneca.

Key Points: 
  • SAN FRANCISCO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced today that FibroGen and AstraZeneca have agreed to terminate the U.S./RoW roxadustat collaboration agreement entered into on July 30, 2013, under which AstraZeneca held development and commercialization rights in the United States and other territories outside of China not licensed to Astellas Pharma Inc. Pursuant to a termination and transition agreement entered into between the parties, AstraZeneca is returning all U.S./RoW roxadustat rights to FibroGen (with the exception of South Korea) and providing certain assistance during a transition period.
  • FibroGen’s collaboration agreement with AstraZeneca for roxadustat in China remains in place and roxadustat remains the leader in China by brand value share in the chronic kidney disease (CKD) anemia category.
  • In the event FibroGen subsequently monetizes or commercializes roxadustat in the territories formerly licensed under the U.S./RoW collaboration agreement, FibroGen will have certain financial obligations to AstraZeneca.
  • “We continue to believe that roxadustat represents an important potential therapy for patients in the U.S. and other territories where it has not yet been approved,” said Thane Wettig, FibroGen Chief Executive Officer.

FibroGen Reports Fourth Quarter and Full Year 2023 Financial Results

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星期一, 二月 26, 2024

Fourth quarter FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $23.5 million compared to $23.4 million in the fourth quarter of 2022.

Key Points: 
  • Fourth quarter FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $23.5 million compared to $23.4 million in the fourth quarter of 2022.
  • Fourth quarter total roxadustat net sales in China¹ by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $66.5 million, compared to $53.1 million in the fourth quarter of 2022, an increase of 25%.
  • Total revenue for the fourth quarter of 2023 was $27.1 million, as compared to $34.4 million for the fourth quarter of 2022.
  • At December 31, 2023, FibroGen had $248.1 million in cash - defined as cash, cash equivalents, investments, and accounts receivable.

Simple HealthKit Launches Expanded Kidney Health Evaluation for Patients with Diabetes (KED) Program to Help Payers Improve Patient Health, Boost STAR Ratings & Meet HEDIS Measures

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星期一, 二月 26, 2024

At the heart of the program is Simple HealthKit’s new Expanded Kidney Health Test, which evaluates kidney function and kidney damage, and is available via in-clinic or at-home settings.

Key Points: 
  • At the heart of the program is Simple HealthKit’s new Expanded Kidney Health Test, which evaluates kidney function and kidney damage, and is available via in-clinic or at-home settings.
  • Diabetes is the leading cause of chronic kidney disease (CKD)—about 1 in 3 adults with diabetes have CKD.
  • At-home kidney health tests could drastically reduce Medicare expenditures associated with CKD, while boosting Star Ratings, and satisfying KED HEDIS® measures for MY2024.
  • Simple HealthKit already works with multiple payers across the U.S. including government agencies, universities and private healthcare plans like Imperial Health.

Ardelyx Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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星期四, 二月 22, 2024

WALTHAM, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • During the fourth quarter of 2023, IBSRELA U.S. net product sales revenue was $28.1 million, reflecting 26% growth compared to the third quarter of 2023.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.
  • U.S. net product sales revenue in the fourth quarter of 2023 were $2.5 million.
  • U.S. net product sales revenue in 2023 for XPHOZAH was $2.5 million following its commercial launch in November 2023.

Where You Live Impacts Your Ability to Save a Life Through Living Organ Donation, According to the 2024 American Kidney Fund Report Card

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星期四, 二月 22, 2024

Receiving a kidney from a living donor is the best option for someone in need of a new kidney.

Key Points: 
  • Receiving a kidney from a living donor is the best option for someone in need of a new kidney.
  • However, six states – Alabama, Montana, New Hampshire, Tennessee, South Dakota and Vermont – have zero policy protections (F grade) for living organ donors.
  • How All 50 States + DC Fared on the 2024 State of the States: American Kidney Fund Report Card
    Currently, chronic kidney disease (CKD) affects more than 1 in 7 adults in the U.S.
  • “Where you live should not impact whether you are able to save a life through kidney donation, but our 2024 Report Card suggests that this may be the case.

Can-Fite Broadens its Strong Intellectual Property (IP) for NASH: Received Patent Allowance in Canada

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星期三, 二月 28, 2024

(NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced it received a Notice of Allowance from the Canadian Intellectual Property Office for its patent application titled “An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation”.

Key Points: 
  • (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced it received a Notice of Allowance from the Canadian Intellectual Property Office for its patent application titled “An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation”.
  • This invention addresses the use of Namodenoson for the reduction of liver fat in patients with NASH a clinical indication that is being developed by Can-Fite.
  • The Company also has a distribution agreement in Canada for its anti-inflammatory drug, Piclidenoson, for the treatment of psoriasis.
  • “This additional patent in Canada for fatty liver disease adds to our growing IP estate for this high-value indication of the Namodenoson drug candidate.