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EPZM

Epizyme

$18.22

2.9 (18.93%)

10:09
12/07/19
12/07
10:09
12/07/19
10:09

Epizyme announces 'positive, mature data' for Phase 2 trial of tazemetostat

Epizyme reported "positive, mature data" at the 2019 American Society of Hematology Annual Meeting from its ongoing Phase 2 trial of tazemetostat, an oral EZH2 inhibitor, as a monotherapy for patients with follicular lymphoma, both with or without EZH2 activating mutations, who have received at least two prior lines of systemic therapy. The data show that treatment with tazemetostat demonstrated "meaningful" clinical activity as assessed by both investigators and an Independent Review Committee, and was generally well tolerated in both FL patients with EZH2 activating mutations and FL patients with wild-type EZH2, the company said. The IRC assessment was conducted for inclusion in Epizyme's planned NDA submission to the Food and Drug Administration in December 2019. As assessed by the IRC, as of an August 9, 2019 data cutoff date, tazemetostat treatment resulted in: Objective response rate of 69% for patients with an EZH2 mutation and 35% for patients with wild-type EZH2; Median duration of response of 11 months for patients with an EZH2 mutation and 13 months for patients with wild-type EZH2; Median progression-free survival of 14 months for patients with an EZH2 mutation and 11 months for patients with wild-type EZH2; Overall survival has not yet been reached for either FL patient. "Follicular lymphoma remains an incurable disease today, and it's essential that patients be able to receive treatment for an extended period of time," said Dr. Shefali Agarwal, Chief Medical Officer of Epizyme. "We believe the clinically meaningful benefit of tazemetostat seen across both FL patient populations in this trial, along with its continued tolerability, are impressive findings. We are particularly pleased with the robust response rates, extended durability and consistency of data as assessed by investigators and independent reviewers. These data support tazemetostat's potential to make a difference for FL patients, and we look forward to submitting our NDA for both patient populations later this month."

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    Jan

EPZM Epizyme
$18.22

2.9 (18.93%)

06/13/19
HCWC
06/13/19
NO CHANGE
Target $25
HCWC
Buy
Epizyme selloff yesterday an overreaction, says H.C. Wainwright
Yesterday, Epizyme's abstract to be presented at the International Conference on Malignant Lymphoma indicated a slip of the median duration of response in EZH2 wild type patients, H.C. Wainwright analyst Andrew Fein tells investors in a research note. He believes the stock overreacted due to concern "about a possible regulatory hiccup and a potentially narrower label." The analyst, however, continues to believe tazemetostat's data package should support a broad label in follicular lymphoma. He reiterates a Buy rating on Epizyme with a $25 price target.
12/05/19
MSCO
12/05/19
UPGRADE
Target $22
MSCO
Overweight
Epizyme upgraded to Overweight from Equal Weight at Morgan Stanley
Morgan Stanley analyst David Lebowitz upgraded Epizyme to Overweight from Equal Weight with a $22 price target.
12/05/19
MSCO
12/05/19
UPGRADE
Target $22
MSCO
Overweight
Morgan Stanley upgrades Epizyme to Overweight ahead of lymphoma data
Morgan Stanley analyst David Lebowitz upgraded Epizyme to Overweight from Equal Weight with a price target of $22, up from $12. The stock in after-hours trading is up 3%, or 40c, to $15.70. The analyst expects data this weekend at the American Society of Hematology meeting to bolster confidence in tazemetostat for follicular lymphoma. The data, which will include more mature results and median progression-free survival in the mutant patients, should be "incrementally positive," Lebowitz tells investors in a research note. The analyst raised his 2021 adjusted tazemetostat sales estimate to $23M from $18M and 2026 estimate to $733M from $377M.
12/06/19
12/06/19
UPGRADE

Fly Intel: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Ingersoll-Rand (IR) upgraded to Outperform from Market Perform at Wells Fargo with analyst Deepa Raghavan saying she believes the standalone ClimateCo potential is ready to be realized post-split. 2. Epizyme (EPZM) upgraded to Overweight from Equal Weight at Morgan Stanley with analyst David Lebowitz saying he expects data this weekend at the American Society of Hematology meeting to bolster confidence in tazemetostat for follicular lymphoma. 3. Philips (PHG) upgraded to Overweight from Equal Weight at Morgan Stanley with analyst Michael Jungling saying he thinks its organic sales growth momentum will continue and he believes its Q3 margin outlook downgrade has reset expectation. 4. Montage Resources (MR) upgraded to Outperform from Sector Perform at Scotiabank. 5. HCA Healthcare (HCA) upgraded to Buy from Neutral at BofA/Merrill with analyst Kevin Fischbeck saying the recent trend of elevated utilization with few catalysts in the coming 6 months should benefit hospitals but hurt managed care organizations. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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$146.63

0.33 (0.23%)

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EOLS

Evolus

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VEL

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$NYE

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-0.26 (-0.81%)

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$34.30

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VEL

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