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Moleculin Biotech, Inc. (NASDAQ: MBRX) is a clinical stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses. Known for its innovative drug candidates, Moleculin's pipeline aims to address significant unmet medical needs. The company's flagship product, Annamycin, is a next-generation anthracycline designed to overcome multidrug resistance mechanisms and minimize cardiotoxicity. Annamycin is currently in Phase II clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
Moleculin's research is rooted in discoveries from the acclaimed M.D. Anderson Cancer Center. In addition to Annamycin, the company is developing WP1066, an Immune/Transcription Modulator targeting brain tumors, pancreatic cancer, and other malignancies. WP1066 aims to inhibit oncogenic transcription factors such as p-STAT3 while stimulating the patient's immune response.
Another promising candidate, WP1220, an analog of WP1066, is being developed for the topical treatment of cutaneous T-cell lymphoma. The company also has a robust antimetabolite portfolio, including WP1122, which is being investigated for its potential in treating both viral infections and various cancers.
Recent achievements highlight Moleculin's significant progress. Positive preclinical data for Annamycin were presented at the American Association for Cancer Research (AACR) Annual Meeting, demonstrating its non-cardiotoxic properties and potent inhibition of topoisomerase II-beta. Annamycin has also received Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA) for AML, providing Moleculin with extended market exclusivity and reduced regulatory fees.
Financially, Moleculin maintains a solid footing with sufficient capital to support its ongoing clinical trials and future projects. The company's recent financial report indicates a strategic focus on advancing its clinical and regulatory strategies. With multiple patents issued and pending, Moleculin continues to strengthen its intellectual property portfolio, positioning itself favorably for potential partnerships and market expansion.
Collaborations with leading institutions such as Northwestern University and funding from entities like the National Institutes of Health (NIH) underscore the robust support for Moleculin's initiatives. The company's innovative approach and commitment to addressing challenging medical conditions make it a noteworthy entity in the biopharmaceutical landscape.
For more details, please visit Moleculin's website and connect on Twitter, LinkedIn, and Facebook.
Moleculin Biotech announced the publication of preclinical data demonstrating the significant activity of Annamycin in treating venetoclax-resistant acute myeloid leukemia (AML) cell lines. The study, presented at the American Society of Hematology Annual Meeting, revealed that Annamycin effectively targets both Cytarabine (Ara-C) and Venetoclax resistant AML cell lines from heavily pretreated relapsed/refractory primary AML patients in vitro.
The data showed Annamycin's synergy with Ara-C and Venetoclax in reducing cell viability, a lack of cardiotoxicity, improved organotropism, and potential immune-memory reinforcing properties. These findings correlate with preliminary clinical data showing a 60% composite complete remission (CRc) rate in subjects using Annamycin and Ara-C (AnnAraC) as a second-line treatment.
Annamycin's favorable toxicity profile, as compared to DOX, and its ability to extend survival in combination with Ara-C, underscore its potential as a breakthrough treatment. Moleculin is advancing Annamycin in a Phase 3 trial, 'MIRACLE,' set to begin patient treatment in Q1 2025. Annamycin has Fast Track Status and Orphan Drug Designation from the FDA and EMA.
Moleculin Biotech (MBRX) announced new findings showing Annamycin's effectiveness in treating Venetoclax-resistant acute myeloid leukemia (AML). Preliminary clinical results demonstrate that Annamycin plus Ara-C achieved a 60% CR/CRi rate in subjects previously treated with Venetoclax regimens, which is more than 4 times higher than historical rates. The MB-106 trial showed median overall survival of 11.6 months in subjects receiving AnnAraC as second-line therapy. The company is advancing to a Phase 3 'MIRACLE' trial, with patient treatment expected to begin in Q1 2025. Annamycin has received Fast Track Status and Orphan Drug Designation from both FDA and EMA.
Moleculin Biotech (MBRX) has amended its Phase 3 MIRACLE trial protocol for Annamycin in combination with Cytarabine (AnnAraC) for treating relapsed/refractory AML. The amended protocol allows for earlier unblinding of preliminary efficacy data at 45 subjects in H2 2025, accelerating from the previous 2026 timeline. The trial will use an adaptive design with two parts: Part A will randomize 75-90 subjects across three arms, while Part B will include 244 additional subjects. The study maintains its planned first subject treatment start in Q1 2025. Annamycin holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications.
Moleculin Biotech (NASDAQ: MBRX) has received Institutional Review Board (IRB) approval for its MIRACLE Phase 3 pivotal trial evaluating Annamycin in combination with Cytarabine for treating relapsed or refractory AML. The global trial is designed for possible accelerated approval and is expected to begin enrollment in Q1 2025. The study will use an adaptive design with initial enrollment of 75-90 subjects in Part A, followed by approximately 240 additional subjects in Part B. Annamycin holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications.
Moleculin Biotech reported its Q3 2024 financial results and provided a corporate update. Key highlights include the initiation of dosing in the Phase 3 MIRACLE trial for Annamycin in Q1 2025. The median durability of CRc in the MB-106 trial has exceeded 8 months. Moleculin hosted a virtual AML KOL event and appointed Dr. Daniel D. Von Hoff to its Scientific Advisory Board.
Financially, R&D expenses rose to $4.9 million from $3.3 million year-over-year, while G&A expenses decreased to $2.2 million from $2.6 million. The company closed a $5.5 million financing and has $9.4 million in cash reserves, expected to fund operations into Q1 2025.
Upcoming milestones include the first subject treated in the MIRACLE trial in Q1 2025 and final data readout for the STS lung metastases trial in 2025. Moleculin will host a conference call on November 11, 2024, at 8:30 AM ET to discuss these updates.
Moleculin Biotech (MBRX) has scheduled its third quarter 2024 financial results announcement for November 8, 2024. The company will host a conference call and webcast to discuss operational and financial results on November 11, 2024, at 8:30 AM ET. Participants can join via phone using the numbers (877) 407-0832 (domestic) or (201) 689-8433 (international). The webcast will be available on the company's website and archived for 90 days.
Moleculin Biotech (NASDAQ: MBRX) has appointed Dr. Daniel D. Von Hoff to its Annamycin Scientific Advisory Board. Dr. Von Hoff, a Distinguished Professor at the Translational Genomics Research Institute and expert in pancreatic cancer, joins following promising preclinical evidence of Annamycin's potential in treating pancreatic cancer presented at AACR. Annamycin is currently in clinical trials for treating relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases. The drug holds Fast Track Status and Orphan Drug Designation from FDA for AML treatment, plus Orphan Drug Designation for soft tissue sarcoma and from EMA for AML.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has announced that the transcript from its recent Virtual Acute Myeloid Leukemia (AML) Key Opinion Leader (KOL) event is now available. The event featured Moleculin's executives and renowned AML experts discussing the potential of Annamycin in changing the AML treatment landscape. The transcript can be accessed on the company's website and SEC Filings page.
The event included an overview of Annamycin, the use of anthracyclines, and Moleculin's recently announced global Phase 3 pivotal trial (MIRACLE) for treating AML patients who are refractory to or relapsed after induction therapy. Walter Klemp, CEO of Moleculin, expressed gratitude to the KOLs for their insights and support, highlighting the growing body of positive preliminary data for Annamycin in addressing the unmet need for safe and effective therapies for R/R AML.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has announced a Virtual Acute Myeloid Leukemia (AML) KOL event scheduled for October 14, 2024, from 11:00 AM to 1:00 PM ET. The event will feature discussions on Annamycin, the company's drug candidate for treating relapsed or refractory AML, and its ongoing pivotal Phase 3 clinical trial (the 'MIRACLE' trial).
Key participants include Moleculin's management team and renowned AML experts from prestigious institutions. The event will cover topics such as the use of anthracyclines, Annamycin's potential impact on AML treatment, and details about the global Phase 3 trial. Interested parties can join via conference call or watch the live video webcast on Moleculin's website.
Moleculin Biotech, Inc. (Nasdaq: MBRX), a late-stage pharmaceutical company focusing on hard-to-treat tumors and viruses, has announced its participation in two upcoming investor conferences. The first is the 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024, where Moleculin will participate in a panel discussion on Innovative Therapies for Liquid Tumors at 1:15 PM ET. The panel will cover drug developments, competitive positioning, and upcoming data readouts.
The second event is the 2024 Healthcare Virtual Summit, presented by Maxim Group and hosted by M-Vest, scheduled for October 16, 2024, at 3:00 PM ET. Moleculin will participate in a fireside chat format. This virtual event will be accessible to M-Vest members, with registration available online. Both conferences offer opportunities for Moleculin to showcase its drug candidates and engage with the investor community.
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