Moleculin Biotech, Inc. - MBRX STOCK NEWS

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.

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.

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.

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.

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.

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.

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.

Moleculin Biotech, Inc. (Nasdaq: MBRX) has partnered with IQVIA Biotech to initiate clinical trials for WP1122, a drug aimed at treating COVID-19. The decision stems from delays in obtaining FDA approval due to the unavailability of validated COVID-19 animal models in the U.S. However, the company believes it has completed necessary preclinical testing to qualify for foreign IND submission. WP1122 is designed to enhance the drug-like properties of 2-deoxy-D-glucose (2-DG), which has shown efficacy against SARS-CoV-2.

Moleculin Biotech has received FDA Fast Track Designation for its drug Annamycin, aimed at treating soft tissue sarcoma lung metastases. This milestone allows the company to pursue accelerated approval and priority review for its New Drug Application (NDA). The company plans to initiate a clinical trial in the US by mid-2021, backed by a $1.5 million grant for a related clinical trial in Poland. Annamycin is positioned to potentially replace doxorubicin, with significantly lower cardiotoxicity and up to 30-fold lung accumulation. This addresses a major unmet need in STS treatment.