Moleculin Receives Positive FDA Feedback on Pediatric Study Plan for Annamycin in Children with R/R AML [Yahoo! Finance]
Moleculin Biotech, Inc. (MBRX)
Last moleculin biotech, inc. earnings: 8/16 05:35 pm
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Source: Yahoo! Finance
FDA recommends inclusion of patients as young as 6 months – younger than Moleculin had proposed – to be allowed in the pediatric clinical study Enrollment and dosing are ongoing in pivotal, adaptive design 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 HOUSTON, June 18, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc. , (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today 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 (also known as naxtarubicin) in combination with Cytar
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News
- Moleculin Announces Positive Results from Phase 1 Clinical Trial Evaluating WP1066 for the Treatment of Pediatric Recurrent Malignant Brain TumorsGlobeNewswire
- Moleculin Biotech (NASDAQ:MBRX) had its "buy" rating reaffirmed by analysts at Roth Capital.MarketBeat
- Moleculin Biotech (NASDAQ:MBRX) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
- Moleculin Announces Exercise of Warrants for $6.8 Million Gross ProceedsGlobeNewswire
- Moleculin Announces Completion of Treatment for the 45 Patients in Pivotal “MIRACLE” Phase 3 AML Trial on Pace for Q1 2026GlobeNewswire
MBRX
Sec Filings
- 12/23/25 - Form S-3
- 12/23/25 - Form 424B5
- 12/22/25 - Form PRER14A
- MBRX's page on the SEC website