BioStock: Saniona on the positive feedback from FDA
Last week, Saniona announced that the FDA had granted Orphan Drug Designation (ODD) for the drug candidate Tesomet for the treatment of Prader-Willi syndrome (PWS). A few days later, a different Division at the FDA returned with positive feedback on the regulatory path forward in the rare disease of hypothalamic obesity. Saniona now looks set to follow its planned timeline and start phase IIb studies in both PWS and HO before the summer. BioStock reached out to Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona, for a comment.
Read the full interview with Rudolf Baumgartner at biostock.se:
This is a press release from BioStock - Connecting Innovation & Capital. https://www.biostock.se