Moleculin Biotech announced updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial for Annamycin combined with cytarabine in patients with relapsed or refractory acute

Reported Monday, Sep 28 - 7:09am EDT (TheFly subscription required to read more.)

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Annamycin plus cytarabine produced a potential overall survival benefit in acute myeloid leukemia.

Moleculin $MBRX: AACR pancreatic cancer findings are preclinical, not a clinical pancreas program or new MIRACLE AML efficacy readout.

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Second-line annamycin plus cytarabine injections demonstrated promising responses in patients with relapsed or refractory acute myeloid leukemia.

Moleculin Biotech announced updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial for Annamycin in combination with cytarabine for treating relapsed or refractory acut

Moleculin (Nasdaq: MBRX) announced that CEO Walter Klemp appeared in a Virtual Investor “What This Means” segment.He discussed reaching enrollment of the 45th subject in the pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) in adult R/R AML, and preparations for interim data unblinding targeted for mid-2026.

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Moleculin Biotech, a late-stage pharmaceutical firm, announces the exercise of warrants generating $5.8 million to advance its cancer treatments.

New research reveals Annamycin's potential in multiple cancer drug combinations. MD Anderson to present groundbreaking findings at prestigious AACR conference. See full details.

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Moleculin Biotech (MBRX) received Mexican Patent No. 436849 covering its proprietary lung-targeted liposomal Annamycin technology, extending protection in Mexico until November 23, 2040.The patent reinforces a growing global intellectual property estate around Annamycin, a novel anthracycline being evaluated in the pivotal MIRACLE Phase 2/3 trial for relapsed or refractory acute myeloid leukemia (AML). The patented liposomal formulation is designed to enhance delivery of Annamycin to pulmonary tumors and metastatic disease, supporting potential use beyond hematologic cancers. Management describes strong international patent coverage as central to protecting the long-term commercial opportunity of the Annamycin platform.

Reported Wednesday, Sep 23 - 8:27am EDT (TheFly subscription required to read more.)

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Moleculin Biotech (MBRX) will present new preclinical data on its lead cancer drug candidate Annamycin (naxtarubicin) at three scientific meetings in September 2026, including the AACR Conference on Pancreatic Cancer.Talks in Wroclaw, Poland, at the XIII Congress of the Polish Medical Diaspora and an invited lecture at the Hirszfeld Institute will address Annamycin’s lipophilic tissue distribution (“organotropism”) and its topoisomerase II–targeting mechanism. A separate AACR presentation in San Diego will cover antitumor activity in pancreatic cancer and potential CD8+ T cell–mediated effects; its abstract remains embargoed until September 25, 2026, at 1:00 p.m. ET. These efforts run alongside Moleculin’s MIRACLE Phase 2/3 AnnAraC trial in relapsed or refractory AML, which the company states is its primary development focus.

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Moleculin Biotech (Nasdaq: MBRX) announced that CEO and Chairman Walter Klemp participated in the Virtual Investor “Why Now” on-demand conference, where he highlighted the Company’s clinical progress and long-term opportunity.The presentation discussed encouraging interim results from the pivotal Phase 2/3 MIRACLE trial (MB-108) of Annamycin (naxtarubicin) for relapsed or refractory acute myeloid leukemia (AML), its differentiated clinical profile, continued enrollment, expanding commercial opportunity, and an upcoming 90-patient interim analysis viewed by the Company as a key potential value catalyst toward registration. The webcast is now available for on-demand viewing. Moleculin also outlined its broader pipeline, including Annamycin for soft tissue sarcoma lung metastases, the immune/transcription modulator WP1066 for various cancers, and antimetabolites such as WP1122 for pathogenic viruses and certain cancers.

Moleculin Biotech (Nasdaq: MBRX) reported second quarter 2026 results and progress in its pivotal Phase 2/3 MIRACLE trial of Annamycin in relapsed/refractory AML. According to Moleculin, interim unblinded data from the first 45 Part A patients showed complete remission (CR) rates of 43% and 36% in the two Annamycin plus cytarabine arms versus 12% in the cytarabine control arm, with composite CR (CRc) of 50% and 57% versus 29% for control, and no evidence of cardiotoxicity.Enrollment is on track to complete the 90-patient Part A in September 2026, with an unblinded efficacy readout expected between December 2026 and February 2027 and Part B initiation planned for the first half of 2027. Research and development expenses rose to $5.5 million from $3.6 million year over year, while general and administrative expenses were stable at $2.1 million. Moleculin reported a Q2 2026 net loss of $7.6 million and ended June 30, 2026 with $7.3 million in cash and equivalents; together with $9.3 million raised after quarter-end, this is expected to fund operations into the first quarter of 2027.

Moleculin (Nasdaq: MBRX) reported updated preliminary blinded data from Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) in relapsed/refractory AML. Among 62 evaluable subjects, blinded complete remission (CR) was 24% and composite CR (CRc) was 37% after a single treatment cycle.Of these, 30 patients had failed prior first-line venetoclax-based therapy, with blinded CR and CRc of 23% and 37%, respectively. According to Moleculin, this compares with published salvage CRc of about 13% and median survival of 2.4 months after venetoclax failure, though this is not a controlled comparison. Enrollment has reached 74 of 90 subjects, with final Part A treatment expected in September 2026 and comprehensive unblinded Part A results anticipated between December 2026 and February 2027. Across three blinded looks, CRc has remained near 37–40%, and the company reports no evidence of cardiotoxicity to date.

Interim MIRACLE trial data showed Annamycin complete remission rates up to 43% versus 12% for control in relapsed or refractory AML patients.