Persistence Pays Off For Chiasma And Its Oral Acromegaly Therapy
Chiasma has bounced back from a 2016 CRL for Mycapssa with a new SPA-agreed Phase III trial meeting all its primary and secondary endpoints. The product is positioned to be the first oral treatment for acromegaly.
You may also be interested in...
Public Company Edition: Two months before the deadline for the company's sNDA, the US FDA has not indicated it will hold an advisory committee meeting for the triglyceride-lowering drug. Also, Seattle Genetics raises $575m, Atara and Ra bring in $150m each and Cara completes $145.5m offering.
The FDA tried to warn Chiasma Inc. in 2014 its single-arm, open-label Phase III trial may not be enough to pass muster for the agency to approve the company's new drug application (NDA) for its investigational acromegaly drug Mycapssa (octreotide) and pointed out having a controlled trial would be a better option.
The largest-ever rise in the number of active R&D companies, particularly in China, helped propel an unprecedented increase in the size of the biopharma pipeline in 2019. Meanwhile, the number of new active substances launched in their first market last year dropped as 2018’s superlative performance gave way to something more usual.