Waltham, MA's Syndax Pharmaceuticals is setting out to raise $69 million in an IPO, planning to take its promising cancer therapy through Phase III and into the hands of regulators.
The company grabbed headlines in the fall when it became one of very few small biotechs to pick up the FDA's coveted breakthrough therapy designation, guaranteeing its lead candidate, entinostat, a priority review. The drug is an oral histone deacetylase inhibitor designed to work in tandem with hormone therapy to treat metastatic, HR-positive breast cancer, and its compelling Phase II results in progression-free survival and overall survival convinced regulators to add it the shortlist.
Now Syndax plans to test entinostat's mettle in Phase III, raising $26.6 million last year to gear up for the trial and looking to use its $69 million IPO haul to follow through with the 600-patient study. Alongside its co-sponsor, the National Cancer Institute, Syndax expects to kick off enrollment in April, studying the drug's effect on advanced breast cancer and expecting to read out progression-free survival data in 2017. Separately, Syndax plans fund a Phase II study identifying biomarkers to guide entinostat, and the company has completed Phase I work on the drug in non-small cell lung cancer and other tumor types.
Syndax plans to trade under "SNDX" on the Nasdaq, and the company is yet to specify how many shares it will offer or at what price range.
Meanwhile, biotech is still in the midst of a prolonged honeymoon on the IPO front, as 28 life sciences companies have pulled off market debuts since the start of 2014. And despite the quarter-long gold rush, most of the year's entrants have performed well on Wall Street. Akebia, which priced at $17 a share last week, leapt 57% in its first day of trading, while Dicerna ($DRNA) and Ultragenyx ($RARE) have more than doubled in value since going public.
However, widespread skittishness over biotech's sustainability has chipped away at the industry's index over the past week, spurred by drug pricing concerns for high-flyers like Gilead Sciences ($GILD) and trickling down to weaken the shares of small drugmakers. As has been the case all along, any bout market shakiness has led to renewed fears that biotech's of-late success is another bubble primed to burst, and if the outlook stays grim, Syndax may find itself among the industry's first class of IPO hopefuls to be met with an unfavorable market.
- here's the filing