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Grail

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Grail stock slumps after NHS Galleri trial misses primary endpoint
healthcare8 days ago

Grail stock slumps after NHS Galleri trial misses primary endpoint

Grail's stock fell more than 45% after-hours after NHS-Galleri trial failed to meet its primary endpoint, showing no statistically significant reduction in later-stage cancers overall; however, a pre-specified group of 12 deadly cancers showed a favorable trend toward fewer stage III-IV cancers, with greater reductions in stage IV diagnoses across sequential screening rounds. The company will extend follow-up by 6-12 months to seek stronger effects, and it also reported 17% full-year revenue growth to $147.2 million, with U.S. Galleri revenue up 26% to $136.8 million.

via Fierce Biotech|
#clinical-trials#galleri#grail
Major UK Trial Undermines Promise of Galleri Multi-Cancer Blood Test
health9 days ago

Major UK Trial Undermines Promise of Galleri Multi-Cancer Blood Test

In a large UK trial of 142,000 adults over three years, Grail's Galleri multi-cancer blood test did not reduce late-stage cancers (stages 3–4), though researchers noted a secondary signal of fewer Stage 4 cancers; the test remains FDA-unapproved, is sold with limited insurer coverage, and Medicare coverage remains under legislative review.

via The New York Times|
#cancer-detection#clinical-trial#galleri
"Challenges to Grail's Galleri Cancer Liquid Biopsy Evaluation Plan"
healthscience1 year ago

"Challenges to Grail's Galleri Cancer Liquid Biopsy Evaluation Plan"

WHO scientists are questioning the clinical trial endpoint being used by Grail to evaluate its Galleri blood test, which aims to detect multiple types of tumors early. The test is currently available in the U.S. but not yet approved by the FDA or reimbursed by Medicare, and Grail generated $30 million in revenue in the fourth quarter of 2023 while incurring a $197 million loss. If successful, the Galleri test could revolutionize cancer screening as a multi-cancer early detection test, but concerns about its evaluation process persist.

via STAT|
#cancer-screening#clinical-trial#galleri
"Grail's Blood Cancer Tests: New Owner Found, Big Plans Ahead"
health2 years ago

"Grail's Blood Cancer Tests: New Owner Found, Big Plans Ahead"

Grail, a company specializing in blood cancer tests, is seeking a new owner as it aims to expand its services. The company's tests have proven effective in detecting pancreatic cancer, a typically hard-to-diagnose disease. Patients like Paul Schneider, who was diagnosed with pancreatic cancer through a Grail blood test, have benefited from early detection and subsequent treatment.

via Endpoints News|
#blood-cancer-tests#chemotherapy#diagnosis
Illumina's Divestment of Cancer Test Maker Grail Resolves Antitrust Battles
business2 years ago

Illumina's Divestment of Cancer Test Maker Grail Resolves Antitrust Battles

Illumina, a gene sequencing company, has announced plans to divest cancer diagnostic test maker Grail after facing antitrust battles with U.S. and European regulators for over two years. The divestiture will be executed through a third-party sale or capital markets transaction, with the terms expected to be finalized by the second quarter of 2024. Grail, valued at $7.1 billion, is seeking to market a blood test that can diagnose various types of cancer. Illumina had reacquired Grail in 2021 despite competition concerns, and a U.S. appeals court recently ordered the Federal Trade Commission (FTC) to conduct a new review of the acquisition. The FTC had expressed concerns about Illumina's dominant position in DNA sequencing and its potential impact on competition. The divestment is also a response to pressure from activist investor Carl Icahn, who led a successful board challenge and sued Illumina over the Grail deal.

via Reuters|
#antitrust-battles#business#cancer-diagnostic-test
Illumina's Divestment of Grail Marks the End of a Troubled Merger Attempt
business2 years ago

Illumina's Divestment of Grail Marks the End of a Troubled Merger Attempt

Illumina, the leading maker of DNA sequencing machines, has announced that it will divest Grail, the developer of a multi-cancer screening test, following a court decision that deemed their merger anti-competitive. Illumina plans to sell or list Grail on capital markets by the end of the second quarter of 2024, marking the end of a disastrous attempted merger that began in 2016 when Illumina spun out Grail to raise funds before re-acquiring it for $7.1 billion in 2020.

via STAT|
#biotech#business#dna-sequencing
Illumina to Sell Cancer Test Developer Grail Amid Antitrust Battles
business2 years ago

Illumina to Sell Cancer Test Developer Grail Amid Antitrust Battles

Gene-sequencing company Illumina has announced its decision to sell Grail, a cancer test developer that it acquired for $7.1 billion in 2021. This move comes after a federal appeals court largely upheld a Federal Trade Commission ruling that Illumina should unwind its deal with Grail on antitrust grounds. The sale of Grail will be executed through a third-party sale or a capital market transaction, with the goal of finalizing the deal by the end of the second quarter next year. This case is seen as a test of regulators' efforts to prevent big companies from acquiring fledgling innovators, and it may have implications for other tech giants and dominant companies in their respective fields.

via The New York Times|
#antitrust#business#cancer-test
Illumina's $7.1B Grail Deal Rejected by Appeals Court
business2 years ago

Illumina's $7.1B Grail Deal Rejected by Appeals Court

The planned $7.1 billion acquisition of cancer test developer Grail by Illumina has been sent back to the Federal Trade Commission (FTC) by a U.S. appeals court, which upheld the regulator's finding that the deal is anticompetitive. The court determined that the FTC used a standard incompatible with the Clayton Act and vacated its order, remanding the case for reconsideration. Illumina has filed a draft registration statement for a potential divestiture of Grail, and if it fails to overturn the European Commission's order or the appeals court rules against it, Illumina will proceed with the divestiture.

via Seeking Alpha|
#anticompetitive#business#divestiture
US Court Overturns FTC's Ruling on Illumina's Acquisition of Grail
business2 years ago

US Court Overturns FTC's Ruling on Illumina's Acquisition of Grail

A U.S. appeals court has struck down a Federal Trade Commission (FTC) order against Illumina's acquisition of cancer diagnostic test maker Grail, stating that the agency applied the wrong legal standard. The court's decision requires the FTC to reconsider the deal. While the panel acknowledged the FTC's evidence of potential competition reduction, it also noted that the agency failed to properly consider Illumina's commitment to continue selling its DNA sequencing services to other firms. Illumina had argued that the FTC unconstitutionally exercised its powers, but the court rejected this claim. The FTC sees the decision as a victory for antitrust enforcement, while Illumina is reviewing the ruling.

via Reuters|
#acquisition#antitrust#business
SEC Investigates Illumina's Grail Deal
business2 years ago

SEC Investigates Illumina's Grail Deal

The U.S. Securities and Exchange Commission (SEC) has launched an investigation into Illumina's $7.1 billion acquisition of cancer detection test maker Grail. The SEC has requested documents and communications related to the acquisition, as well as information on the "conduct and compensation" of certain members of the companies' management. Illumina is cooperating with the investigation, while its shares fell 3.6% following the news. The gene sequencing company had previously repurchased Grail in 2021, despite opposition from antitrust regulators, and was fined €432 million by the EU last month for closing the deal before approval.

via Reuters|
#acquisition#business#grail
SEC Probes Illumina's Acquisition of Grail Amidst Cancer Test Development
business2 years ago

SEC Probes Illumina's Acquisition of Grail Amidst Cancer Test Development

The Securities and Exchange Commission (SEC) is investigating Illumina over its $7.1 billion acquisition of cancer test developer Grail. The SEC has requested documents and communications related to the deal, as well as information about the "conduct and compensation" of certain members of both companies' management. Illumina, which has already faced scrutiny from antitrust regulators, is cooperating with the investigation. The company's market value has significantly declined since closing the deal, and it has also been fined by the European Commission for closing the acquisition without regulatory approval. Illumina has appealed the decision and expects a final outcome in late 2023 or early 2024.

via CNBC|
#acquisition#antitrust-regulators#business
EU Slaps Illumina with $476M Fine for Unapproved Grail Deal
business2 years ago

EU Slaps Illumina with $476M Fine for Unapproved Grail Deal

The European Commission has ordered Illumina to pay a €432 million ($476 million) fine for acquiring cancer-testing firm Grail without regulatory approval. Illumina closed the deal in 2021 despite an ongoing antitrust investigation by the EU. The EU stated that merging companies must not implement mergers until approved by the Commission, and failure to comply with this "standstill obligation" has resulted in the significant fine.

via Endpoints News|
#business#eu#fine