Moleculin Biotech (MBRX) announced it has received a written response from the Office of Oncologic Diseases – Pediatric Oncology, of the U.S. Food and Drug Administration, FDA, regarding the Company’s Initial Pediatric Study Plan, iPSP, which was submitted after a June 2024 end-of-phase 1/2 meeting. The FDA has agreed to a single pediatric approval study in which Annamycin in combination with Cytarabine will be evaluated as second line therapy in pediatric patients with relapsed/refractory acute myeloid leukemia, R/R AML, a form of cancer. Enrollment and dosing are ongoing in the Phase 3 MIRACLE trial of Annamycin in adult patients with R/R AML; Initial data readout is on track for the second half of 2025
Don’t Miss TipRanks’ Half-Year Sale
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
- Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on MBRX:
- Moleculin Biotech announces ‘What This Means’ virtual investor segment
- Moleculin Biotech assumed with a Buy at H.C. Wainwright
- Moleculin Biotech: Positive Clinical Trial Results and Strategic Developments Support Buy Rating
- Moleculin Biotech Hosts Key Opinion Leaders Event
- Moleculin Biotech releases KOL webcast to discuss Phase 1B/2 annamycin data