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EPZM

Epizyme

$15.25

-0.65 (-4.09%)

16:46
04/23/18
04/23
16:46
04/23/18
16:46

Epizyme places a Hold on Tazemetostat Clinical Program enrollment

Epizyme announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration issued a partial clinical hold affecting new enrollment of patients with genetically defined solid tumors and hematologic malignancies, while the company updates the informed consent, investigator's brochure and study protocols. Patients on study who have not experienced disease progression may continue to receive tazemetostat. Epizyme has begun developing the modifications to address the partial clinical hold, and will need to confirm alignment with the FDA in order to resume U.S. enrollment. The partial clinical hold was initiated following a safety report, submitted by Epizyme to the FDA and other regulatory authorities, regarding a patient with advanced poorly differentiated chordoma in the company's Phase 1 pediatric study who developed a secondary T-cell lymphoma. Doses explored in this study are higher than those in the company's Phase 2 adult studies, an approach not uncommon to drug development in aggressive, difficult-to-treat pediatric cancers. At the time of the safety report, the patient had been on study for approximately 15 months and had achieved a confirmed partial response. This patient has now discontinued tazemetostat and is being treated for T-cell lymphoma. Secondary malignancies are known to be potential adverse events associated with many cancer therapies, including chemotherapy and radiation treatment. T-cell lymphoma has been identified as a potential adverse event in tazemetostat study protocols and is included in the investigator's brochure and the informed consent. More than 750 patients have been treated with tazemetostat to date, and this is the only case of secondary lymphoma that has been observed across the tazemetostat clinical program.

  • 25

    Apr

EPZM Epizyme
$15.25

-0.65 (-4.09%)

02/01/18
ROTH
02/01/18
INITIATION
Target $24
ROTH
Buy
Epizyme initiated with a Buy at Roth Capital
Roth Capital analyst Jotin Marango started Epizyme with a Buy rating and $24 price target as he believes its lead agent tazemetostat, an inhibitor of the histone methyltrasferase EZH2, has laid out a sufficiently wide clinical footprint, and is sufficiently close to an NDA in several indications, that even his conservative approach of ranking its clinical programs shows that the company still remains undervalued.
02/01/18
02/01/18
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Epizyme (EPZM) initiated with a Buy at Roth Capital. 2. Take-Two (TTWO) initiated with an Overweight at Morgan Stanley. 3. AMERI Holdings (AMRH) initiated with an Outperform at Northland. 4. Simply Good Foods (SMPl) initiated with a Buy at SunTrust. 5. Zynerba (ZYNE) assumed with a Buy at H.C. Wainwright. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
03/14/18
RHCO
03/14/18
NO CHANGE
Target $27
RHCO
Buy
Epizyme price target raised to $27 from $21 at SunTrust
SunTrust analyst Peter Lawson raised his price target on Epizyme to $27, saying the company's Q4 earnings call reiterated expectations of on-track data flow in epithelioid sarcoma registrations / NDA filing later this year, the combo data for DLBCL, and the follicular lymphoma data and registration path in the second half of 2018. Lawson keeps his Buy rating and attributes his price target revision to the treatment's higher probability of success.
04/11/18
JEFF
04/11/18
NO CHANGE
Target $27
JEFF
Buy
Epizyme recent pullback creates attractive risk/reward, says Jefferies
Jefferies analyst Michael Yee believes the recent pullback in shares of Epizyme creates an attractive risk/reward ahead of a "catalyst-rich" 2018. The company's market capitalization could appreciate from less than $1B to $2-$3B over time if data in the second half "starts to play out like we expect," Yee tells investors in a research note. He thinks Epizyme's mixed shelf filing last week has some investors concerned that an equity financing could be possible in the near term. Yee believes, however, that the filing "simply replaces and refreshes" an existing one that has always been on hand as opposed to suggesting the company is getting ready to raise near-term cash. The analyst keeps a Buy rating on the shares with a $27 price target.

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