BRIEF-OS Therapies Applies For Meeting Per FDA Suggestion Received On April 2, 2025

Reuters
04-07
BRIEF-<a href="https://laohu8.com/S/OSTX">OS Therapies</a> Applies For Meeting Per FDA Suggestion Received On April 2, 2025

April 7 (Reuters) - OS Therapies Inc OSTX.A:

  • OS THERAPIES REQUESTS MEETING WITH FDA TO GAIN AGREEMENT ON SURROGATE ENDPOINT$(S)$ FOR BREAKTHROUGH THERAPY DESIGNATION & ACCELERATED APPROVAL OF OST-HER2 IN THE PREVENTION OF RECURRENCE OF FULLY RESECTED, LUNG METASTATIC OSTEOSARCOMA

  • OS THERAPIES: APPLIES FOR MEETING PER FDA SUGGESTION RECEIVED ON APRIL 2, 2025

  • OS THERAPIES -SUFFICIENT CASH ON HAND TO OPERATE INTO MID-2026

  • OS THERAPIES: MEETING IS EXPECTED TO OCCUR IN Q2 OF 2025

  • OS THERAPIES: INTENDS TO INITIATE ROLLING BLA SUBMISSION WITH POTENTIAL TO GET ACCELERATED APPROVAL AS EARLY AS YEAR-END 2025

Source text: ID:nBw21PR7wa

Further company coverage: OSTX.A

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