In October 2024, BioWorld logged 219 clinical trial updates, marking a decrease from 252 in September but a rise from 92 in August. The month featured 14 positive phase III trial outcomes and one unsuccessful trial.
Arovella Therapeutics Ltd. is heading toward the clinic with its lead product, ALA-101, which consists of a chimeric antigen receptor (CAR) targeting CD19 and invariant natural killer T (iNKT) cells.
Outlook Therapeutics Inc. is forging onward with plans to resubmit the BLA for ONS-5010, an ophthalmic version of Avastin (bevacizumab, Roche AG), after a missed endpoint in phase III with the VEGF binder for wet age-related macular degeneration (AMD).
Wall Street began comparing and contrasting what’s available after Amgen Inc. rolled out phase II data with weight loss candidate Maritide – a disclosure that led shares of the biotech heavyweight (NASDAQ:AMGN) to close Nov. 26 at $280.01, down $13.99.
Edwards Lifesciences Corp. revealed excellent one-year data highlighting the performance of its newest generation Sapien 3 Ultra Resilia valve. Patients treated with the transcatheter aortic valve replacement system experienced lower rates of mortality and reintervention compared to its predecessors.
The Alzheimer’s disease (AD) space took another blow along with the shares of Cassava Sciences Inc. (NASDAQ:SAVA), which plummeted by 83.8%, or $22.19, to end Nov. 25 at $4.30 after the firm unveiled top-line data from the phase III Rethink-Alz study with simufilam. The study tested simufilam in mild to moderate AD, where results fell short of each of the prespecified co-primary, secondary and exploratory biomarker endpoints.
Researchers developed a novel electrochemical biosensor technology capable of assessing symmetric dimethylarginine to detect early kidney disease, which could be adapted to detect other biomarkers for conditions like cancer.
Medtronic plc and Tempus AI Inc. launched the ALERT study to better understand and address the racial, ethnic, gender and geographic disparities associated with guideline-recommended treatments for aortic stenosis and mitral valve regurgitation. Currently, white patients represent 91% of people who receive TAVR procedures, a minimally invasive procedure that sharply reduces complications and improves quality of life in patients with narrowed heart valves.
The bad news keeps piling up for Sage Therapeutics Inc. Having absorbed other study stumbles in the past few months, the company now has halted development of dalzanemdor in treating Huntington’s disease after top-line phase II data showed it missed a statistically significant difference compared to placebo on the primary endpoint.
“It all comes down to outcomes,” said Michael Davidson, CEO of Newamsterdam Pharma Co. NV, which hailed “robust” and “consistent” data from its phase III study testing a fixed-dose combination of CETP inhibitor obicetrapib plus established anti-cholesterol drug ezetimibe, even as investors focused on a couple of findings that turned up lower than expected, sending shares of the company (NASDAQ:NAMS) down 15.5% to close Nov. 20 at $20.01.
RSS
