NasdaqGM:RYTMBiotechs
FDA Review Extension for IMCIVREE Might Change the Case for Investing in Rhythm Pharmaceuticals (RYTM)
Rhythm Pharmaceuticals recently announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for IMCIVREE (setmelanotide) in acquired hypothalamic obesity, moving the PDUFA goal date from December 20, 2025, to March 20, 2026, after requesting further sensitivity analyses on clinical efficacy data.
This regulatory update was classified as a major amendment but did not involve new data submissions or concerns related to safety or manufacturing,...