Shares of mRNA therapeutics specialist Translate Bio Inc. (NASDAQ:TBIO) fell 30.9% to $17.76 on March 18 over concerns about a new interim analysis of phase I/II data for its cystic fibrosis (CF) candidate, MRT-5005. Several dosing regimens of the inhaled candidate failed to improve a key measure of lung function vs. placebo, in contrast to an earlier readout on other doses tested in the ongoing study, called Restore-CF.
Libtayo (cemiplimab-rwlc) became the first PD-1 therapy to score a phase III win in cervical cancer, a pleasing development not only for investors in Regeneron Pharmaceuticals Inc. and partner Sanofi SA but for patients with the stubborn disease.
DUBLIN – Immatics NV reported unexpected signs of efficacy in a first cut of data from several phase I trials of its autologous engineered T-cell therapies in heavily pretreated patients with recurrent or refractory solid tumors.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alessa, Erx, Eyenovia, GT, Harmony, Sage, Spruce, Versantis.
PERTH, Australia – Sydney-based Azura Ophthalmics Ltd. has moved into a registration trial following positive phase II results for lead candidate AZR-MD-001 in Meibomian gland dysfunction, the leading cause of dry eye disease.
Kintor Pharmaceutical Ltd. said its androgen receptor (AR) antagonist, proxalutamide, reduced mortality risk by 92% and shortened median hospital length stay by nine days vs. standard of care, based on a preliminary analysis of phase III data from 590 hospitalized COVID-19 patients in Brazil. The company expects to have final data ready by the end of this month or early April, Chief Financial Officer Lucy Lu told BioWorld.
When Amgen Inc. won approval of the oncolytic virus (OV) therapy Imlygic (talimogene laherparepvec, t-vec) for melanoma in late October 2015, hopes ran high for the space. The mood has since faded in some quarters – but hardly all.
Less than two months after scrubbing a phase III non-small-cell lung cancer trial of the bifunctional fusion protein immunotherapy bintrafusp alfa, Merck KGaA said a phase II test of the candidate in another indication, biliary tract cancer, has missed a predefined threshold that would have enabled a regulatory filing for it. Both studies are part of a rich alliance between Merck and licensee Glaxosmithkline plc.
In a tough indication and a space crowded with developers, Eli Lilly and Co.’s phase III study of the monoclonal antibody mirikizumab for treating moderate to severe ulcerative colitis made a mark by meeting its primary endpoint of clinical remission and all key secondary endpoints compared to placebo.
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