Aardvark: Inilagay ng FDA ang buong clinical hold sa ARD-101 IND

Ginawa ng FDA ang boluntaryong paghinto ng kumpanya bilang buong clinical hold sa ARD-101 IND, na huminto sa parehong Phase 3 HERO trial at OLE trial. I-unblind ng kumpanya ang naipon na datos ng HERO at OLE upang suriin ang efficacy at safety at gabayan ang susunod na hakbang sa ahensya.

Mahahalagang fact

Na-file: May 14, 2026, 08:15 PM
Kaganapan: Complete response letter
Direksyon: Negatibo
Kumpanya: AARDAardvark Therapeutics
Asset: ARD-101
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Pondo: $91.2 milyon
pasyente dosed ole: 19
pasyente dosed hero: 68

Sipi mula sa source

EX-99.1 2 ck0001774857-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Aardvark Therapeutics Plans to Unblind HERO and OLE Data to Inform Path Forward Following FDA Clinical Hold SAN DIEGO, May 14, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark or the Company) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101 related to the Company’s previously announced voluntary pause. The clinical hold applies to all ongoing clinical studies under the IND, including the Phase 3 HERO trial (AV

SEC 8-K