Epizyme: First In Class Risk Remains Among Improving Odds
Poonam A. Arora
Poonam A. Arora
Epizyme: Shares Oversold On Mixed Data From Early Studies
Poonam A. Arora
Poonam A. Arora
Thu, Jan. 7, 9:15 AM
- Gainers: INVT +35%. DVAX +27%. QURE +14%. HMY +9%.
- Losers: TLOG -75%. EPZM -20%. GALE -19%. FINL -17%. SUNE -14%. AKBA -11%. RLYP -8%. FRO -8%. OTIC -8%. CIG -7%. SYN -7%. ATNM -7%. JKS -7%. KBH -7%. SAGE -7%. CEMP -7%. DNR -6%. ATML -6%. WLL -6%. SDRL -6%. ADMS -6%. BHP -6%. BBL -5%. AEZS -5%. VALE -5%. GGB -5%.
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Sep. 28, 2015, 1:22 PM
- Encouraging news on lead product candidate tazemetostat can't keep thinly traded small cap Epizyme (EPZM -28.5%) above water. Shares are down on more than double normal volume, albeit on turnover of only 900K.
- Phase 1 data presented at the European Cancer Congress in Vienna, Austria showed tazemetostat produced clinical activity in a broader group of patients with INI1-negative and SMARCA4-negative tumors that previously reported, achieving inhibition of EZH2 in tumor tissue.
- The company intends to start a Phase 2 study in adults and a Phase 1 study in children with INI1-negative tumors and synovial sarcoma in Q4.
- INI1-negative and SMARCA4-negative tumors, like rhabdoid tumors and epitheloid sarcoma, are very serious cancers that strike ~1,400 people worldwide each year. There are no approved treatments for the conditions.
Sep. 28, 2015, 12:43 PM
Aug. 24, 2015, 12:46 PM
Jun. 30, 2015, 12:47 PM
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Jun. 22, 2015, 12:01 PM
- Thinly traded Epizyme (EPZM +32.7%) heads north on a 6x surge in volume in response to its announcement that 60% (n=9/15) of evaluable advanced B-cell non-Hodgkin lymphoma (NHL) patients responded to treatment with tazemetostat (EPZ-6438) in a Phase 1 study. The responders included the first patient treated who had an EZH2-positive mutation. The data were presented at the 13th International Conference on Malignant Lymphoma in Lugano, Switzerland.
- Two of the nine (22%) NHL responders show an ongoing complete response. Five of nine (56%) evaluable diffuse large B-cell lymphoma (DLBCL) patients achieved an objective response. One patient remains on study at 18 months of treatment. Three of five (60%) evaluable patients with follicular lymphoma achieved an objective response. One patient with a complete response remains on study at 13 months as is one patient with a partial response.
- The patient with the EZH2 mutation, who was refractory or had relapsed to six previous treatment regimens, achieved a partial response after 16 weeks of therapy and remains on study.
- Five grade 3 or greater (severe/life threatening) adverse events were observed.
- Additional data from the Phase 1 study will be reported by the end of the year. The company plans to advance tazemetostat to Phase 2 development.
- Tazemetostat is a small molecule inhibitor of EZH2, an enzyme that is upregulated in certain cancers.
Nov. 6, 2014, 12:35 PM
- Thinly-traded micro cap Epizyme (EPZM -17.4%) gets the rude treatment today in response to its report of preliminary Phase 1 results for EPZ-5676, a selective inhibitor of the DOT1L histone methyltransferase, for the treatment of acute leukemia with alterations in the MLL gene (MLL-r) or partial tandem duplications within MLL.
- Of the 28 subjects evaluable for efficacy, two MLL-r patients in the 54 mg/m2 cohort achieved complete responses. These were the same two patients Epizyme reported on in January.
- Biological activity was observed in several patients who experienced resolution of cutaneous leukemia or leukemia cell differentiation effects. The majority of subjects did not exhibit an observable therapeutic effect from the drug.
- Chief Development Officer Peter Ho, M.D., Ph.D,, says the company is pleased with the safety profile of EPZ-5676 and the two complete responses.
Jan. 7, 2014, 12:46 PM
Jan. 7, 2014, 9:16 AM
Jan. 7, 2014, 8:02 AM
- Epizyme (EPZM) rallies 32% (low volume) in premarket action.
- Monday evening, the company reported that it has achieved the "POC milestone in the EPZ-5676 DOT1L inhibitor clinical program," an event which triggers a $25M payment from partner Celgene (CELG).
- Objective responses in patients with translocations of the MLL-r observed in the fourth dose cohort of an ongoing Phase 1 study were the triggering event.
- Additionally, the company says "a development candidate milestone has been achieved for one of the three HMT targets included" in the GlaxoSmithKline (GSK) partnership, triggering another $4M milestone payment.
- 2013 end-of-year cash now seen at $145M versus $115M previous. (PR)
Nov. 14, 2013, 12:45 PM
Epizyme, Inc. operates as a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative personalized therapeutics for patients with genetically defined cancers. It is engaged in the creation of small molecule histone methyltransferase inhibitors, a new... More
Industry: Drug Manufacturers - Other
Country: United States
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