While investors focused on the top-line miss from Avalo Therapeutics Inc.’s phase II study of AVTX-002 (quisovalimab) in non-eosinophilic asthma, sending company shares (NASDAQ:AVTX) falling 89% to close at 50 cents June 26, the company pointed to promising trends seen in an exploratory analysis affirming the potential of targeting LIGHT.
Clinical data in the first five months of 2023 is remarkably consistent to last year. BioWorld reported on 1,449 drugs in phase I-III this year, compared to 1,452 in the same time period in 2022. Numbers are down 12.13% from 1,649 in 2021, but up from 2020’s 1,419 and 2019’s 1,173.
A recent population study in Morocco reinforced the importance of early diagnosis in handling – at best physicians can – Prader-Willi syndrome (PWS) and served, at least indirectly, to remind investors of the potentially lucrative space, where the lone drug labeled for the indication is a growth hormone.
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
The early detection of chronic liver disease (CLD) could help in the prevention of cardiovascular diseases (CVD), according to a study published in the Journal of Hepatology. Using Perspectum Ltd.’s Livermultiscan, a noninvasive MRI scan, researchers analyzed liver data and found that liver disease activity measured by MRI corrected T1 (cT1) is associated with higher risk of major CVD events.
Exact Sciences Corp. demonstrated a significant increase in accuracy with the latest version of its Cologuard test for colorectal cancer in its pivotal BLUE-C study. Top-line results released this week showed that the next-generation test exceeded the specificity and sensitivity seen in the DEEP-C study that underpinned U.S. FDA approval of the commercially available version of Cologuard, a stool-based assay.
Many of the available treatments for the autoimmune conditions ulcerative colitis (UC) and Crohn’s disease come with drawbacks such as safety issues or inconvenient dosing regimens. Describing itself as a biomarker-driven immunoregulatory therapeutics company, Nimmune Biopharma Inc. is striving to fulfil what it perceives as a high need for safer, more effective options with candidates that target the lanthionine synthetase C-like 2 (LANCL2) pathway.
Shares in Uniqure NV fell sharply on inconclusive interim data from a U.S. phase I/II trial of its gene therapy for Huntington’s disease. The stock (NASDAQ:QURE) hit a six-year low during trading on June 21, ending the day at $11.62, down 40%.
Following the death of a patient, the U.S. FDA halted Arcellx Inc.’s phase II pivotal trial of its CAR T-cell therapy for relapsed or refractory multiple myeloma (MM), putting Gilead Sciences Inc., which in December made the risky decision to part with $225 million up front for rights to the immunotherapy, in likely turmoil.
For the second time in a week, measures of serum neurofilament light chain (NfL) took center stage, this time as Denali Therapeutics Inc. unveiled interim data from the open-label, single-arm phase I/II study testing DNL-310 in children with mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.
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