Welcome to our dedicated page for Moleculin Biotech news (Ticker: MBRX), a resource for investors and traders seeking the latest updates and insights on Moleculin Biotech stock.
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) has appointed Dr. Wolfram C. M. Dempke as its EU Chief Medical Officer to lead upcoming clinical trials in Europe. Dr. Dempke brings over 30 years of experience in oncology and hematology, having contributed to significant drug developments in various companies. He will oversee the Company's initiatives targeting highly resistant tumors. Moleculin's lead program, Annamycin, aims to address acute myeloid leukemia and soft tissue sarcoma with minimal cardiotoxicity. The Company continues to advance its clinical pipeline, focusing on unmet oncological needs.
Moleculin Biotech (Nasdaq: MBRX) announced the FDA's clearance of its Investigational New Drug (IND) application for WP1066, aimed at treating recurrent malignant glioma. The company plans to conduct a Phase 1 trial to assess the safety and efficacy of this treatment in adult patients. WP1066 has shown significant anti-tumor activity in preclinical studies and is currently being evaluated in pediatric brain tumor trials at Emory University, where preliminary results have demonstrated clinical improvement in a treated subject.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a corporate rebranding and the launch of a new website, aiming to align its branding with its vision to combat resistant cancers and viruses. The company emphasizes its commitment to overcoming medical challenges through innovative treatments, particularly highlighting Annamycin, a next-generation anthracycline that shows promise in treating relapsed acute myeloid leukemia and soft tissue sarcoma lung metastases without cardiotoxicity. The refreshed branding and website reflect Moleculin's dedication to advancing its clinical programs and development pipeline.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced robust preclinical data for Annamycin in models of metastatic colorectal cancer. The findings indicate significant antitumor activity, showing a 272% extension of survival in lung metastasis models and complete elimination of tumors in liver metastasis models. Annamycin's efficacy positions it favorably for clinical studies, with ongoing development for acute myeloid leukemia and soft tissue sarcoma. The drug has Fast Track Status and Orphan Drug Designation from the FDA, reinforcing its potential in treating aggressive cancers.
Moleculin Biotech (Nasdaq: MBRX) reported positive preliminary safety and efficacy results from its Phase 1 AML study, leading to plans for a Phase 1/2 trial of Annamycin in combination with Cytarabine. Annamycin demonstrated no cardiotoxicity in trials for Acute Myeloid Leukemia and Soft Tissue Sarcoma. The FDA cleared the IND application for WP1122's use in GBM, with Phase 1a trials for COVID-19 also pending. Financial results show a 2021 R&D expense of $14.4 million, with a net loss of $15.9 million, but sufficient cash reserves to fund operations until 2024.
Moleculin Biotech, Inc. (Nasdaq: MBRX) will participate in the 2022 Virtual Growth Conference hosted by Maxim Group LLC and M-Vest from March 28-30, 2022. Walter Klemp, Chairman and CEO, will present during the event which will feature discussions from various sectors including biotech and healthcare. Attendees can view a video webcast of the presentation on-demand. Moleculin focuses on developing drug candidates for resistant tumors and viruses, with key programs like Annamycin for acute myeloid leukemia and WP1066 targeting brain tumors.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that its Chairman and CEO, Walter Klemp, will present at the Oppenheimer 32nd Annual Healthcare Conference on March 17, 2022, at 9:20 AM ET. The company focuses on developing drug candidates for resistant tumors and viruses, including its lead program, Annamycin, for treating acute myeloid leukemia and soft tissue sarcoma. The presentation will be available via a live webcast, and a replay will be archived for 90 days. Investors can expect virtual one-on-one meetings with management.
Moleculin Biotech, Inc. (Nasdaq: MBRX) recently announced the appointment of Dr. Joy Yan, M.D., Ph.D. to its Board of Directors. Dr. Yan brings extensive experience in clinical program development from her roles at major pharmaceutical companies, including Bristol Myers Squibb. Walter Klemp, Chairman and CEO, expressed confidence that her expertise will enhance the company's strategic direction and growth. Moleculin focuses on drug candidates for resistant tumors and viruses, including its lead program Annamycin for acute myeloid leukemia and soft tissue sarcoma.
Moleculin Biotech (Nasdaq: MBRX) announced positive preliminary results from its second Phase 1 trial (MB-105) for Annamycin, a treatment for relapsed and refractory acute myeloid leukemia (AML), in Poland. The recommended Phase 2 dose was determined to be 240 mg/m² with no signs of cardiotoxicity. Furthermore, Annamycin's combination with Cytarabine showed a 68% improvement in median overall survival compared to Annamycin alone. The company is poised to advance into a Phase 1/2 trial in Europe, leveraging data from the completed trials for further development.
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