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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, Inc. (Nasdaq: MBRX) announced its participation in the LD Micro 500 Virtual Investor Conference on September 1, 2020. CEO Walter Klemp will present at 4:40 pm ET. The company focuses on oncology drug candidates for resistant tumors, including Annamycin for AML, WP1066 for brain tumors, and WP1220 for cutaneous T-cell lymphoma. Investors can schedule one-on-one meetings with company management during the event. For more details, visit Moleculin's website.
Moleculin Biotech (MBRX) reported its Q2 2020 financial results, highlighting progress across its drug development platforms amidst COVID-19 challenges. The company emphasized advancements in its antiviral candidate, WP1122, showing significant efficacy against SARS-CoV-2 in preclinical studies. Additionally, Annamycin for acute myeloid leukemia met its Phase 1 trial endpoints with a favorable safety profile. However, the company faced a net loss of $10.1 million, up from $1.2 million in Q2 2019, mainly due to increased R&D expenses. As of June 30, 2020, cash reserves stood at $16.7 million.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a study from the University of Campinas, Brazil, revealing that elevated glucose levels support SARS-CoV-2 infection. The research indicates that inhibiting glycolysis with 2-deoxy-D-glucose (2-DG) can significantly reduce viral load in vitro. CEO Walter Klemp emphasized the importance of targeting glucose metabolism in COVID-19 treatment and highlighted WP1122's potential as an antimetabolite prodrug. The findings align with previous studies linking glycolysis to SARS-CoV-2 replication, underscoring the significance of WP1122's unique delivery system.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced on July 21, 2020, that independent laboratory tests confirmed the antiviral activity of WP1122 against coronavirus. Conducted by IIT Research Institute, the tests showed that WP1122, a 2-DG prodrug, demonstrated significant effects in a cell viability assay with a focus on realistic glucose levels. CEO Walter Klemp noted the importance of this validation and indicated plans for animal model testing for IND status. The company is also exploring other compounds in its portfolio for viral treatments.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a contract with Sterling Pharma USA LLC for the US production of WP1122, aimed at supporting its development for COVID-19 treatment. This collaboration is expected to enhance preclinical studies and the submission of an Investigational New Drug (IND) application to the FDA. The company is expanding its testing of WP1122 and its analogs against various viruses, yet acknowledges challenges in obtaining in vivo testing due to high demand. The outcomes will also contribute to advancing WP1122 for treating other viral infections and cancers.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a significant update on its Annamycin clinical development for treating relapsed acute myeloid leukemia (AML). Following collaboration with US and European regulators, the company will expand cardiotoxicity testing in its Phase 1 trial. European authorities approved increasing the dose-escalation increment from 30 mg/m2 to 60 mg/m2. The first patient has been treated at 240 mg/m2 without cardiotoxicity. Moleculin anticipates establishing a recommended Phase 2 dose in 2021 and is preparing for a Phase 1 trial for lung metastases by year's end.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a significant advancement in cancer research with the publication of a peer-reviewed article in Clinical Cancer Research. The study demonstrates that the combination of Moleculin's STAT3 inhibitor, WP1066, and whole brain radiation therapy (WBRT) enhances median survival time and induces long-term survival in mice with human brain tumors. The findings suggest an improved therapeutic effect and the potential to develop immune memory, potentially preventing tumor recurrence.
Moleculin Biotech announced significant preclinical findings on Annamycin at the AACR Annual Meeting, which took place from June 22-24, 2020. The poster presentation highlighted Annamycin's ability to achieve high concentrations in lung tissues, leading to superior anti-tumor efficacy against lung-localized tumors in mice. Annamycin demonstrated nearly six times the lung accumulation compared to doxorubicin, indicating potential for improved treatment outcomes in patients with metastatic lung cancer. The company aims to explore Annamycin's clinical applications further.
Moleculin Biotech, Inc. (Nasdaq: MBRX) will present at the virtual Life Sciences Investor Forum on June 25, 2020, from 1:30 PM to 2:00 PM ET. CEO Walter Klemp will lead the presentation, allowing real-time questions from investors. An archived webcast will be available for those who miss the live event. Investors are encouraged to pre-register via the event's page. Moleculin focuses on developing oncology drug candidates targeting resistant tumors, including Annamycin for acute myeloid leukemia, WP1066 for brain tumors, and WP1220 for cutaneous T-cell lymphoma.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced confirmed in vitro testing results demonstrating the antiviral potential of WP1122 against Human Coronavirus 229E, a surrogate for SARS-CoV-2, on June 1, 2020. The company plans to pursue further in vitro and in vivo studies, anticipating an IND filing for COVID-19 treatment by the end of 2020. Moleculin intends to leverage non-GLP toxicology data in its IND submission. The FDA's guidance was received positively, helping shape the company’s clinical development strategy for WP1122.
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