MedPath

Tagged News

Tempus AI Raises $650 Million Through Convertible Notes to Advance AI-Driven Precision Medicine Platform

AIPrecision Medicine
  • Tempus AI successfully priced a $650 million convertible senior notes offering, increasing from the initially announced $400 million, to fund its AI-enabled precision medicine platform development.
  • The company plans to use approximately $274.7 million of proceeds to repay existing debt and $36.2 million for capped call transactions, with remaining funds allocated to general corporate purposes including potential acquisitions.
  • The notes carry a 0.75% annual interest rate and mature in 2030, with conversion features that allow holders to convert to Tempus Class A common stock at approximately $84.19 per share.
  • Tempus operates one of the world's largest multimodal healthcare data libraries and provides AI-powered precision medicine solutions to physicians for personalized patient care and therapeutic development.

Stalicla Secures CHF 2 Million Financing from Addex Therapeutics to Advance Precision Medicine for Autism and Neurodevelopmental Disorders

Precision Medicine
  • Geneva-based Stalicla SA closed a CHF 2 million financing round led by Addex Therapeutics to sustain operations and advance its precision medicine programs for neurodevelopmental disorders.
  • The funding supports Stalicla's DEPI precision neuro platform and autism-focused assets STP1 and STP2, while the company prepares for Phase 2 trials targeting specific autism subpopulations.
  • Stalicla's STP7 (mavoglurant) program, the most clinically advanced mGluR5 negative allosteric modulator, continues toward Phase 3 trials with full NIH-NIDA funding.
  • Tim Dyer, CEO of Addex Therapeutics, has been appointed Chairman of Stalicla's Board of Directors as part of the financing agreement.

FDA Grants Breakthrough Therapy Designation for Daraxonrasib in KRAS-Mutated Pancreatic Cancer

Targeted TherapyPrecision MedicineOncology
  • FDA has granted Breakthrough Therapy Designation to daraxonrasib, a RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) in patients with KRAS G12 mutations.
  • The designation represents a significant regulatory milestone for targeting KRAS mutations in pancreatic cancer, one of the most challenging malignancies to treat.
  • Daraxonrasib's multi-selective RAS(ON) inhibition mechanism offers a novel therapeutic approach for patients with limited treatment options in the metastatic setting.

RetinalGenix Partners with LabCorp to Launch DNA/GPS Platform for Genetic and Retinal Disease Screening

Precision Medicine
  • RetinalGenix Technologies has entered into an agreement with LabCorp to support the rollout of its DNA/RNA/GPS Pharmaco-Genetic Mapping platform for early detection of ocular and systemic diseases.
  • The platform enables anonymous genetic testing and retinal imaging at LabCorp locations nationwide, analyzing blood, tears, nasal secretions, and saliva using proprietary algorithms.
  • The cost-effective methodology aims to reduce reliance on expensive diagnostic procedures like MRIs and CT scans while improving access to early disease detection.
  • High-resolution retinal imaging will be introduced as an additional service to boost diagnostic accuracy and enable mass screening by general practitioners and standard eye clinics.

Zenocutuzumab Achieves 30% Response Rate in NRG1 Fusion-Positive Solid Tumors, Receives FDA Approval

Targeted TherapyDrug ApprovalPrecision Medicine
  • The Phase 2 eNRGy trial demonstrated zenocutuzumab's clinical efficacy with a 30% objective response rate and 11.1-month median duration of response in patients with NRG1 fusion-positive solid tumors.
  • Pancreatic cancer patients showed particularly promising results with a 42% response rate and 9.2-month median progression-free survival, offering hope for this historically difficult-to-treat malignancy.
  • Zenocutuzumab received accelerated FDA approval as the first targeted therapy for NRG1-positive non-small cell lung cancer and pancreatic adenocarcinoma.
  • The bispecific antibody demonstrated a favorable safety profile with treatment-related adverse events in 95% of participants but fewer than 10% experiencing grade 3 or higher toxicities.

A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours

NCT05057013Active, Not RecruitingPhase 1
Cancer Research UK
Posted 11/10/2021

Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors

NCT04383210TerminatedPhase 2
Elevation Oncology
Posted 9/29/2020

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors

NCT01966445CompletedPhase 1
GlaxoSmithKline
Posted 11/26/2013

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

NCT02693535RecruitingPhase 2
American Society of Clinical Oncology
Posted 3/14/2016

Patritumab Deruxtecan in Patients with Solid Tumor Harboring an NRG1 Fusion

NCT06383884RecruitingPhase 2
Samsung Medical Center
Posted 8/13/2024

A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

NCT02912949Active, Not RecruitingPhase 2
Partner Therapeutics, Inc.
Posted 1/1/2015

Ambry Genetics' CARE Program Achieves 99.5% Accuracy in Hereditary Cancer Risk Assessment

Precision Medicine
  • Ambry Genetics' CARE Program demonstrated 99.5% accuracy in interpreting NCCN Clinical Practice Guidelines for hereditary cancer risk assessment in a peer-reviewed study published in the Journal of the National Comprehensive Cancer Network.
  • The digital tool successfully identified 398 out of 400 real-world patient cases that met hereditary cancer testing criteria, matching the assessments of certified genetic counselors.
  • The HIPAA-compliant platform integrates with electronic health records and streamlines hereditary cancer risk assessment, addressing the gap where approximately 5% of individuals have cancer predisposition gene mutations but most remain unaware.

Circulating Tumor DNA Testing Transforms Breast Cancer Monitoring and Treatment Selection

Precision Medicine
  • Circulating tumor DNA (ctDNA) testing is increasingly used alongside tissue biopsies to rapidly identify molecular targets in metastatic hormone receptor-positive breast cancer patients.
  • Serial ctDNA monitoring at disease progression detects emerging resistance mutations like ESR1, enabling timely treatment adjustments based on evolving tumor biology.
  • Current symptom-driven surveillance often detects recurrence at advanced stages, but ctDNA testing offers potential for earlier intervention before clinical symptoms emerge.
  • Ongoing trials are evaluating ctDNA-guided adjuvant therapy decisions, including CDK4/6 inhibitors for hormone receptor-positive disease and targeted agents for other breast cancer subtypes.

Evotec Joins NURTuRE-AKI Consortium to Advance Multi-Omics Research for Acute Kidney Injury Treatment

Precision MedicineDrug Discovery
  • Evotec has joined the NURTuRE-AKI consortium led by Kidney Research UK to establish the world's most comprehensive patient cohort for acute kidney injury research.
  • The longitudinal study will collect multi-omics data from 950 patients across three cohorts, including cardiac surgery patients and those experiencing AKI-to-CKD progression.
  • The initiative aims to identify novel therapeutic targets and biomarkers for AKI, a condition affecting millions worldwide with no current preventive or therapeutic treatments available.

Extended Imatinib Therapy Shows Promise in High-Risk GIST Patients as Novel Agents Enter Clinical Development

Precision Medicine
  • The phase 3 IMADGIST trial demonstrated that extending imatinib therapy to 6 years versus 3 years significantly improved disease-free survival in localized GIST patients (72% vs 42% at 3 years).
  • Multiple ongoing phase 3 trials including INSIGHT and Peak are evaluating mutation-specific treatment approaches using circulating tumor DNA to guide therapy selection in advanced GIST.
  • Novel agents NB003 and IDRX-42 are advancing through clinical development, while established drugs like ripretinib and avapritinib continue to address specific resistance mutations.
  • The treatment paradigm is shifting from all-comers approaches to precision medicine strategies based on mutational profiling and biomarker-informed decisions.

Efficiency of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST)

NCT02260505CompletedPhase 3
Centre Leon Berard
Posted 12/24/2014

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

NCT03673501Active, Not RecruitingPhase 3
Deciphera Pharmaceuticals, LLC
Posted 2/8/2019

MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

NCT01991379Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 11/1/2013

Three Versus Five Years of Adjuvant Imatinib as Treatment of Patients With Operable GIST

NCT02413736Active, Not RecruitingPhase 3
Heikki Joensuu
Posted 5/1/2015

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

NCT03465722CompletedPhase 3
Blueprint Medicines Corporation
Posted 3/26/2018

Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies

NCT03353753CompletedPhase 3
Deciphera Pharmaceuticals, LLC
Posted 2/27/2018

Prospective Multicentric Randomized Study of Glivec® in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance

NCT00367861CompletedPhase 3
Centre Leon Berard
Posted 5/1/2002

Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)

NCT01271712CompletedPhase 3
Bayer
Posted 1/4/2011

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

NCT05208047Active, Not RecruitingPhase 3
Cogent Biosciences, Inc.
Posted 4/14/2022

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

NCT05734105RecruitingPhase 3
Deciphera Pharmaceuticals, LLC
Posted 12/13/2023

PathPresenter Receives FDA 510(k) Clearance for Digital Pathology Clinical Viewer

Precision Medicine
  • PathPresenter has received FDA 510(k) clearance for its Clinical Viewer platform, enabling primary diagnosis using digital pathology workflows.
  • The clearance is specifically for use with Hamamatsu NanoZoomer S360MD slide scanners and Barco NV MDPC-8127 display devices.
  • The platform addresses a critical need in healthcare, as pathology guides nearly 70% of clinical decision-making processes.
  • This regulatory milestone advances the adoption of digital workflows in pathology and supports precision medicine initiatives.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.