4 - Inozyme Pharma, Inc. (0001693011) (Issuer)

3 - Inozyme Pharma, Inc. (0001693011) (Issuer)

4 - Inozyme Pharma, Inc. (0001693011) (Issuer)

4 - Inozyme Pharma, Inc. (0001693011) (Issuer)

4 - Inozyme Pharma, Inc. (0001693011) (Issuer)

4 - Inozyme Pharma, Inc. (0001693011) (Issuer)

4 - Inozyme Pharma, Inc. (0001693011) (Issuer)

4 - Inozyme Pharma, Inc. (0001693011) (Issuer)

4 - Inozyme Pharma, Inc. (0001693011) (Issuer)

4 - Inozyme Pharma, Inc. (0001693011) (Issuer)

BOSTON, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced Doug Treco, Ph.D., CEO and Chairman of Inozyme, will present at the following investor conferences: The Stifel 2024 Healthcare Conference. The presentation will take place on Monday, November 18 from 3:35-4:05pm ET.The Jefferies London Healthcare Conference. The presentation will take place on Wednesday, November 20 from 2:30-2:55pm GMT / 9:30-9:55am ET. A live webcast of the presentations can be accessed from the Investor

- Interim data from ENERGY 1, a Phase 1b trial of INZ-701 in infants with ENPP1 Deficiency, on track for fourth quarter of 2024 – - Topline data from ENERGY 3, a pivotal trial of INZ-701 in pediatric patients with ENPP1 Deficiency, expected in early 2026 - - Company plans to initiate registrational trials in calciphylaxis and ABCC6 Deficiency in 2025 subject to regulatory alignment and sufficient funding - - Cash, cash equivalents, and short-term investments as of September 30, 2024, expected to fund operations into the fourth quarter of 2025 – BOSTON, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical c

- INZ-701 was well-tolerated and significantly increased plasma pyrophosphate (PPi) levels in patients with end-stage kidney disease (ESKD) undergoing hemodialysis; low PPi levels are associated with calciphylaxis, a rare, life-threatening complication of ESKD - - Company plans to initiate a registrational trial in calciphylaxis in 2025 subject to regulatory alignment and sufficient funding - BOSTON, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced positive interim data from its

BOSTON, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced that interim data from the Company's ongoing Phase 1 SEAPORT 1 of INZ-701 in patients with end-stage kidney disease (ESKD) receiving hemodialysis will be presented during a poster session at the American Society of Nephrology (ASN) Kidney Week 2024, which is being held October 24-27, 2024, in San Diego. Details of the poster are as follows: Title: SEAPORT 1: An Open-label Study to Evaluate the Safety, Pharmacokinet

BOSTON, Oct. 07, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced the appointment of Erik Harris to its Board of Directors, effective October 3, 2024. Mr. Harris, who currently serves as Chief Commercial Officer and Executive Vice President at Ultragenyx, brings to Inozyme over 20 years of commercial expertise within the biopharma industry. "It is a privilege to welcome Erik to the Inozyme Board of Directors at this exciting juncture for Inozyme as we continue to lay the groundwork for ou

- Data underscore the urgent need for therapies that address the cardiovascular and musculoskeletal complications and long-term systemic effects of ENPP1 and ABCC6 Deficiencies in children - - Inozyme and GACI Global launched PROPEL Registry to further understanding of these rare, life-threatening diseases (NCT06302439) - BOSTON, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, is presenting four posters at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting, includi

BOSTON, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced that Matt Winton, Ph.D., Senior Vice President and Chief Operating Officer of Inozyme, will participate in a fireside chat at the 2024 Wells Fargo Healthcare Conference on Thursday, September 5, 2024 from 3:45-4:20 pm ET. A live webcast of the fireside chat can be accessed from the Investor Relations section of Inozyme's website under events, where a replay of the event will also be available for a limited time. About Inoz

- Complete enrollment in ENERGY 3, a pivotal trial of INZ-701 in pediatric patients with ENPP1 Deficiency, expected third quarter of 2024 - - Interim data from ENERGY 1, a Phase 1b trial of INZ-701 in infants with ENPP1 Deficiency, on track for fourth quarter of 2024 – - Interim data from SEAPORT 1, a Phase 1 trial of INZ-701 in patients with end-stage kidney disease receiving hemodialysis, on track for fourth quarter of 2024 – - Cash, cash equivalents, and short-term investments as of June 30, 2024, expected to fund operations into the fourth quarter of 2025 – BOSTON, Aug. 06, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage ra

- Treatment with INZ-701 shown to prevent intimal proliferation in both ENPP1-deficient and wild-type mice, supporting its potential therapeutic application beyond traditional ERT - BOSTON, July 25, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases that affect bone health and blood vessel function, today announced the publication of preclinical data supporting the potential of INZ-701, the Company's lead ENPP1 enzyme replacement therapy (ERT) development candidate, to treat a broad range of diseases mediated by the PPi-Adenosine Pathway, which regulates minera

BOSTON, July 02, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to INZ-701 for the treatment of ABCC6 Deficiency. "Through Fast Track designation, the FDA recognizes the potential of INZ-701 in ABCC6 Deficiency. We plan to work closely with the agency to establish an efficient path to approval. Receipt of Fast Track designation underscores our belief that INZ-701 could serve as an importan

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10-Q - Inozyme Pharma, Inc. (0001693011) (Filer)

8-K - Inozyme Pharma, Inc. (0001693011) (Filer)

8-K - Inozyme Pharma, Inc. (0001693011) (Filer)

8-K - Inozyme Pharma, Inc. (0001693011) (Filer)

424B5 - Inozyme Pharma, Inc. (0001693011) (Filer)

10-Q - Inozyme Pharma, Inc. (0001693011) (Filer)

8-K - Inozyme Pharma, Inc. (0001693011) (Filer)

8-K - Inozyme Pharma, Inc. (0001693011) (Filer)

10-Q - Inozyme Pharma, Inc. (0001693011) (Filer)

8-K - Inozyme Pharma, Inc. (0001693011) (Filer)

Stifel initiated coverage of Inozyme Pharma with a rating of Buy and set a new price target of $16.00

Jefferies resumed coverage of Inozyme Pharma with a rating of Buy and set a new price target of $17.00 from $16.00 previously

Wells Fargo initiated coverage of Inozyme Pharma with a rating of Overweight and set a new price target of $14.00

Jefferies upgraded Inozyme Pharma from Hold to Buy and set a new price target of $6.00 from $4.50 previously

Jefferies initiated coverage of Inozyme Pharma with a rating of Hold and set a new price target of $5.00

HC Wainwright & Co. initiated coverage of Inozyme Pharma with a rating of Buy and set a new price target of $33.00

Needham initiated coverage of Inozyme Pharma with a rating of Buy and set a new price target of $23.00

HC Wainwright & Co. analyst Edward White reiterates Inozyme Pharma (NASDAQ:INZY) with a Buy and maintains $14 price target.

Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to INZ-701 for the treatment of ABCC6 Deficiency.

Wells Fargo analyst Tiago Fauth initiates coverage on Inozyme Pharma (NASDAQ:INZY) with a Overweight rating and announces Price Target of $14.

Needham analyst Joseph Stringer reiterates Inozyme Pharma (NASDAQ:INZY) with a Buy and maintains $23 price target.

Inozyme Pharma (NASDAQ:INZY) reported quarterly losses of $(0.38) per share which missed the analyst consensus estimate of $(0.36) by 5.56 percent. This is a 5 percent increase over losses of $(0.40) per share from the same period last year.

Gainers GeneDx Hldgs (NASDAQ:WGS) shares increased by 21.8% to $13.4 during Monday's after-market session. The market value of their outstanding shares is at $349.1 million. The company's, Q1 earnings came out today. InnovAge Holding (NASDAQ:INNV) shares increased by 7.25% to $3.99. The market value of their outstanding shares is at $542.2 million. Mustang Bio (NASDAQ:MBIO) shares increased by 5.48% to $0.25. The market value of their outstanding shares is at $2.5 million. Lucid Diagnostics (NASDAQ:LUCD) stock moved upwards by 5.23% to $0.79. The market value of their outstanding shares is at $38.1 million. Seelos Therapeutics (NASDAQ:SEEL) shares increased by 4.88% to $0.29. The market

Needham analyst Joseph Stringer reiterates Inozyme Pharma (NASDAQ:INZY) with a Buy and maintains $23 price target.

- Interim data from ENERGY 1, a Phase 1b trial of INZ-701 in infants with ENPP1 Deficiency, on track for fourth quarter of 2024 – - Topline data from ENERGY 3, a pivotal trial of INZ-701 in pediatric patients with ENPP1 Deficiency, expected in early 2026 - - Company plans to initiate registrational trials in calciphylaxis and ABCC6 Deficiency in 2025 subject to regulatory alignment and sufficient funding - - Cash, cash equivalents, and short-term investments as of September 30, 2024, expected to fund operations into the fourth quarter of 2025 – BOSTON, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical c

BOSTON, Oct. 07, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage biopharmaceutical company developing innovative therapeutics for rare diseases that affect bone health and blood vessel function, today announced the appointment of Erik Harris to its Board of Directors, effective October 3, 2024. Mr. Harris, who currently serves as Chief Commercial Officer and Executive Vice President at Ultragenyx, brings to Inozyme over 20 years of commercial expertise within the biopharma industry. "It is a privilege to welcome Erik to the Inozyme Board of Directors at this exciting juncture for Inozyme as we continue to lay the groundwork for ou

- Founding CEO, Axel Bolte, MSc, MBA, to retire; Douglas A. Treco, Ph.D., to succeed as CEO - - Matthew Winton, Ph.D., appointed COO - - Upcoming clinical and regulatory milestones remain on track with previous guidance - - Current cash, cash equivalents and short-term investments anticipated to fund cash flow requirement into the fourth quarter of 2024 - BOSTON, March 22, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical- stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today reported financial results for the full year ended December 31, 2022, and provided recent

- Recently reported positive preliminary biomarker and safety data from ongoing Phase 1/2 clinical trials of INZ-701 in ENPP1 Deficiency and ABCC6 Deficiency – - Appointed Kurt Gunter, M.D. as senior vice president and chief medical officer - - Secured flexible debt facility for up to $70 million - - Cash, cash equivalents and investments as of quarter end, together with first tranche of debt facility, funds cash flow requirements into the second quarter of 2024 – BOSTON, Aug. 15, 2022 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today reporte

BOSTON, June 07, 2022 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today announced the appointment of Kurt Gunter, M.D., as chief medical officer. Dr. Gunter, who most recently served as chief medical officer, cell therapy, and head of regulatory affairs at Athenex, brings to Inozyme over 30 years of expertise in regulatory affairs, clinical development, and government relations. "It is a pleasure to welcome Kurt to the Inozyme team to lead Inozyme's clinical development and regulatory strategy," said Axel Bolte, MSc, MBA, Inozyme's co-founder, pre

– Recently reported positive preliminary biomarker and safety data from ongoing Phase 1/2 clinical trial of INZ-701 in ENPP1 Deficiency – – Preliminary biomarker and safety data from ongoing Phase 1/2 trial of INZ-701 in ABCC6 Deficiency on track for the second quarter of 2022 – – Cash, cash equivalents and investments as of quarter end, together with proceeds from April 2022 offering, extends runway into the fourth quarter of 2023 – BOSTON, May 10, 2022 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today reported financial results for the first q

– Phase 1/2 trial of INZ-701 in adult patients with ENPP1 Deficiency underway – – Expect to enroll first patient in Phase 1/2 trial of INZ-701 for ABCC6 Deficiency in the second quarter of 2022 – – Preliminary safety and biomarker data from Phase 1/2 trials in ENPP1 Deficiency and ABCC6 Deficiency on track for the first half of 2022 – BOSTON, March 15, 2022 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today reported financial results for the full year ended December 31, 2021, and provided recent business highlights. "2021 was a transformational

BOSTON, March 08, 2022 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today announced the appointment of Sanjay S. Subramanian, M.S., MBA, as chief financial officer (CFO), effective as of the later of (i) March 21, 2022 and (ii) the date immediately following the date of the filing of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, and Soojin Kim, Ph.D., as senior vice president and chief technical operations officer (CTOO). Dr. Kim succeeds Inozyme senior vice president and CTOO, Steven Jungles, who has retired

BOSTON, July 13, 2021 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today announced that Gayle Gironda has been appointed as senior vice president of human resources. Ms. Gironda is a human resources leader with more than 20 years of experience in organizational design, talent recruitment, performance culture, planning and leadership development. "Gayle brings a deep knowledge of life sciences, stemming from her work across large multinational pharmaceutical organizations and small biotech companies, and a passion for supporting people living with rare diseases,"

BOSTON, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced the appointment of Deborah Wenkert, M.D. as senior vice president and chief medical officer, effective February 2, 2021. Dr. Wenkert, a leading pediatric rheumatologist with more than 20 years of experience in metabolic bone and genetic disorders, will direct Inozyme’s clinical development programs as well as scientific communications activities. She succeeds Pedro Huertas, M.D., Ph.D., who has stepped down fro

- Favorable safety and immunogenicity profile in ABCC6 Deficiency, with clinical improvements in vascular pathology, visual function and patient reported outcomes (PROs) - - Natural history study highlights stroke as common feature among patients with early-onset ABCC6 Deficiency - - Favorable safety, immunogenicity and clinical outcome data were maintained through 48 weeks in Cohorts 1-3 in ENPP1 Deficiency; Data from Cohort 4 support once weekly dosing in ongoing and future clinical trials - - Company to host conference call and webcast today at 8:00 a.m. ET - BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage

- Company to host conference call and webcast featuring key opinion leaders on Monday, April 8, 2024 at 8:00 a.m. ET - BOSTON, March 26, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("the Company" or "Inozyme"), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced that it will host a conference call and webcast on Monday, April 8, 2024 at 8:00 a.m. Eastern Time. During the conference call and webcast, the Company will discuss topline data from its ongoing Phase 1/2 trial of INZ-701 in adults with ABCC6 Deficiency (pseudoxanthoma elasticum or PXE), and

- Data from ongoing trial suggest clinical benefit for ENPP1 Deficiency, including improvement in key biomarkers, patient reported outcomes (PROs) and functional outcomes - - Improvement in the Global Impression of Change (GIC) observed in all three dose cohorts in ABCC6 Deficiency (PXE) trial - - INZ-701 was generally well tolerated and exhibited a favorable safety and immunogenicity profile in both trials - - Company to host conference call and webcast today at 8:00 a.m. ET - BOSTON, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("Inozyme" or the "Company"), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the t

BOSTON, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY)("Inozyme" or the "Company"), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced that it will host an Investor and Analyst Event on Tuesday, September 26, 2023 at 8:00 a.m. Eastern Time. During the webcast and conference call, members of Inozyme management will review interim data from the Phase 2 portion of the ongoing trial of INZ-701 in adult patients with ENPP1 Deficiency. The Company will also provide an update on the safety and pharmacodynamic data from the ongoing Phase 1/2 tri

- Change in plasma pyrophosphate (PPi) as primary endpoint in the U.S. and co-primary endpoint in the EU for planned ENERGY-3 pivotal trial in pediatric patients - - ENERGY-3 pivotal trial in pediatric patients expected to initiate in October 2023, topline data expected to be reported in mid-2025 - - Updated cash runway expected to fund cash flow requirements into Q1 2025 - - Company to host conference call today at 8am ET - BOSTON, July 26, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("Inozyme" or the "Company"), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation

– Conference call and webcast to be held on July 26, 2023, at 8am ET – BOSTON, July 19, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY) ("Inozyme" or the "Company"), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced that it will host a conference call to provide an update on the Company's ENPP1 Deficiency program on July 26, 2023, at 8am ET. During the call, members of Inozyme management will provide an overview of the Company's global development strategy for INZ-701 in patients with ENPP1 Deficiency, including the advancement of INZ-701 in infants an

BOSTON, June 27, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced dosing of the first patient in its ENERGY-1 trial, a Phase 1b clinical trial of INZ-701 in infants with ENPP1 Deficiency. "Initiation of the ENERGY-1 trial in infants is an important milestone as we continue to advance INZ-701 with the goal of improving the lives of patients with ENPP1 Deficiency across all age groups. We are committed to a global program to identify and treat all newborns with this condition," said Kurt Gunter, M.D., seni

- Rapid, significant, and sustained increase in plasma pyrophosphate (PPi) observed and encouraging patient reported outcome data in all dose cohorts in ENPP1 Deficiency trial - - Rapid and significant increase in PPi observed in all dose cohorts with sustained increase observed in highest dose cohort in ABCC6 Deficiency (PXE) trial - - INZ-701 was generally well-tolerated and exhibited a favorable safety profile in both trials - - Company updates its cash runway guidance to fund cash flow requirements into fourth quarter of 2024 - - Company to host virtual investor and analyst event at 8:00 a.m. ET on February 16, 2023 - BOSTON, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Inozyme Pha

- Company to share topline data from ongoing Phase 1/2 trials of INZ-701 in ENPP1 Deficiency and ABCC6 Deficiency (PXE) – BOSTON, Feb. 06, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (NASDAQ:INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced that it will host an Investor and Analyst Event on Thursday, Feb. 16, 2023 at 8 a.m. ET. During the webcast and conference call members of Inozyme management will review topline pharmacokinetic, pharmacodynamic (PK/PD), and safety data from the ongoing Phase 1/2 clinical trials of INZ-701 in ENPP1 Deficiency and ABCC6 D