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