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Hot Stocks
BrainStorm announces NurOwn trial data published in Multiple Sclerosis Journal » 06:09
09/15/22
09/15
06:09
09/15/22
06:09
BCLI

BrainStorm

$4.18 /

+0.12 (+2.96%)

BrainStorm announced the…

BrainStorm announced the peer reviewed publication of data from the Phase 2 trial of NurOwn in progressive multiple sclerosis, or MS, in Multiple Sclerosis Journal. Results from the Phase 2, single-arm, open-label study demonstrated NurOwn's safety and provided preliminary evidence of its efficacy in people with progressive MS. Additionally, biomarker analyses confirmed NurOwn's proposed mechanism of action by showing consistent treatment effects in neuroinflammation and neuroprotection pathways. Twenty participants were enrolled into the Phase 2 trial, with seventeen receiving all three scheduled NurOwn treatments. The mean age of study participants was 47 years with a mean expanded disability status scale, or EDSS, score of 5.4 at screening. Results from the trial were compared to 48 matched control patients who were selected from the from the Comprehensive Longitudinal Investigation of Multiple Sclerosis, or CLIMB, registry at the beginning of the trial. Treatment with NurOwn resulted in large, clinically meaningful improvements in some patients, as defined by response criteria, across all endpoints measured. These endpoints included timed 25-foot walk speed, 9-hole peg test, multiple sclerosis walking scale, symbol digit modality test and low contrast letter acuity. These observed improvements diverged from what was seen in matched patients with progressive MS from the CLIMB registry. Key data from the trial, as well as relevant comparisons to the matched CLIMB registry patients, are shown below. In total, 19% of treated trial participants were responders, compared to 4% of the matched CLIMB registry patients; 38% of treated trial participants showed a 10-point improvement from baseline in the 12-item MSWS; 27% of treated trial participants showed a =8-letter improvement in LCLA binocular at a 2.5% contrast threshold, compared to 6% of the matched CLIMB registry patients; 67% of treated trial participants showed a 3-point improvement in the SDMT, compared to 18% of the matched CLIMB registry patients; 47% of treated trial participants showed a 8-point improvement in LCLA binocular at a 1.25% contrast threshold. Across all participants, improvements in function as measured by LCLA, SDMT and MS Functional Composite were observed. Mean improvements from baseline of 3.3 points in the LCLA binocular, 3.8 points on the SDMT, and 0.18 points in MSFC were observed in treated trial participants. The corresponding changes in matched CLIMB registry patients estimated at 28 weeks showed declines in function on the LCLA and MSFC. The average change in function decline as measured by T25FW, 9HPT, and EDSS across all treated trial participants demonstrated stabilization of functional decline, with similar or slightly worse findings observed in the matched CLIMB registry patients for the same endpoints.There were no adverse events related to worsening of MS disease and no clinically significant changes in safety lab results/vital signs, confirming NurOwn's favorable safety profile. Two patients developed symptoms of low back and leg pain, consistent with arachnoiditis, occurring in one of three treatments in both participants.Treatment also consistently resulted in increases in cerebrospinal fluid neuroprotective factors and reductions in inflammatory biomarkers, confirming NurOwn's proposed mechanism of action in progressive MS.

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BCLI BrainStorm
$4.18 /

+0.12 (+2.96%)

BCLI BrainStorm
$4.18 /

+0.12 (+2.96%)

Over a month ago
On The Fly
Fly Intel: Pre-market Movers » 08:56
08/15/22
08/15
08:56
08/15/22
08:56
VRDN

Viridian Therapeutics

$14.72 /

+1.11 (+8.16%)

, AGS

PlayAGS

$7.52 /

+1.525 (+25.46%)

, LOCL

Local Bounti

$3.74 /

-0.46 (-10.95%)

, DOYU

DouYu

$1.25 /

+0.055 (+4.62%)

, YOU

Clear Secure

$29.00 /

+0.32 (+1.12%)

, BCLI

BrainStorm

$3.47 /

+0.52 (+17.63%)

, UPH

UpHealth

/

+

, LI

Li Auto

$32.50 /

-0.21 (-0.64%)

, IDYA

Ideaya Biosciences

$15.64 /

+0.73 (+4.90%)

, AKUS

Akouos

$3.09 /

+0.3 (+10.75%)

, CLNN

Clene

$3.47 /

+0.035 (+1.02%)

, ITW

Illinois Tool Works

$217.42 /

+4.385 (+2.06%)

Check out this morning's…

ShowHide Related Items >><<
YOU Clear Secure
$29.00 /

+0.32 (+1.12%)

VRDN Viridian Therapeutics
$14.72 /

+1.11 (+8.16%)

UPH UpHealth
/

+

LOCL Local Bounti
$3.74 /

-0.46 (-10.95%)

LI Li Auto
$32.50 /

-0.21 (-0.64%)

ITW Illinois Tool Works
$217.42 /

+4.385 (+2.06%)

IDYA Ideaya Biosciences
$15.64 /

+0.73 (+4.90%)

CLNN Clene
$3.47 /

+0.035 (+1.02%)

AKUS Akouos
$3.09 /

+0.3 (+10.75%)

AGS PlayAGS
$7.52 /

+1.525 (+25.46%)

VRDN Viridian Therapeutics
$14.72 /

+1.11 (+8.16%)

06/23/22 B. Riley
B. Riley starts Viridian Therapeutics at Buy with $25 price target
06/23/22 B. Riley
Viridian Therapeutics initiated with a Buy at B. Riley
11/18/21 SVB Securities
Viridian Therapeutics initiated with an Outperform at SVB Leerink
11/05/21 JMP Securities
Viridian Therapeutics price target lowered to $36 from $44 at JMP Securities
AGS PlayAGS
$7.52 /

+1.525 (+25.46%)

08/09/22 B. Riley
PlayAGS price target raised to $14 from $12 at B. Riley
08/01/22 Stifel
PlayAGS price target lowered to $9 from $11 at Stifel
07/20/22 Truist
PlayAGS price target lowered to $12 from $13 at Truist
07/14/22 Deutsche Bank
PlayAGS price target lowered to $11 from $12 at Deutsche Bank
LOCL Local Bounti
$3.74 /

-0.46 (-10.95%)

04/20/22 Morgan Stanley
Local Bounti initiated with an Equal Weight at Morgan Stanley
01/04/22 Deutsche Bank
Local Bounti initiated with a Buy at Deutsche Bank
12/21/21 Oppenheimer
Oppenheimer starts Local Bounti at Outperform, sees it positioned for success
12/21/21 Oppenheimer
Local Bounti initiated with an Outperform at Oppenheimer
DOYU DouYu
$1.25 /

+0.055 (+4.62%)

03/17/22 Citi
DouYu price target lowered to $2.40 from $3.60 at Citi
03/14/22 JPMorgan
JPMorgan downgrades DouYu to Underweight on low visibility
03/14/22 JPMorgan
DouYu downgraded to Underweight from Neutral at JPMorgan
12/27/21 BofA
Huya resumed with a Neutral at BofA
YOU Clear Secure
$29.00 /

+0.32 (+1.12%)

06/14/22 JPMorgan
JPMorgan 'incrementally constructive' on Clear Secure after U.S. survey
03/30/22 Loop Capital
Clear Secure price target lowered to $26 from $40 at Loop Capital
03/23/22 Stifel
Clear Secure price target raised to $34 from $32 at Stifel
03/15/22 Wells Fargo
Clear Secure price target lowered to $21 from $29 at Wells Fargo
BCLI BrainStorm
$3.47 /

+0.52 (+17.63%)

UPH UpHealth
/

+

05/13/22 Benchmark
UpHealth price target lowered to $4 from $5 at Benchmark
03/31/22 Lake Street
Lake Street downgrades UpHealth to Hold, thinks credibility must be rebuilt
03/31/22 Northland
UpHealth price target lowered to $4.50 from $10.50 at Northland
03/31/22 Lake Street
UpHealth downgraded to Hold from Buy at Lake Street
LI Li Auto
$32.50 /

-0.21 (-0.64%)

08/08/22 CLSA
Li Auto initiated with a Buy at CLSA
06/29/22 Morgan Stanley
Li Auto capital replenishment a strategic positive, says Morgan Stanley
06/21/22 Citi
Li Auto price target raised to $58.60 from $26.80 at Citi
05/11/22 Citi
Li Auto price target lowered to $26.80 from $51.50 at Citi
IDYA Ideaya Biosciences
$15.64 /

+0.73 (+4.90%)

07/15/22 Oppenheimer
Ideaya Biosciences assumed with an Outperform at Oppenheimer
05/17/22 Roth Capital
Ideaya Biosciences price target raised to $46 from $42 at Roth Capital
03/15/22 Stifel
Ideaya Biosciences price target lowered to $17 from $20 at Stifel
03/15/22 Roth Capital
Ideaya Biosciences' IDE397 update 'incrementally positive,' says Roth Capital
AKUS Akouos
$3.09 /

+0.3 (+10.75%)

05/17/22 Piper Sandler
Akouos price target lowered to $18 from $40 at Piper Sandler
CLNN Clene
$3.47 /

+0.035 (+1.02%)

07/18/22 H.C. Wainwright
Clene initiated with a Buy at H.C. Wainwright
05/02/22 Canaccord
Clene initiated with a Buy at Canaccord
11/03/21 Cantor Fitzgerald
Clene price target lowered to $15 from $24 at Cantor Fitzgerald
11/02/21 Roth Capital
Roth reiterates Buy on Clene after unblinded analysis of CNM-Au8 in ALS trial
ITW Illinois Tool Works
$217.42 /

+4.385 (+2.06%)

08/15/22 Deutsche Bank
Illinois Tool Works downgraded to Sell at Deutsche Bank on valuation
08/15/22 Deutsche Bank
Illinois Tool Works downgraded to Sell from Hold at Deutsche Bank
08/03/22 Wells Fargo
Illinois Tool Works price target raised to $187 from $180 at Wells Fargo
08/03/22 Citi
Illinois Tool Works price target raised to $210 from $191 at Citi
YOU Clear Secure
$29.00 /

+0.32 (+1.12%)

VRDN Viridian Therapeutics
$14.72 /

+1.11 (+8.16%)

UPH UpHealth
/

+

LOCL Local Bounti
$3.74 /

-0.46 (-10.95%)

LI Li Auto
$32.50 /

-0.21 (-0.64%)

ITW Illinois Tool Works
$217.42 /

+4.385 (+2.06%)

IDYA Ideaya Biosciences
$15.64 /

+0.73 (+4.90%)

DOYU DouYu
$1.25 /

+0.055 (+4.62%)

CLNN Clene
$3.47 /

+0.035 (+1.02%)

BCLI BrainStorm
$3.47 /

+0.52 (+17.63%)

AKUS Akouos
$3.09 /

+0.3 (+10.75%)

AGS PlayAGS
$7.52 /

+1.525 (+25.46%)

  • 05
    Oct
  • 21
    Sep
LOCL Local Bounti
$3.74 /

-0.46 (-10.95%)

LI Li Auto
$32.50 /

-0.21 (-0.64%)

DOYU DouYu
$1.25 /

+0.055 (+4.62%)

CLNN Clene
$3.47 /

+0.035 (+1.02%)

AGS PlayAGS
$7.52 /

+1.525 (+25.46%)

YOU Clear Secure
$29.00 /

+0.32 (+1.12%)

UPH UpHealth
/

+

LOCL Local Bounti
$3.74 /

-0.46 (-10.95%)

LI Li Auto
$32.50 /

-0.21 (-0.64%)

ITW Illinois Tool Works
$217.42 /

+4.385 (+2.06%)

DOYU DouYu
$1.25 /

+0.055 (+4.62%)

AGS PlayAGS
$7.52 /

+1.525 (+25.46%)

LOCL Local Bounti
$3.74 /

-0.46 (-10.95%)

LI Li Auto
$32.50 /

-0.21 (-0.64%)

CLNN Clene
$3.47 /

+0.035 (+1.02%)

Earnings
BrainStorm reports Q2 EPS (19c), consensus (15c) » 07:07
08/15/22
08/15
07:07
08/15/22
07:07
BCLI

BrainStorm

$3.47 /

+0.52 (+17.63%)

"Brainstorm Cell…

"Brainstorm Cell Therapeutics is at a pivotal moment as a company as we finalize the regulatory filing for NurOwn in the treatment of ALS. The continued analysis and the feedback received from the many scientific presentations of NurOwn's Phase 3 data have uncovered key insights that furthered our understanding of the product mechanism of action and therapeutic potential and strengthened the conclusions of NurOwn's efficacy," said Chaim Lebovits, CEO. "After carefully considering these learnings, the totality of the evidence from NurOwn's clinical studies, and the feedback received from key opinion leaders and the broader ALS community, we will submit a Biologics License Application to the FDA. We are deeply grateful to the ALS clinical experts, members of the ALS community and faithful investors for their contribution to the development of NurOwn and what it may mean to those living with ALS. Their contributions and commitment made our current progress possible and continue to inspire us as we prepare for the considerable work ahead. We intend to provide additional updates upon learning whether the FDA files our BLA submission."

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BCLI BrainStorm
$3.47 /

+0.52 (+17.63%)

Over a quarter ago
Hot Stocks
BrainStorm receives patent in Brazil covering methods to manufacture NurOwn » 07:36
02/15/22
02/15
07:36
02/15/22
07:36
BCLI

BrainStorm

$3.07 /

-0.12 (-3.76%)

Brainstorm Cell…

Brainstorm Cell Therapeutics announced that the Brazilian Patent Office has granted the patent application titled: "A method of generating cells which secrete Brain Derived Neurotrophic Factor, or BDNF, Glial Derived Neurotrophic Factor, or GDNF, Hepatocyte Growth Factor, or HGF, And Vascular Endothelial Growth Factor, or VEGF, wherein said cells do not Secrete Nerve Growth Factor, or NGF." The granted claims cover a method of manufacturing MSC-NTF cells, or NurOwn.

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BCLI BrainStorm
$3.07 /

-0.12 (-3.76%)

BCLI BrainStorm
$3.07 /

-0.12 (-3.76%)

BCLI BrainStorm
$3.07 /

-0.12 (-3.76%)

On The Fly
Fly Intel: Pre-market Movers » 09:04
12/27/21
12/27
09:04
12/27/21
09:04
MBOT

Microbot Medical

$5.42 /

+0.19 (+3.63%)

, BORR

Borr Drilling

$1.99 /

-0.05 (-2.45%)

, STRO

Sutro Biopharma

$14.21 /

-0.53 (-3.60%)

, BCLI

BrainStorm

$3.77 /

+0.36 (+10.56%)

, GDDY

GoDaddy

$75.98 /

+0.22 (+0.29%)

, BBIO

BridgeBio

$40.65 /

+2.28 (+5.94%)

, DIDI

Symbol changed to DIDIY

$5.60 /

-0.025 (-0.44%)

, VLD

Velo3D

$7.62 /

+0.19 (+2.56%)

, DAL

Delta Air Lines

$39.30 /

+0.18 (+0.46%)

, JBLU

JetBlue

$14.66 /

+0.025 (+0.17%)

, UAL

United Airlines

$44.87 /

+0.31 (+0.70%)

, AAL

American Airlines

$18.26 /

+0.01 (+0.05%)

, SYK

Stryker

$268.39 /

+4.41 (+1.67%)

Check out this morning's…

ShowHide Related Items >><<
VLD Velo3D
$7.62 /

+0.19 (+2.56%)

UAL United Airlines
$44.87 /

+0.31 (+0.70%)

SYK Stryker
$268.39 /

+4.41 (+1.67%)

STRO Sutro Biopharma
$14.21 /

-0.53 (-3.60%)

MBOT Microbot Medical
$5.42 /

+0.19 (+3.63%)

JBLU JetBlue
$14.66 /

+0.025 (+0.17%)

GDDY GoDaddy
$75.98 /

+0.22 (+0.29%)

DIDI Symbol changed to DIDIY
$5.60 /

-0.025 (-0.44%)

DAL Delta Air Lines
$39.30 /

+0.18 (+0.46%)

BORR Borr Drilling
$1.99 /

-0.05 (-2.45%)

BCLI BrainStorm
$3.77 /

+0.36 (+10.56%)

BBIO BridgeBio
$40.65 /

+2.28 (+5.94%)

AAL American Airlines
$18.26 /

+0.01 (+0.05%)

MBOT Microbot Medical
$5.42 /

+0.19 (+3.63%)

BORR Borr Drilling
$1.99 /

-0.05 (-2.45%)

STRO Sutro Biopharma
$14.21 /

-0.53 (-3.60%)

11/17/21 Berenberg
Sutro Biopharma initiated with a Buy at Berenberg
06/18/21
Fly Intel: Top five analyst initiations
06/18/21 H.C. Wainwright
Sutro Biopharma initiated with a Buy at H.C. Wainwright
05/20/21 Piper Sandler
Sutro Biopharma ovarian cancer data 'impressive,' says Piper Sandler
BCLI BrainStorm
$3.77 /

+0.36 (+10.56%)

02/05/21 Maxim
BrainStorm upgraded to Buy from Hold at Maxim
02/04/21 Maxim
BrainStorm upgraded to Buy from Hold at Maxim
GDDY GoDaddy
$75.98 /

+0.22 (+0.29%)

11/04/21 JPMorgan
GoDaddy results positive for Wix.com, Squarespace, says JPMorgan
10/26/21 Berenberg
GoDaddy initiated with a Buy at Berenberg
09/08/21 Piper Sandler
GoDaddy transferred with Neutral rating at Piper Sandler
08/05/21 JMP Securities
GoDaddy price target lowered to $100 from $108 at JMP Securities
BBIO BridgeBio
$40.65 /

+2.28 (+5.94%)

12/27/21 Stifel
BridgeBio trial failure positive for Alnylam, says Stifel
09/10/21 BofA
BridgeBio upgraded to Buy from Neutral at BofA
07/27/21 Mizuho
Bristol-Myers deal a positive signal about BridgeBio's BBP-398, says Mizuho
07/13/21 Oppenheimer
Prothena price target raised to $76 from $54 at Oppenheimer
DIDI Symbol changed to DIDIY
$5.60 /

-0.025 (-0.44%)

07/28/21 Alliance Global Partners
Alliance Global Partners bullish on Aurora Mobile despite regulatory changes
07/28/21 Alliance Global Partners
iClick Interactive price target lowered to $15 from $21 at Alliance Global
07/26/21 Atlantic Equities
Atlantic Equities downgrades DiDi to Neutral amid active investigations
07/26/21 Atlantic Equities
DiDi downgraded to Neutral from Overweight at Atlantic Equities
VLD Velo3D
$7.62 /

+0.19 (+2.56%)

10/26/21 Needham
Needham starts Velo3D at Buy on potential to scale business
10/26/21 Needham
Velo3D initiated with a Buy at Needham
10/25/21 William Blair
William Blair starts Velo3D with Outperform on 'rapid' growth
10/25/21 William Blair
Velo3D initiated with an Outperform at William Blair
DAL Delta Air Lines
$39.30 /

+0.18 (+0.46%)

12/23/21 Deutsche Bank
Hertz, Nio among stocks added to Deutsche Bank's 'Fresh Money List'
12/17/21 Citi
Delta Air Lines price target lowered to $56 from $58 at Citi
11/19/21 Wolfe Research
Delta Air Lines upgraded to Outperform from Peer Perform at Wolfe Research
10/29/21 BTIG
Call with Sharecare customers raises BTIG conviction in long-term outlook
JBLU JetBlue
$14.66 /

+0.025 (+0.17%)

11/17/21
Fly Intel: Top five analyst upgrades
11/17/21 Exane BNP Paribas
JetBlue upgraded to Neutral from Underperform at Exane BNP Paribas
10/12/21 Susquehanna
Susquehanna sees constructive backdrop for air travel in 2022
10/06/21
Fly Intel: Top five analyst downgrades
UAL United Airlines
$44.87 /

+0.31 (+0.70%)

10/21/21 Cowen
United Airlines price target raised to $78 from $72 at Cowen
08/11/21 Redburn
United Airlines initiated with a Sell at Redburn
07/22/21 MKM Partners
United Airlines price target lowered to $61 from $65 at MKM Partners
07/22/21 Susquehanna
United Airlines price target lowered to $51 from $56 at Susquehanna
AAL American Airlines
$18.26 /

+0.01 (+0.05%)

12/06/21 Evercore ISI
American Airlines upgraded to In Line at Evercore ISI following 15% pullback
12/06/21 Evercore ISI
American Airlines upgraded to In Line from Underperform at Evercore ISI
10/06/21 Goldman Sachs
American Airlines downgraded to Sell from Neutral at Goldman Sachs
SYK Stryker
$268.39 /

+4.41 (+1.67%)

12/15/21 Citi
Stryker price target lowered to $300 from $307 at Citi
12/09/21 RBC Capital
Stryker initiated with a Sector Perform at RBC Capital
12/09/21 RBC Capital
Stryker initiated with a Sector Perform at RBC Capital
12/06/21 Loop Capital
Stryker initiated with a Buy at Loop Capital
VLD Velo3D
$7.62 /

+0.19 (+2.56%)

UAL United Airlines
$44.87 /

+0.31 (+0.70%)

SYK Stryker
$268.39 /

+4.41 (+1.67%)

STRO Sutro Biopharma
$14.21 /

-0.53 (-3.60%)

JBLU JetBlue
$14.66 /

+0.025 (+0.17%)

GDDY GoDaddy
$75.98 /

+0.22 (+0.29%)

DAL Delta Air Lines
$39.30 /

+0.18 (+0.46%)

BORR Borr Drilling
$1.99 /

-0.05 (-2.45%)

BCLI BrainStorm
$3.77 /

+0.36 (+10.56%)

BBIO BridgeBio
$40.65 /

+2.28 (+5.94%)

AAL American Airlines
$18.26 /

+0.01 (+0.05%)

  • 30
    Jun
  • 12
    Feb
UAL United Airlines
$44.87 /

+0.31 (+0.70%)

JBLU JetBlue
$14.66 /

+0.025 (+0.17%)

GDDY GoDaddy
$75.98 /

+0.22 (+0.29%)

DIDI Symbol changed to DIDIY
$5.60 /

-0.025 (-0.44%)

DAL Delta Air Lines
$39.30 /

+0.18 (+0.46%)

AAL American Airlines
$18.26 /

+0.01 (+0.05%)

UAL United Airlines
$44.87 /

+0.31 (+0.70%)

SYK Stryker
$268.39 /

+4.41 (+1.67%)

JBLU JetBlue
$14.66 /

+0.025 (+0.17%)

GDDY GoDaddy
$75.98 /

+0.22 (+0.29%)

DIDI Symbol changed to DIDIY
$5.60 /

-0.025 (-0.44%)

DAL Delta Air Lines
$39.30 /

+0.18 (+0.46%)

AAL American Airlines
$18.26 /

+0.01 (+0.05%)

VLD Velo3D
$7.62 /

+0.19 (+2.56%)

UAL United Airlines
$44.87 /

+0.31 (+0.70%)

JBLU JetBlue
$14.66 /

+0.025 (+0.17%)

DIDI Symbol changed to DIDIY
$5.60 /

-0.025 (-0.44%)

DAL Delta Air Lines
$39.30 /

+0.18 (+0.46%)

AAL American Airlines
$18.26 /

+0.01 (+0.05%)

Hot Stocks
BrainStorm announces FDA authorizes further NurOwn dosing under EAP » 07:03
12/27/21
12/27
07:03
12/27/21
07:03
BCLI

BrainStorm

$3.77 /

+0.36 (+10.56%)

BrainStorm Cell…

BrainStorm Cell Therapeutics announced plans for a dosing extension of NurOwn for participants who completed the Expanded Access Protocol, EAP. The U.S. Food and Drug Administration recommended that BrainStorm submit an EAP protocol amendment to provide additional dosing for these participants. Under the original EAP protocol, participants who had completed the Phase 3 NurOwn trial and who met specific eligibility criteria had the opportunity to receive 3 doses of NurOwn. Under the amended EAP protocol, these eligible participants will receive up to 3 additional doses. Data collected from the original EAP treatments informed the decision to move forward with additional doses for participants who completed it. Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics, commented, "We are pleased to be able to provide additional treatments to these patients. This program is an outcome of a fruitful collaboration between the FDA, Patient Advocacy groups and Brainstorm. We look forward to continuing this dialogue with the FDA for the best path forward."

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BCLI BrainStorm
$3.77 /

+0.36 (+10.56%)

BCLI BrainStorm
$3.77 /

+0.36 (+10.56%)

02/05/21 Maxim
BrainStorm upgraded to Buy from Hold at Maxim
02/04/21 Maxim
BrainStorm upgraded to Buy from Hold at Maxim
BCLI BrainStorm
$3.77 /

+0.36 (+10.56%)

Hot Stocks
BrainStorm announces presentation of new analyses from Phase 3 trial of NurOwn » 07:32
11/29/21
11/29
07:32
11/29/21
07:32
BCLI

BrainStorm

$3.82 /

+0.4 (+11.70%)

BrainStorm Cell…

BrainStorm Cell Therapeutics announced the presentation of new analyses from the Phase 3 trial of NurOwn at the 4th Annual ALS ONE Research Symposium. The presentation, which will be delivered Tomorrow, showed that although the Phase 3 trial did not reach statistical significance on the primary and secondary endpoints, pre-specified and post hoc analyses leveraging different methods of exploring the heterogeneity of baseline disease in the trial, revealed the potential for a meaningful treatment effect across endpoints when focusing on a subset of participants with less severe disease at baseline. Additional key findings from the presentation included: The observed potential treatment effect of NurOwn on ALS disease progression in participants with less severe disease was protected by randomization; The Phase 3 trial of NurOwn in ALS included a higher percentage of participants with advanced ALS at baseline compared to other trials, resulting in a lower baseline mean; In the subgroup of participants that are predicted by the ENCALS model to have long to very long survival, NurOwn treated participants had a greater percentage of responders compared to placebo; In the pre-specified subgroup of participants with ALSFRS-R greater than or equal to 35 at baseline, NurOwn had a greater percentage of responder compared to placebo; and Analyses that focus both on baseline ALSFRS-R and ENCALS model categories suggest that efficacy measurements are impacted in participants with more severe disease. "These compelling analyses add to the positive momentum behind our ALS program, and we were pleased to have the opportunity to share them with the clinical community at this year's ALS ONE Research Symposium," said Stacy Lindborg, PhD, Executive Vice President and Chief Development Officer, Brainstorm Cell Therapeutics. "We are very encouraged by the observation that there appears to be a meaningful treatment effect in patients with less severe disease at baseline that is consistent when using baseline ALSFRS-R scores and the ENCALS model which incorporates additional important disease characteristics that have been shown to be predictive of survival time. We believe this is an important finding, especially since this effect was protected by randomization. Looking ahead, we are eager to share additional analyses from our Phase 3 trial with the clinical community through a peer reviewed publication and remain committed to pursuing the best and most expeditious path forward to bring NurOwn to patients with ALS."

ShowHide Related Items >><<
BCLI BrainStorm
$3.82 /

+0.4 (+11.70%)

BCLI BrainStorm
$3.82 /

+0.4 (+11.70%)

02/05/21 Maxim
BrainStorm upgraded to Buy from Hold at Maxim
02/04/21 Maxim
BrainStorm upgraded to Buy from Hold at Maxim
BCLI BrainStorm
$3.82 /

+0.4 (+11.70%)

Earnings
BrainStorm reports Q3 EPS (15c), two estimates (20c) » 07:18
11/15/21
11/15
07:18
11/15/21
07:18
BCLI

BrainStorm

$2.97 /

-0.035 (-1.16%)

Cash, cash equivalents,…

Cash, cash equivalents, and short-term bank deposits were approximately $28M as of September 30, 2021, compared to approximately $35M on June 30, 2021. "We made strong progress towards our goal of advancing NurOwn in ALS and MS over the past months," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "Our productive discussions with leading clinical experts continue, and we continue to bring forward new evidence of NurOwn's effectiveness in the scientific domain, as highlighted by our recent NEALS presentation of Phase 3 ALS data showing that NurOwn drove significant changes in important neural biomarkers that could be used to predict treatment outcomes within the trial. The insights we have gained from these discussions have generated strong momentum in our pursuit of the best and most expeditious path forward to bring NurOwn to patients. We also strengthened our leadership team and increased our manufacturing capacity, supporting our readiness to provide broad patient access as we seek paths for potential regulatory approval. The devastating and progressive nature of ALS creates an urgent unmet need for patients, and one that we are fully committed to addressing through NurOwn's continued advancement."

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BCLI BrainStorm
$2.97 /

-0.035 (-1.16%)

BCLI BrainStorm
$2.97 /

-0.035 (-1.16%)

02/05/21 Maxim
BrainStorm upgraded to Buy from Hold at Maxim
02/04/21 Maxim
BrainStorm upgraded to Buy from Hold at Maxim
11/18/20 Maxim
BrainStorm downgraded to Hold from Buy at Maxim
11/17/20 Maxim
BrainStorm downgraded to Hold from Buy at Maxim
BCLI BrainStorm
$2.97 /

-0.035 (-1.16%)

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