Founded in , Cirius Therapeutics is a life science startup with research and development operations in Kalamazoo, MI. The company secured investment from Michigan-based Hopen Life Science Ventures, Renaissance Venture Capital Fund , and several prominent Michigan family offices in addition to attracting significant out-of-state investment. NASH is usually caused by excessive caloric intake and a sedentary lifestyle, resulting in a state of overnutrition and pathological metabolic processes in the liver.
Effects can include insulin resistance, increased fat storage, decreased fat oxidation, inflammation, cell damage and scarring, or fibrosis. The prevalence of NASH is growing globally and in the United States alone, an estimated 16 million people have NASH, a number that is projected to increase to 27 million by the year Enrollment has been completed with NASH patients.
Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here. While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues.
And the latest batch of numbers from ASCO is a decidedly mixed bag. While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.
At the end of January, the European Medicines Agency officially launched its new clinical trials info system CTIS , although the migration to the new platform has only really just begun, and sponsors have until the end of January before all initial trial applications must be submitted through CTIS. Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. By comparison, about 4, new trials are authorized each year across Europe.
As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid vaccine doses. Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.
The Senate is joining its House counterparts and advancing accelerated approval pathway reforms to the FDA user fee legislation that must be signed by President Joe Biden before the end of September or else the FDA will have to start laying off its staff. While Sen. Richard Burr R-NC warned yesterday that the user fee deals could be delayed by the infant formula crisis, the newly introduced bill on Friday shows how the Senate is aligning with its House counterparts on similar accelerated approval reforms.
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Cirius Therapeutics didn't wait for the government shutdown to end before it filed its IPO in January. It was, as JP Morgan analysts had. Cirius Therapeutics, a Phase 2 biotech developing therapies for NASH, withdrew its plans for an initial public offering on Friday. Cirius Therapeutics is a clinical-stage pharmaceutical company focused on the development of innovative therapies for the treatment of liver and metabolic.