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Moleculin Biotech, Inc. - MBRX STOCK NEWS

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.

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Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that CEO Walter Klemp will present at the virtual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 20, 2021, at 4:35 PM ET. The management team will also hold virtual one-on-one meetings with registered investors. A live webcast of the presentation will be available on the Company's website, with a replay accessible for 90 days post-event. Moleculin focuses on developing drug candidates for highly resistant tumors and viruses, including Annamycin for acute myeloid leukemia and WP1066 for brain tumors.

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On September 8, 2021, Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that CEO Walter Klemp will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The company specializes in developing drug candidates for resistant tumors and viruses.

Management will also hold virtual one-on-one meetings with registered investors. A video webcast of the presentation will be available on-demand on September 13, 2021, at 7:00 AM ET and archived for 90 days.

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Moleculin Biotech, Inc. (Nasdaq: MBRX) reported its financial results for Q2 2021, showing R&D expenses of $3.0 million, down from $3.3 million in Q2 2020, primarily due to previous cost timings. General and administrative expenses rose to $2.4 million, up from $1.7 million, driven by increased consulting fees. The company reported a net loss of $8.7 million for the first half of 2021, an improvement from $11.3 million in 2020. Moleculin ended the quarter with $79.5 million in cash, sufficient for projected operating needs through 2024. Upcoming milestones include progress in multiple clinical trials.

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Moleculin Biotech, Inc. (Nasdaq: MBRX) has received approval from the Bioethics Committee of the Medical University of Poznań and the Polish Department of Registration of Medicinal Products for a protocol amendment in its Phase 1/2 trial of Annamycin, aimed at treating acute myeloid leukemia (AML). This amendment permits continued dose escalation based on new dose-limiting toxicity (DLT) criteria, allowing the study to evaluate Annamycin's safety further. Preliminary data shows promising clinical benefits and a clean safety profile. Annamycin has also received Fast Track Status and Orphan Drug Designation from the FDA.

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Moleculin Biotech (Nasdaq: MBRX) has initiated enrollment and has dosed its first patient in a Phase 1b/2 clinical trial of Annamycin, aimed at treating soft tissue sarcoma (STS) lung metastases. This trial addresses serious limitations in existing chemotherapy options, particularly the cardiotoxicity associated with doxorubicin. Annamycin has shown promising results in animal models, demonstrating superior lung accumulation and reduced cardiotoxicity. With Fast Track Status and Orphan Drug Designation from the FDA, this study may fill a significant therapeutic gap in treating resistant tumors.

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Moleculin Biotech, Inc. (Nasdaq: MBRX) announced its inclusion in the Russell 2000® Index, effective after market close on June 25, 2021. This milestone reflects the company's ongoing efforts to gain market exposure for its drug development programs targeting resistant tumors and viruses. The Russell 2000® Index represents about 10% of the total market capitalization of the Russell 3000® Index, which utilizes approximately $9 trillion in assets for investment benchmarks. Moleculin is focused on developing oncology drug candidates, including Annamycin for acute myeloid leukemia, and WP1066 for various cancers.

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Moleculin Biotech, Inc. (Nasdaq: MBRX) has received clearance to initiate its Phase 1b/2 clinical trial for Annamycin, targeting soft tissue sarcoma (STS) lung metastases. The trial aims to evaluate patient safety and optimal dosing, following promising animal data indicating Annamycin's superior lung accumulation and lack of cardiotoxicity compared to doxorubicin. Up to 25 subjects will be enrolled, and the study has Fast Track and Orphan Drug Designation from the FDA. A second trial in Europe is anticipated, alongside ongoing developments in oncology drug candidates.

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Moleculin Biotech (MBRX) reported its Q1 financial results on May 12, 2021, highlighting significant advancements in its oncology portfolio. Key achievements include receiving Rare Pediatric Disease Designation for WP1066, Fast Track Designation for Annamycin, and successfully closing a public offering for approximately $78 million. Total R&D expenses rose to $4.1 million, with a net loss of $4.4 million. The company has the potential for up to seven clinical trials this year, indicating strong momentum for future growth and shareholder value.

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Moleculin Biotech, Inc. (Nasdaq: MBRX), a clinical stage pharmaceutical firm, announced its participation in the Q2 Virtual Investor Summit on May 17, 2021, at 12:30 PM ET. CEO Walter Klemp will present, with management available for one-on-one meetings with investors. The conference aims to highlight Moleculin's innovative drug candidates that target resistant tumors and viruses. A live video webcast will be available on the company's Investor Relations page and archived for 90 days. For details, visit www.moleculin.com.

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Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that the FDA has granted Rare Pediatric Disease Designation to its drug WP1066 for treating ependymoma, a rare tumor affecting the brain and spinal cord, mainly in children. This designation recognizes the unmet medical needs in this area and allows for potential incentives, including a priority review voucher upon approval. Moleculin already holds Orphan Drug Designation for WP1066 and aims to advance its development program, believing WP1066 has the potential for effective therapy in pediatric patients.

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FAQ

What is the current stock price of Moleculin Biotech (MBRX)?

The current stock price of Moleculin Biotech (MBRX) is $1.82 as of December 24, 2024.

What is the market cap of Moleculin Biotech (MBRX)?

The market cap of Moleculin Biotech (MBRX) is approximately 5.8M.

What is Moleculin Biotech's lead product candidate?

Moleculin's lead product candidate is Annamycin, a next-generation anthracycline designed to treat relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

What are the key focus areas of Moleculin Biotech's research?

Moleculin Biotech focuses on developing therapies for hard-to-treat tumors and viruses, including drug candidates like Annamycin for AML and STS, and WP1066 for brain tumors and pancreatic cancer.

What recent achievements has Moleculin Biotech reported?

Moleculin has presented positive preclinical data on Annamycin's non-cardiotoxic properties, received Orphan Drug Designation for AML from both the FDA and EMA, and secured new patents for Annamycin.

How is Moleculin Biotech financially positioned?

Moleculin maintains sufficient capital to support its ongoing Phase IIB/2 clinical programs and additional future projects, as indicated by its latest financial report.

What collaborations is Moleculin Biotech involved in?

Moleculin collaborates with top institutions like Northwestern University and receives funding from entities such as the National Institutes of Health (NIH).

What is the significance of Annamycin's Orphan Drug Designation?

Orphan Drug Designation grants Moleculin benefits like reduced regulatory fees and market exclusivity for Annamycin, supporting its development for rare conditions like AML.

What is WP1066, and what does it target?

WP1066 is an Immune/Transcription Modulator targeting brain tumors, pancreatic cancer, and other malignancies. It aims to inhibit oncogenic transcription factors and stimulate the immune response.

What is WP1220 used for?

WP1220 is an analog of WP1066, being developed for the topical treatment of cutaneous T-cell lymphoma.

What is the potential of WP1122?

WP1122 is part of Moleculin's antimetabolite portfolio, currently being explored for treatment of viral infections and various cancers, including brain and pancreatic tumors.

Where can I find more information about Moleculin Biotech?

For more information, visit Moleculin's website at www.moleculin.com and follow them on social media platforms like Twitter, LinkedIn, and Facebook.

Moleculin Biotech, Inc.

Nasdaq:MBRX

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5.81M
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3.34%
15.34%
1.8%
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