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Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Tuesday
Jun192012

Medgenics, Inc. Raises $9.5 Million in Private Placement (MDGN)

Medgenics (NYSE AMEX: MDGN) is developing and commercializing Biopump, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.

The Company announced that 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 plans to use these proceeds "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."

Maxim Group LLC acted as the exclusive placement agent for the private placement.

President and Chief Executive Officer of Medgenics Andrew L. Pearlman, Ph.D, stated,

"To date in 2012 we have achieved several regulatory milestones towards launching new clinical trials in the U.S. and in Israel. The capital we raised will be applied towards funding key studies in anemia and hepatitis, as well as advancing our technologies along the path towards commercialization."
Tuesday
Jun192012

Tonix Pharmaceuticals to Present at Marcum MicroCap Conference (TNXP)

Tonix Pharmaceuticals (OTCBB: TNXP) develops new treatments for challenging disorders of the central nervous system (CNS). The Company’s lead programs are potential new treatments for fibromyalgia and post-traumatic stress disorder, which are chronic CNS syndromes. In each of these programs, TONIX seeks to use new doses and formulations of cyclobenzaprine in new treatment regimens. Cyclobenzaprine is the active ingredient of two prescription muscle relaxants that have been approved by the U.S. Food and Drug Administration (FDA) and are marketed by other companies.

The company has announced that Chief Executive Officer Seth Lederman, M.D. will be presenting at the inaugural Marcum MicroCap Conference on June 20th at the Roosevelt Hotel in New York City. Dr. Lederman's presentation is scheduled to begin at 3:30 p.m. Eastern time.

A live audio webcast of this presentation will be available through the conference website: http://execvid.com/marcum-microcap-conference-2012


The Marcum MicroCap Conference is dedicated to introducing investors to the very best, undiscovered companies under $500 million in market capitalization and will feature presentations by CEOs and CFOs of approximately 60 promising high-growth companies, as well as panel discussions. This invitation-only event is expected to attract top fund managers who focus on small cap equities and qualified high-net-worth investors.

For full event details and registration information, please visit http://www.marcumllp.com/microcap.

 

Monday
Jun182012

NeoStem Signs a Definitive Agreement to Divest its 51% Ownership Interest in Suzhou Erye (NBS)

NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.  ItsJanuary 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.

The Company announced that it has "entered into a definitive agreement to sell its 51% interest in Suzhou Erye Pharmaceutical Co. Ltd. (“Erye”), a China-based generic pharmaceutical company, for  $12,280,000 in cash and the return to the Company of (i) 1,040,000 shares of the Company’s Common Stock and (ii) the cancellation of 1,170,000 options and 640,000 Common Stock warrants, which collectively represent 1.3% of the Company’s fully diluted issued and outstanding shares. The closing of the transaction is subject to the approval of NeoStem shareholders and certain other conditions." The transaction is expected to close by the fourth quarter of 2012.

Chairman and CEO of NeoStem Dr. Robin L. Smith stated,

"We are pleased to have reached this significant milestone in our business. This divestiture will enable NeoStem to bolster its cash position in the United States, reduce its legal and financial reporting expenditures, simplify its financials and become a pure play in the rapidly growing cell therapy industry. Consummation of the transaction will also eliminate significant Erye debt from the Company's balance sheet, which was over $37 million as of March 31, 2012."

NeoStem first gained its interest in Erye in October 2009. At the time, the company was heralded for its innovative business move into the emerging Chinese pharmaceutical industry. In 2011, "the Chinese government imposed new policies affecting price and volume controls of certain pharmaceutical products, including generic antibiotics, which reduced the division’s profitability and positive cash flows. This dampened Erye’s operating results and was the catalyst for NeoStem to begin to evaluate opportunities to monetize its interest in Erye."

The divestiture "will enable NeoStem to focus full time on its goal to emerge as a leader in the cell therapy market. The Company is enrolling patients in its PreSERVE AMR-001 Phase 2 clinical trial for preserving heart function after a heart attack and expanding its cell therapeutic contract manufacturing business, PCT. NeoStem also plans to continue to develop and to build on its core capabilities in cell therapy to capitalize on the paradigm shift that is occurring in medicine."
Monday
Jun182012

Unilife Signs Long-Term Supply Contract for the Unifill Prefilled Syringe (UNIS)

Unilife Corp. (NASDAQ: UNIS) is an emerging medical device manufacturer with business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices.

The company has announced the signing of a seven-year commercial supply contract with a pharmaceutical company for the Unifill® ready-to-fill (prefilled) syringe.

The press release addresses the target drug and market, exclusivity of supply, and projected revenue.

Mr. Alan Shortall, CEO of Unilife, stated,

"Pharmaceutical companies are actively seeking access to innovative, differentiated devices for delivery of their brand name, generic and biosimilar drugs. The long-term supply contract that we have signed today underscores this growing trend and demonstrates how our proprietary portfolio of innovative device technologies can enable and enhance their commercial strategies for injectable drugs. 

"Through the pairing of the Unifill syringe with their drug, this pharmaceutical customer can set a new benchmark for safety and functionality within this high-value therapeutic class, and turn compliance with needlestick prevention laws into a competitive market advantage. We look forward to building a strong relationship with this pharmaceutical customer to help them generate powerful differentiation and market demand for their drug."

He continued,

"While full terms of this long-term contract cannot be fully disclosed for commercial purposes, I am pleased that it contains multiple revenue-generating components, including exclusivity fees, an attractive unit price and significant commercial upside moving forward as other reserved international territories are added.

This is just one of many supply contracts that we expect to be generated for the Unifill syringe moving forward. We expect the Unifill syringe will be selected for a number of brand name and generic drugs targeted for use across a wide variety of therapeutic indications that are either approved and at various stages in their commercial lifecycle, or in clinical development. To best align ourselves with the commercial strategies of these pharmaceutical customers, and to drive shareholder value for Unilife, I expect these upcoming contracts will all vary in terms of size, scope and structure."
Monday
Jun182012

FluoroPharma CEO Provides Shareholders With a "State of the Union" Communication (FPMI)

FluoroPharma Medical, Inc. (OTCQB: FPMI) engages in the discovery, development and commercialization of proprietary medical diagnostic imaging products. The company’s initial focus is the development of breakthrough positron emission tomography (PET) imaging agents for the efficient detection and assessment of acute and chronic forms of coronary artery disease (CAD). Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, amyloid plaque in Alzheimer’s disease and agents for detection of certain types of cancer.

The Company has announced the release of a company overview as presented by FluoroPharma's President, CEO and Chairman of the Board, Thijs Spoor. This second "State of the Union" address serves to provide shareholders with a perspective on the company, its evolution and future potential.

Mr. Spoor began the communication by stating,

"Our company vision is clear, our financial position is sound, our promising product portfolio is on track and our company is led by a highly qualified team with significant and directly applicable experience in the successful development of radiopharmaceuticals. Our comprehensive technology platform was developed by scientists at the Massachusetts General Hospital and we are well positioned to capitalize on its superior technology.

As we advance our business model, we recognize the importance of keeping shareholders informed, and it is with this intention that I present this to you today."

The overview covers FluoroPharma's business outlook and company portfolio, including information on clinical programs and intellectual property, as well as an overview summary. 
Monday
Jun182012

Tonix Pharmaceuticals Featured on GLX-TV OpenCEOLive Series (TNXP)

Tonix Pharmaceuticals (OTCBB: TNXP.OB) is developing innovative prescription medications for challenging disorders of the central nervous system. The Company targets conditions characterized by significant unmet medical need, inadequate existing treatment options, and high dissatisfaction among both patients and physicians. TONIX’s core technology improves the quality of sleep in patients with chronic pain syndromes. TONIX’s lead products are designed to be fundamental advances in sleep hygiene and pain management and to be safer and more effective than currently available treatments. TONIX’s products are the result of a program to harvest advances in science and medicine to search for potential therapeutic solutions among known pharmaceutical agents. TONIX is developing new formulations that have been optimized for new therapeutic uses. Its most advanced product candidates, TNX-102 for fibromyalgia and TNX-105 for PTSD, are novel dosage formulations of cyclobenzaprine, the active ingredient in two U.S. FDA-approved muscle relaxants.

The Company announced that Seth Lederman, M.D., Chief Executive Officer of Tonix, was interviewed by GLX-TV Financial News. During an eight-minute overview of the Company, "Dr. Lederman stated that TONIX is focused on treating fibromyalgia pain in an entirely new, opiate-free approach that targets sleep problems associated with chronic pain syndromes."

Dr. Lederman’s full interview as part of the GLX-TV OpenCEOLive series is available to watch on YouTube at http://www.youtube.com/watch?v=l8hb2E5CO0k&feature=player_embedded

In the interview, "Dr. Lederman noted that by treating sleep problems in fibromyalgia patients, symptoms of the entire syndrome improve. He pointed out that opiate addiction is a major problem among chronic pain sufferers and acknowledged that fibromyalgia has not been optimally treated by the medical community." According to the National Institutes of Health, an estimated five million Americans suffer from fibromyalgia. Additionally, "the growing drug market for fibromyalgia is $1.2 billion a year and that only the U.S. and Canada have approved drugs to treat fibromyalgia. Only three drugs are indicated for fibromyalgia, none of which have been shown to address the underlying sleep disturbance that is a hallmark of the disorder."

Read more here

Friday
Jun152012

CytoSorbents to Present at the Marcum MicroCap Conference - $CTSO

CytoSorbents Corporation (CTSO), a critical care-focused company using blood purification to modulate the immune system to prevent or treat organ failure caused by life-threatening illnesses, announced that Dr. Phillip Chan, Chief Executive Officer, will present at the Marcum MicroCap Conference on June 20th in New York City at the Roosevelt Hotel. The event is held by Marcum LLP and co-presented by CCG Investor Relations.

Presentation Details

  • Date: Wednesday, June 20, 2012
  • Time: 4:00PM
  • Location: The Roosevelt Hotel, 45 East 45th Street, New York, NY

A live audio webcast of this presentation will be available through the conference website: http://execvid.com/marcum-microcap-conference-2012

The Marcum MicroCap conference is designed for investors interested in the micro-cap arena, and is expected to gather over 500 participants, including institutional investors, mutual funds, hedge funds, wealth managers, and family offices. The conference will also feature panels on subjects highly relevant to small-cap corporate finance. The event is free to attend for qualified investors and the company will make a formal presentation and be available for one-on-ones.

For full event details and registration information, please visit http://www.marcumllp.com/microcap

About Marcum LLP
Marcum LLP is one of the largest independent public accounting and advisory services firms in the nation. Ranked among the top firms in the nation, Marcum offers the resources of more than 1,100 professionals, including more than 150 partners, in 23 offices throughout New York, New Jersey, Massachusetts, Connecticut, Pennsylvania, California, Florida, Grand Cayman, China and Hong Kong. The Firm's presence runs deep with full service offices strategically located in major business markets. Marcum is a member of the Marcum Group , the gateway to a group of organizations that provide a variety of professional services including accounting and advisory, technology solutions, recruiting, and wealth management. These organizations include Marcum LLP ; Marcum Technology LLC ; MarcumBuchanan Associates LLC ; Marcum Search LLC ; Marcum Financial Services LLC ; Marcum Cronus Partners LLC ; Marcum Bernstein and Pinchuk LLP ; and Marcum Healthcare LLC .

About CCG Investor Relations
CCG is a leading global investor relations and strategic communications consulting firm. In business for more than 30 years, the agency provides a complete range of investor communications, counseling, and IT and data solutions through our global network to over 100 clients across multiple capital markets. CCG has been awarded a number of industry honors for its handling of complex investor relations and crisis communications matters. The agency's corporate headquarters is in Los Angeles with additional offices in New York, Beijing, Shanghai, Hong Kong, London and Tel Aviv. For further information, contact CCG directly, or visit the Company's web sites at http://www.ccgir.com/ and http://www.ccgirasia.com.

About CytoSorbents, CytoSorb®, and HemoDefend
CytoSorbents Corporation is a critical care focused therapeutic device company using blood purification to modulate the immune system and fight multi-organ failure in life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption. In March 2011, CytoSorb®, the Company's flagship product, achieved European regulatory approval as an extracorporeal cytokine filter, and can now be sold throughout the European Union (E.U.) under the CE Mark to be used in clinical situations where cytokines are elevated. The goal of CytoSorb® is to modulate the immune system by removing excessive cytokines, often called "cytokine storm," in critically-ill patients that can lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death in common illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome, and pancreatitis. CytoSorb® has demonstrated statistically significant reductions in mortality in septic patients at high risk of death and is now available for sale in Germany for the treatment of critical care illnesses under a controlled market release, with a planned broad product launch in Germany starting in the first half of 2012 and availability in other E.U. countries, assuming adequate and timely funding, and continued positive results from our clinical studies. HemoDefend is a development-stage blood purification technology platform for the blood transfusion industry intended to reduce transfusion reactions and safeguard the quality and safety of blood products. The HemoDefend technology utilizes the Company's polymer bead technology to remove many substances, such as antibodies, free hemoglobin and inflammatory mediators that can cause potentially serious and sometimes fatal transfusion reactions. CytoSorb® and HemoDefend are just two of a number of different polymers the Company has designed for various medical applications, including improved dialysis, reduction of post-surgical complications, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, drug detoxification, and others. Additional information is available for download on the Company's website: www.cytosorbents.com

Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and additional CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company's medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate and timely financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company's products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company's Form 10-K filed with the SEC on March 30, 2012, which is available at http://www.sec.gov.

Contact:
CytoSorbents Corporation
David Lamadrid
Chief Financial Officer
(732) 329-8885 ext. *816
DavidL@cytosorbents.com

Source: CytoSorbents Corporation

Thursday
Jun142012

Brean Murray Initiates Coverage on Ventrus Biosciences (VTUS)

Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoids, anal fissures and fecal incontinence. There are approximately 12.5 million Americans suffering from hemorrhoids, 7 million from fecal incontinence and over 4 million from anal fissures.

Analysts at Brean Murray, Carret & Co have initiated research on Ventrus Biosciences, assigning it a "buy" rating and a $30.00 price target. 

The analysts wrote,

"We are initiating coverage of Ventrus Biosciences Inc. with a Buy rating, as we believe that VEN 309 has blockbuster potential, given its proven efficacy, large target market and the lack of competitive prescription hemorrhoid drugs. Our Buy rating and 12?month target price of $30 are based on a DCF analysis using a 40% discount rate and a 6x multiple of the terminal value for the projected 2022 EBITDA of $936 million. Ventrus is focused on developing drugs for gastrointestinal indications. The company’s lead drug candidate, VEN 309, has completed several Phase 2 trials in patients with hemorrhoids, and within weeks, Phase 3 data will be released that we believe will support approval."
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