Aardvark Therapeutics' Prader-Willi Drug Faces Full FDA Clinical Hold FDA imposed full clinical hold. Aardvark unblinded Phase 3 trial data. Pivotal program timeline jeopardized. EMA has no related action recorded. Aardvark Therapeutics' lead candidate for Prader-Willi Syndrome (PWS) received a full clinical hold from the FDA. This action impacts all ongoing Phase 3 studies. The company proactively unblinded trial data early to assess the situation. The specific metric triggering the hold remains undisclosed, but it signals significant safety or efficacy concerns within the pivotal program. A full clinical hold, per 21 CFR 312.42(b), halts all new subject enrollment and drug administration. The FDA typically issues such holds due to unreasonable risk to subjects or insufficient information to assess risk. Aardvark must address all FDA concerns before resuming trials. This process often involves submitting a complete response to the agency. This hold severely impacts Aardvark's market position in PWS. Competitors like Soleno Therapeutics (DCCR) and Rhythm Pharmaceuticals (setmelanotide) may gain an advantage. Aardvark's stock price will likely reflect this setback. The company aims to provide an update on the data analysis by Q3 2026.