Last $12.30 USD
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Volume 483.0K
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sarepta therapeutics inc (SRPT) Snapshot

Open
$12.00
Previous Close
$12.00
Day High
$12.30
Day Low
$11.85
52 Week High
04/21/14 - $40.00
52 Week Low
01/14/15 - $11.33
Market Cap
508.1M
Average Volume 10 Days
675.8K
EPS TTM
$-2.54
Shares Outstanding
41.3M
EX-Date
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Current Stock Chart for SAREPTA THERAPEUTICS INC (SRPT)

sarepta therapeutics inc (SRPT) Details

Sarepta Therapeutics, Inc., a biopharmaceutical company, focuses on the discovery and development of RNA-based therapeutics for the treatment of rare and infectious diseases. Its lead product candidate is Eteplirsen, an antisense PMO-based therapeutic in clinical development for the treatment of individuals with Duchenne muscular dystrophy. The company is also involved in developing treatments that are in clinical development include AVI-7288 for the treatment of Marburg virus and AVI-7100 for the treatment of influenza. In addition, it focuses on developing preclinical research product candidates for the treatment of other neuromuscular, infectious, and rare diseases. Sarepta Therapeutics, Inc. was founded in 1980 and is headquartered in Cambridge, Massachusetts.

146 Employees
Last Reported Date: 03/3/14
Founded in 1980

sarepta therapeutics inc (SRPT) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $580.0K
Chief Financial Officer, Chief Accounting Off...
Total Annual Compensation: $457.2K
Chief Medical Officer and Senior Vice Preside...
Total Annual Compensation: $377.7K
Senior Vice President, General Counsel and Co...
Total Annual Compensation: $376.9K
Senior Vice President of Technical Operations
Total Annual Compensation: $320.5K
Compensation as of Fiscal Year 2013.

sarepta therapeutics inc (SRPT) Key Developments

Sarepta Therapeutics, Inc. Announces Encouraging Data from Phase IIb DMD Study

Sarepta Therapeutics, Inc. announced encouraging data through week 168 from Study 202, a Phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy, or DMD. After more than three years of treatment, results of the 6-minute walk test (6MWT) at 168 weeks showed continued ambulation across all patients evaluable on the test, however all patients showed a decline in distance walked on this measure since the week 144 timepoint. In addition, a continued stability of respiratory muscle function was observed, as assessed by pulmonary function tests. As previously reported, Study 202 met its primary endpoint of increased novel dystrophin as assessed by muscle biopsy at Week 48. At Week 168, the six patients in the modified Intent-to-Treat or mITT population in the 30 and 50 mg/kg eteplirsen cohorts who were able to perform the 6MWT experienced a decline of 76.7 meters, or about 19.5%, from baseline in walking ability. A statistically significant treatment benefit of 65.4 meters (p less than or equal to 0.017) was observed compared with the placebo/delayed-treatment cohort (n=4), which initiated treatment at Week 25 following 24 weeks of placebo. This cohort, after experiencing a substantial decline of 68.4 meters from baseline to Week 36, demonstrated a decline of 73 meters in walking ability from Week 36 through Week 168, the period from which meaningful levels of dystrophin were likely produced. These analyses were based on the maximum 6MWT score when the test was performed on two consecutive days. In addition, there were no treatment-related hospitalizations or discontinuations. Patients performed two 6MWT evaluations on consecutive days at time points coinciding with a muscle biopsy procedure at baseline and at Weeks 12, 24 and 48. Two 6MWT evaluations were also performed at Weeks 120, 144, and 168, and will be performed at all future functional assessment visits. All other evaluations were a single 6MWT. The pre-specified primary analysis included the maximum distance walked at those clinic visits where repeated tests were taken. Other analyses of the repeated 6MWT results assessed mean, minimum, and Day 1 (first measure) scores. Results from these additional 6MWT analyses confirm the data observations in the primary analysis. Results through Week 168 for other exploratory efficacy endpoints, including timed function tests (e.g., Gowers' maneuver, 10 meter run/walk and timed 4-step test) and the North Star Ambulatory Assessment have shown continued declines compared to baseline, though at potentially slower rates as compared to the limited available natural history data. These endpoints are less well characterized in DMD patients than the 6MWT and pulmonary function tests and have more inter- and intra-patient variability, although they may be predictors of decline at various stages of this disease. All patients evaluable on measures of ambulation (modified Intent-to-Treat, or mITT population) are still able to perform these tests including the 10 meter run/walk and 4-step test, with the exception of three patients who are no longer able to perform the Gowers' maneuver. Study 201 was a randomized, double-blind, placebo-controlled clinical study conducted at Nationwide Children's Hospital in Columbus, Ohio. Twelve boys aged 7 to 13 years with a confirmed genotype amenable to treatment with an exon-51 skipping drug were randomized to one of three cohorts: 30 mg/kg (n=4), 50 mg/kg (n=4), and placebo/delayed treatment (n=4). Eteplirsen and placebo were administered weekly by intravenous infusion. At Week 25, all patients rolled over to Study 202, a long-term open-label extension study, and placebo-treated patients initiated eteplirsen treatment at 30 mg/kg (n=2) or 50 mg/kg (n=2). The primary efficacy endpoint in Study 201 and Study 202 was the increase in novel dystrophin as assessed by muscle biopsy at Weeks 12 and 24 and at Week 48, respectively. The primary clinical endpoint was the 6MWT, a well-accepted measure of ambulation and clinical function in DMD. Long-term follow up in Study 202 continues to evaluate safety and clinical outcomes including the 6MWT.

Sarepta Therapeutics Inc. Initiates Dosing of SRP-4053 in First Human Trial

Sarepta Therapeutics Inc. announced that it has initiated dosing of SRP-4053 in its first human trial, a Phase I/II study in Duchenne muscular dystrophy (DMD). This multiple-dose study will assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in DMD patients with genotypes amenable to exon-53 skipping. The study will be conducted at four sites in Europe under a consortium agreement between Sarepta and various European hospitals, institutions, and scientists established to conduct the study and which is funded in part by the European Union’s Seventh Programme for research, technological development and demonstration under grant agreement No. 305370.

Sarepta Therapeutics, Inc. Reports 168 Weeks Results from Phase IIb Study of Eteplirsen in Duchenne Muscular Dystrophy

Sarepta Therapeutics, Inc. announced data through Week 168 from Study 202, a Phase IIb open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy (DMD). After more than three years of treatment, results of the 6-minute walk test (6MWT) at 168 weeks showed continued ambulation across all patients evaluable on the test, however all patients showed a decline in distance walked on this measure since the week 144 timepoint. In addition, a continued stability of respiratory muscle function was observed, as assessed by pulmonary function tests. At Week 168, the six patients in the modified Intent-to-Treat or mITT population in the 30 and 50 mg/kg eteplirsen cohorts who were able to perform the 6MWT experienced a decline of 76.7 meters, or about 19.5%, from baseline in walking ability. A statistically significant treatment benefit of 65.4 meters (p<= 0.017) was observed compared with the placebo/delayed-treatment cohort (n=4), which initiated treatment at Week 25 following 24 weeks of placebo. This cohort, after experiencing a substantial decline of 68.4 meters from baseline to Week 36, demonstrated a decline of 73 meters in walking ability from Week 36 through Week 168, the period from which meaningful levels of dystrophin were likely produced. These analyses were based on the maximum 6MWT score when the test was performed on two consecutive days. Respiratory muscle function from baseline through Week 168 in the Intent-to-Treat population (n=12), as measured by maximum inspiratory and expiratory pressure (MIP and MEP), continued to show a 11.1% mean increase in MIP and a 14.7% mean increase in MEP. Analyses of MIP percent predicted (MIP adjusted for weight) and MEP percent predicted (MEP adjusted for age) demonstrated a mean change from 91.7% at baseline to 89.5% at Week 168 in MIP percent predicted, and a mean change from 79.3% at baseline to 74.3% at Week 168 in MEP percent predicted. In addition, there was a mean increase in forced vital capacity (FVC), a measure of lung volume, of 11.6%. FVC percent predicted (FVC adjusted for age and height) was maintained above a mean of 90% at Week 168, with 101.3% at Baseline and 91.9% at Week 168. Through 168 weeks, eteplirsen was well tolerated and there were no reported clinically significant treatment-related adverse events and no treatment-related serious adverse events. In addition, there were no treatment-related hospitalizations or discontinuations.

 

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