Last $8.64 USD
Change Today +0.01 / 0.12%
Volume 99.3K
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As of 8:10 PM 07/25/14 All times are local (Market data is delayed by at least 15 minutes).

concert pharmaceuticals inc (CNCE) Snapshot

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concert pharmaceuticals inc (CNCE) Details

Concert Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, discovers and develops small molecule drugs for central nervous system disorders, renal disease, inflammation, and cancer. The company’s clinical-stage product candidates include CTP-354, which in Phase I clinical trial for spasticity associated with multiple sclerosis and spinal cord injury; CTP-499 that is in Phase II clinical trial for diabetic kidney disease; and AVP-786 for neurologic and psychiatric disorders. Its preclinical compounds comprise CTP-730 for inflammatory diseases; JZP-386, a deuterated analog of sodium oxybate for narcolepsy; and C-10068, an oral deuterium-substituted analog of dextroethorphan, which is used for the treatment of pain and seizure-generating diseases and injuries, such as epilepsy, ischemic stroke, and traumatic brain injury. The company has collaborations with Avanir Pharmaceuticals, Inc., Celgene Corporation, Celgene International Sàrl, and Jazz Pharmaceuticals, Inc. Concert Pharmaceuticals, Inc. was founded in 2006 and is headquartered in Lexington, Massachusetts.

45 Employees
Last Reported Date: 03/31/14
Founded in 2006

concert pharmaceuticals inc (CNCE) Top Compensated Officers

Co-Founder, Chief Executive Officer, Presiden...
Total Annual Compensation: $373.2K
Chief Operating Officer
Total Annual Compensation: $300.1K
Senior Vice President and General Counsel
Total Annual Compensation: $295.4K
Compensation as of Fiscal Year 2013.

concert pharmaceuticals inc (CNCE) Key Developments

Jazz Pharmaceuticals plc and Concert Pharmaceuticals, Inc. Provide Phase 1 Clinical Trial Update on JZP-386

Jazz Pharmaceuticals plc and Concert Pharmaceuticals, Inc. announced the initiation of the first Phase 1 clinical trial of JZP-386, a deuterium-containing analog of sodium oxybate--the active ingredient in Xyrem (sodium oxybate) oral solution. The Phase 1 clinical trial is designed to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of JZP-386, and includes Xyrem as an active control. The study is expected to enroll up to 28 healthy subjects at a single center in Europe. The results of the study are intended to assess the PK/PD profile of JZP-386 to identify a safe and tolerable dose or doses of JZP-386 that could be used in subsequent clinical trials and to determine whether JZP-386 is suitable for once nightly dosing. Under its 2013 agreement with Concert, Jazz Pharmaceuticals has worldwide rights to develop and commercialize JZP-386. Concert has the potential to realize milestone payments upon meeting development objectives and tiered royalties on any worldwide sales. Jazz Pharmaceuticals and Concert are working collaboratively on development of JZP-386, and Concert is responsible for conducting clinical activities for JZP-386 through Phase 1.

Concert Pharmaceuticals Announces FDA Lifts Partial Clinical Hold for CTP-354

Concert Pharmaceuticals, Inc. announced that the FDA has provided notification that the Company has completed the necessary preclinical toxicology testing in order to administer repeated doses of CTP-354 in excess of 6 mg per day, lifting its partial clinical hold. As a result, the Company intends to initiate dosing of 12 mg per day of CTP-354 in the third quarter of this year as part of its ongoing multiple ascending dose Phase 1 trial. CTP-354 is a novel, potentially first-in-class, non-sedating, once-daily oral treatment for spasticity. Concert is initially developing CTP-354 for use in patients with spinal cord injury and in patients with multiple sclerosis to address significant unmet medical needs. CTP-354 is a subtype-selective GABA(A) receptor modulator. GABA(A) receptors are found in the nervous system and, when activated, reduce the transmission of certain nerve signals. Several classes of widely used drugs target GABA(A) receptors, including benzodiazepines, but do not have the receptor subtype selectively of CTP-354.

Concert Pharmaceuticals, Inc. Announces Successful End-Of-Phase 2 Meeting with FDA for CTP-499

Concert Pharmaceuticals, Inc. announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for CTP-499, its investigational therapy targeting diabetic nephropathy. During the meeting, the FDA indicated general agreement with Concert's proposed Phase 3 development plan providing flexibility to conduct either two clinical trials with CTP-499 or a single trial evaluating two doses of CTP-499 compared to placebo. A reduction in the rate of progression of renal disease, measured by a time-to-event analysis of the composite of increases in serum creatinine (greater than or equal to 50%) or end stage renal disease, versus placebo-treated patients, was agreed to be an acceptable Phase 3 endpoint to support the filing of a potential New Drug Application (NDA). The Company currently plans to submit a request for a Special Protocol Assessment (SPA) to the FDA later this year.


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