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SNDX

Syndax

$6.04

0.14 (2.37%)

17:53
10/25/18
10/25
17:53
10/25/18
17:53

Syndax says PFS analysis did not show statistically significant benefit

Syndax Pharmaceuticals announced it will provide an update on E2112, its NCI-sponsored, ECOG-ACRIN led pivotal trial of entinostat plus exemestane in hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer as well as its registration strategy for entinostat in combination with KEYTRUDA in patients with non-small cell lung cancer, NSCLC, on Thursday, October 25 at 4:15 p.m. ET. As planned, ECOG-ACRIN is confidentially holding the findings from the PFS analysis until reporting final OS results. After recently performing the third interim OS analysis, ECOG-ACRIN informed the Company that the trial will continue as planned until either it observes an OS benefit or the final target number of events occur. The next interim analysis for the OS primary endpoint is scheduled for 2Q19 with additional interim analyses every six months. Based on the trial design, any positive OS assessment would enable the Company to file for full regulatory approval."While the PFS analysis did not show a statistically significant benefit, E2112 was primarily designed to determine whether the combination of entinostat and exemestane could improve OS based on the compelling OS results obtained in the Phase 2b ENCORE 301 trial," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "It was Phase 2b OS results that led to the FDA granting Breakthrough Therapy Designation for this indication and we remain confident in the opportunity for a positive OS trial."

  • 25

    Oct

SNDX Syndax
$6.04

0.14 (2.37%)

01/05/18
01/05/18
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. Becton Dickinson (BDX) initiated with an Overweight at KeyBanc. 2. Syndax (SNDX) initiated with a Buy at B. Riley FBR. 3. Sutherland Asset Management (SLD) initiated with an Outperform at JMP Securities. 4. Nike (NKE) was assumed with a Buy at Buckingham while Under Armour (UA, UAA) was assumed with a Neutral. 5. Regulus (RGLS) initiated with an Outperform at Leerink. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
05/09/18
NOMU
05/09/18
NO CHANGE
Target $22
NOMU
Buy
Syndax risk/reward positive into data, says Nomura Instinet
Nomura Instinet analyst Christopher Marai sees a positive risk/reward on Syndax Pharmaceuticals into the entinostat readout, expected in Q3. The analyst believes downside is limited on this readout, given expectations and the potential for success on the overall survival endpoint. He calls the stock "significantly undervalued" and keeps a Buy rating on Syndax with a $22 price target.
07/12/18
HCWC
07/12/18
INITIATION
Target $30
HCWC
Buy
Syndax initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Edward White started Syndax Pharmaceuticals with a Buy rating and $30 price target. The company's company's lead pipeline candidate entinostat "could be a potent combination with other drugs," White tells investors in a research note.
09/25/18
MSCO
09/25/18
NO CHANGE
Target $24
MSCO
Overweight
Syndax delay likely to disappoint investors, says Morgan Stanley
Morgan Stanley analyst David Lebowitz noted that Syndax reported last night that the completion of enrollment in its entinostat/pembrolizumab combination trial has been delayed from the end of this month until the end of October, which he said is likely to disappoint investors. However, he adds that the delay provides no read through to results since management is still blinded. The ENCORE 601 NSCLC biomarker analysis continues to suggest potential for improved efficacy in patients with elevated monocyte levels, said Lebowitz. He keeps an Overweight rating and $24 price target on Syndax shares, which he expects to be weak on the open following the company's trial update.

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GOOG

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UBER

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MYOV

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MYOV

Myovant Sciences

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NVS

Novartis

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, QGEN

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Avianca

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AAPL

Apple

$179.03

-0.64 (-0.36%)

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SHSP

SharpSpring

$16.37

-0.24 (-1.44%)

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CREG

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FENC

Fennec

$3.88

(0.00%)

16:36
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  • 29

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TD

Toronto-Dominion

$56.66

0.65 (1.16%)

16:35
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16:30
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16:30
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16:30
Options
Preliminary option volume of 15.7M today »

Preliminary option volume…

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