Key Developments: Repligen Corp (RGEN.O)
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9 Feb 2010
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Latest Key Developments
Repligen Corporation Reaffirms FY 2010 Revenue Guidance-Conference Call
Repligen Corporation announced that it is confirming total revenue projection for fiscal 2010 between $21 million and $22 million. According to Reuters Estimates, analysts on an average were expecting the Company to report revenue of $21 million for fiscal 2010.
Repligen Corporation Receives Notice of Allowance for Recombinant Protein A Patent
Repligen Corporation announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for a patent covering a recombinant form of Protein A which is identical in structure to the commercial form of Protein A from Staphylococcus aureus which is used in the production of many of the world's approved monoclonal antibodies. The patent, which will remain in force until 2028, covers a new Repligen proprietary product which is now available in commercial quantities. This product has been developed as an alternative to the legacy Staphylococcus aureus Protein A and will be the basis of Repligen's future chromatography product development.
Repligen Corporation Announces Long Term Supply Agreement With GE Healthcare For Recombinant Protein A
Repligen Corporation announced that it has extended its longstanding relationship with GE Healthcare Bio-Sciences AB by entering into a five-year supply agreement for recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies, a highly successful class of biopharmaceutical. Repligen has manufactured recombinant Protein A for GE Healthcare for more than 10 years. This agreement provides for Repligen to continue to be a strategic supplier to GE Healthcare through 2014. GE Healthcare sells chromatography products which incorporate Repligen's recombinant Protein A to the biopharmaceutical industry for the manufacture of monoclonal antibodies.
Repligen Corporation Reports Phase 3 Clinical Trial Results Of RG1068 In Pancreatic Imaging
Repligen Corporation announced top-line results from a Phase 3 clinical trial to evaluate the safety and efficacy of RG1068, synthetic human secretin, to improve magnetic resonance imaging (MRI) of the pancreas in patients with a history of pancreatitis. The study's co-primary endpoints were improvements in sensitivity of detection of structural abnormalities of the pancreatic ducts using RG1068 in combination with MRI compared to MRI alone with minimal loss in specificity (<7.5%). The study design used endoscopy as the standard for determination of structural abnormalities. The predetermined criteria for a successful study were achievement of a statistically significant improvement in sensitivity with minimal loss in specificity from two of the three central radiologists reading the MRI images. In this study, one radiologist achieved a statistically significant improvement in sensitivity with RG1068 (p<0.001) while a second radiologist showed a trend but did not achieve statistical significance (p=0.088). There was minimal loss in specificity for all radiologists. While it was not a pre-specified endpoint, pooled data from all three radiologists resulted in a statistically significant improvement in sensitivity with RG1068 (p=0.005) with minimal loss in specificity.
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.
Repligen Corporation Sees FY 2009 Revenue Outlook At High End Of Prior Outlook; Raises FY 2009 Earnings Outlook; Issues Q4 2009 Revenue Outlook In Line With Analysts' Estimate-Conference Call
Repligen Corporation announced that for fiscal 2009, it expects revenue at the high end of previous projection of $28 million to $30 million. The Company has raised its GAAP net profit and now expects it to be between $5 million and $6 million. The Company also announced that for fourth quarter of 2009, it expects to record revenue of approximately $5 million. According to Reuters Estimates, analysts are expecting the Company to report revenue of $30 million for fiscal 2009 and revenue of $5 million for fourth quarter of 2009.
UPDATE 1-Repligen pancreatic imaging agent does not meet goal
* Trial did not achieve pre-specified statistical outcome
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