Eureka Therapeutics, a clinical stage biotechnology company developing antibody-TCR (AbTCR) T-cell therapies, announced that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for ET140202 ARTEMIS T-cell therapy in AFP-positive patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer.
Roche’s Genentech has decided to stop two phase 3 trials evaluating its anti-beta-amyloid molecule crenezumab in early Alzheimer’s disease (AD) for futility reasons.
Pfizer and Eli Lilly have announced positive top-line results from a phase 3 study evaluating tanezumab 2.5 mg or 5 mg in patients with moderate-to-severe osteoarthritis (OA) pain.
Shield Therapeutics said that its oral ferric iron therapy Feraccru succeeded in the open-label extension phase of the AEGIS-CKD study held in chronic kidney disease (CKD) patients with iron deficiency anaemia (IDA).
Takeda Pharmaceutical’s investigational live-attenuated tetravalent dengue vaccine (TAK-003) candidate has met the primary endpoint in the pivotal phase 3 efficacy trial.
Alexion Pharmaceuticals announced that the Phase 3 study of ULTOMIRIS (ravulizumab-cwvz), the company’s long-acting C5 complement inhibitor, met its primary objective in complement inhibitor-naïve patients with atypical hemolytic uremic syndrome (aHUS).
Destiny Pharma has reported positive data and non-irritant classification for the nasal gel formulation of its synthetic antimicrobial drug XF-73 in the second phase 1 skin irritation study.
Navitor Pharmaceuticals announced the initiation of Part B of its Phase 1 clinical study with its lead candidate, NV-5138, for treatment-resistant depression (TRD).
Ironwood Pharmaceuticals announced the initiation of a Phase 1 study evaluating IW-6463 in healthy volunteers. IW-6463 is an orally administered central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator that is being developed for the treatment of serious and orphan CNS disorders.
Redx has secured approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to restart a phase 1/2a trial for its cancer candidate RXC004 in advanced solid tumors.
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