On Friday, BofA Securities updated its stance on PTC Therapeutics (NASDAQ:PTCT) shares, increasing its price target to $32 from $25, while maintaining an Underperform rating on the company's stock.
The adjustment follows PTC (NASDAQ:PTC) Therapeutics' announcement of interim 12-month results from Part 2 of the Phase 2 PIVOT-HD trial, which is evaluating PTC518 for the treatment of Huntington's disease.
The company reported that the treatment led to a dose-dependent reduction in mutant huntingtin protein (mHTT) in both peripheral blood and cerebrospinal fluid (CSF). However, the clinical assessment data varied among different groups, and a definitive connection between mHTT reduction and clinical benefits has not been established at this point.
PTC Therapeutics has expressed optimism about a possible accelerated approval path and plans to initiate discussions with the FDA soon, following the lifting of a partial clinical hold. Nevertheless, BofA Securities anticipates that a Phase 3 registrational trial may still be required.
The firm indicated that it is looking forward to additional data from a larger patient group and longer follow-up to gain a clearer understanding of PTC518's clinical profile. BofA Securities noted that an agreement with regulatory authorities on an accelerated approval pathway would be a significant event that could reduce the risk associated with the development program.
The updated price objective also takes into account the ongoing dynamics of Translarna's market removal in the EU, which BofA Securities believes adds to the necessity for further clarity on the de-risking process for the Huntington's disease program.
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