Phase III

The trial is evaluating oral ibrexafungerp as a salvage treatment in difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to or intolerant of current standards of care.
Apellis Pharmaceuticals announced that its pegcetacoplan beat out Alexion Pharmaceuticals’ Soliris in its Phase III PEGASUS study in adults with paroxysmal nocturnal hemoglobinuria.
The study met one of its dual primary endpoints, progression-free survival, but missed the other endpoint, overall survival.
“Bavencio is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma,” said Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development.
Even with the holiday week, there was still some clinical trial news coming out. Here’s a look.
The company emphasizes that the data was “near statistically significant” in B-SIMPLE2 and was statistically significant in the secondary endpoint and several pre-specified sensitivity analyses.
Company shares dropped almost 10% at the news.
Although the reduction in mHTT with the drug compared to placebo was statistically significant, there was no change in total huntingtin protein (tHTT) compared to placebo.
With the holidays, it’s not surprising that it was a quiet week for clinical trial news. Nonetheless, some companies did have clinical trial stories to report. Here’s a look.
Companies from across the globe provide updates on their business and pipeline progress.
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