On Tuesday, Actinium Pharmaceuticals (NYSE:ATNM) stock saw a significant reduction in its price target from $50.00 to $4.00 by H.C. Wainwright, although the firm maintained a Buy.
This adjustment follows Actinium's latest update on its Iomab-B program, which included outcomes from recent interactions with the U.S. Food and Drug Administration (FDA).
The FDA has expressed that the SIERRA trial's design and analysis were insufficient, requiring an additional randomized trial to demonstrate an overall survival benefit for a Biologics License Application (BLA) filing. The SIERRA study, a Phase 3 trial, compared Iomab-B against salvage therapy in patients with relapsed/refractory Acute Myeloid Leukemia (r/r AML).
While the study showed a disease control rate (DCR) of 22% at six months for the Iomab-B group versus 0% for the control, it failed to meet the secondary endpoint of overall survival on an intent-to-treat basis, largely due to a high crossover rate of nearly 60% from the control arm.
In response to the FDA's requirements, Actinium is planning to conduct a new trial without allowing crossover to avoid confounding survival outcomes. Alongside this, the company is seeking a strategic partner for Iomab-B in the U.S.
Despite the challenges, Actinium is reported to be in a strong financial position, with a first-quarter cash balance of $84.05 million, equating to an operational runway of two to three years.
The firm acknowledges the setback as a blow to shareholders' confidence but emphasizes the importance of viewing it in context. With a robust balance sheet and a pipeline of early-stage but promising assets in the radiopharmacy space, Actinium is poised to potentially deliver value to its shareholders in the future.
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