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Repligen Corporation (Nasdaq: RGEN) $3.19. Today announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved the Company's proposal to re-analyze the images from our Phase 3 study to establish the utility of RG1068, synthetic human secretin, in improving magnetic resonance imaging (MRI) of the pancreas (Phase 3 re-read). The FDA and EMA have agreed to the Phase 3 re-read based on the numerous deficiencies with the analysis of the radiographic images by the contract research organization hired to oversee analysis of the Phase 3 data. A successful re-read of the Phase 3 data may support registration of RG1068 for MRI imaging of the pancreas. The goal of the Phase 3 study is to evaluate the sensitivity and specificity of RG1068 in combination with MRI to improve the detection of structural abnormalities of the pancreatic ducts relative to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis.
What They Do: Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for neurological disorders.
Cytokinetics, Incorporated (Nasdaq: CYTK) $2.87. Today announced that the company has opened to enrollment a Phase IIa "Evidence of Effect" (EoE) clinical trial of CK-2017357 in patients with peripheral artery disease and claudication. CK-2017357 is a fast skeletal muscle troponin activator and the lead drug candidate from the company's skeletal muscle contractility program. CK-2017357 selectively activates the fast skeletal muscle troponin complex and increases its sensitivity to calcium, resulting in increased skeletal muscle force and slowing of time to muscle fatigue.
This Phase IIa EoE clinical trial is a double-blind, randomized, placebo-controlled, three-period crossover, pharmacokinetic and pharmacodynamic study of CK-2017357 in patients with peripheral artery disease and claudication. At least 36 and up to 72 patients may be enrolled in this trial. In each dosing period, patients will receive a single oral dose of placebo, 375 mg or 750 mg of CK-2017357; over the course of the three dosing periods, each patient will receive, in random order, each one of these three single doses. A wash out period of at least 6 days (to a maximum of 10 days) will be employed between the individual doses for each patient.
What They Do: Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions.
BioDelivery Sciences International (Nasdaq: BDSI) $2.92. Today announced that it has entered into a license and supply agreement with Kunwha Pharmaceutical Co., Ltd., for the exclusive rights to develop and commercialize BEMA Fentanyl (marketed as ONSOLIS in the U.S.) in the Republic of Korea. The agreement results in potential milestone payments to BDSI of up to $1,275,000, which includes an upfront payment of $300,000. In addition, BDSI will receive an ongoing royalty based on net sales.
What They Do: BioDelivery Sciences is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics.
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