Catatan sumber primer
PenentuHasil topline
IDEAYA: OptimUM-02 Fase 2/3 darovasertib + crizotinib mencapai titik akhir PFS
Uji coba OptimUM-02 mencapai titik akhir utamanya, menunjukkan penurunan risiko progresi sebesar 58% yang signifikan secara statistik (HR 0.42) dan median PFS 6,9 bulan dibandingkan 3,1 bulan dengan terapi pilihan investigator. ORR adalah 37,1% dibandingkan 5,8%, dengan 5 respons lengkap pada kelompok darovasertib. IDEAYA berencana mengajukan NDA pada H2 2026 berdasarkan data ini.
Fakta utama
- Diajukan
- 13 Apr 2026, 10.05
- Peristiwa
- Hasil topline
- Arah
- Positif
- Perusahaan
IDYAIDEAYA- Aset
- darovasertib
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
- HR
- 0.42
- nilai p
- <0.0001
- Median PFS
- 6.9 berbanding 3.1 bulan
Kutipan sumber
8-K false 0001676725 0001676725 2026-04-13 2026-04-13 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 13, 2026 IDEAYA Biosciences, Inc. (Exact name of registrant as specified in its charter) Delaware 001-38915 47-4268251 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification Number) 5000 Shoreline Court , Suite 300 South San Francisco , California 94080 (Address of principal executive offices, including Zip Code) Registrant’s telephone number, including area code: (650) 443-6209 Check the appropriate box below if the Form 8-K filing is intended to simultaneous