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Mirna Therapeutics Could See A Clinical Hold On MRX34

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August 16, 2016 2:28 pm
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Oppenheimer has warned that Mirna Therapeutics Inc (NASDAQ: MIRN) could face a clinical hold on its MRX34 on safety concerns.

The company “disclosed another patient death from an immune-mediated SAE in Phase 1 study of MRX34 in multiple advanced cancers, deemed possibly related to MRX34 therapy by the investigator,” according to the research note.

FDA Involvement

Oppenheimer disclosed that roughly one week ago, management has submitted documentation to the FDA. The brokerage noted that this event “provides additional evidence of an immune component to MRX34’s mechanism and immune-mediated AEs are likely an on-target toxicity.”

“Mirna has not heard from the FDA, though we do believe a clinical hold is possible; we note this as a key risk in delaying MRX34 development. However, we note patients on study were heavily pretreated. Approximately 145 patients have been treated so far,” analyst Michelle Gilson wrote in a note.

Related Link: Citi Downgrades Mirna Therapeutics To Neutral

Steps Forward

“Mirna now plans to initiate Phase 2 studies of MRX34 in RCC and acral melanoma following results from both Phase 1/2 translational and Phase 1 expansion studies,” Gilson continued. “MRX34 appears to be an active agent; however, it is possible that MRX34’s safety profile may limit combinations, particularly with checkpoint inhibitors.”

As such, despite maintaining an Outperform rating, the analyst cut the price target to $7 from $13.

At time of writing, Mirna shares were down 2.36 percent on the day at $3.92.

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