LONDON – Liquid biopsy specialist Inivata Ltd. has been granted a U.S. FDA breakthrough device designation for its Radar assay for detecting residual disease or relapse, following treatment for cancer. The personalized assay, which tracks a set of up to 48 genetic variants isolated from excised tumor tissue, is built on Inivata’s approved Invision platform for detecting circulating tumor DNA (ctDNA) in blood samples.
Following an interim futility analysis, Affimed NV has decided to continue enrolling its phase II, registration-directed study of AFM-13, a tetravalent, bispecific innate cell engager, as a monotherapy for treating relapsed or refractory CD30-positive peripheral T-cell lymphoma.
Four years after leaving the Nasdaq, Sciclone Pharmaceuticals Holdings Ltd. returned to the market March 3, issuing 116 million shares to raise HK$2.18 billion (US$281 million) on the Hong Kong Stock Exchange (HKEX). Shares were priced at HK$18.8 each.
In an unusual move for a Chinese company, Bio-Thera Solutions Ltd. terminated the clinical development of its Trop2 antibody-drug conjugate (ADC), BAT-8003, and its PD-1 monoclonal antibody, BAT-1306, a month after it halted the phase III-stage HER2-ADC candidate BAT-8001.
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