Key Developments For Repligen Corp
Repligen Corp (RGEN.O) (Consolidated Issue listed on NASDAQ Global Market)
Repligen Corporation Reaffirms FY 2010 Revenue Guidance; Lowers FY 2010 Earnings Guidance-Conference Call
Repligen Corporation reaffirmed fiscal 2010 guidance for revenue of between $20 and $22 million and updated expectation for net loss to be between $7 and $8 million compared to earlier guidance of $5 to $6 million. According to Reuters Estimates, analysts on an average were expecting the Company to report net loss of $6 million on revenue of $21 million for the same period.
Repligen Corporation Licenses Potential Treatment For Spinal Muscular Atrophy
Repligen Corporation announced that it has entered into an exclusive license agreement with Families of Spinal Muscular Atrophy (FSMA) for intellectual property covering compounds which may have utility in treating Spinal Muscular Atrophy (SMA). SMA is an inherited neurodegenerative disease in which a defect in the SMN1 (survival motor neuron) gene results in low levels of the protein SMN and leads to progressive damage to motor neurons, loss of muscle function and, in many patients, early death. The licensed compounds increase the production of SMN in cells derived from patients. Further testing of these compounds in two transgenic mouse models of SMA demonstrated significantly increased survival suggesting potential clinical utility.
Repligen Corporation Announces Completion Of Patient Treatment In Phase 3 Clinical Trial Of RG1068 In MRI Imaging Of Pancreas
Repligen Corporation announced that it has completed patient treatment in its Phase 3 clinical trial of RG1068, synthetic human secretin, in magnetic resonance imaging (MRI) of the pancreas. The study is designed to assess the sensitivity and specificity of RG1068 in conjunction with MRI for the detection of pancreatic duct abnormalities compared to MRI alone. Additional assessments include safety, physician confidence in the identification of structural abnormalities, the number of pancreatic duct segments visualized and the improvement in the quality of the MRI images. The study enrolled 258 patients at 23 clinical sites within the U.S. and Canada. Detailed visual assessment of the pancreatic ducts is important in the diagnosis and treatment of diseases such as acute and chronic pancreatitis. Structural abnormalities of the pancreatic ducts were assessed by RG1068 used in conjunction with MRI and independently by endoscopy, a commonly used invasive procedure. There were no serious adverse events (SAEs) associated with the RG1068/MRI procedure compared to 68 patients with an SAE associated with endoscopy. The most commonly reported SAE following endoscopy was acute pancreatitis requiring hospitalization.
Repligen Corporation Announces Identification of Drug Target for Friedreich's Ataxia
Repligen Corporation announced publication of research that identifies histone deacetylase 3 (HDAC 3) as an important enzyme target for therapeutic intervention in Friedreich's ataxia. These research findings confirm the drug target of the HDAC inhibitors that Repligen is currently developing for the treatment of inherited neurodegenerative diseases such as Friedreich's ataxia. The study entitled 'Chemical Probes Identify a Role for Histone Deacetylase 3 in Friedreich's Ataxia Gene Silencing' published today in the journal Chemistry & Biology (volume 16, 980-989, September 25, 2009) was conducted in collaboration with scientists at The Scripps Research Institute.
Repligen Corporation Issues FY 2010 Guidance-Conference Call
Repligen Corporation announced that for fiscal 2010, it expects total revenue of between $20-$22 million, including $10 million to $11 million in product sales, $9 million to $10 million in royalty income, and between $1 million and $1.5 million in other revenue. Not counting the impact of any acquisition or other significant transaction, it expects a GAAP net loss of approximately $5-$6 million for fiscal 2010.
