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Curis, Inc. (Nasdaq: CRIS) $3.21. Today announced that positive data are being presented by its collaborator Genentech, a member of the Roche Group, from a pivotal Phase II clinical trial conducted by Roche and Genentech of vismodegib in patients with advanced basal cell carcinoma (BCC), an often life-threatening form of skin cancer that can have disfiguring and debilitating effects. The results will be presented on June 21st at the Seventh European Association of Dermato-Oncology (EADO) Congress taking place in Nantes, France.
Vismodegib is a first-in-class investigational, oral medicine designed to selectively inhibit signaling in the Hedgehog pathway, which is implicated in more than 90 percent of BCC cases. Genentech has indicated that it anticipates submitting a new drug application to the U.S. Food and Drug Administration (FDA) in 2011 to seek approval to commercialize vismodegib based on the positive outcome of this study. Roche has indicated that the timing of a European regulatory submission is subject to planned discussions with the European Medicines Agency (EMA).
What They Do: Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer.
Harbin Electric (Nasdaq: HRBN) $8.39. Today announced that it has entered into a definitive agreement and plan of merger with Tech Full Electric Company Limited, a Cayman Islands company wholly owned indirectly by Mr. Tianfu Yang, the Company's Chairman and Chief Executive Officer, and Tech Full Electric Acquisition, Inc. ("Merger Sub"), a Nevada corporation wholly owned by Parent.
Under the terms of the Merger Agreement, each of the Company's shares of common stock issued and outstanding immediately prior to the effective time of the merger will be converted into the right to receive $24.00 in cash without interest, except for Shares owned by Parent and Merger Sub (including shares to be contributed to Parent by Mr. Tianfu Yang, affiliates of Abax Global Capital and certain of the Company's employees and officers prior to the effective time of the merger pursuant to a contribution agreement between Parent, each member of the Purchasing Group and Tianfu Investments Limited. Collectively, the Purchasing Group beneficially owns approximately 40.6% of the outstanding Shares.
What They Do: Harbin Electric, headquartered in Harbin, China, is a leading developer and manufacturer of a wide array of electric motors with a focus on innovative, customized, and value-added products.
PROLOR Biotech (AMEX: PBTH) $4.60. Today announced that its paediatric investigation plan for clinical development of its long-acting human growth hormone (hGH-CTP) has been accepted for review by the Paediatric Committee of the European Medicines Agency (EMA). Following promising efficacy and safety interim results in its ongoing Phase II trial of hGH-CTP in growth hormone-deficient adults, PROLOR is now actively pursuing development of hGH-CTP for the treatment of growth hormone-deficient children.
Last April, PROLOR announced positive interim efficacy results from its Phase II trial of hGH-CTP in adults. The interim efficacy data showed that a single weekly injection of hGH-CTP, even when administered at relatively low doses, has the potential to replace seven consecutive daily injections of currently marketed human growth hormone. These positive interim data followed PROLOR's announcement in February that hGH-CTP has demonstrated a good safety profile in the Phase II trial, as confirmed in a review of interim data by the independent Data and Safety Monitoring Board.
In the European Union, a company submitting a first-time Marketing Authorization Application (MAA) to the EMA for a new drug product must have in place an approved paediatric investigation plan (PIP) detailing both the timelines for development and special measures that will be taken when developing the drug for children, even if the first submission is for use in adult populations. If an approved PIP is not in place, the EMA will not approve the MAA for use in adults.
What They Do: PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its patented CTP technology and its Reversible PEGylation technology, primarily to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales.
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