sarepta therapeutics inc (SRPT) Snapshot

Sarepta Therapeutics, Inc. reported unaudited earnings results for the first quarter ended March 31, 2013. For the quarter, the company reported revenues from grants and research contracts of $4,474,000 compared to $11,212,000 a year ago. The $6.7 million decrease was due to the August 2012 stop-work-order and subsequent termination for convenience of the Ebola portion of the Ebola-Marburg U.S. government contract due to a lack of available U.S. government funding. Operating loss was $15,415,000 compared to $6,874,000 a year ago. Net loss was $42,084,000 or $1.32 basic and diluted per share compared to $17,704,000 or $0.78 basic and diluted per share a year ago. Non-GAAP net loss was $13,045,000 or $0.41 basic and diluted per share compared to $6,017,000 or $0.27 basic and diluted per share a year ago.

Sarepta Therapeutics, Inc. announced that it has initiated dosing in a Phase 1 multiple ascending dose (MAD) clinical trial of AVI-7288, the company's lead drug candidate for the treatment of Marburg virus infection. The Phase I MAD study is designed to characterize the safety, tolerability and pharmacokinetics of AVI-7288 after repeat dosing in healthy adult volunteers. The initiation of this study follows the successfully completed Phase 1 single ascending dose study, which showed AVI-7288 was well tolerated in healthy volunteers. Sarepta is developing AVI-7288 under a contract from the U.S. Department of Defense through the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office. AVI-7288 utilizes Sarepta's advanced and proprietary PMOplus(R) chemistry. The randomized, double-blind, placebo-controlled MAD study will be overseen by an independent Data and Safety Monitoring Board, who will review safety and clinical laboratory data after each dose cohort prior to enrolling the next high dose cohort. Thirty-two volunteers will be enrolled in one of four cohorts made up of eight subjects each. The cohorts will include six subjects who receive the therapeutic, and two who will receive a placebo. In completed single ascending dose studies of Sarepta's Marburg and Ebola drug candidates, which both utilized the PMOplus(R) chemistry, no safety issues were identified from a total of 48 subjects receiving doses up to 9 mg/kg of either drug candidate. Data from preclinical studies demonstrated that AVI-7288 provides post-exposure efficacy in infected non-human primates with survival rates between 83 and 100% when the drug is administered up to four days after exposure to the Marburg virus.

Sarepta Therapeutics, Inc. Presents at UBS Global Healthcare Conference, May-21-2013 08:30 AM. Venue: Sheraton New York Hotel, 811 Seventh Avenue, New York, New York, United States. Speakers: Christopher Nishan Garabedian, Chief Executive Officer, President and Director.