Aardvark menghentikan sementara uji coba Fase 3 HERO/OLE dan ARD-201; panduan Q2 2026

Aardvark secara sukarela menghentikan pendaftaran dan pemberian dosis dalam uji coba Fase 3 HERO dan OLE ARD-101 untuk hiperphagia PWS dan menghentikan program obesitas ARD-201 setelah sinyal perpanjangan QRS reversibel terlihat dalam studi keamanan jantung sukarelawan sehat. Perusahaan sedang meninjau data dengan FDA dan akan memberikan panduan lebih lanjut tentang kedua program pada Q2 2026.

Fakta utama

Diajukan: 23 Mar 2026, 20.09
Peristiwa: Perubahan registri uji klinis
Arah: Negatif
Perusahaan: AARDAardvark Therapeutics
Aset: ARD-101
Sumber: SEC 8-K
Keyakinan: Bersumber
kas: $110.0 juta
runway kas: hingga kuartal 2 2027

Kutipan sumber

EX-99.1 2 ck0001774857-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Aardvark Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates Voluntary pause of the Phase 3 HERO and OLE trials evaluating ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi Syndrome, further guidance on the program expected in Q2 2026 ARD-201 obesity program, including POWER and STRENGTH trials, on voluntary pause pending next steps with ARD-101; further guidance on the program expected in Q2 2026 Clinical and preclinical data from ARD-101 program published in Molecular Metabolism $110.0 million in cash, cash equivalents and short-term investments as of December 31, 2025, supports projected operations into the second quarter of 2027 SAN DIEGO, Ma

SEC 8-K