Two phase III stumbles of Iterum Therapeutics plc’s sulopenem have cast the company’s future in doubt. The latest problem is the failure of the penem anti-infective compound, with oral and I.V. formulations, failing to achieve statistical noninferiority relative to ertapenem in treating complicated urinary tract infection (cUTI).
Allogene Therapeutics Inc. investors will have to wait for an update in the second half of this year to find out more about whether off-the-shelf ALLO-501 can durably stand up to autologous CAR T-cell therapies, but early data disclosed at the American Society of Clinical Oncology meeting is creating buzz in the meantime.
LONDON – A vast new body of genomics research has identified thousands of rare genetic variants that are predicted to cause loss of function in protein coding genes, providing novel in vivo models of human gene inactivation.
A phase III test of roluperidone, a drug developed by Minerva Neurosciences Inc. with a goal of treating negative symptoms in schizophrenia, found that the experimental medicine failed to deliver statistically significant differences vs. placebo in improving both the trial's primary endpoint, a common measure of symptom severity, and its secondary endpoint, a score measuring social function.
Astrazeneca plc’s Tagrisso (osimertinib) seems poised to become standard of care in the adjuvant setting for early stage (IB, II and IIIA) EGFR-mutated non-small-cell lung cancer (NSCLC), thanks to phase III data from the study called Adaura, made public at the American Society of Clinical Oncology (ASCO) meeting.
HONG KONG – South Korea’s Qurient Co. Ltd., located in Gyeonggi-do, is preparing to send its novel drug, Q-702, into the clinic after receiving clearance from the U.S. FDA, roughly a month after submitting the application on April 24.
Arca Biopharma Inc., of Westminster, Colo., is developing AB-201, a selective inhibitor of tissue factor (TF), as a treatment for COVID-19-associated coagulopathy, abnormal blood clotting and related inflammatory response. The move gave the company new life Thursday.
VANCOUVER, British Columbia – With some positive early data for an antibody to block the COVID-19 virus, San Diego-based Sorrento Therapeutics Inc. is now looking to test a product in a few dozen intensive care patients by the end of July or early August and move into a much broader pool of patients by October.