It's an Interesting Time in the Biotech Market, and with Labor Day on the Horizon, here's a few Biotechs that could Bring You Closer to Financial Independence
LAS VEGAS, NV / ACCESSWIRE / August 4, 2016 / Endonovo Therapeutics, Inc. (ENDV), a developer of non-invasive Electroceuticals™ targeting inflammation in vital organs, announced it is acquiring Rio Grande Neurosciences (RGN), a clinical-stage developer of non-invasive Electroceuticals™ targeting neuro-inflammatory conditions and central nervous system disorders for $21.5 million in cash and stock. The acquisition, which is subject to the execution of a definitive purchase agreement and shareholder approvals, is expected to close by the end of the third quarter - September 30, 2016.
ENDV will be funding and taking over the clinical trials of RGN's Electroceuticals™ for various inflammatory conditions in the brain and central nervous system, including Traumatic Brain Injury (TBI), acute concussions, post-concussion syndrome, multiple sclerosis (MS) and major resistant depression disorder.
Electroceuticals™ broadly encompass all bioelectronic medicines employing electrical stimulation to affect and modify functions of the body, including the inflammatory response. Neural implants, such as cochlear implants to restore hearing, retinal implants to restore eyesight, spinal cord stimulators to relieve pain, implantable vagus nerve electric stimulators and non-invasive electromagnetic stimulators to reduce inflammation and the immune response are examples of Electroceuticals™.
What makes Electroceuticals™ particularly attractive for treating central nervous system disorders such as multiple sclerosis is unlike drugs, Electroceuticals are not dependent on being able to penetrate the blood-brain barrier to elicit a therapeutic response. An estimated 98 percent of potential drug treatments for brain disorders are not able to penetrate the blood-brain barrier, according to BrainFacts.org and as a result limited options exist for patients with neurological diseases and disorders. Some disorders, like traumatic brain injury can result in a breakdown of the blood-brain barrier and result in a secondary injury, such as edema.
Thus, neuroinflammatory and central nervous system (CNS) diseases and disorders are a massive unmet opportunity with no effective treatments currently approved. Traumatic brain injury (TBI) is sustained from severe or mild damage to the brain tissue from accidents or assaults. According to the Centers for Disease Control and Prevention (CDC) over 1.7 million TBI's occur annually in the United States and TBI's are a contributing factor in about 30.5% of all injury-related deaths. The subsequent medical care costs of treating traumatic brain injuries exceed $70 billion.
ENDV also previously announced receiving a notice of allowance from the USPTO on a patent application titled, "Biological Molecules Produced by Electromagnetically Stimulating Living Mammalian Cells." The patent application covers the production of fully human biologics, including growth factors and cytokines in adult stem cells using the company's proprietary technologies. The notice of allowance concluded a substantive examination of the patent application and is expected to result in the issuance of a U.S. patent in the very near future.
According to Thomson Reuters, the biologics sector is set for an unprecedented level of activity as U.S. companies have rapidly increased their biologics development during the past five years. The market for next-generation biologics is estimated to reach a value of $30 billion by 2024, according to Visiongain. These next-generation biologics will seek to address shortcomings in current therapies, including inconvenient dosing and potential side-effects.
With ENDV trading at around 19 cents per share, this biotech looks to be undervalued and investors looking for attractive growth opportunities should take a second look.
AcelRx Pharmaceuticals, Inc (ACRX) a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, announced a clinical update of its two late-stage candidates ARX-04 and Zalviso. AcelRx completed enrollment of two Phase 3 studies for ARX-04. Pending successful results of its two Phase 3 studies, AcelRx anticipates submitting a New Drug Application (NDA) for the treatment of moderate-to-severe acute pain to the U.S. Food and Drug Administration (FDA) by the end of 2016.
Cytokinetics, Inc. (CYTK) a biopharmaceutical company focused on the discovery and development of small molecule therapeutics that modulate muscle function for the treatment of serious diseases and medical conditions, announced that it has expanded its collaboration with Astellas Pharma Inc. in skeletal muscle activators to include amyotrophic lateral sclerosis (ALS). Through that expansion, CYTK has granted Astellas an option right for the development and commercialization of tirasemtiv, and investigational skeletal muscle activator. Upon execution of the amended agreement, Cytokinetics will receive $65 million in committed capital from Astellas which includes upfront payments for Astellas' option right exercisable for tirasemtiv and amended terms of the companies' collaboration agreement to include ALS for CK-2127107. Cytokinetics and Astellas have also agreed on a development plan for CK-2127107 in ALS. Cytokinetics will receive approximately $30 million in additional sponsored research and development funding through 2017 which includes Astellas' sponsorship of Cytokinetics' conduct of the Phase 2 clinical development of CK-2127107 in ALS as well as the continuing research collaboration.
Innovus Pharmaceuticals, Inc (INNV) is an emerging leader in OTC and consumer products for men's and women's health and vitality. INNV has an upcoming FDA decision regarding the approval of the Fluticasone Propionate ANDA for FlutiCare™, which it has rights to market as an over-the-counter product worldwide. As a leading prescription brand with 40 million units sold in 2014, FlutiCare™ is capable of generating in excess of $100 million per year in revenue once full market penetration is achieved. FlutiCare™ would be competing with GlaxoSmithKline plc's (NYSE: GSK) Flonase®, which generated nearly $100 million in its first 16 weeks on the shelf, according to IRI figures. If the company is successfully in leveraging FlutiCare's™ prescription brand strength, it could become a viable competitor to Flonase® and others in the corticosteroid nasal spray market.
Repros Therapeutics Inc (RPRX) is a development stage biopharmaceutical company focused on the development of oral small molecule drugs for major unmet medical needs in male and female health. The Company's product candidates include enclomiphene, which is a single isomer of clomiphene citrate, an orally active small molecule compound, and Proellex, which is an orally administered selective blocker of the progesterone receptor in women, for the treatment of uterine fibroids and endometriosis. Enclomiphene is for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. The Company's Proellex product candidate for female reproductive health is a chemical entity, which acts as a selective blocker of the progesterone receptor. It is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis The Company has an active Investigational New Drug (IND) for the vaginal delivery of Proellex for the treatment of uterine fibroids.
Sangamo Biosciences, Inc. (SGMO) is a clinical stage biopharmaceutical company focused on the research, development and commercialization of engineered zinc finger DNA-binding proteins (ZFPs) as novel ZFP Therapeutics® targeting various monogenic and infectious diseases with unmet medical needs, announced a new gene therapy clinical development program for the treatment of Hemophilia A. Sangamo scientists presented preclinical data demonstrating high levels of Factor VIII protein expression from its proprietary therapeutic AAV cDNA construct at the World Federation of Hemophilia 2016 World Congress held in Orlando, Florida, from July 24 – 28, 2016.
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