What happened

Shares of Epizyme (NASDAQ:EPZM) are skyrocketing after the company disclosed that it has won coveted fast-track status for tazemetostat in additional cancer indications. As of 1:51 p.m. EDT, the stock had gained 15.1%.

So what

Last November, tazemetostat won fast-track status for use in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) with an EZH2-activating mutation. Today, management announced it's secured fast-track designation for tazemetostat in relapsed or refractory follicular lymphoma, either wild type EZH2 or with EZH2 activating mutations.

A man looking at his computer shows surprise at what he sees.

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The company also said today that its presentation of data on tazemetostat in these indications has been selected for the opening plenary session at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, on June 14. 

The fast-track designation provides the company with greater contact with the FDA regarding its data, trial design, and FDA submission for approval of tazemetostat. It may also allow the company to eventually score priority review, which reduces the FDA decision timeline from 10 months to six months.

Now what

Epizyme plans to hold a conference call to discuss updated tazemetostat results on the same day as its presentation at the industry conference, so investors will have a little waiting to do before learning the latest efficacy and safety data for this drug.

Previously, preliminary phase 2 results reported last year showed up to a 60% disease control rate in DLBCL patients treated with tazemetostat. At the time, management also reported the disease control rate was 100% in three patients with follicular lymphoma.

News of the fast-track designation, and the presentation, suggests data remains strong, but investors will need to parse through the full trial results, including safety data, before determining the commercial opportunity that may lie ahead for Epizyme. This remains a high-risk, high-reward stock that all but the most risk-tolerant investors ought to watch from the sidelines.

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