SynAct Pharma was expected to release data from the 4-week RESOLVE trial in early November. Instead, the company announced it has found multiple irregularities in the data and has therefore initiated a third-party audit of both the RESOLVE and EXPAND trials (as several sites are the same and the same CRO has run the trials). Data should now be released in early 2024 instead. This news has further increased the risk and introduced more uncertainty about the result of the post-hoc analysis from th...
SynAct Pharma presented disappointing data today (4 September), stating that the EXPAND trial failed to reach a difference between the active arm and placebo. Although the placebo effect might have been greater than expected, the proportion of patients in the active arm that reached ACR20 was also lower than expected. We believe this puts a lot of pressure on the company, as the financial situation is stretched and new capital likely needs to be raised in H2. We have downgraded to HOLD (BUY) and...
SynAct Pharma is a development-stage biotech company focusing on rheumatoid arthritis (RA), with scope for potential indications in other inflammatory diseases. We believe two positive data readouts in September/October could pave the way for a large out-licensing deal. We initiate coverage with a BUY and SEK170 target price.
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