Epizyme, Inc. (EPZM) stock prices were down by 9.44% as of the market closing on May 6th 2021, bringing the price per share down to USD$6.81 at the end of the trading day. Subsequent current-market fluctuations have seen the stock rally by 20%, bringing it up to USD$8.17.
Financial Reports Indicate Strong Growth
The first quarter of the fiscal year 2021 saw TAZVERIK generate net product revenue of USD$6.2 million, with March breaking the record of the highest level of commercial demand since launch. Commercial demand for bottles grew 31% in the first quarter of 2021 as compared to the fourth quarter of 2020, with revenue having grown by 37% in that time. Q1 2021 also reported a 38% increase in new prescribing accounts over Q4 2020.
Promising Early Trial Results
The Phase 1b/3 confirmatory study in relapsed/refractory Follicular Lymphoma patients is designed to evaluate the effectiveness of a combination of TAZVERIK and R2 as treatment. Preliminary safety and activity data were shown to exhibit encouraging initial treatment responses in each cohort the 13 patients were divided amongst. Any adverse effects reported were in line with forecasts based on the respective safety profile of each individual agent.
Ahead of Schedule
Following discussions with the U.S. FDA, Phase 3 protocol has been amended to include a second interim analysis upon the occurrence of 65% of progression free survival events. This change facilitates access to efficacy data ahead of schedule and could result in a stoppage of the study should the predefined treatment effect be realized.
Expansion of Patient Cohorts
Furthermore, the Phase 1b segment of the Epizyme study has been expanded to include a minimum of 15 patients in the 600 and 800 mg BID cohorts to aid the selection for the Phase 3 dose. With enrollment nearing completion for the two cohorts, patients are currently being evaluated for the required follow-up of three months before the initiation of the Phase 3 randomization portion of the trial.
Progress in Several Trials
Designed to evaluate the effectiveness of TAZVERIK and Rituxan in patients with relapsed/refractory FL, EZPM’s Phase 2 trial EZH-1401 is actively enrolling and is on schedule. Enrollment is also continuing in the Lymphoma Study Association (LYSA) trial. In the study evaluating the effectiveness of TAZVERIK and doxorubicin as a front-line treatment for Epithelioid Sarcoma patients, enrollment has been completed in the Phase 1b safety run-in portion of the trial.
Future Outlook for EPZM
With consistently progressing developments across studies for a varied pipeline of treatments, the company is striving towards increased commercialization. Current and potential investors are hopeful for continued success in trials that will usher in a future of significant and sustained increases in shareholder value.