Key Developments: Medgenics Inc (MDGN.A)
4.25USD
17 May 2013
$-0.07 (-1.62%)
$4.32
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1,700
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$16.29
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Latest Key Developments (Source: Significant Developments)
Medgenics Inc Announces Exercise By Underwriters Of Over-Allotment Option
Medgenics Inc announced that, in connection with its previously announced public offering, the underwriters have exercised their option to purchase 470,000 shares of common stock at $5.24 per share and 840,000 Series 2013-A warrants (the Warrants) at $0.01 per Warrant, which allows for the purchase of 420,000 shares of Common Stock at an initial exercise price of $6.78. The Warrants are exercisable and will expire February 13, 2018. Further details of the Warrants were announced in a press release on February 14, 2013. Net proceeds to Medgenics were $2,274,000, after deducting underwriting discounts. Full Article
Medgenics Inc Announces Closing Of Public Offering Of Common Stock And Warrants
Medgenics Inc announced closing of an underwritten public offering of 5,600,000 shares of common stock and Series 2013-A warrants to purchase up to an aggregate of 2,800,000 shares of common stock. The shares and the warrants were sold together as a fixed combination, each consisting of one share of common stock and a warrant to purchase one-half of a share of common stock, at a price to the public of $5.25 per fixed combination. The shares of common stock and warrants were issued separately. The warrants have an initial exercise price of $6.78, are currently exercisable and will expire on February 13, 2018. Gross proceeds to Medgenics were $29,400,000, before deducting underwriting discounts and commissions and other offering expenses payable by Medgenics. In addition, Medgenics granted the underwriters a 45-day option to purchase up to an aggregate of 840,000 additional shares of common stock and/or additional warrants to purchase up to an aggregate of 420,000 shares of common stock. Maxim Group LLC acted as sole book-running manager for the offering. National Securities Corporation and MLV & Co. acted as co-managers for the offering. Nomura Code Securities Limited and SVS Securities Plc acted as sub-agents to the offering in Europe. Full Article
Medgenics Inc Prices Public Offering Of Common Stock And Warrants
Medgenics Inc announced that it has priced an underwritten public offering of 5,600,000 shares of common stock and Series 2013-A warrants to purchase up to an aggregate of 2,800,000 shares of common stock at an initial exercise price of $6.78. The shares and the warrants will be sold together as a fixed combination, each consisting of one share of common stock and a warrant to purchase one-half of a share of common stock, at a price to the public of $5.25 per fixed combination. The shares of common stock and warrants will be issued separately. Gross proceeds to Medgenics will be $29,400,000. The offering is expected to close on February 13, 2013. Maxim Group LLC is acting as sole book-running manager for the offering. National Securities Corporation and MLV & Co. are acting as co-managers for the offering. Nomura Code Securities Limited and SVS Securities Plc acted as sub-agents to the offering in Europe. Medgenics has granted the underwriters a 45-day option to purchase up to an aggregate of 840,000 additional shares of common stock and/or additional warrants to purchase up to an aggregate of 420,000 shares of common stock. Full Article
Medgenics, Inc. Launches First Clinical Trial in Hepatitis to Use INFRADURE Tissue Treatment
Medgenics, Inc. (Medgenics) announced that the first patient has been enrolled in a Phase I/II clinical trial with the Company's INFRADURE Biopump for the treatment of hepatitis C. This is the first clinical trial of INFRADURE, a subcutaneous autologous skin tissue implant for the continuous production and delivery of interferon-alpha (INFa) being developed by Medgenics to treat hepatitis B, C and D, aimed at replacing months of weekly injections of INFa, along with their serious side effects. Full Article
Medgenics, Inc. Appoints Dr. Sol Barer As Chairman
Medgenics, Inc announced that Sol J. Barer has been appointed as the Chairman of the Board. Eugene Bauer, who has served as Chairman will continue his active involvement as a Director and consultant to the Company. Full Article
Medgenics, Inc. Receives Orphan Drug Designation From U.S. Food and Drug Administration
Medgenics, Inc. announced that its INFRADURE Biopump has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for the treatment of hepatitis D. INFRADURE is the version of Medgenics' Biopump technology platform which produces interferon alpha, commonly used to treat hepatitis. This marks the first Orphan Drug Designation granted for treatment of a clinical indication using the Biopump. Full Article
Medgenics, Inc. Raises $9.5 Million In Private Placement
Medgenics, Inc. announced it has raised gross proceeds of approximately $9.5 million (approximately $8.4 million net) through the sale of 1,944,734 units (the Units), with each Unit consisting of one share of the Company’s Common Stock, $0.0001 par value per share (the Common Stock), and a warrant to purchase 0.75 of one share of Common Stock (the Warrants). Each Unit was sold for a purchase price of $4.90 to institutional and other accredited investors in a private placement transaction. The Warrants expire in five years, have an initial exercise price of $8.34 per full share and become first exercisable on December 15, 2012. Medgenics intends to use the proceeds from this private placement to further its clinical trial programs for its EPODURE Biopump producing erythropoietin for the treatment of anemia, and its INFRADURE Biopump producing interferon-alpha for the treatment of hepatitis, as well as for other research and development, patent maintenance and other intellectual property support and general corporate purposes. Full Article
Medgenics, Inc. Receives FDA Clearance To Commence Phase IIb Trial Of EPODURE For Sustained Anemia Treatment In Dialysis Patients
Medgenics, Inc. announced receipt of clearance from the U.S. Food and Drug Administration (FDA or the Agency) to proceed with a Phase IIb clinical trial of EPODURE for the treatment of anemia in patients undergoing renal dialysis. EPODURE is intended to produce and deliver erythropoietin (EPO) on a sustained basis. This multi-center, randomized clinical trial will be the first study in the U.S. using the Company`s Biopump technology, and will evaluate the safety and efficacy of sustained EPO therapy delivered via Medgenics' EPODURE Biopump. Treatment of anemia in dialysis patients with EPODURE is intended to replace frequent injections of EPO or other erythropoietic stimulating agents (ESAs). The FDA cleared the Phase IIb study protocol based on results from the Company`s prior Phase I/II anemia study of EPODURE in Israel, which reported safety and maintenance of hemoglobin for months from a single EPODURE treatment in pre-dialysis patients without requiring injections of EPO or ESAs, as well as on the complete preclinical package. The Company was particularly encouraged that clearance was received within the 30-day required regulatory response period from submission of the IND application and without issues being raised. Medgenics views this as an early, second validation from an independent critical review in the U.S. of its Biopump platform. Full Article
Medgenics, Inc. Files For U.S. Orphan Drug Designation For INFRADURE For The Treatment Of Hepatitis D
Medgenics, Inc. announced that it has filed for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for INFRADURE for the treatment of hepatitis D. INFRADURE is based on Medgenics' tissue-based Biopump platform technology, which uses the patient's own tissue to continuously produce and deliver therapeutic proteins, such as interferon-alpha for use in the treatment of hepatitis. Orphan Drug Designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process. This application for Orphan Drug Designation follows Medgenics' recent submission of an Investigational New Drug (IND) application to the FDA for a Phase IIb anemia trial in dialysis patients using EPODURE, a different implementation of the same Biopump platform that produces erythropoietin (EPO). Full Article
Medgenics, Inc. Files IND Application For EPODURE Biopump Phase IIb Anemia Study In Dialysis Patients
Medgenics, Inc. announced that it has filed an Investigational New Drug application with the U.S. Food and Drug Administration to initiate a Phase IIb multi-center, 100-patient clinical trial. The trial is designed to evaluate the safety and efficacy of sustained erythropoietin therapy delivered via the Company’s EPODURE Biopump for the treatment of anemia in dialysis patients with end-stage renal disease. EPODURE is an autologous dermal Biopump, a small tissue implant made from the patient’s own dermal (skin) tissue. The filing of this IND application follows two key events that occurred in March 2012: the regulatory approval for a smaller Phase IIa study for the same indication in Israel; and positive meetings with the National Institutes of Health’s Recombinant DNA Advisory Committee in the U.S. Full Article
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