Record mula sa primary source
MateryalOpinyon ng EMA
OS Therapies: Sinimulan ng EMA ang rolling review ng OST-HER2 CMA
Sinimulan na ng EMA’s CAT, CHMP at PRAC ang rolling review ng dossier ng OST-HER2 Conditional Marketing Authorisation. Naisaayos ng ahensya at ng kumpanya ang 3-taong overall survival bilang approvable endpoint, na may 2.5-taong OS data na inaasahan sa kalagitnaan ng Q2 2026 at 3-taong OS data na inaasahan sa simula ng Q4 2026, na naglalagay sa EMA para sa potensyal na desisyon ng CMA sa Q4 2026.
Mahahalagang fact
- Na-file
- Abr 30, 2026, 08:06 PM
- Kaganapan
- Opinyon ng EMA
- Direksyon
- Positibo
- Kumpanya
OSTXOS Therapies- Asset
- OST-HER2
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Benta sa 2027
- higit sa $50 milyon
- Pinakamataas na benta sa Europa
- lampas sa $300 milyon
Sipi mula sa source
EX-99.1 2 ea028858801ex99-1.htm PRESS RELEASE ISSUED BY OS THERAPIES INCORPORATED ON APRIL 30, 2026 Exhibit 99.1 OS Therapies Announces EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected Pulmonary Metastatic Osteosarcoma Conference call scheduled for Thursday, April 30, 2026, at 8:30 am ET to review new OST-HER2 immune pharmacodynamic biomarker response (seroconversion) data and review regulatory successes validating the OST-HER2 approach. Participants will include strategic advisors Dr. Craig Eagle and Dr. Bob Langer, and Osteosarcoma key opinion leader Dr. Peter Anderson from Cleveland Clinic. ● EMA and Australia TGA (ATGA) align on 3-year overall survival as the approvable clinical e