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ERYP

Erytech Pharma

$4.90 /

+ (+0.00%)

16:34
04/20/20
04/20
16:34
04/20/20
16:34

Erytech sees TRYbeCA-1 interim analysis around year-end 2020

Erytech provided an update on the pivotal Phase 3 clinical trial for advanced metastatic pancreatic cancer, which is evaluating the efficacy and safety of Erytech's lead product candidate eryaspase in combination with chemotherapy as second-line therapy. "We are pleased that the TRYbeCA-1 trial has continued to progress well despite the challenges caused by the COVID-19 global pandemic," said Gil Beyen, CEO of Erytech. "The third independent safety review has once again confirmed the favorable safety profile of our lead product candidate eryaspase, and the trial has now surpassed 75% of the planned target enrollment. While prioritizing the safety of patients, health care providers and our employees, we have successfully deployed measures to safeguard the integrity of the trial by ensuring patients' continued access to treatment and appropriate follow-up. The enrollment of new patients is also continuing, but at a slower pace than over the past few weeks. We currently anticipate a limited delay in completing patient enrollment of 3 to 4 months from previous plans. In addition, and unrelated to COVID-19, the average time to events appears longer than originally expected. We now expect the interim superiority analysis around the end of this year and final results in the second half of 2021." The independent data monitoring committee has reviewed the safety data for the first 320 patients enrolled and treated in the TRYbeCA-1 trial. In line with the two earlier safety reviews, no safety issues were identified and the IDMC recommended to continue the trial as planned. To date, more than 75% of the approximately 500 patients to be enrolled in the trial have been randomized. Various measures have been put in place to facilitate compliance with the study schedule and to preserve study data integrity. Through March 2020, new patient enrollment continued as planned notwithstanding the increasing difficulties experienced by the hospitals to organize the proper treatment and follow-up. Over the past two weeks, ERYTECH has observed a reduction in enrollment rate due to the COVID-19 pandemic and now believes new patient enrollment will be below plan in the coming months. The Company currently expects a delay of 3 to 4 months in completion of patient enrollment, bringing the time of complete enrollment to the fourth quarter of this year. With more than 75% of the patients enrolled in the trial, the Company believes that the planned interim superiority analysis, to be conducted by an IDMC when two-thirds of the total death events have been reached, will not be significantly affected by the expected delay in enrollment. However, based on recent tracking of the total death events in the trial, the average time to event appears longer than originally anticipated. As a result, the Company now expects to report the interim analysis around year-end 2020 and the final analysis in the second half of 2021.

ERYP Erytech Pharma
$4.90 /

+ (+0.00%)

09/05/19 JMP Securities
Erytech Pharma resumed with an Outperform at JMP Securities

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Recommendations
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Recommendations
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NI

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NI NiSource
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Recommendations
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GNRC

Generac

$180.72 /

+2.52 (+1.41%)

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GNRC Generac
$180.72 /

+2.52 (+1.41%)

GNRC Generac
$180.72 /

+2.52 (+1.41%)

09/14/20
Fly Intel: Top five analyst initiations
09/14/20 Argus
Generac initiated with a Buy at Argus
09/03/20 Roth Capital
Generac price target raised to $210 from $190 at Roth Capital
08/21/20 Baird
Generac price target raised to $202 from $165 at Baird
GNRC Generac
$180.72 /

+2.52 (+1.41%)

Recommendations
Identiv benefitting as Apple supports NFC, says Northland » 07:50
09/28/20
09/28
07:50
09/28/20
07:50
INVE

Identiv

$5.85 /

+0.16 (+2.81%)

, AAPL

Apple

$112.22 /

+4.02 (+3.72%)

Northland analyst Michael…

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INVE Identiv
$5.85 /

+0.16 (+2.81%)

AAPL Apple
$112.22 /

+4.02 (+3.72%)

INVE Identiv
$5.85 /

+0.16 (+2.81%)

09/22/20 Lake Street
Identiv price target raised to $8 after management meeting at Lake Street
02/05/20 Imperial Capital
Identiv price target lowered to $8 from $9 at Imperial Capital
01/31/20 Lake Street
Identiv price target lowered to $7 from $9 at Lake Street
10/10/19 Lake Street
Identiv risk/reward 'compelling' at these levels, says Lake Street
AAPL Apple
$112.22 /

+4.02 (+3.72%)

09/25/20 Exane BNP Paribas
Exane double upgrades Qualcomm on share gains from Huawei ban
09/23/20 Jefferies
Facebook risk/reward 'remains compelling,' says Jefferies
09/22/20
UBS assumes Apple with Neutral from Buy amid 'maturing' iPhone growth
09/22/20 UBS
Apple assumed with Neutral from Buy at UBS
INVE Identiv
$5.85 /

+0.16 (+2.81%)

AAPL Apple
$112.22 /

+4.02 (+3.72%)

AAPL Apple
$112.22 /

+4.02 (+3.72%)

AAPL Apple
$112.22 /

+4.02 (+3.72%)

AAPL Apple
$112.22 /

+4.02 (+3.72%)

AAPL Apple
$112.22 /

+4.02 (+3.72%)

Hot Stocks
Oragenics trading resumes  07:50
09/28/20
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OGEN

Oragenics

$0.63 /

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OGEN Oragenics
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OGEN Oragenics
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04/16/20 H.C. Wainwright
Oragenics downgraded to Neutral from Buy at H.C. Wainwright

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