Marker Therapeutics Inc.’s update from the safety lead-in stage of its phase II study of MT-401 in treating post-transplant acute myeloid leukemia saw response in one of the six participants. The results from the study of the multitumor-associated antigen-specific T-cell product also known as zelenoleucel saw firms such as Oppenheimer cut its target price for Marker to $5 from $8 and Piper Sandler to cut its target price from $5.50 to $4.
Modra Pharmaceuticals BV is planning to move its oral formulation of docetaxel into a pivotal trial, hoping to offer advanced prostate cancer patients a safer treatment option than intravenous chemotherapy. The Amsterdam, the Netherlands-based company has just announced phase IIb results in metastatic castration-resistant prostate cancer from ModraDoc-006/r, a tablet containing docetaxel and co-administered with ritonavir to enhance bioavailability.
A phase III study of Sage Therapeutics Inc.’s zuranolone in major depressive disorder hit not only its primary endpoint but also its key secondary endpoint. Despite that, the Cambridge, Mass.-based company’s share value (NASDAQ:SAGE) closed 17.4% lower Feb. 16, at $35.91 each.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.
PERTH, Australia – Impedimed Ltd.’s L-Dex bioimpedance technology could quickly become the standard of care for measuring cancer-related lymphedema following clinical trial results that showed a 59% relative reduction in progression compared to the standard of care, Impedimed CEO Rick Carreon told BioWorld.
Inivata Ltd. published new data from a prospective clinical study assessing its Radar diagnostic test in head and neck squamous cell carcinoma (HNSCC). Results from the Liquid Biopsy for Minimal Disease Detection in HNSCC (LIONESS) study suggest the assay demonstrated 100% specificity in patients with no recurrence and 100% sensitivity in patients with clinical recurrence. The personalized assay can track up to 48 tumor-specific variants in a patient using a blood sample. Last year the test was granted breakthrough device designation by the FDA.
As investors await the Sept. 10 PDUFA date for deucravacitinib from Bristol Myers Squibb Co. (BMS) in psoriasis, handicappers continue to weigh the odds of other tyrosine kinase 2 (TYK2) inhibitors, and ponder what a regulatory victory – or defeat – might mean for the space.
Paragonix Technologies Inc. will soon release performance data from sterile, temperature-controlled systems for transporting donor organs to recipient patients, this after a breath-taking transport last year of a donor lung and heart from Alaska to Washington and North Carolina. Paragonix’s organ preservation technology provides thermal protection for donor organs for up to 40 hours, making them ideal for transportation over long distances, said the company.
Abbott Laboratories reported the commencement of a pivotal clinical trial for its Aveir pacemaker in a two-device configuration to provide dual-chamber pacing without the need for leads to deliver the charge. This configuration required the development of i2i technology to ensure that the two Aveirs communicated in a manner that ensures consistent pacing, but the 500-enrollee study has a long road ahead of it before the company can finalize the application with the FDA.
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