The FDA has revised the prescription drug user fee act goal date to June 16 as it needs more time to review additional subgroup analyses of the clinical efficacy data from Rhythm's phase 3 trial, the company said.
Rhythm said it also withdrew the proposed Alstrom syndrome indication from its pending type II variation application to the European Medicines Agency for setmelanotide in order enable the review for Bardet-Biedl syndrome within the planned timeline.
Rhythm shares were down nearly 17% in recent trading.
Price: 6.95, Change: -1.42, Percent Change: -16.97
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