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Inozyme Pharma, Inc. - INZY STOCK NEWS

Welcome to our dedicated page for Inozyme Pharma news (Ticker: INZY), a resource for investors and traders seeking the latest updates and insights on Inozyme Pharma stock.

Inozyme Pharma, Inc. (INZY) is a clinical-stage biopharmaceutical company pioneering enzyme replacement therapies for rare mineralization disorders. This page provides investors and healthcare stakeholders with essential updates on INZY's progress in addressing conditions like ENPP1 Deficiency and calciphylaxis through its lead candidate INZ-701.

Access consolidated news about clinical trial developments, regulatory milestones, and scientific advancements. Our repository includes press releases on study results, partnership announcements with research organizations, and analyses of INZY's therapeutic approach targeting the PPi-Adenosine pathway.

Key updates cover safety/efficacy data from ongoing trials, manufacturing collaborations, and presentations at medical conferences. Bookmark this page to efficiently track INZY's progress in developing treatments for diseases with significant unmet needs.

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Inozyme Pharma announced that interim data from its ongoing Phase 1 SEAPORT 1 trial of INZ-701 in patients with end-stage kidney disease (ESKD) receiving hemodialysis will be presented at the American Society of Nephrology (ASN) Kidney Week 2024. The presentation, titled 'SEAPORT 1: An Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of INZ-701 in Participants with ESKD Undergoing Hemodialysis: Interim Analysis,' will be delivered during a poster session on October 24, 2024, at 10:00 a.m. PT in San Diego. The presenting author is Dr. Asghar Chaudhry of South Florida Nephrology Research.

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Inozyme Pharma (Nasdaq: INZY) has appointed Erik Harris to its Board of Directors, effective October 3, 2024. Mr. Harris, currently Chief Commercial Officer and Executive Vice President at Ultragenyx, brings over 20 years of commercial expertise in the biopharma industry. This appointment comes as Inozyme prepares for its transition into a commercial-stage company.

CEO Douglas A. Treco highlighted Harris's track record in launching rare disease therapies and his commercial insights as valuable assets for advancing INZ-701 through late-stage development. Harris expressed enthusiasm for INZ-701's potential in treating rare diseases affecting bone health and blood vessel function.

Harris's previous roles include senior positions at Ultragenyx, Crescendo Bioscience, Intermune, Elan Pharmaceuticals, Genentech, and Bristol-Myers Squibb. He also serves on the Board of Directors at Denali Therapeutics. Harris holds an M.B.A. from the Wharton School of Business and a B.S. from the United States Naval Academy.

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Inozyme Pharma (Nasdaq: INZY) presented new data at the ASBMR 2024 Annual Meeting, highlighting the urgent need for therapies addressing cardiovascular and musculoskeletal complications in ENPP1 and ABCC6 Deficiencies. Key findings include:

1. In ENPP1 Deficiency, 88% of patients experienced ectopic calcifications, with 76% showing cardiovascular complications.

2. 95% of surviving ENPP1 Deficiency patients are expected to face lifelong complications.

3. ABCC6 Deficiency patients showed significant cardiovascular issues, with 44% experiencing stroke.

Inozyme and GACI Global launched the PROPEL Registry to further understand these rare diseases. The company is developing INZ-701 as a potential treatment for these conditions.

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Inozyme Pharma (Nasdaq: INZY), a clinical-stage biopharmaceutical company focused on rare diseases affecting bone health and blood vessel function, has announced its participation in the 2024 Wells Fargo Healthcare Conference. Matt Winton, Ph.D., Senior Vice President and Chief Operating Officer of Inozyme, will engage in a fireside chat on Thursday, September 5, 2024, from 3:45-4:20 pm ET.

Investors and interested parties can access a live webcast of the fireside chat through the Investor Relations section of Inozyme's website. A replay of the event will also be available for a time after the conference. This participation provides an opportunity for Inozyme to showcase its innovative therapeutics and engage with the investment community.

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Inozyme Pharma (INZY) reported Q2 2024 financial results and provided business highlights. Key points include:

  • Enrollment completion in ENERGY 3 pivotal trial for pediatric ENPP1 Deficiency expected in Q3 2024
  • Interim data from ENERGY 1 (infants with ENPP1 Deficiency) and SEAPORT 1 (calciphylaxis) trials expected in Q4 2024
  • Cash position of $144.5 million as of June 30, 2024, expected to fund operations into Q4 2025
  • FDA Fast Track designation granted for INZ-701 in ABCC6 Deficiency
  • Net loss of $27.0 million ($0.44 per share) for Q2 2024

The company is advancing its clinical programs for INZ-701 with several milestones expected by year-end, including updates on ABCC6 Deficiency approval pathway and infant ENPP1 Deficiency trial data.

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Inozyme Pharma (Nasdaq: INZY) has published preclinical data in the journal Cells, supporting the potential of INZ-701, their lead ENPP1 enzyme replacement therapy (ERT) candidate, to treat a broad range of rare diseases affecting bone health and blood vessel function. The study demonstrates INZ-701's ability to inhibit intimal proliferation in both ENPP1-deficient and wild-type mice, suggesting potential applications beyond traditional ERT.

Key findings show that INZ-701 increases levels of inorganic pyrophosphate (PPi) and adenosine, addressing deficiencies in the PPi-Adenosine Pathway. This pathway is critical for regulating bone health and blood vessel function. The research reveals ENPP1's role in adenosine production, explaining its dual action in preventing abnormal mineralization and inhibiting intimal proliferation. These results position INZ-701 as a promising therapeutic for multiple rare diseases driven by PPi-Adenosine Pathway disruptions.

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Inozyme Pharma announced that the FDA has granted Fast Track designation to INZ-701 for treating ABCC6 Deficiency, a rare, severe condition affecting children and leading to significant clinical events such as stroke and severe neurological and cardiovascular diseases. The decision is based on nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase 1/2 trial in adults. This designation will facilitate more frequent FDA engagement and expedited regulatory review. Inozyme aims to finalize plans for a pivotal pediatric study by the end of 2024.

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Inozyme Pharma (Nasdaq: INZY), a clinical-stage biopharmaceutical company, will present findings from a radiographic study on pediatric patients with ENPP1 Deficiency at the 11th International Conference on Children’s Bone Health (ICCBH) in Salzburg, Austria, from June 22-25, 2024.

The presentation titled, 'Expanding the spectrum of radiographic features in children with ENPP1 Deficiency: Novel skeletal findings from an international collaboration,' will be delivered by Dr. Leanne Ward on June 24, 2024, between 11:00-12:00 CEST. Additionally, Inozyme will sponsor a symposium on June 22, 2024, from 13:45-14:45 CEST, focusing on ENPP1 Deficiency as an overlooked cause of hypophosphatemic rickets, chaired by Dr. Agnes Linglart and featuring presentations by Dr. Zulf Mughal and Dr. David Weber.

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Inozyme Pharma (Nasdaq: INZY), a clinical-stage biopharmaceutical company specializing in rare diseases, announced that its CEO and Chairman, Doug Treco, Ph.D., will present at the Jefferies Global Healthcare Conference. The presentation is scheduled for Thursday, June 6, 2024, from 12:30 to 12:55 pm ET. A live webcast will be available on the Investor Relations section of Inozyme's website, with a replay accessible for a time.

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Inozyme Pharma (Nasdaq: INZY) announced that it will present topline data from its Phase 1/2 clinical trials of INZ-701 in adults with ENPP1 Deficiency and ABCC6 Deficiency at two upcoming medical conferences. The presentations will occur at the European Calcified Tissue Society Congress (ECTS) 2024 in Marseille, France, from May 25-28, and at the Endocrine Society's Annual Meeting (ENDO) 2024 in Boston, Massachusetts, from June 1-4. Key topics include the impact of INZ-701 on bone and mineral metabolism biomarkers and clinical outcomes in adults with ENPP1 Deficiency, as well as the safety and exploratory efficacy of INZ-701 in adults with ABCC6 Deficiency manifesting as pseudoxanthoma elasticum (PXE).

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Inozyme Pharma, Inc.

Nasdaq:INZY

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Biotechnology
Pharmaceutical Preparations
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United States
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