Cell Therapy News/Articles, page-17068

Time for Takeda to look for another treatment for Crohn's Disease and UC me thinks .... perhaps they will look at licensing Remestemcel-L once the results are released by Mesoblast ? SI has to sell / license something - just sayin'


https://clinicaltrials.gov/study/NCT04548583?intr=Remestemcel-L&rank=1

Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis


https://clinicaltrials.gov/study/NCT04543994?intr=Remestemcel-L&rank=2

Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)



https://www.fiercepharma.com/pharma...-alofisel-trial-flop-exkivity-market-withdraw

Takeda takes $770M in write-downs after Alofisel flop, Exkivity withdrawal decision

Oct 26, 2023


After one Takeda drug flunked a phase 3 trial and as the company pulls another from the market, the drugmaker is taking some hefty impairment charges.


In its most recent quarter, the Japanese company took 115.8 billion Japanese yen ($770 million) in impairment losses. The charges largely stem from recent setbacks for stem cell treatment Alofisel and cancer therapy Exkivity.


Takeda reported that Alofisel failed a phase 3 trial in Crohn’s disease complex perianal fistulas (CPF) just last week. In a study of 594 patients, the treatment missed the mark of combined remission at 24 weeks.


While the full data hasn’t yet been revealed, the company had flagged a potential revenue loss and expressed its disappointment with the trial outcome.


The write-down associated with that setback was worth 74 billion yen ($490 million), the company said Thursday.