Analyst Vernon Bernardino of H.C. Wainwright reiterated a Buy rating on Moleculin Biotech (MBRX – Research Report), retaining the price target of $8.00.
Vernon Bernardino’s rating is based on Moleculin Biotech’s promising advancements in their pivotal Phase 3 trial, MIRACLE, which evaluates Annamycin in combination with high-dose cytarabine for treating acute myeloid leukemia (AML) patients who are refractory to or have relapsed after induction therapy. Annamycin’s differentiation from other anthracyclines due to its lack of cumulative cardiotoxicity positions it as a potentially safer long-term treatment option.
Furthermore, the Fast Track and Orphan Drug Designation from the FDA and EMA for Annamycin increase its potential for accelerated approval. The adaptive design of the MIRACLE trial allows for early unblinding of preliminary efficacy and safety data, which could expedite the drug’s development timeline. Positive results from Part A of the trial could lead to a rolling New Drug Application process as early as late 2026, with potential approval in 2027. These factors contribute to Bernardino’s Buy rating and the $8 price target for Moleculin Biotech.