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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 that the FDA has granted Orphan Drug Designation to Annamycin for the treatment of soft tissue sarcomas. This designation can facilitate drug development and provides benefits like tax credits and market exclusivity. The FDA also allowed the company to begin a Phase 1B/2 clinical trial targeting patients with STS that has spread to the lungs. Annamycin shows a significant increase in lung accumulation compared to doxorubicin and lacks cardiotoxicity. This marks the second Orphan Drug designation for Annamycin.
Moleculin Biotech, Inc. announced the FDA's approval of its IND application to commence a Phase 1B/2 clinical trial for Annamycin, targeting soft tissue sarcoma lung metastases. This approval allows the company to address a significant unmet need, as approximately 36,000 new cases of soft tissue sarcoma occur annually in key markets, with a potential market size exceeding $177 million. Annamycin shows promising in vivo antitumor activity and high uptake in lung tissues, potentially outperforming existing treatments. The trial is expected to begin by mid-2021.
Moleculin Biotech (Nasdaq: MBRX) announced the presentation of animal data on December 3, 2020, at the American Society for Hematology's annual meeting. The data demonstrates improved efficacy of its drug, Liposomal Annamycin (L-ANN), in combination with cytarabine (Ara-C) against acute myeloid leukemia (AML). In a mouse model, the combination resulted in median survival extending from 13 to 56-76 days, with some animals completely cured. CEO Walter Klemp expressed optimism about further clinical trials for this promising combination.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that the FDA has granted its drug candidate WP1066 a "Rare Pediatric Disease" designation. This approval allows the company to receive a transferrable Priority Review Voucher (PRV) upon New Drug Approval for three indications: diffuse intrinsic pontine glioma, medulloblastoma, and atypical teratoid rhabdoid tumor. PRVs have been valued at over $100 million, highlighting a significant future revenue opportunity for Moleculin.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced new animal study results showing significant improvements in survival rates for acute myeloid leukemia (AML) when Liposomal Annamycin (L-ANN) is combined with Ara-C (cytarabine). The combination therapy led to median survival times ranging from 56 to 76 days, representing a 585% increase compared to single-agent treatments. Moleculin plans to initiate clinical trials for the combination therapy, termed 'AnnAraC,' following these promising results. The findings were presented at the 62nd Annual Meeting of the American Society for Hematology.
Moleculin Biotech, Inc. (Nasdaq: MBRX) reported a net loss of $3.4 million for Q3 2020, improving from $4.1 million in Q3 2019. R&D expenses rose to $4.4 million, mainly due to increased clinical trials. The company advances its lead drug, Annamycin, in multiple indications with promising preclinical results, especially targeting lung tumors. The ongoing WP1066 trials for brain tumors show positive preliminary data. The company holds $12.8 million in cash, expected to fund operations into Q3 2021. A new collaboration aims to enhance antiviral drug WP1122's development.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has partnered with the University of Campinas, Brazil, to advance research on WP1122, a drug candidate targeting COVID-19. Recent studies indicate that WP1122, a pro-drug of 2-deoxy-D-glucose (2-DG), may inhibit SARS-CoV-2 replication by targeting glycolysis. The collaboration aims to enhance resources for WP1122's development, with potential in vivo testing slated for early 2021. The company continues to evaluate its strategy and plans for an Investigational New Drug request to the FDA.
Moleculin Biotech, a clinical stage pharmaceutical company, announced its participation in ROTH Capital's healthcare event titled "COVID-19 Therapeutics in Development" on October 28, 2020. The session, titled "Indirect Antivirals Against SARS-CoV2 Virus," will take place from 12:00 to 1:20 PM ET. The company focuses on developing drug candidates for treatment-resistant tumors and viruses, including Annamycin for AML and WP1066 for brain tumors and pancreatic cancer. For details, visit their website.
Moleculin Biotech (Nasdaq: MBRX) announced validation of Annamycin's ability to target lung-localized tumors through independent laboratory studies. Annamycin may address significant unmet needs in treating sarcomas that have metastasized to the lungs, outperforming the standard treatment, doxorubicin. The drug accumulates in lungs 9-fold higher than doxorubicin and more than 30-fold in its liposomal form. The company plans to submit an IND application for Annamycin before year-end, with potential applications for various cancers beyond sarcoma.
Moleculin Biotech (Nasdaq: MBRX) announced additional preliminary data from its Phase 1 clinical trial of WP1066, an immuno-stimulating STAT3 inhibitor for glioblastoma (GBM). Three patients completed treatment in the third cohort with no adverse events, allowing progression to the fourth and final dose escalation of 16 mg/kg. WP1066 is designed to cross the blood-brain barrier, and trials indicate it may enhance immune response against tumors. A future study is proposed to examine WP1066 in combination with radiation therapy.
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