SVB Leerink raised its price target for Wave Life Sciences (NASDAQ:WVE) to $46 from $40 after the FDA approved Sarepta Therapeutics’ (NASDAQ:SRPT) golodirsen for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping. Shares of Wave closed at $36.37 on Dec. 12.
Wave also is developing its suvodirsen drug candidate for the treatment of DMD in patients amenable to exon 51 skipping.
FDA clearance of Sarepta’s golodirsen was based on a statistically significant increase in dystrophin production in skeletal muscle observed in patients treated with golodirsen.
“With the approval of golodirsen, we believe these increases in dystrophin expression represent reasonable benchmarks for approvability of suvodirsen ahead of the upcoming open-label extension study readout, and are incrementally more positive on potential approval of suvodirsen as a result,” writes analyst Dr. Mani Foroohar, who also raised his probability of success for suvodirsen to 25% from 15%.
Wave is expected to present an interim analysis of the suvodirsen open-label extension study that will include a readout of dystrophin expression in patients after 22 weeks of treatment with suvodirsen by the end of 2019.
Dr. Foroohar said the company believes these data will support an accelerated approval filing in the second half of 2020, if positive. Topline clinical data from the PRECISION-HD2 trial in Huntington’s disease is also expected to be disclosed by the end of 2019.