Delcath Systems Inc. reported that the FDA approved its Hepzato Kit for the treatment of adults with unresectable hepatic-dominant metastatic uveal melanoma (mUM). The FDA nod also triggered a second tranche of financing of approximately $35 million from a private placement in March.
Biocity Biopharmaceutics Co. Ltd. is advancing its pipeline of differentiated, modality-independent therapeutics for oncology that include small molecules, monoclonal and bispecific antibodies, as well as antibody-drug conjugates (ADCs). The Wuxi, China-headquartered company is focused on first-in-class molecules for different modalities that can be combined with other treatments, Biocity Co-founder and Executive Vice President Ivy Wang told BioWorld.
Dermasensor Inc.’s elastic scattering spectroscopy device appears to have solved one of the more challenging issues in dermatology—early detection of skin cancers in individuals with darker skin tones. The device demonstrated very high sensitivity across all skin cancer types compared to histopathological exams with minimal variation between Fitzpatrick skin type groups in an analysis of the DERM-SUCCESS trial.
Enochian Biosciences Inc.changed its name toRenovaro Biosciences Inc. and reported a deal to merge part of the company with Gedi Cube Intl Ltd. in an effort to move on from recent controversies. “Renovaro, Latin for ‘renewal,’ represents our company’s mission,” said Mark Dybul, CEO of the company.
Accuray Inc. offered a classic good news-bad news set-up for investors on Wednesday, with a notable FDA 510(k) clearance balanced by a miss on fourth quarter revenue and projections for fiscal year 2024 significantly below consensus expectations. Still, the takeaway is generally positive, with several strong catalysts expected to build momentum for the company in the coming year and much of the underperformance attributable to foreign exchange headwinds that have plagued many med-tech companies.
Laboratory for Advanced Medicine & Health Group (LAMH)’s subsidiary Guangzhou Youze Biotechnology Co. Ltd. received marketing approval in China for its methylation test, which the company says is the first methylation test kit for liver cancer on the market in the world.
Mirxes Holding Company Ltd. raised $50 million in a series D funding round to expand its cancer early detection blood tests, including its lead product stomach cancer blood test Gastroclear, in the Asia Pacific region. Mirxes uses RNA technology to develop diagnostic solutions for the early detection of diseases.
Personadx Inc. and researchers from the University of Chicago Medicine Comprehensive Cancer Center have developed a method to accurately predict which patients with metastatic colorectal cancer will have a favorable treatment outcome following surgical removal of liver metastases, according to a study published in JAMA Oncology. The prognostic tool combines a panel of genetic biomarkers and clinical features of the tumor to determine distinct subgroups of cancer that correspond to different treatment outcomes.
Results from a meta-analysis of magnetic resonance imaging (MRI)-guided adaptive radiation for prostate cancer by radiation oncologists from the Dana Farber Cancer Institute demonstrated the treatment reduces complications while comparing well to standard approaches. The study was published in Cancer.
Magentiq-Eye Ltd. received U.S. FDA 510(k) clearance for its Magentiq-Colo, an artificial intelligence (AI) gastrointestinal software system that helps detect lesions in real time during colonoscopy procedures. With the rate of colorectal cancer expected to increase steadily through the decade, the company hopes that Magentiq-Colo will offer the gastroenterology community and its patients a significant increase in the adenoma detection rate.