Aardvark Therapeutics said it is seeking a path forward after the FDA placed its Prader-Willi syndrome program under clinical hold. The full hold halted all tests of the company’s small-molecule therapy following a cardiovascular problem observed in a healthy volunteer earlier in the program. Aardvark also noted that it had voluntarily paused trials before the formal hold, indicating the issue was identified during ongoing development activities. The company’s next steps will hinge on what the FDA requires to restart, including safety assessment and protocol modifications. For rare disease sponsors, the incident underscores how safety signals in early testing can quickly translate into regulatory stoppage and delayed timelines.