In a report released today, Vernon Bernardino from H.C. Wainwright reiterated a Buy rating on Moleculin Biotech (MBRX – Research Report), with a price target of $8.00.
Vernon Bernardino has given his Buy rating due to a combination of factors that highlight the potential of Moleculin Biotech’s Annamycin. The recent feedback from the FDA on the Investigational New Drug application amendment for the MIRACLE study supports an accelerated timeline for the pivotal Phase 3 trial. This trial aims to evaluate Annamycin in combination with cytarabine for treating acute myeloid leukemia patients who are refractory to or have relapsed after induction therapy. The FDA’s guidance, which includes a reduction in the trial size, allows Moleculin to expedite the opening of trial sites in the U.S., Europe, and the Middle East, with the first patient expected to be treated in the first quarter of 2025.
Additionally, Annamycin’s designation as a Fast Track and Orphan Drug by both the FDA and EMA underscores its potential for quicker approval. The promising findings from the MB-106 trial, showing improved median overall survival rates, further bolster confidence in Annamycin’s safety and efficacy. These developments, along with the strategic adjustments following a reverse stock split and recent financings, have led to an adjusted price target of $8, reinforcing the Buy recommendation.
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