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Hot Stocks
Brickell Biotech completes patient enrollment in Phase 3 Cardigan I study » 07:41
04/27/21
04/27
07:41
04/27/21
07:41
BBI

Brickell Biotech

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+

Brickell Biotech…

Brickell Biotech announced completion of patient enrollment in the Phase 3 pivotal Cardigan I study and that the Cardigan II study has surpassed 50% enrollment. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary hyperhidrosis. Brickell's U.S. Phase 3 clinical program for sofpironium bromide gel, 15% is comprised of two pivotal clinical studies, Cardigan I and Cardigan II. Each study is expected to enroll approximately 350 subjects nine years of age and older with primary axillary hyperhidrosis. The studies are multicenter, randomized, double-blinded, vehicle-controlled studies evaluating the efficacy and safety of topically applied sofpironium bromide gel, 15%. Subjects will apply sofpironium bromide gel, 15% or placebo to their underarms once daily at bedtime for 6 consecutive weeks, with a 2-week post-treatment follow-up. The co-primary efficacy endpoints of both studies include the proportion of subjects achieving at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillaryscale, a proprietary and validated patient-reported outcome measure, and change in gravimetric sweat production, each from baseline to end of treatment. Safety and tolerability assessments will be performed throughout the studies. The company expects to announce results from the Cardigan I and Cardigan II clinical studies in the fourth quarter of 2021. If successful, the results from the studies are expected to form the basis of a prospective New Drug Application in the U.S. for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis.

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BBI Brickell Biotech
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BBI Brickell Biotech
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04/26/21 Lake Street
Brickell Biotech Phase 3 safety results build confidence, says Lake Street
09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun
Recommendations
Brickell Biotech Phase 3 safety results build confidence, says Lake Street » 09:14
04/26/21
04/26
09:14
04/26/21
09:14
BBI

Brickell Biotech

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+

Lake Street analyst…

Lake Street analyst Thomas Flaten said the data Brickell Biotech presented from the Phase 3 safety study of sofpironium bromide at the American Academy of Dermatology virtual meeting is supportive of the safety and efficacy profile builds "further confidence" in the ongoing pivotal program. He keeps a Buy rating and $6 price target on Brickell Biotech shares following the data presentation.

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BBI Brickell Biotech
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+

BBI Brickell Biotech
/

+

09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun
Hot Stocks
Brickell Biotech reports results from ARGYLE phase 3 study » 10:07
04/23/21
04/23
10:07
04/23/21
10:07
BBI

Brickell Biotech

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Brickell Biotech…

Brickell Biotech announced results from its Phase 3 open-label, long-term safety study, which were also presented today in a late-breaking oral presentation at the American Academy of Dermatology's 2021 Virtual Meeting Experience. The ARGYLE study assessed the long-term safety and efficacy of topical, once-daily treatment with sofpironium bromide gel, 5% and 15% for 48 weeks in patients nine years and older with primary axillary hyperhidrosis, or excessive underarm sweating. With respect to studied efficacy, the 5% and 15% gel groups exhibited clinically meaningful improvement in axillary hyperhidrosis severity as measured by the Hyperhidrosis Disease Severity Measure-Axillary, a proprietary patient-reported outcome scale. For both 5% and 15% dose groups, responders with a 1-point and 2-point improvement on HDSM-Ax PRO scale showed a gradual and continual improvement in sweat severity through the 48 weeks of treatment. "Overall, the safety, tolerability and efficacy results for sofpironium bromide gel, 5% and 15% in ARGYLE were consistent with prior clinical experience and no unexpected safety findings were observed. There were no clinically significant changes in laboratory parameters or vital signs over 48 weeks of treatment," the company said. "We are pleased that the ARGYLE study results further strengthen the safety, tolerability and efficacy data previously observed in our Phase 2b study of sofpironium bromide gel." said Deepak Chadha, Brickell's Chief Research & Development Officer. "As was observed with earlier clinical studies, the majority of side effects were mild or moderate in severity and transient in nature. Sofpironium bromide gel, 5% and 15% both led to sustained improvements in sweating severity for the majority of patients through the end of 48 weeks of treatment. These data contribute to our understanding of the long-term use of sofpironium bromide gel as a potential novel treatment for the millions of patients suffering from this chronic and debilitating condition."

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BBI Brickell Biotech
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BBI Brickell Biotech
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09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun
Hot Stocks
Brickell Biotech announces publication of HDSM-Ax scale validation results » 08:10
04/15/21
04/15
08:10
04/15/21
08:10
BBI

Brickell Biotech

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Brickell Biotech…

Brickell Biotech announced that results from a Phase 2b study evaluating the use of Hyperhidrosis Disease Severity Measure-Axillary, or HDSM-Ax, Brickell's proprietary patient reported outcome scale, to measure primary axillary hyperhidrosis, or AHH, severity were published in the peer-reviewed Journal of Drugs in Dermatology. The article, entitled "Hyperhidrosis Disease Severity Measure-Axillary: Evaluation of Measurement Performance," can be accessed online here. The psychometric analyses conclude that HDSM-Ax is a "well-defined and reliable measure of primary AHH severity that is expected to improve the assessment of axillary hyperhidrosis treatment effects compared to pre-existing scales, such as the Hyperhidrosis Disease Severity Scale," the company said. The analyses determine that a 1-point change in HDSM-Ax severity score represents a clinically meaningful change in AHH severity.

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BBI Brickell Biotech
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BBI Brickell Biotech
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09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun
Over a month ago
Conference/Events
Brickell Biotech to hold a conference call » 09:25
03/26/21
03/26
09:25
03/26/21
09:25
BBI

Brickell Biotech

$1.19 /

+0.02 (+1.72%)

Management holds a…

Management holds a conference call to provide an overview of Hyperhidrosis (excessive sweating) on March 26 at 10 am. Webcast Link

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BBI Brickell Biotech
$1.19 /

+0.02 (+1.72%)

BBI Brickell Biotech
$1.19 /

+0.02 (+1.72%)

09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun
Conference/Events
Brickell Biotech to hold a conference call » 04:55
03/26/21
03/26
04:55
03/26/21
04:55
BBI

Brickell Biotech

$1.19 /

+0.02 (+1.72%)

Management holds a…

Management holds a conference call to provide an overview of Hyperhidrosis (excessive sweating) on March 26 at 10 am. Webcast Link

ShowHide Related Items >><<
BBI Brickell Biotech
$1.19 /

+0.02 (+1.72%)

BBI Brickell Biotech
$1.19 /

+0.02 (+1.72%)

09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun
Conference/Events
Brickell Biotech to hold a conference call » 15:31
03/19/21
03/19
15:31
03/19/21
15:31
BBI

Brickell Biotech

$1.26 /

+0.0299 (+2.43%)

Management holds a…

Management holds a conference call to provide an overview of Hyperhidrosis (excessive sweating) on March 26 at 10 am. Webcast Link

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BBI Brickell Biotech
$1.26 /

+0.0299 (+2.43%)

BBI Brickell Biotech
$1.26 /

+0.0299 (+2.43%)

09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun
Syndicate
Brickell Biotech files $150M mixed securities shelf  16:30
03/09/21
03/09
16:30
03/09/21
16:30
BBI

Brickell Biotech

$1.23 /

+0.095 (+8.37%)

 
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BBI Brickell Biotech
$1.23 /

+0.095 (+8.37%)

BBI Brickell Biotech
$1.23 /

+0.095 (+8.37%)

09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun
Hot Stocks
Brickell Biotech to host KOL webinar on the hyperhidrosis market » 08:08
03/05/21
03/05
08:08
03/05/21
08:08
BBI

Brickell Biotech

$1.17 /

+ (+0.00%)

Brickell Biotech…

Brickell Biotech announced that it will host a key opinion leader webinar on the hyperhidrosis market on Friday, March 26, 2021 at 10:00 am EDT. This webinar will feature presentations by hyperhidrosis KOLs Adam Friedman, MD, The George Washington University School of Medicine & Health Sciences, and Joel L. Cohen, MD, AboutSkin Dermatology, who will provide an overview of hyperhidrosis through both the eyes of a patient and diagnosing clinician. Both dermatologists will discuss the unmet need that exists in hyperhidrosis, the current treatment landscape, and the negative quality of life impacts experienced by both pediatric and adult patients. Drs. Friedman and Cohen will be available to answer questions following the formal presentations. Robert Brown, CEO of Brickell, also will provide a corporate update. Brickell's lead investigational product candidate, sofpironium bromide, is a new chemical entity that is currently being evaluated in a pivotal Phase 3 clinical program in the U.S. as a potential best-in-class therapy for treatment of primary axillary hyperhidrosis. Brickell expects to report topline data from this Phase 3 clinical program in the fourth quarter of 2021.

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BBI Brickell Biotech
$1.17 /

+ (+0.00%)

BBI Brickell Biotech
$1.17 /

+ (+0.00%)

09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun
Over a quarter ago
Hot Stocks
Brickell announces Japan Phase 3 study results for sofpironium bromide gel » 07:38
01/19/21
01/19
07:38
01/19/21
07:38
BBI

Brickell Biotech

$1.10 /

+0.03 (+2.80%)

Brickell Biotech…

Brickell Biotech announced that the efficacy and safety results from the pivotal Phase 3 study conducted in Japan by its development partner, Kaken Pharmaceutical were published in the peer-reviewed Journal of Dermatology. The paper, entitled "A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis," is available online in English at the Wiley Online Library. Kaken and Brickell first announced the release of the Japan pivotal Phase 3 study results in June 2020. Subsequently, Kaken received regulatory approval to manufacture and market ECCLOCK in Japan for the treatment of primary axillary hyperhidrosis in September 2020 and launched commercial sales in November 2020. Japan is the first country to approve sofpironium bromide, which also marks the first approval of a topical prescription product for the treatment of primary axillary hyperhidrosis in Japan. In addition, Brickell recently initiated its U.S. pivotal Phase 3 clinical program evaluating sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis. Brickell expects to report topline data from the U.S. pivotal Phase 3 program in the fourth quarter of 2021.

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BBI Brickell Biotech
$1.10 /

+0.03 (+2.80%)

BBI Brickell Biotech
$1.10 /

+0.03 (+2.80%)

09/25/20 Lake Street
Approval in Japan validating for Brickell Biotech, says Lake Street
08/28/20 Lake Street
Brickell Biotech initiated with a Buy at Lake Street
08/25/20 Oppenheimer
Brickell Biotech initiated with an Outperform at Oppenheimer
  • 23
    Oct
  • 18
    Jun

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