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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) will report its full year 2022 financial results on March 22, 2023, after market close. The Company is in the clinical stage, developing treatments for hard-to-treat tumors and viruses. The management will host a conference call on March 23, 2023, at 8:30 AM ET to discuss operational and financial results. Investors can access the call via phone or through a live webcast.

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Moleculin Biotech, Inc. (NASDAQ: MBRX) announced its participation in the Oppenheimer 33rd Annual Healthcare Conference on March 14, 2023 at 12:40 PM ET. Jonathan P. Foster, the Chief Financial Officer, will present a live video webcast, accessible on the Company's website. This event will also allow one-on-one meetings with registered investors. Moleculin focuses on developing treatments for hard-to-treat tumors and viruses, highlighted by its lead program Annamycin for acute myeloid leukemia and soft tissue sarcoma. The Company is also advancing several other oncology and antiviral candidates.

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Moleculin Biotech, Inc. (NASDAQ: MBRX) announced on March 13, 2023, that it has no exposure to Silicon Valley Bank (SVB), which has been taken over by the Federal Deposit Insurance Corp. due to liquidity issues. The company confirmed it does not hold any deposits or investments at SVB. Moleculin is a clinical stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses, including its lead drug Annamycin, aimed at relapsed acute myeloid leukemia and soft tissue sarcoma lung metastases. The company's pipeline includes several promising drug candidates targeting various cancers and viral infections.

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Moleculin Biotech, Inc. (NASDAQ: MBRX) announced the publication of data supporting Annamycin, a non-cardiotoxic anthracycline. The research shows Annamycin's potential in treating hard-to-treat tumors. An independent review of 42 subjects indicated no cardiotoxicity, distinguishing Annamycin from traditional anthracyclines like doxorubicin. Key modifications to Annamycin have enhanced its efficacy against multidrug-resistant tumors. Annamycin is currently being evaluated for soft tissue sarcoma and acute myelogenous leukemia. The manuscript, titled ‘Anthracycline-induced cardiotoxicity – are we about to clear this hurdle?’ was published in the European Journal of Cancer.

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Moleculin Biotech, Inc. (NASDAQ: MBRX) announced the treatment of the first subject in Italy as part of its Phase 1/2 trial, MB-106, evaluating Annamycin combined with Cytarabine for refractory acute myeloid leukemia (AML). The Phase 1/2 trial builds on earlier successful trials, with the MB-105 study showing an 80% overall response rate. Annamycin is designed to avoid cardiotoxicity and demonstrate higher efficacy against chemotherapy-resistant cancers. The company aims to expand recruitment and has received Fast Track and Orphan Drug Designation from the FDA for Annamycin. The final clinical study report is expected to be published soon.

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Moleculin Biotech, Inc. (MBRX) announced positive topline results from its MB-105 Phase 1 trial assessing Annamycin for treating relapsed or refractory acute myeloid leukemia (AML). The trial showcased an 80% overall response rate (ORR) in patients aged 60 and above, with no reported cardiotoxicity. The median number of prior therapies was four, indicating a challenging patient population. The company is optimistic about Annamycin, especially given its encouraging preliminary efficacy data and safety profile. Annamycin is also in ongoing combination trials with Cytarabine, aiming for further indications in AML treatment.

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Moleculin Biotech, Inc. (Nasdaq: MBRX) announces a presentation by CEO Walter Klemp at the Virtual Investor 2023 Companies to Watch Event on January 17, 2023, at 9:00 AM ET. The event will focus on Moleculin's innovative drug candidates designed to combat resistant tumors and viruses, including Annamycin for acute myeloid leukemia and WP1066 for brain tumors. A live video webcast will be accessible, with a replay available for 90 days.

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Moleculin Biotech, Inc. (MBRX) announced the approval from Italy's AIFA and ISS for its Phase 1/2 trial of Annamycin in combination with Cytarabine (Ara-C) for treating refractory or relapsed Acute Myeloid Leukemia (AML). This adds to the ongoing approval in Poland, where three sites are already recruiting. The company expects to treat its first subject in Italy in Q1 2023. Annamycin has shown significant potential in preclinical studies, enhancing overall survival rates. The company is expanding its clinical trial efforts across Europe to improve recruitment rates.

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Moleculin Biotech announced an impressive 80% overall response rate (ORR) in the final cohort of its Phase 1 clinical trial for Annamycin in treating relapsed/refractory acute myeloid leukemia (AML). The drug has shown significant safety results, with an independent report confirming no cardiotoxicity in 42 subjects across three trials. Additionally, Annamycin has received FDA Fast Track and Orphan Drug Designation for AML and STS lung metastases. The company is expanding its clinical trials into Europe to improve recruitment.

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Moleculin Biotech, Inc. (Nasdaq: MBRX) announced on December 7, 2022, that the FDA granted Fast Track designation for its drug WP1122 to treat Glioblastoma Multiforme (GBM). This designation aims to expedite the development of therapies for serious conditions with unmet needs, allowing more frequent regulatory communication. Walter Klemp, CEO, emphasized the significance of this designation and the promising preclinical data for WP1122. With GBM having a median survival of only 15 months, WP1122 shows potential as a treatment option, especially after receiving Orphan Drug Designation and IND clearance for a Phase 1 study.

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FAQ

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

The current stock price of Moleculin Biotech (MBRX) is $2.71 as of November 15, 2024.

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

The market cap of Moleculin Biotech (MBRX) is approximately 8.5M.

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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