Moleculin Biotec Stock Price, News & Analysis

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.

Moleculin Biotech (NASDAQ: MBRX) has secured two new U.S. patents for its novel drug candidate Annamycin, extending patent protection until June 2040. The patents cover methods of making liposomal Annamycin and its suspension. Annamycin is being developed as the first non-cardiotoxic anthracycline for treating acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases.

The drug has received Fast Track Status and Orphan Drug Designation from both FDA and EMA. The company is currently conducting its pivotal Phase 3 MIRACLE trial, with initial data expected in H2 2025. These new patents bring Moleculin's total to four U.S. patents for Annamycin, complementing its existing European patents.

Moleculin Biotech presented new pre-clinical data for their cancer drug Annamycin at the AACR Annual Meeting 2025 in Chicago. The research shows Annamycin's potential to treat multiple cancer types, including pancreatic cancer.

Key findings demonstrate that Annamycin can work synergistically with various FDA-approved anticancer drugs both in laboratory tests (in vitro) and in living organisms (in vivo). The drug showed promising results against resistant cell lines, including those resistant to cytarabine and venetoclax.

The study explored Annamycin's effectiveness in combination with approved cancer treatments, focusing on leukemia, sarcoma, and pancreatic cancer models. CEO Walter Klemp highlighted this as a significant market expansion opportunity, particularly valuable for combination therapy approaches in cancer treatment.

The research was presented by Dr. Waldemar Priebe from MD Anderson Cancer Center, focusing on Annamycin's combination potential with drugs like azacitidine, cytarabine, gemcitabine, ifosfamide, trabectedin, and vincristine.

Moleculin Biotech (NASDAQ: MBRX) has announced that its research on Annamycin, their next-generation anthracycline drug candidate, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The presentation, scheduled for April 28, 2025, will focus on combining Annamycin with various other drugs to enhance anticancer effects.

The poster presentation, titled 'Combining Annamycin, a Non-cardiotoxic Potent Topo II Poison, with Azacitidine, Cytarabine, Gemcitabine, Ifosfamide, Trabectedin, or Vincristine to Synergize Anticancer Effects and Identify Potential Clinical Applications' will be delivered by Dr. Rafal Zielinski from MD Anderson Cancer Center. The presentation is part of the Drug Combination Strategies for Cancer Treatment session.

Moleculin Biotech (MBRX) has initiated patient dosing in its pivotal Phase 3 MIRACLE trial, evaluating Annamycin combined with Cytarabine (AnnAraC) for treating AML patients who are refractory to or relapsed after induction therapy.

The global approval trial, conducted across the US, Europe, and Middle East, features an adaptive design with two parts. Part A will randomize 75-90 subjects (1:1:1) to receive high dose cytarabine with either placebo, 190 mg/m2, or 230 mg/m2 of Annamycin. Part B will enroll approximately 220 additional subjects.

The company expects preliminary data unblinding from the first 45 subjects in H2 2025, with a second unblinding anticipated in H1 2026. Annamycin holds Fast Track Status and Orphan Drug Designation from FDA for R/R AML treatment, plus Orphan Drug Designation for soft tissue sarcoma and from EMA.