FDA Lifts Partial Clinical Hold on MDS and AML Magrolimab Studies

U.S. Pivotal Studies to Restart Enrollment Immediately –

Decision Based on Review of the Comprehensive Safety Data from Each Trial –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. The FDA removed the partial clinical hold after a review of the comprehensive safety data from each trial.

With today's decision from the FDA, enrollment in the U.S. can resume for the studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Gilead, in close coordination with regulatory authorities, is planning to re-open enrollment in the magrolimab studies that were placed on a voluntary hold outside of the U.S. The company is also working with the FDA regarding the remaining partial clinical hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma. The ongoing clinical studies evaluating magrolimab in solid tumors were not subject to the clinical hold.

"Our confidence in the risk-benefit profile of magrolimab has been unwavering, and we continue to believe in the potential for this treatment to address the unmet medical needs faced by people living with MDS and AML," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "This is a significant milestone for Gilead and, more importantly, for patients diagnosed with these cancers. We look forward to continuing our work developing magrolimab and advancing this potential cancer treatment option."

During the partial clinical hold, patients already enrolled in the affected Gilead magrolimab studies, including the pivotal, Phase 3 ENHANCE study, continued receiving treatment. Prior to the trial hold, Gilead already met the pre-specified enrollment threshold required for the first interim analysis of the ENHANCE study. Based on this, Gilead is confident the readout for the first interim analysis remains on schedule for 2023.

Magrolimab was granted Breakthrough Therapy designation for the treatment of newly diagnosed MDS by the FDA in 2020. In addition to MDS and AML, magrolimab is being developed in several hematologic cancers and solid tumor malignancies. Magrolimab is an investigational product and is not approved by any regulatory authority for any use; its safety and efficacy have not been established.

About Myelodysplastic Syndrome (MDS)

MDS is a rare, often unrecognized, under-diagnosed, bone marrow disorder widely considered to be a form of cancer. In MDS, the body's bone marrow does not make enough mature, healthy red blood cells, white blood cells and/or platelets. While many cases may go undiagnosed, current estimates show that ~100,000 new cases are diagnosed each year. Therapeutic advancement for higher-risk MDS has been limited in the last 15 years and stem cell transplant is the only potential cure, but those older than 65 or with other conditions are often not eligible.

One in three people with MDS will progress to AML, one of the most common types of leukemia in adults. Approximately 10,000 people die every year from AML in the U.S.

About Acute Myeloid Leukemia (AML)

AML is a type of cancer that starts in the bone marrow and can quickly move to the blood and other parts of the body, including the lymph nodes, spleen and central nervous system. AML most often develops from cells that would turn into red blood cells, neutrophils, and platelets but can also evolve from other blood disorders such as myelodysplastic syndromes. Approximately 20,000 Americans will be diagnosed with AML each year.

About Magrolimab

Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the "don't eat me" signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) as well as solid tumor malignancies. More information about clinical trials with magrolimab is available at www.clinicaltrials.gov .

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, the risk that FDA or other regulatory authorities may not remove other clinical holds currently in place on clinical trials, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involved magrolimab; Gilead's ability to submit regulatory applications in the currently anticipated timelines or at all, including those relating to magrolimab; Gilead's ability to receive regulatory approvals in a timely manner or at all, including regulatory approvals of magrolimab, and the risk that any such approvals, if granted, may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of magrolimab and that, as a result, magrolimab may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Gilead and the Gilead logo are trademarks of   Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Jacquie Ross, Investors
investor_relations@gilead.com

Marian Cutler, Media
marian.cutler1@gilead.com

News Provided by Business Wire via QuoteMedia

GILD
The Conversation (0)
CHMP Adopts Positive Opinion Recommending Hepcludex®  for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

CHMP Adopts Positive Opinion Recommending Hepcludex® for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

--   If Granted by the European Commission, Hepcludex will Become the Only Approved Treatment for HDV in the EU --

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex ® (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease, and recommended granting full Marketing Authorisation (MA) that is no longer subject to specific obligations. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment. The CHMP recommendation for full Marketing Authorisation of bulevirtide follows the submission of the Phase 3 MYR301 Week 48 study data, which reinforces the efficacy and safety profile of bulevirtide for the treatment of HDV.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Gilead Remains Steadfast in Support for Hepatitis C Elimination Efforts

Gilead Remains Steadfast in Support for Hepatitis C Elimination Efforts

The recent national conversation on hepatitis C (HCV) is an encouraging step towards viral hepatitis elimination in the U.S. With its long history of leadership in viral hepatitis, Gilead continues to support efforts that focus on HCV elimination. Gilead is proud that its medicines have treated over four million individuals living with HCV globally. Today, some 2.4 million people are living with HCV in the U.S., even though ~95% of those treated with direct-acting antivirals (DAAs) are cured. Prices of HCV medicines have dropped significantly, and many acknowledge that price is not a barrier for most payers and patients. Curative HCV drug therapies are just one part of an elimination strategy that needs to dedicate considerable resources and attention to screening and linkage to care so that all patients in need of HCV treatment can access it in a timely manner and achieve a cure

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Gilead Sciences Announces First Quarter 2023 Financial Results

Gilead Sciences Announces First Quarter 2023 Financial Results

Product Sales Excluding Veklury Increased 15% Year-Over-Year to $5.7 billion

Biktarvy Sales Increased 24% Year-Over-Year to $2.7 billion

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Gilead Sciences Releases Inaugural ESG Impact Report

Gilead Sciences Releases Inaugural ESG Impact Report

Gilead Sciences recently released its inaugural Environmental, Social and Governance (ESG) Impact Report. This is an evolution of our traditional Year in Review, and uses the ESG framework to highlight the successes and achievements of the prior year

Though the report itself is new, our commitment to practicing ESG is not: We've been guided by Environmental, Social and Governance principles for more than 35 years.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
abigail echo-hawk

CORRECTION: Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

This document corrects and updates the final paragraph in the body of this news release. No other changes were required in this release.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Elixinol Wellness Limited

Strategic Acquisition and Capital Raising - Investor Presentation | 3 October 2024

Elixinol Wellness Ltd. (”EXL”) has entered into a binding agreement to acquire 100% of the business assets from the entities ("Acquisition") that together form The Healthy Chef business ("Healthy Chef").

Keep reading...Show less
Radiopharm Theranostics

Significant Progress with B7-H3 Targeting Radio-Antibody (BetaBart)

Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce regulatory and manufacturing progress for its B7-H3 targeting radio-antibody, BetaBart.

Keep reading...Show less
Hydralyte

Completion of Divesture of Non-US Assets

Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte US” or “the Company”) refers to its announcement released pre-open on 2 October 2024 regarding entry into an Intellectual Property Sales Agreement (the ‘Agreement’) and related documents with Prestige Consumer Healthcare Inc. and associated subsidiaries.

Keep reading...Show less
Hydralyte

Divesture of Non-US Assets for ~US$9.5M (~A$13.7M) Allowing for Payoff of A$8.2M Debt Facility while Funding Expansion of US Business

Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte North America” or “the Company”) is pleased to announce that it has entered into an Intellectual Property Sales Agreement (the ‘Agreement’) with Prestige Consumer Healthcare Inc. and associated subsidiaries (together, ‘Prestige’). Pursuant to the Agreement and associated arrangements, the Company will assign and transfer the exclusive right to sell Hydralyte products, and associated intellectual property rights, to Prestige in all relevant jurisdictions other than the United States of America.1

Keep reading...Show less

LA LA ANTHONY PARTNERS WITH AMGEN TO SHARE CANDID, BEHIND-THE-SCENES LOOK AT HOW PLAQUE PSORIASIS AFFECTS HER LIFE

Campaign Encourages Open Dialogue With Doctor About Unmanaged Symptoms to Find the Right Treatment Option

Amgen (NASDAQ: AMGN) has partnered with multi-talented actress, producer and entrepreneur La La Anthony to share her personal journey living with plaque psoriasis, and to inspire people to be open with their doctors about how the disease affects their daily lives. As one of the more than 6 million people in the United States living with plaque psoriasis, La La understands the frustrations of living with this disease. Symptoms can distract from everyday moments, big and small, even influencing clothing or makeup choices. 1,2

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Cardiex Announces Publication of Breakthrough Study Validating Noninvasive Fingertip Photoplethysmography  for Central Aortic Pressure Waveform Analysis

Cardiex Announces Publication of Breakthrough Study Validating Noninvasive Fingertip Photoplethysmography for Central Aortic Pressure Waveform Analysis

Cardiex Limited (ASX: CDX), a global health technology company focused on cardiovascular diagnostics and arterial health solutions, today announced the publication of a peer-reviewed study validating its innovative method for measuring central aortic pressure—an important indicator of heart health—using a noninvasive fingertip sensor. The study, co-authored by Cardiex's team, was published in the respected journal Pulse.

Cardiex logo (PRNewsfoto/CardieX Limited)

The study, titled "Validation of Noninvasive Derivation of the Central Aortic Pressure Waveform from Fingertip Photoplethysmography Using a Novel Selective Transfer Function Method," demonstrates that Cardiex's technology can accurately capture key cardiovascular data from a simple fingertip sensor. The method leverages photoplethysmography (PPG)—an optical technique widely used in wearables such as fitness trackers and smartwatches—offering a powerful and accessible tool for advanced heart health monitoring.

Key findings include:

  • Strong correlation between fingertip sensor measurements and traditional methods, with heart health indicators showing excellent alignment.
  • The fingertip sensor offers a user-friendly, noninvasive way to measure central aortic pressure parameters without calibration, making heart health monitoring more accessible and comfortable.
  • Twenty clinically relevant parameters were captured from the converted PPG waveforms, including central systolic blood pressure, central diastolic blood pressure, central pulse pressure, central augmentation pressure, central augmentation index, subendocardial viability, and pulse pressure amplification, amongst others.

Relevance in the Wearable Health Market:

The use of PPG technology in this study is especially significant as the wearable market continues to expand, with consumers seeking more advanced health insights without the need for frequent calibration. Cardiex's innovation aligns with this trend offering consumers the ability to track clinical grade biomarkers in real-time. These biomarkers have applications in various healthcare fields, including cognitive, renal, maternal, metabolic health, and heart failure management. The technology's ease of use and capacity for continuous monitoring place Cardiex at the forefront of the growing wearable health sector, which increasingly prioritizes deeper and more accurate health data.

"This study is a significant validation of Cardiex's technology and its ability to deliver critical heart health insights in a simpler, more convenient way," said Craig Cooper , CEO of Cardiex. "Our PPG-based fingertip technology has the potential to transform heart health monitoring, offering a more accessible option for both patients and healthcare providers. This breakthrough also opens up exciting opportunities for integration into the wearable health tech market, where continuous and noninvasive monitoring is becoming the gold standard."

The study confirms that Cardiex's PPG-based solution can provide valuable cardiovascular data in a comfortable, portable format, paving the way for broader adoption in both medical and consumer-grade wearables.

The full study is now available online in the journal Pulse DOI: 10.1159/000540666.

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/cardiex-announces-publication-of-breakthrough-study-validating-noninvasive-fingertip-photoplethysmography-ppg-for-central-aortic-pressure-waveform-analysis-302259185.html

SOURCE Cardiex Limited

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×