Regulatory Developments
In 2016 as a result of the negative TQT study that demonstrated cardiovascular safety and by virtue of the drug being essentially non absorbable, the Company received a waiver from the FDA foregoing the need to perform a cardiovascular safety outcomes trial.
Renexxion has announced several IND Applications:
Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD
Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States
See latest regulatory developments.
Renexxion has announced several IND Applications:
Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients
Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD
Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States
See latest regulatory developments.