VDYNE gets FDA nod to launch pivotal US trial for tricuspid valve device
The approval clears the way for a US study at leading clinical centers to evaluate the safety and effectiveness of VDYNE’s system in patients
The approval clears the way for a US study at leading clinical centers to evaluate the safety and effectiveness of VDYNE’s system in patients
The data will be presented at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Munich, April 17-21
The financing includes a four-year interest-only period, extendable to five years if a net sales milestone is achieved
The drug meets all primary endpoints across 608 patients in Europe and India, strengthening the company's biosimilars pipeline
Safety was equally impressive. ENV-294 was well tolerated
The study targets patients with refractory, unresectable microsatellite-stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC)
Ac-225, an alpha-emitting radionuclide, can be paired with molecules designed to selectively target cancer cells.
Lonza will take on technology transfer, process optimization, and cGMP manufacturing, leveraging its global network and expertise in highly potent compounds
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