Latest from Alaric DeArment
The company said the NEAT trial in ataxia telangiectasia did not meet the primary and key secondary endpoints.
Vyvanse weighed on sales growth in the third quarter amid generic competition, but the losses are declining and the Japanese drugmaker is looking to new launches this year.
The company said the FDA placed the hold on RGX-111 and RGX-121 after a patient in its RGX-111 trials developed a brain tumor, the cause of which remains under investigation.
The company announced Phase II data and plans for its registrational Phase III trial as CEO Mark Erlander and chief financial officer James Levine left the company.
The Phase I/II study’s trial page was updated to say it was no longer recruiting patients after recruiting only 23 of the originally planned 260.
The company said amorphous rifaximin solid soluble dispersion did not meet the primary endpoint in two Phase III RED-C trials in the prevention of hepatic encephalopathy in patients with cirrhosis.
