- PTC Therapeutics ( NASDAQ: PTCT ), a biotech focused on rare disorders, fell ~14% pre-market Wednesday after the company said it paused enrollment in Phase 2 PIVOT-HD trial for Huntington's disease candidate PTC518 in the U.S.
- The decision follows a request made by the FDA seeking additional data to permit the study to advance in the U.S., PTCT said, adding that the findings from the global trial indicated no treatment-related adverse events so far.
- The 12-week trial, designed to evaluate two dose levels, 5 milligrams and 10 milligrams of PTC518, with the potential to test a third dose level, started initially in the U.S. The company plans to share data from the 12-week portion of the trial in 1H 2023.
- Read: Cantor Fitzgerald has a "high conviction" on a Phase 3 readout PTCT plans to share for its phenylketonuria candidate PTC923 by the year-end.
For further details see:
PTC pauses enrollment in mid-stage study for Huntington's disease candidate in U.S.