Drug Development
New data on Hengrui Pharma and Kailera Therapeutics’ investigational oral GLP-1 have validated the late-stage weight loss asset and paved the road for a regulatory submission in China, but analysts pointed to high rates of nausea and vomiting that could challenge the ongoing U.S. study.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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Following strong treatment response data for Adaptimmune’s lete-cel, the biotech is planning to initiate a rolling BLA submission to the FDA, set to start by the end of 2025.
Following patient deaths in a lupus trial that led to the termination of that program, Kezar’s autoimmune candidate zetomipzomib faces a partial clinical hold barring four trial participants from continuing treatment in the open-label portion of the trial, though the trial itself will continue as planned.
With the Phase III failure, Syros will discontinue the study of tamibarotene for myelodysplastic syndrome and will default on its loan from Oxford Finance LLC.
Cantor Fitzgerald analyst Olivia Brayer found supplementary bone mineral density data for Amgen’s obesity candidate MariTide that could point to a potentially greater fracture risk than previously revealed, but some other analysts view the findings as a nonissue.
A tale of two multi-billion schizophrenia deals, AstraZeneca touts strong sales while deflecting questions about an investigation into China exec, the Huntington’s pipeline builds momentum and layoffs continue with Sana Biotechnology and 23andMe.
With $70 million upfront and more than $1.8 billion on the line, Roche will gain access to Flare’s drug discovery engine to bolster its oncology pipeline.
In a small Phase IIa trial, Insilico’s generative AI-designed idiopathic pulmonary fibrosis drug improved lung function and was well-tolerated across all dosing groups.
Analysts did not seem very concerned by the treatment-related serious adverse event, noting that NGN-401 was well-tolerated at a lower dose and showed promising efficacy outcomes.
The shocking failure of AbbVie’s emraclidine has investors questioning the Big Pharma’s long-term neuroscience strategy, which put the drug at the center of expectations.
Novavax’s shared jumped 12% in pre-market trading on the news.