Cell Therapy Company and Chinese Firm Sign Marketing Deal
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When It Comes to Weight Loss in Overweight and Obese Adults with Knee Osteoarthritis, More is Better
First Trust NYSE Arca Biotech ETF ( NYSEArca: FBT ) The investment seeks investment results that correspond generally to the price and yield (before the fund's fees and expenses) of an equity index called the NYSE Arca Biotechnology Index(SM). The fund will normally invest at least 90% of its net assets plus the amount of any borrowings for investment purposes in common stocks that comprise the index. The index is an equal-dollar weighted index designed to measure the performance of a cross section of companies in the biotechnology industry that are primarily involved in the use of biological processes to develop products or provide services. The fund is non-diversified.
iShares US Healthcare ( NYSEArca: IYH ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Health Care Index (the "underlying index"), which measures the performance of the healthcare sector of the U.S. equity market. The fund is non-diversified.
iShares US Healthcare Providers ( NYSEArca: IHF ) The investment seeks to track the investment results of an index composed of U.S. equities in the healthcare providers sector. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. It seeks to track the investment results of the Dow Jones U.S. Select Health Care Providers Index (the "underlying index"), which measures the performance of the healthcare providers sector of the U.S. equity market. The fund is non-diversified.
iShares US Medical Devices ( NYSEArca: IHI ) The investment seeks to track the investment results of an index composed of U.S. equities in the medical devices sector. The fund seeks to track the investment results of the Dow Jones U.S. Select Medical Equipment Index (the "underlying index"), which measures the performance of the medical equipment sector of the U.S. equity market. The underlying index includes medical equipment companies such as manufacturers and distributors of medical devices such as magnetic resonance imaging (MRI) scanners, prosthetics, pacemakers, X-ray machines, and other non-disposable medical devices. The fund is non-diversified.
iShares Nasdaq Biotechnology ( NasdaqGIDS IBB ) The investment seeks to track the investment results of an index composed of biotechnology and pharmaceutical equities listed on the NASDAQ. The fund generally invests at least 90% of its assets in securities of the underlying index and in depositary receipts representing securities of the underlying index. The underlying index contains securities of NASDAQ® listed companies that are classified according to the Industry Classification Benchmark as either biotechnology or pharmaceuticals and that also meet other eligibility criteria determined by the NASDAQ OMX Group, Inc. The fund is non-diversified.
Market Vectors Biotech ETF ( NYSE MKT:BBH ) seeks to replicate as closely as possible, before fees and expenses, the price and yield performance of the Market Vectors® US Listed Biotech 25 Index. The fund normally invests at least 80% of its total assets in securities that comprise the fund&#39;s benchmark index. The Biotech Index is comprised of common stocks and depositary receipts of U.S. exchange-listed companies in the biotechnology sector. Such companies may include medium-capitalization companies and foreign companies that are listed on a U.S. exchange. It is non-diversified.
PowerShares Dynamic Biotech & Genome ETF ( NYSEArca: PBE ) The investment seeks investment results that generally correspond (before fees and expenses) to the price and yield of the Dynamic Biotechnology & Genome IntellidexSM Index. The fund generally will invest at least 90% of its total assets in common stocks of biotechnology companies and genome companies that comprise the underlying intellidex. The underlying intellidex was composed of common stocks of 30 U.S. biotechnology and genome companies. These companies are engaged principally in the research, development, manufacture and marketing and distribution of various biotechnological products, services and processes, etc. It is non-diversified.
4SC (XETRA: VSC.DE) is an innovative biotech company with a strong focus on clinical development. We discover and develop targeted small molecule drugs with an epigenetic mode of action for the treatment of cancer in indications with a high unmet medical need and major economic potential.
Aastrom Biosciences, Inc. (NasdaqCM: ASTM) is the leader in developing patient-specific expanded cellular therapies for use in the treatment of patients with severe diseases and conditions. Aastrom markets two autologous cell therapy products in the United States for the treatment of cartilage repair and skin replacement. Aastrom is also developing MACI(TM), a third-generation autologous chondrocyte implant for the treatment of cartilage defects in the knee, and ixmyelocel-T, a patient-specific multicellular therapy for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy.
ABBOTT LABORATORIES (NYSE: ABT) is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 69,000 people.76
Abeona Therapeutics Inc. (NasdaqCM:ABEO) develops and delivers gene therapy and plasma-based products for severe and life-threatening rare diseases. Abeona's lead programs are AB0-101 (AAV NAGLU) and ABO-102 (AAV SGSH), adeno-associated virus (AAV)-based gene therapies for Sanfilippo syndrome (MPS IIIB and IIIA). We are also developing ABO-201 (AAV CLN3) gene therapy for juvenile Batten disease (JBD); and ABO-301 (AAV FANCC) for Fanconi anemia (FA) disorder using a novel CRISPR/Cas9-based gene editing approach to gene therapy program for rare blood diseases. In addition, we are also developing rare plasma protein therapies including SDF Alpha™ (alpha-1 protease inhibitor) for inherited COPD using our proprietary SDF™ (Salt Diafiltration) ethanol-free process.
Ablynx (Brussels: ABLX.BR) is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, thrombosis, oncology and pulmonary disease.
Acadia Pharmaceuticals Inc. (NasdaqGS: ACAD) is a biopharmaceutical company focused on the development and commercialization of innovative medicines that address unmet medical needs in neurological and related central nervous system disorders. ACADIA has a pipeline of product candidates led by pimavanserin, for which we have reported positive Phase III trial results in Parkinson's disease psychosis and which has the potential to be the first drug approved in the United States for this disorder. We are currently completing NDA-enabling clinical and manufacturing activities for pimavanserin and are planning to submit an NDA with the FDA near the end of 2014. Pimavanserin is also in Phase II development for Alzheimer's disease psychosis and has successfully completed a Phase II trial in schizophrenia. ACADIA also has clinical-stage programs for chronic pain and glaucoma in collaboration with Allergan, Inc. and two preclinical programs directed at Parkinson's disease and other neurological disorders. All product candidates are small molecules that emanate from internal discoveries.
Access Pharmaceuticals, Inc. (OTC:ACCP) is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access developed MuGard and ProctiGard and is developing multiple follow-on products. Access also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.
AcelRx Pharmaceuticals, Inc. (NasdaqGM:ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. The Company's late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg), designed for the treatment of moderate-to-severe acute pain in medically supervised settings; and Zalviso® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU as well as Norway, Iceland, and Liechtenstein and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx retains all other world-wide rights.
Acorda Therapeutics, Inc. (NasdaqGS:ACOR) is a biotechnology company focused on developing therapies that improve the lives of people with neurological disorders. Acorda markets three FDA-approved therapies including: AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve walking in patients with multiple sclerosis (MS); ZANAFLEX CAPSULES® (tizanidine hydrochloride) and Zanaflex tablets, a short-acting drug for the management of spasticity; and QUTENZA® (capsaicin) 8% Patch, for the management of neuropathic pain associated with postherpetic neuralgia. AMPYRA is marketed outside the United States as FAMPYRA® (prolonged-release fampridine tablets) by Biogen Idec under a licensing agreement from Acorda. Acorda has one of the leading pipelines in the industry of novel neurological therapies. The Company is currently developing six clinical-stage therapies and one preclinical stage therapy that address a range of disorders including post-stroke deficits, epilepsy, stroke, peripheral nerve damage, spinal cord injury, neuropathic pain, and heart failure.
Acrux Limited (ASX:ACR.AX) is a dynamic Australian drug delivery business developing and commercialising a range of patient-preferred pharmaceutical products for global markets, using innovative, patented technology to administer drugs through the skin. Fast drying, non-occlusive topical sprays or liquids provide an enhanced transdermal delivery platform with low or no skin irritation, superior cosmetic acceptability, and simple, accurate and flexible dosing.See the full stock directory here
Research to Explore Potential for CAP-2003 to Address Trauma-related Injuries
LOS ANGELES, July 17, 2018 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ:CAPR) today announced it has entered into an agreement with the U.S. Army Institute of Surgical Research (USAISR) to study the potential for the company’s next-generation investigational therapeutic platform, designated CAP-2003, which represents extracelluar vesicles (e.g., exosomes and microvesicles) to address a wide spectrum of trauma-related injuries and conditions, which are now the third leading cause of death in the U.S.
CAP-2003 is derived from Capricor’s proprietary cardiosphere-derived cells (CDCs), which comprise adult cardiac progenitor cells from donor heart tissue. CAP-2003 has shown promising results in various pre-clinical experiments using established animal models of diseases by exerting anti-inflammatory, anti-fibrotic, pro-angiogenic, and anti-apoptotic effects.
“In developing CAP-2003, Capricor has distilled the active pharmaceutical ingredient (API) of the cells and created a therapeutic that may be easier to use than cell-based therapeutics,” said Linda Marbán, Ph.D., Capricor president and CEO. “CAP-2003 doesn’t require refrigeration or special handling, potentially making it well suited for treating and stabilizing injured soldiers in the field, potentially improving their chances of surviving until they can be transported and receive treatment at medical facilities.”
USAISR entered into the collaboration with Capricor after determining cell-free therapies offer great promise for treating conditions that contribute to soldier morbidity and mortality. Capricor will provide CAP-2003 for testing of function, potency and safety for eventual use in therapeutic indications. Because this is potentially a very important clinical use of CAP-2003, Capricor will work closely with USAISR on its studies and in publishing results of those studies in peer-reviewed journals.
“We were very pleased to enter into this collaboration with Capricor and look forward to studying the utility and delivery of exosomes for trauma-related injuries that soldiers experience on the battlefield,” said James Bynum, Ph.D., USAISR principal investigator. “One of the goals of this collaboration is to test whether CAP-2003 will provide a useful tool on the battlefield to stabilize injured soldiers while they wait for transport to a medical facility. If we can achieve this goal, we will be able to potentially make a meaningful difference in the preservation of life. One of the reasons exosomes are so exciting as a potential therapeutic is their stability, which may allow them to be carried in a medic’s pack and deployed immediately. This is in contrast to earlier cell-based therapies where the necessity of a frozen product prevented easy access. This could be the beginning of a completely new therapeutic paradigm in stabilizing injured warriors.”
The exosomes produced by the CDCs are quantitatively different in terms of contents compared to mesenchymal stem cells (MSC) and other types of exosomes. Preclinical studies suggest that CAP-2003 might lead to different and perhaps augmented clinical benefit when directly compared to other types of exosomes.
“This collaboration will provide the much-needed standardization of extracellular vesicle production, usage and identification for this rapidly growing field, further positioning us as one of the leaders in the development of therapeutic exosomes,” said Dr. Marbán. “This endeavor stands to open up a new arena in biotechnology, where the benefits of cells can be distilled down to the API now known to be extracellular vesicles. Our work with USAISR is also important for the further development of our CAP-2003 technology because if it proves to be promising, we will work on developing large-scale manufacturing as well as clinical development as a result of it.”
About Capricor Therapeutics
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings, and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2017 as filed with the Securities and Exchange Commission on March 22, 2018, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, together with the prospectus included therein and prospectus supplements thereto and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the Securities and Exchange Commission on May 14, 2018. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.
CAP-1002 is an Investigational New Drug and is not approved for any indications. CAP-2003 has not yet been approved for clinical investigation.
CONTACT: For more information, please contact: AJ Bergmann, Chief Financial Officer +1-310-358-3200 firstname.lastname@example.org
SEATTLE, July 16, 2018 (GLOBE NEWSWIRE) -- Nohla Therapeutics, a leading developer of universal, off-the-shelf cell therapies for patients with hematologic malignancies and other critical diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Nohla’s lead product candidate, dilanubicel (NLA101), Orphan Drug Designation for reduction of morbidity and mortality associated with hematopoietic stem cell transplant (HSCT). Dilanubicel received Orphan Drug Designation from the European Commission in January 2018.
Under the Orphan Drug Act of 1983, the FDA provides incentives for companies developing treatments that are expected to provide significant therapeutic advantage over existing treatments, and that target rare medical conditions affecting fewer than 200,000 U.S. patients per year. Incentives include seven-year market exclusivity, tax credits on U.S. clinical trials, fast-tracking of regulatory proceedings, exemption from certain fees, such as waiver of filing fees under the Prescription Drug User Fee Act (PDUFA), and orphan drug grants.
“Dilanubicel has shown encouraging initial activity as a novel cell therapy in patients with hematologic malignancies receiving a cord blood transplant,” said Katie Fanning, President and CEO of Nohla Therapeutics. “We believe the addition of dilanubicel has the potential to make a meaningful difference for these patients and we look forward to having the top-line results from the fully enrolled randomized Phase 2b trial later this year.”
The dilanubicel FDA Orphan Drug Designation was supported by efficacy and safety data from a Phase 2 single arm study in patients with hematologic malignancies who underwent a myeloablative cord blood transplant. The results of this study demonstrated that infusion of dilanubicel was safe and led to faster neutrophil and platelet recovery with excellent long-term survival when compared to a separate control group. In addition, dilanubicel-treated patients experienced no severe acute Graft-versus-Host Disease (GVHD) and no transplant-related mortality.
Dilanubicel is a universal donor, off-the-shelf, ex vivo expanded hematopoietic stem and progenitor cell investigational product intended to provide rapid, transient hematopoiesis with long-term immunologic benefits. Unlike autologous or patient-specific allogeneic cell therapies, dilanubicel does not require Human Leukocyte Antigen (HLA) tissue matching. Intentionally developed to provide short-term, temporary bone marrow function until a patient’s immune system recovers, dilanubicel may also induce long-term immunologic benefits with the potential for improved survival. Dilanubicel is manufactured ahead of time, cryopreserved, and intended for immediate off-the-shelf use.
About Nohla Therapeutics
Sunnyvale, July 16, 2018 (GLOBE NEWSWIRE) -- July 16, 2018 - Sunnyvale, CA – Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, announces the sale of clinical instrumentation to the United States Food and Drug Administration (FDA). Arrayit uses the same clinical instrumentation in its Clinical Laboratory Improvement Amendments (CLIA) laboratory licensed by the Centers for Medicare and Medicaid Services (CMS) and the State of California Department of Public Health (CDPH). The instrumentation reads and reports test results for the company’s allergy and dietary wellness tests and pipeline tests for ovarian cancer and Parkinson’s Disease (PD).
Arrayit recently scored 100% on immunoglobulin E (IgE) proficiency testing with the College of American Pathologists, announced a nationwide sales network of 1,700 professional sales representatives to sell and distribute the company’s finger stick tests, and completed pilot testing with one the nation’s largest chains of retail stores. Arrayit microarray tests conveniently use a few drops of blood collected on a blood card to assist doctors in identifying and treating allergy, asthma, dietary intolerance and pipeline indications for ovarian cancer and PD. The company recently met with top officials at the FDA to discuss FDA approval of a major product line. The FDA ensures the safety of food, drugs and medical devices by regulating consumer products exceeding $1,000,000,000,000 ($1 trillion) in annual revenues.
Arrayit CEO Rene Schena states, “The sale of clinical instrumentation to the FDA advances our personalized medicine initiatives by strengthening ties with the nation’s preeminent regulatory agency. Our transformative healthcare products and services benefit from transparency in the hands of top FDA scientists.”
Safe Harbor Statement
CONTACT: CONTACT Public Relations Arrayit Corporation Tel: 408-744-1331 Email: email@example.com Web: www.arrayit.com
Company Release no. 13/2018
To: NASDAQ Copenhagen A/S
Copenhagen, Denmark, 13 July 2018
Veloxis Pharmaceuticals A/S Grants Warrants Under Existing Warrant Program
Today, the Board of Directors of Veloxis Pharmaceuticals A/S has decided to issue and grant warrants to current employees of the Company under the existing Warrant Program covered by the authority under section 5E of the Company's Articles of Association. Thus, the Board of Directors of the Company has today partly exercised its authorization pursuant to the Articles of Association.
The purpose of the grant of warrants is to reflect the Company's objective to incentivize long-term shareholder value creation. The grant of warrants shall ensure to create - both in the short and in the long run - common interests between employees and the shareholders of the Company.
A total of 3,700,000 warrants have been issued, giving the right to subscribe for up to 3,700,000 shares of nominally DKK 0.1 each. The exercise price is fixed at DKK 0.91.
The warrant holders earn the right to exercise the warrants with 1/36 vesting each month as from the date of grant, 13 July 2018. Warrants which are not exercised on 13 July 2025 expire automatically.
The issued warrants are estimated to have a total market value of USD 217,780. The market value of the issued warrants is calculated on basis of the Black-Scholes model with a volatility calculated as 52%, an interest level of 0.32% and a share price of DKK 0.91.
For more information, please contact:
Craig A. Collard
About Veloxis Pharmaceuticals
Veloxis Pharmaceuticals A/S is a commercial-stage specialty pharmaceutical company committed to improving the lives of transplant patients. A Danish company, Veloxis Pharmaceuticals A/S operates in the U.S. through Veloxis Pharmaceuticals Inc., a wholly-owned subsidiary headquartered in Cary, North Carolina, USA. Veloxis has successfully developed Envarsus XR (tacrolimus extended-release tablets) based upon the company's unique and patented delivery technology, MeltDose®, which is designed to enhance the absorption and bioavailability of select orally administered drugs. The company is focused on the direct commercialization of Envarsus XR in the U.S., expansion of partnerships for markets around the world, and acquisition of assets utilized in transplant patients and by adjacent medical specialties. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO. For further information, please visit www.veloxis.com.
SOUTH SAN FRANCISCO, Calif., July 12, 2018 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that it is scheduled to report second quarter results on July 26, 2018 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.
The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9599438.
An archived replay of the webcast will be available via Cytokinetics’ website until August 2, 2018. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9599438 from July 26, 2018 at 7:30 PM Eastern Time until August 2, 2018.
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to increase muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (“Amgen”) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of GALACTIC-HF, an international Phase 3 clinical trial in patients with heart failure. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is collaborating with Astellas Pharma Inc. (“Astellas”) to develop reldesemtiv, a next-generation FSTA. Reldesemtiv has been granted orphan drug designation by the FDA for the potential treatment of spinal muscular atrophy. Reldesemtiv was the subject of a positive Phase 2 clinical study in patients with spinal muscular atrophy which showed increases in measures of endurance and stamina consistent with the mechanism of action. Reldesemtiv is currently the subject of two ongoing Phase 2 clinical trials in patients with chronic obstructive pulmonary disease and amyotrophic lateral sclerosis. Astellas is also conducting a Phase 1b clinical trial of reldesemtiv in elderly adults with limited mobility. Astellas holds an exclusive worldwide license to develop and commercialize reldesemtiv. Licenses held by Amgen and Astellas are subject to Cytokinetics' specified co-development and co-commercialization rights. Cytokinetics continues its 20-year history of innovation with three new muscle biology directed compounds advancing from research to development in 2018. For additional information about Cytokinetics, visit www.cytokinetics.com.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities of Cytokinetics’ product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics' business outlined in Cytokinetics' filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
February 13, 2018 (Investorideas.com Newswire) Medical malpractice affects thousands of individuals around the world. If you think you have been injured, or wrongfully treated by a medical professional, you may be entitled to compensation.