Aardvark Therapeutics said it is preparing to unblind data from its Prader-Willi syndrome (PWS) phase 3 program after the FDA imposed a full clinical hold tied to a cardiac safety signal in healthy volunteers. The hold covers ARD-101 across the phase 3 study and its open-label extension, alongside downstream impact to ARD-201 trials that combine ARD-101 with a DPP-4 inhibitor. The company previously paused work voluntarily in March and later expanded the pause as the situation evolved. With the hold now formalized, Aardvark is moving to unblind 68 randomized patients plus 19 in the extension to assess the totality of efficacy and safety data and to decide next steps for ARD-101. The immediate investor impact was visible in after-hours trading following the update. Aardvark says its cash runway extends into mid-2027, but the timing of data sharing and trial completion remains critical for its fundraising and partnering options.