Moleculin Biotec (MBRX) Stock News

Moleculin Biotech (MBRX) participated in a Virtual Investor segment to discuss recent FDA feedback on their Pediatric Study Plan for Annamycin. The segment focused on the drug's potential application in treating children with relapsed/refractory acute myeloid leukemia (R/R AML). CEO Walter Klemp led the discussion, highlighting the company's progress in developing treatments for challenging tumors and viruses. The segment is available for viewing online.

Moleculin Biotech (NASDAQ: MBRX) has received positive FDA feedback on its Initial Pediatric Study Plan (iPSP) for Annamycin in treating children with relapsed/refractory acute myeloid leukemia (R/R AML). The FDA agreed to a single pediatric approval study of AnnAraC (Annamycin + Cytarabine combination) and recommended including patients as young as 6 months old. Notably, Annamycin has shown no cardiotoxicity in 84 adult patients treated to date, addressing a significant concern as about 60% of children with cancer are treated with potentially cardiotoxic anthracyclines. The company plans to initiate the pediatric trial in H2 2027. Meanwhile, Moleculin's pivotal Phase 3 MIRACLE trial for adult R/R AML patients is ongoing with initial data expected in H2 2025. Annamycin has received Fast Track Status and Orphan Drug Designations from both FDA and EMA.

Moleculin Biotech (NASDAQ: MBRX) participated in a Virtual Investor segment featuring Dr. Brian Andrew Van Tine, who discussed positive topline results from their completed U.S. Phase 1B/2 clinical trial of Annamycin for Soft Tissue Sarcoma Lung Metastases (MB-107). The trial was a multi-center, open-label, single-arm study that determined the Maximum Tolerable Dose and Recommended Phase 2 Dose in Phase 1B, while Phase 2 evaluated Annamycin's efficacy as a monotherapy for STS lung metastases patients eligible for chemotherapy.

Moleculin Biotech (MBRX) has released an on-demand KOL webcast discussing final data from its U.S. Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases. The webcast features presentations from company executives Walter Klemp (CEO) and Dr. Paul Waymack (Senior CMO), alongside expert KOLs including Dr. Mohamad Cherry from Atlantic Health System, Prof. Bernd Kasper from Mannheim Cancer Center, and Dr. Sant P. Chawla from Sarcoma Oncology Center. The webcast is available on Moleculin's website investor section for 90 days.

Moleculin Biotech (MBRX) announced positive topline efficacy results from its completed U.S. Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases. The trial achieved a Clinical Benefit Rate of 59.4% (n=32), with 18 subjects showing stable disease and 1 achieving partial response. The study demonstrated median Overall Survival of 411 days and Progression-Free Survival of 63 days. In Phase 2 at 330 mg/m2, patients showed median PFS of 105 days and OS of 13.5 months, exceeding typical second-line monotherapy results. Notably, patients with fewer prior therapies (≤2) showed improved OS/PFS of 19.9 months/127 days. The drug showed no cardiotoxicity and has potential to address 13,500 new STS cases annually, with a market opportunity expected to reach $2.6B by 2030.

Moleculin Biotech (MBRX) reported Q1 2025 financial results and provided updates on its clinical programs. The company's pivotal Phase 3 MIRACLE trial for Annamycin (naxtarubicin) in treating R/R AML is progressing, with 38 sites selected across US, Europe, and Middle East. The EMA approved clinical trials in nine additional EU countries. The company expects interim data readout in H2 2025. Financial results showed R&D expenses of $3.4M (down from $4.3M in Q1 2024) and G&A expenses of $2.5M. Moleculin had $7.7M in cash as of March 31, 2025, sufficient to fund operations into Q3 2025. The company also completed enrollment in Phase 2 trials for Annamycin in treating soft tissue sarcoma lung metastases, with final data expected by June 2025.

Moleculin Biotech (NASDAQ: MBRX) has received EMA approval to expand its Phase 3 MIRACLE clinical trial for Annamycin to nine additional EU countries. The trial evaluates Annamycin combined with cytarabine (AnnAraC) for treating relapsed/refractory acute myeloid leukemia (R/R AML). The global approval trial now includes sites in the US, Europe, and Middle East, with approval granted in Belgium, Czechia, France, Germany, Italy, Lithuania, Poland, Romania, and Spain. The study targets venetoclax regimen failures, with interim data expected in H2 2025. The Phase 2B/3 trial will evaluate two Annamycin doses (190 mg/m² and 230 mg/m²) combined with high-dose cytarabine versus placebo. The trial's first phase will include 75-90 subjects, with preliminary data unblinding at 45 subjects, followed by approximately 220 additional subjects in Part B.

Moleculin Biotech (NASDAQ: MBRX), a late-stage pharmaceutical company focused on developing treatments for hard-to-treat cancers and viruses, has scheduled its first quarter 2025 financial results announcement for May 13, 2025. The company will host a conference call and webcast to discuss these results on May 14, 2025, at 8:30 AM ET.

Investors can join the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international). The webcast will be available on the Events page of Moleculin's website and archived for 90 days.

The World Health Organization has approved "naxtarubicin" as the international non-proprietary name for Moleculin Biotech's (NASDAQ: MBRX) drug candidate Annamycin. The drug is currently in development for treating relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases.

The company is conducting a pivotal, adaptive Phase 3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for AML treatment, with initial data expected in H2 2025. The global trial includes sites across the US, Europe, and the Middle East.

Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for AML treatment, plus Orphan Drug Designation for soft tissue sarcoma. The EMA has also granted Orphan Drug Designation for AML treatment.