GH

Guardant Health Named to TIME100 Most Influential Companies

Retrieved on: 
fredag, maj 31, 2024
Biotechnology, Oncology, General Health, Health, Medical Devices, Hospitals, Health Technology, Other Health, Risk, Food, Colorectal cancer, TIME, FDA, Helmy Eltoukhy, Disease, Cancer, Molecule, Innovation, Entrepreneurship, Pharmaceutical industry

Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced its inclusion in the fourth-annual TIME100 Most Influential Companies list, highlighting companies making an extraordinary impact around the world.

Key Points: 
  • Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced its inclusion in the fourth-annual TIME100 Most Influential Companies list, highlighting companies making an extraordinary impact around the world.
  • TIME solicited nominations across sectors, and polled its global network of contributors and correspondents, as well as outside experts.
  • TIME editors then evaluated companies on key factors, including impact, innovation, ambition, and success.
  • Guardant was included in the Innovators section of the list, which includes 20 companies across diverse industries.

Guardant Health to Present Studies at 2024 ASCO Annual Meeting Highlighting Contributions of Its Blood Tests and Real-World Data to Advancing Precision Oncology and Cancer Screening

Retrieved on: 
torsdag, maj 30, 2024
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Incidence, DNA, Plasma, MBC, Circulating tumor DNA, Helmy Eltoukhy, PIK3CA, Neoplasm, Nucleic acid thermodynamics, Chinese, Interim, Biomarker, ASCO, ESR1, Society, Liquid biopsy, ABC, Annual general meeting, Medical imaging

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present data from 16 studies highlighting the role of Guardant blood tests and real-world data in advancing precision oncology and cancer screening at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, May 31-June 4 in Chicago.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present data from 16 studies highlighting the role of Guardant blood tests and real-world data in advancing precision oncology and cancer screening at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, May 31-June 4 in Chicago.
  • Additional studies will present data supporting the application of genomic and epigenomic biomarkers in areas such as minimal residual disease detection and cohort characterization.
  • “The robust data we present at ASCO will further demonstrate the important scientific and clinical developments in cancer care that are possible using liquid biopsy,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO.
  • For more information and updates from the meeting, follow Guardant Health on LinkedIn and X (Twitter) or visit ASCO booth #28115.

Lumos Pharma Announces Positive End-of-Phase 2 Meeting with FDA and Reports First Quarter 2024 Financial Results

Retrieved on: 
tisdag, maj 14, 2024
Patient, Investment, Transgender hormone therapy, LUMO, Clinical trial, FDA, Conference, Growth hormone, AHV, Research, Therapy, Pharmaceutical industry

AUSTIN, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical stage biopharmaceutical company focused on therapeutics for rare diseases, today announced the outcome from its End-of-Phase 2 meeting with the FDA, provided a clinical programs update, and reported financial results for the quarter ended March 31, 2024.

Key Points: 
  • "We are pleased to announce that, earlier this quarter, we had a very productive End-of-Phase 2 meeting with the FDA," said Rick Hawkins, Chairman and CEO of Lumos Pharma.
  • We expect to finalize design details with the FDA in the third quarter and to be in position to initiate this trial before the end of this year.
  • "In addition to our encouraging engagement with the FDA, we are also very pleased to share updated data from our Phase 2 OraGrowtH trials.
  • Financial Results for Quarter Ended March 31, 2024
    Cash Position – Lumos Pharma ended the quarter on March 31, 2024, with cash, cash equivalents, and short-term investments totaling $23.2 million, as compared to $36.1 million on December 31, 2023.

Guardant Health Stock Trading Temporarily Halted; FDA Panel to Assess Premarket Approval Application for Shield Blood Test for Colorectal Cancer Screening

Retrieved on: 
torsdag, maj 23, 2024
Research, General Health, Professional Services, Oncology, Technology, Artificial Intelligence, Genetics, Data Analytics, Science, FDA, Other Science, Health, Colorectal cancer, PMA, Molecule, Food

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Nasdaq has temporarily halted trading of the company's stock.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Nasdaq has temporarily halted trading of the company's stock.
  • The Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee will meet today to review the premarket approval (PMA) application for ShieldTM, Guardant Health’s blood test to screen for colorectal cancer in average-risk adults.
  • The panel meeting is scheduled to begin at 9:30 a.m.
  • FDA advisory committees provide independent expert advice and non-binding recommendations to the FDA on certain products to help the agency make sound decisions based on the available science.

FDA Advisory Committee Panel Strongly Recommends Approval of Shield™ Blood Test for Colorectal Cancer Screening as a Primary Non-Invasive Screening Option

Retrieved on: 
fredag, maj 24, 2024
Oncology, Medical Supplies, Health, FDA, Medical Devices, Other Health, General Health, Patient, Colorectal cancer, Massachusetts General Hospital, Risk, Food, Disease, Helmy Eltoukhy, MD, Large intestine, PMA, Cancer, Harvard Medical School, Death, CRC, Hospital, Molecule, Vaccine

The recommendation signals the advisory committee panel's consensus on Shield's safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks.

Key Points: 
  • The recommendation signals the advisory committee panel's consensus on Shield's safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks.
  • The committee offers valuable perspective and non-binding recommendations for the FDA to factor in alongside other considerations during approval decisions.
  • “The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk,” said AmirAli Talasaz, co-CEO of Guardant Health.
  • “Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods.

Guardant Health to Participate in Upcoming Investor Conferences

Retrieved on: 
onsdag, maj 22, 2024
Biotechnology, Health, Pharmaceutical, Health Technology, Oncology, Conference, Communications satellite

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company will participate in the following investor conferences.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company will participate in the following investor conferences.
  • Presentation on Tuesday, June 4 at 3:20 p.m. CT / 4:20 p.m.
  • ET / 2:00 p.m. PT
    Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, Florida
    Fireside chat on Tuesday, June 11 at 2:00 p.m.
  • ET / 11:00 a.m. PT
    Interested parties may access live and archived webcasts of the sessions on the “Investors” section of the company website at: www.guardanthealth.com .

Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications

Retrieved on: 
tisdag, maj 21, 2024
Biotechnology, Pharmaceutical, Medical Supplies, Oncology, Health, Medical Devices, Genetics, Clinical Trials, NGS, IVDR, Patient, Progression-free survival, Lung cancer, Diagnosis, Overalls, Helmy Eltoukhy, European, IRST, Breast cancer, Certification, MD, NCI-designated Cancer Center, Blood, Cancer, CGP, Gynaecology, Biomarker, Obstetrics, IVD, Medical imaging

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746).

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746).
  • The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.
  • Under the previous EU regulatory framework (IVD Directive 98/79/EC), manufacturers were able to self-certify most of their molecular assays.
  • Guardant360 CDx is a next generation sequencing (NGS)-based assay that detects genomic alterations using circulating tumor DNA from blood.

Guardant Health Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
fredag, maj 17, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Employment, Helmy Eltoukhy, Compensated emancipation, RSU

The RSUs and stock options were granted as inducements material to the employees entering into employment with Guardant in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The RSUs and stock options were granted as inducements material to the employees entering into employment with Guardant in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Guardant, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Guardant, pursuant to Nasdaq Listing Rule 5635(c)(4).
  • The RSUs are subject to the terms and conditions of the Inducement Plan and the terms and conditions of a RSU award agreement covering the grant.
  • The stock options are subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option award agreement covering the grant.

Guardant Health Reports First Quarter 2024 Financial Results and Increases 2024 Revenue Guidance

Retrieved on: 
torsdag, maj 9, 2024
Software, Professional Services, Pharmaceutical, Oncology, Technology, Genetics, Artificial Intelligence, Health Technology, Data Analytics, Clinical Trials, Biotechnology, FDA, Health, Net, LDT, Depreciation, Webcast, Forecasting, Helmy Eltoukhy, Patient, Medicare, Marketing, GAAP, Growth

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter ended March 31, 2024.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter ended March 31, 2024.
  • Development services and other revenue was $12.3 million for the first quarter of 2024, compared to $15.3 million for the corresponding prior year period.
  • Precision oncology gross margin was 62% in the first quarter of 2024, as compared to 60% in the prior year period.
  • Guardant Health will host a conference call to discuss the first quarter 2024 financial results after market close on Thursday, May 9, 2024 at 1:30 pm Pacific Time / 4:30 pm Eastern Time.

Guardant Health Surpasses 500 Peer-Reviewed Publications Milestone

Retrieved on: 
tisdag, maj 7, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Cancer, NCCN, Lung cancer, Publication, Colorectal cancer, National Comprehensive Cancer Network, Companion diagnostic, National Cancer Institute, Helmy Eltoukhy, NCI, CDX, Trust, Breast cancer, Liquid biopsy

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced its achievement of surpassing a significant milestone of 500 peer-reviewed publications featuring its technology in esteemed scientific journals.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced its achievement of surpassing a significant milestone of 500 peer-reviewed publications featuring its technology in esteemed scientific journals.
  • This milestone highlights Guardant Health’s leadership, amassing one of the most robust portfolios of relevant liquid biopsy research studies in the industry.
  • “We have partnered with thousands of authors representing diverse perspectives and expertise worldwide,” said Dr. Craig Eagle, chief medical officer at Guardant Health.
  • “High-quality science has always been the driving force in our mission to conquer cancer with data,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO.