Moleculin Biotech’s Clinical and Regulatory Advances Drive Buy Rating Amid Promising Phase 3 MIRACLE Study and FDA Feedback

Sara Nik, an analyst from H.C. Wainwright, reiterated the Buy rating on Moleculin Biotech. The associated price target remains the same with $4.00.

Sara Nik’s rating is based on several key developments in Moleculin Biotech’s clinical trials and regulatory progress. The company’s Phase 3 MIRACLE study, which evaluates the efficacy of annamycin in combination with high-dose cytarabine for treating relapsed/refractory AML patients, has expanded its reach by activating more clinical sites and progressing well in patient enrollment. This expansion, including recent approval in Georgia, supports the company’s timeline for an initial data readout by the second half of 2025, which could significantly enhance the stock’s value if results are positive.
Additionally, Moleculin has received favorable feedback from the FDA regarding its Initial Pediatric Study Plan for annamycin, which is a promising development for its application in pediatric cancer treatment. The FDA’s agreement to allow the initiation of a pediatric study before the completion of the MIRACLE trial’s follow-up data, along with the potential for annamycin to address the unmet needs in pediatric oncology, further strengthens the company’s position. These factors collectively contribute to Sara Nik’s Buy rating for Moleculin Biotech, reflecting optimism about the company’s future prospects and potential market impact.

In another report released on June 27, Roth MKM also maintained a Buy rating on the stock with a $13.00 price target.

Based on the recent corporate insider activity of 7 insiders, corporate insider sentiment is positive on the stock. This means that over the past quarter there has been an increase of insiders buying their shares of MBRX in relation to earlier this year.