Catatan sumber primer
PenentuHasil topline
Biomea Fusion melaporkan data Fase II 52-minggu untuk icovamenib pada T2D
Tindak lanjut 52-minggu dari COVALENT-111 menunjukkan icovamenib memberikan penurunan HbA1c yang bertahan sebesar 1.5% pada pasien defisiensi insulin berat dan 1.3% pada non-responder GLP-1 setelah hanya 8–12 minggu pemberian dosis. Profil keamanan tetap sebanding dengan plasebo tanpa penghentian terkait pengobatan, mendukung kemajuan ke dua uji klinis Fase II baru (COVALENT-211 dan COVALENT-212) yang direncanakan untuk Q4 2025 / Q1 2026.
Fakta utama
- Diajukan
- 4 Nov 2025, 21.03
- Peristiwa
- Hasil topline
- Arah
- Positif
- Perusahaan
BMEABiomea Fusion- Aset
- icovamenib
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- nilai p
- 0.01
- minggu tindak lanjut
- 52
- penurunan HBA1C nonresponder GLP1
- 1.3%
- penurunan HBA1C defisiensi insulin berat
- 1.5%
Kutipan sumber
EX-99.1 2 bmea-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Biomea Fusion Reports Third Quarter 2025 Financial Results and Corporate Highlights • Advances diabetes and obesity programs with icovamenib demonstrating durable 52-Week Phase II data and with BMF-650, Biomea’s next generation, oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), dosing its first patient in a Phase I clinical trial • Presented preclinical activity of icovamenib in combination with semaglutide in type 2 diabetes (T2D) animal model at EASD Annual Meeting, demonstrating enhanced glycemic control and body weight reduction with preservation of lean mass • Raised approximately $68 million in gross proceeds through two public offerings, extending projected cash runway into the first quarter of