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Definium Therapeutics' Upcoming Phase 3 Data on DT120 to De-Risk Program, Back FDA Approval, RBC Says

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Definium Therapeutics' (DFTX) upcoming phase 3 data on DT120 in generalized anxiety disorder or GAD is likely to further de-risk the program and back potential approval, RBC Capital Markets said in a Friday note.

The first phase 3 trial in GAD met its primary endpoint and a positive data readout from the second phase 3 trial should ease residual regulatory uncertainty on the therapy's approvability, the brokerage said. Data from the second phase 3 trial is due for release "any day now," RBC noted.

Trial results are likely to support approval from the US Food and Drug Administration given DT120's robust efficacy data, well-powered studies, and the FDA's flexibility for neuropsychiatric drugs, according to the investment firm.

RBC has an outperform rating on Definium Therapeutics, with a $66 price target.

Price: $38.53, Change: $+0.80, Percent Change: +2.12%

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