American Society of Nephrology

Talaris Therapeutics Announces Third Quarter Financial Results and Corporate Update

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Donnerstag, November 10, 2022
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BOSTON and LOUISVILLE, Ky., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today reported financial results for the three- and nine-month periods ended September 30, 2022 and provided an update on its business.

Key Points: 
  • Our investigators continue to remain committed to our programs and we continue to enroll patients in our FCR001 clinical studies.
  • R&D Expenses: Research and development expenses increased to $15.0 million in the third quarter of 2022, up from $9.2 million in the third quarter of 2021.
  • Talaris maintains corporate offices in Boston, MA, a GMP cell processing facility in Louisville, KY, and research and development laboratories in Houston, TX.
  • Talaris explicitly disclaims any obligation to update any forward-looking statements.

Vera Therapeutics Provides Business Update and Reports Third Quarter 2022 Financial Results

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Mittwoch, November 9, 2022
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During the third quarter of 2022, we continued to make progress advancing our late-stage clinical pipeline of atacicept and MAU868, said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.

Key Points: 
  • During the third quarter of 2022, we continued to make progress advancing our late-stage clinical pipeline of atacicept and MAU868, said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.
  • IgAN is a common cause of kidney failure and there is a high unmet medical need for treatment of IgAN globally.
  • We are also pleased to announce initiation of our pivotal Phase 3 COMPASS clinical trial of atacicept in lupus nephritis.
  • Vera reported $114.4 million in cash, cash equivalents, and marketable securities as of September 30, 2022.

Talaris Therapeutics Presents Data on Mechanisms of FCR001 Activity to Induce Immune Tolerance

Retrieved on: 
Montag, November 7, 2022
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The first presentation reported on transcriptional changes following successful tolerization with FCR001.

Key Points: 
  • The first presentation reported on transcriptional changes following successful tolerization with FCR001.
  • We are pleased to present these new analyses that shed light on how FCR001 treatment may modulate the immune landscape to induce durable immune tolerance, said Nancy Krieger, M.D., Chief Medical Officer of Talaris.
  • Talaris Therapeutics, Inc. is a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders.
  • Talaris maintains corporate offices in Boston, MA, its cell processing facility in Louisville, KY, and additional research operations in Houston, TX.

Ionis presents positive Phase 2 data in patients with IgA Nephropathy at American Society of Nephrology's Kidney Week 2022

Retrieved on: 
Montag, November 7, 2022
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CARLSBAD, Calif., Nov. 7, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today presented positive results from a Phase 2 clinical study of IONIS-FB-LRx in patients with immunoglobulin A nephropathy (IgAN). Results from the study were presented in a poster session at the American Society of Nephrology's (ASN) Kidney Week 2022.

Key Points: 
  • CARLSBAD, Calif., Nov. 7, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today presented positive results from a Phase 2 clinical study of IONIS-FB-LRx in patients with immunoglobulin A nephropathy (IgAN).
  • Resultsfrom the study were presented in a poster session at the American Society of Nephrology's (ASN) Kidney Week 2022.
  • Kidney function, as measured by estimated glomerular filtration rate (eGFR), was maintained in all patients in the study.
  • In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our," and "us" refers to Ionis Pharmaceuticals and its subsidiaries.

Correcting and Replacing: CinCor Reports Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Freitag, November 4, 2022
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We are thrilled with the positive topline data reported for baxdrostat in treatment-resistant hypertension earlier this quarter.

Key Points: 
  • We are thrilled with the positive topline data reported for baxdrostat in treatment-resistant hypertension earlier this quarter.
  • We look forward to providing an update once the HALO trial data has been unblinded and analyzed, which is anticipated before year-end 2022.
  • In August 2022, CinCor reported positive topline data for the Phase 2 BrigHtn trial evaluating baxdrostat for patients with rHTN.
  • In October, CinCor announced the publication of the Phase 1 Multiple Ascending Dose Study Data in the journal, Hypertension Research.

XORTX Presents New Proof of Concept Data at American Society of Nephrology

Retrieved on: 
Donnerstag, November 3, 2022
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CALGARY, Alberta, Nov. 03, 2022 (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, is pleased to announce the presentation of a peer-reviewed abstract to be presented November 4, 2022 at the American Society of Nephrology (“ASN”) Annual Conference – Kidney Week.  The abstract presents new discoveries in two species – mouse and rat models of polycystic kidney disease (“PKD”) and reports original work showing the harmful consequence of chronically increased uric acid on both structure and function of kidneys. The Abstract “Raising Serum Uric Acid with a Uricase Inhibitor Worsens PKD in Rat and Mouse models” will be presented during the Session Title: Genetic Diseases of the Kidneys, by Dr. Charles Edelstein of the University of Colorado and Dr. Allen Davidoff, CEO of XORTX.  This presentation will report for the first time, that XORTX's XRx-008 formulation of Xanthine Oxidase inhibitor can substantially and significantly block the increase in kidney size associated with high circulating uric acid in a rodent model of polycystic kidney disease.

Key Points: 
  • The abstract presents the findings of studies conducted at the University of Colorado, by Dr. Charles Edelstein and the PKD research team.
  • Dr. Allen Davidoff, CEO of XORTX, stated, We are pleased to present these important new findings during the ASN Kidney Week 2022.
  • With these results presented today, XORTX now has the information required to prepare and pursue Orphan Drug Designation for XRx-008.
  • At XORTX, we are dedicated to developing medications to improve the quality of life and future health of patients.

SeaStar Medical (Nasdaq: ICU) Announces Positive Interim Safety Findings from Ongoing Study Evaluating the Selective Cytopheretic Device (SCD) in Children

Retrieved on: 
Donnerstag, November 3, 2022
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DENVER, COLORADO, Nov. 03, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:ICU), (“SeaStar Medical” or the “Company”), a medical technology company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced positive interim data in a poster presentation at the American Society of Nephrology (ASN) Kidney Week 2022 taking place November 3-6, 2022 in Orlando, FL.

Key Points: 
  • The study is evaluating children that weigh between 10 and 20kg, have a clinical diagnosis of AKI requiring CKRT and at least one non-renal organ failure.
  • With these subjects the SCD was integrated post CKRT membrane, changed daily, and circuit ionized calcium (iCa) maintained
  • Subjects received SCD treatment for up to 10 days or CKRT discontinuation, whichever came first.
  • Dr. Goldstein served as a consultant to SeaStar Medical in the preparation and submission of the HDE application.

CinCor Reports Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Donnerstag, November 3, 2022
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WALTHAM, Mass., Nov. 03, 2022 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (NASDAQ: CINC) today announced financial results for the third quarter ended September 30, 2022 and provided a corporate update.

Key Points: 
  • We are thrilled with the positive topline data reported for baxdrostat in treatment-resistant hypertension earlier this quarter.
  • In August 2022, CinCor reported positive topline data for the Phase 2 BrigHtn trial evaluating baxdrostat for patients with rHTN.
  • In October, CinCor announced the publication of the Phase 1 Multiple Ascending Dose Study Data in the journal, Hypertension Research.
  • CinCor undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Data Support the Use of KRYSTEXXA® (pegloticase) Injection with Methotrexate to Treat Uncontrolled Gout in People With Mild-to-Moderate Chronic Kidney Disease

Retrieved on: 
Samstag, November 5, 2022
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Horizon Therapeutics plc (Nasdaq: HZNP) today announced new data that indicate KRYSTEXXA (pegloticase) injection with weekly oral methotrexate effectively treats uncontrolled gout without compromising kidney function.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced new data that indicate KRYSTEXXA (pegloticase) injection with weekly oral methotrexate effectively treats uncontrolled gout without compromising kidney function.
  • These data are encouraging and suggest that KRYSTEXXA with methotrexate effectively addressed the systemic burden of uncontrolled gout and did not lead to renal function decline in patients with mild-to-moderate chronic kidney disease.
  • In both the KRYSTEXXA with methotrexate and KRYSTEXXA with placebo treatment groups, eGFR levels were stable during the four-week methotrexate/placebo run-in period.
  • The renal function improvements seen in both treatment arms were shared by these patients with baseline mild-to-moderate chronic kidney disease.

Alpine Immune Sciences Presents Update Of ALPN-303 Phase 1 (RUBY-1) Clinical Data at the American Society of Nephrology Kidney Week 2022 Meeting

Retrieved on: 
Donnerstag, November 3, 2022
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In addition, ALPN-303 also dose-dependently reduces serum Gd-IgA1 by up to 60%, 4 weeks after a single dose.

Key Points: 
  • In addition, ALPN-303 also dose-dependently reduces serum Gd-IgA1 by up to 60%, 4 weeks after a single dose.
  • These data support dose regimens of 80-240 mg SC every 4 weeks in future glomerulonephritis studies.
  • Alpine Immune Sciences is committed to leading a new wave of immune therapeutics.
  • Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development.