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Biotech News

Biotech Marks Progress on Programs for Cancer, Infectious Diseases
August 15, 2018 (Investorideas.com Newswire) This firm, focused on immuno-oncology and infectious diseases including Ebola and Zika, is moving forward on a variety of fronts, according to a Maxim Group analyst.

For Black Women, Cigarette Smoking Linked with Increased Lupus Risk, and Moderate Alcohol Consumption with Decreased Risk
August 9, 2018 (Investorideas.com Newswire) In the United States, systemic lupus erythematosus affects Black women more frequently than people of any other race and sex.

Biopharma Signs Multimillion-Dollar Deal for Key Products in China
August 8, 2018 (Investorideas.com Newswire) An H.C. Wainwright & Co. report reviewed the arrangement.

Biotech Releases White Paper on Alzheimer's Disease Candidate
August 1, 2018 (Investorideas.com Newswire) A company focused on treatment of neurodegenerative diseases has issued a white paper discussing its lead candidate.

Cash Stream from Licensing Deal to Help Biopharma Advance Lead Drug
August 1, 2018 (Investorideas.com Newswire) A Laidlaw & Co. report discussed this firm's revenue and near-term, clinical catalysts.

Interim Readout for Pharma Trial 'Delivers Home Run'
August 1, 2018 (Investorideas.com Newswire) An H.C. Wainwright & Co. report discussed the implications of data indicating "overwhelming evidence of efficacy" for this company's nonantibiotic anti-infective for treatment of catheter-related bloodstream infections.

Biopharma Releases New Antibiotic in the US for Complicated UTIs
July 25, 2018 (Investorideas.com Newswire) A LifeSci Capital report reviewed why uptake of a drug that targets complicated urinary tract infections could be significant and swift.

Australian Regenerative Medicine Firm 'Lands a Great Partner in China'
July 23, 2018 (Investorideas.com Newswire) A Maxim Group report reviewed the deal between the two companies.

Cell Therapy Company and Chinese Firm Sign Marketing Deal
July 16, 2018 (Investorideas.com Newswire) This biotech, in Phase 1 development of regenerative technologies addressing skin and orthopedic indications, has finalized a commercialization deal with YOFOTO.

Preclinical Data for Alzheimer's Therapy to Be Presented at AAIC
July 11, 2018 (Investorideas.com Newswire) A poster outlining data from this company's lead candidate, which targets toxic oligomers identified as a potential cause of Alzheimer's disease, will be presented at the Alzheimer's Association International Conference (AAIC).

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Biotech Stock ETF's

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'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.

Biotech/ Pharma Stock Directory

Preview

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

Biotech News from Global Newswire

BioStem Technologies, Inc. Engages Maxim Group LLC For Strategic Advisory Services

Fort Lauderdale, FL, Aug. 15, 2018 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC: BSEM), (the “Company” or “BioStem Technologies”) a global life sciences corporation, providing innovative technologies with a concentration in Pharmaceuticals and Regenerative Medicine that exponentially improve, extend, and transform the quality of life for patients, announced today that it has engaged Maxim Group LLC (“Maxim”), a leading investment banking, securities and investment management firm, to provide strategic corporate planning and investment banking services to the Company. Maxim will focus on assisting BioStem Technologies with its strategies for maximizing shareholder value through its full scope of investment banking services.

Of the partnership, Jason Matuszewski, Chief Financial Officer of BioStem Technologies stated, “We are very pleased to have partnered with Maxim. Maxim is a well-established investment banking firm with a Reg A+ platform and strong capital-raising capabilities. We believe that Maxim’s Reg A+ platform and financing resources, combined with its ability to assist us on the front of strategic advisory, will benefit us greatly with the successful and efficient execution of our strategic growth plan. It is our desire that Maxim’s Reg A+ platform, and their financing capabilities in particular, will open up new doors for BioStem Technologies to take advantage of the numerous growth opportunities that are presenting themselves to us.”

Added Andrew Van Vurst, Chief Operating Officer of BioStem Technologies: “We look to continue our accelerated growth trajectory with multiple Investigational New Drugs and New Drug Applications in the pharmaceutical and biopharmaceutical sector, along with seeking strategic acquisitions that will help fortify our product portfolio and add multiple revenue verticals in the life science sector. We are very excited to work with Maxim as a key partner of our company.”

About Maxim Group LLC: Maxim Group LLC is a leading full-service investment banking, securities and wealth management firm headquartered in New York. Maxim provides a full array of financial services including investment banking; private wealth management; and global institutional equity, fixed income and derivative sales & trading, equity research and prime brokerage services to a diverse range of corporate clients, institutional investors and high net worth individuals. Maxim Group is a registered broker-dealer with the U.S. Securities and Exchange Commission and the Municipal Securities Rulemaking Board (MSRB), and is a member of the following: Financial Industry Regulatory Authority (FINRA), Securities Insurance Protection Corporation (SIPC), NASDAQ Stock Market and NYSE Arca, Inc. To learn more about Maxim Group, visit www.maximgrp.com.

About BioStem Technologies, Inc. (OTC PINK: BSEM): BioStem Technologies, Inc. is a global life sciences corporation, providing innovative technologies with a concentration in Pharmaceuticals and Regenerative Medicine. The Company’s mission is to discover, develop and produce the most effective Pharmaceutical and Regenerative Medicine products in the world. The Company is comprised of a diverse group of scientists, physicians, and entrepreneurs who collaborate to create innovative products. These technologies improve the Quality of Life for our patients and, as a result, drive shareholder value. 

Forward-Looking Statements: Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” include risks and uncertainties, and describe future expectations, plans, results, or strategies and are generally preceded by words such as “future,” “plan” or “planned,” “expects,” believe” or “projected.” These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the Company’s control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and additional risks factors as discussed in reports filed by the Company with OTC Markets. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to operations, results of operations, growth strategy and liquidity. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

CONTACT: BioStem Technologies, Inc.
Phone: 954-380-8342
Website: http://www.biostemtech.com
Email: info@biostemtech.com
Twitter: @Biostemtech
Facebook: BioStem Technologies

Investor Relations:
Andrew Van Vurst
info@biostemtech.com

ProQR to Present Interim Phase 1/2 Results for QR-110 in Leber’s Congenital Amaurosis 10 at the Symposium for Retinal Degeneration on Sept. 5th

Presentation at the 18th International Symposium on Retinal Degeneration (RD2018) at 8:30 am GMT on Sept. 5th

Investor conference call to be held at 8:15 am ET on Sept. 5th

LEIDEN, The Netherlands and CAMBRIDGE, Mass., Aug. 15, 2018 (GLOBE NEWSWIRE) -- ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced it will issue data from a planned interim analysis in the ongoing Phase 1/2 clinical trial of QR-110 in patients with Leber’s congenital amaurosis 10 (LCA10) due to the p.Cys998X mutation (the PQ-110-001 trial) at the 18th International Symposium on Retinal Degeneration (RD2018), which is being held on Sept. 3-8, 2018 in Killarney, Ireland.

 
Presentation Details:
Presentation title:  Intravitreal Antisense Oligonucleotide Therapy (QR‐110) for the Treatment of
Leber Congenital Amaurosis due to Photoreceptor Cilium Defect in Subjects
with the CEP290 p.Cys998X Mutation
Presenter:  Dr. Artur Cideciyan, Research Professor of Ophthalmology at the Scheie Eye Institute,
University of Pennsylvania and investigator of the PQ-110-001 trial
Date and Time:  Wednesday, Sept. 5, 2018 at 8:30 am GMT
Session Details:  Platform Session V: Drug Therapy
   

Investor conference call

Management will also host a conference call for its investors to discuss the presented interim Phase 1/2 data on Wednesday, Sept. 5, 2018 starting at 8:15 am ET. Details for the call will be included in a press release the same day and will be made available in the “Investors” section of ProQR’s website (www.proqr.com) under “Events and Presentations”.

About PQ-110-001 trial

PQ-110-001 is an open-label trial that has been designed to enroll approximately six children (age 6 - 17 years) and six adults (≥ 18 years) who have LCA10 due to one or two copies of the p.Cys998X mutation in the CEP290 gene. Patients are receiving four intravitreal injections of QR-110 into one eye; once every three months. The trial is being conducted at three specialized centers with significant expertise in genetic retinal disease: the University of Iowa, Iowa City, IA, US, the Scheie Eye Institute at the University of Pennsylvania, Philadelphia, PA, US and the Ghent University Hospital, Ghent, Belgium.

The primary objectives of the trial are safety and tolerability. Secondary objectives include pharmacokinetics as well as restoration/improvement of visual function and retinal structure through ophthalmic endpoints such as visual acuity, full field stimulus testing (FST), optical coherence tomography (OCT), pupillary light reflex (PLR), mobility course and fixation stability. Changes in quality of life in the trial subjects are also being evaluated.

About Leber’s Congenital Amaurosis 10

Leber’s congenital amaurosis (LCA) is the most common cause of blindness due to genetic disease in children and consists of a group of diseases of which LCA 10 is one of the more severe forms. LCA10 is caused by mutations in the CEP290 gene, of which the p.Cys998X mutation is the most common. LCA10 leads to early loss of vision causing most people to lose their sight in the first few years of life. To date, there are no treatments approved or other products in clinical development that treat the underlying cause of the disease. Approximately 2,000 people in the Western world have LCA10 because of this mutation.

About QR-110

QR-110 is a first-in-class investigational RNA-based oligonucleotide designed to address the underlying cause of Leber’s congenital amaurosis 10 due to the p.Cys998X mutation in the CEP290 gene. The p.Cys998X mutation is a substitution of one nucleotide in the pre-mRNA that leads to aberrant splicing of the mRNA and non-functional CEP290 protein. QR-110 is designed to restore wild-type CEP290 mRNA leading to the production of wild-type CEP290 protein by binding to the mutated location in the pre-mRNA causing normal splicing of the pre-mRNA. QR-110 is intended to be administered through intravitreal injections in the eye and has been granted orphan drug designation in the United States and the European Union and fast track status by the FDA.

About ProQR

ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases such as Leber’s congenital amaurosis 10, dystrophic epidermolysis bullosa and cystic fibrosis. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.
*Since 2012*

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Such statements include those relating to the RD2018 presentation, QR-110 and the PQ-110-001 trial, as well as our clinical development plans for and therapeutic potential of our product candidates. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain sections of our annual report filed on Form 20-F. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

ProQR Therapeutics N.V.:
Smital Shah
Chief Financial Officer
T: +1 415 231 6431
ir@proqr.com

 

Mundipharma brings its cancer supportive care expertise to Vietnam after signing agreement with Helsinn Group for ALOXI® (palonosetron HCl) 

Mundipharma brings its cancer supportive care expertise to Vietnam after signing agreement with Helsinn Group for ALOXI® (palonosetron HCl) 

  • Mundipharma and Helsinn Group expand exclusive licensing and distribution agreement for anti-emetic medicine ALOXI®
  • This agreement builds on similar existing arrangements in a range of territories.

SINGAPORE and LUGANO, August 15, 2018: Mundipharma and Helsinn Group signed a licensing and distribution agreement for the anti-emetic agent ALOXI® in Vietnam, extending an international collaboration.

ALOXI® (palonosetron hydrochloride), a 5-HT3 receptor antagonist was approved in Vietnam. For additional information please see the Product Information.

Chemotherapy-Induced Nausea and Vomiting (CINV) is one of the most common and distressing side effects of cancer chemotherapy. Mundipharma and Helsinn are experts in the CINV field with decades of shared experience and are currently providing medicine to CINV sufferers.

Mundipharma CEO, Raman Singh said, “This important extension of our portfolio in Vietnam offers relief to patients suffering from the side effects of chemotherapy and enables patients and healthcare providers to benefit from our expertise in this area.”

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “Helsinn and Mundipharma have an effective, longstanding partnership and Mundipharma successfully markets, promotes and distributes a number of our products across a range of territories.
We’re delighted to be able to extend this relationship through this agreement.”

ENDS

About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco, and China, as well as a product presence in approximately 190 countries globally.

For more information, please visit www.helsinn.com

About Mundipharma
Mundipharma is a network of independent associated companies, which are privately owned entities, covering pharmaceutical markets in Asia-Pacific, Latin America, the Middle East and Africa. The headquarters for these territories is in Singapore. Mundipharma consistently delivers high-quality medicines while standing by the values it represents. Its mission is to alleviate the suffering of patients and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients the benefit of novel treatment options in fields such as pain, oncology, oncology supportive care, ophthalmology, respiratory disease and consumer healthcare.

For further information, please contact:

Helsinn Group Media Contact

Paola Bonvicini
Group Head of Communication
Lugano, Switzerland
Tel: +41 (0) 91 985 21 21

Info-hhc@helsinn.com

For more information, please visit www.helsinn.com and follow us on Twitter, LinkedIn and Vimeo

Mundipharma:
Stephenie Vasko
Head of Communications & Digital Strategy – Asia Pacific, Middle East, Africa & Latin America
+65-6303-9732 | stephenie.vasko@mundipharma.com.sg

Organovo Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

SAN DIEGO, Aug. 14, 2018 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo” or the “Company”) announced the grant of inducement awards on August 14, 2018 to Dr. Steven G. Hughes, its new chief medical officer.  The inducement awards were approved by the compensation committee of the Company’s board of directors and issued as a material inducement to Dr. Hughes agreeing to join the Company in accordance with NASDAQ Listing Rule 5635(c)(4).

Pursuant to the terms of his offer letter, Dr. Hughes received a stock option to purchase 974,694 shares of Organovo’s common stock (the “Stock Option”) and a restricted stock unit award for 160,714 shares of common stock (the “RSU”).  The Stock Option has an exercise price of $1.12 per share, which is equal to the closing price of Organovo’s common stock on August 14, 2018.  One-fourth of the option shares and RSU grant will vest on August 15, 2019, and the remaining option and RSU shares will vest on a quarterly basis over the subsequent three years, subject to Dr. Hughes’ continuous service through the applicable vesting date.  The Stock Option and RSU both have ten-year terms.  While the Stock Option and RSU were issued as inducement grants outside of the Company’s 2012 Equity Incentive Plan (the “Plan”), the terms and conditions applicable to the Stock Option and RSU’s will be consistent with the Plan, the stock option and restricted stock unit awards previously granted to the Company’s executive officers under the Plan and the Company’s Severance and Change in Control Plan. 

About Organovo Holdings, Inc.
Organovo is a biotech platform company that has developed a leadership position with its revolutionary ability to 3D bioprint tissues with human functionality.  The Company is pursuing multiple IND-track programs to develop its NovoTissues® to address a number of serious unmet medical needs in adult and pediatric populations, initially focusing on liver disease.  Organovo’s first IND-track program for Alpha-1-antitrypsin deficiency recently received orphan drug designation from the FDA, and the Company expects to file its first IND in 2020.  In order to help fund its plan to initiate multiple IND-track programs, the Company is providing access to its ExVive™ in vitro tissue disease modeling platform to facilitate high value drug discovery and development collaborations.  Organovo’s wholly-owned subsidiary, Samsara Sciences, provides the Company and its clients with high quality human liver and kidney cells for research applications.  Organovo is changing the shape of life science research and transforming medical care.  Learn more at www.organovo.com.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties.  Forward-looking statements include, but are not limited to, statements regarding the potential benefits and therapeutic uses of the Company’s therapeutic liver tissue, including the benefits of an orphan designation; the Company’s expectations regarding the FDA regulatory pathway and anticipated timelines for its regulatory filings; the potential market opportunity for the Company’s therapeutic tissue candidates; and customer demand for and acceptance of our disease modeling and other in vitro tissue platforms.  The factors that could cause the Company's actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the possibility that the final results of the Company's preclinical studies may be different from the Company's studies or interim preclinical data results and may not support further clinical development of its therapeutic tissues; the Company may not successfully complete the required preclinical and clinical trials required to obtain regulatory approval for its therapeutic tissues on a timely basis or at all; risks that competitive products may adversely impact the market opportunity for the Company’s therapeutic tissue candidates; the Company's ability to develop, market and sell products and services based on its technology; the expected benefits and efficacy of the Company's products, services and technology; the Company’s ability to execute framework agreements involving multi-year commitments and routine use on a timely basis, or at all; the Company’s ability to successfully complete studies and provide the technical information required to support market acceptance of its products, services and technology, on a timely basis or at all; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies, including its use of third party distributors; the Company’s ability to recognize deferred revenue; and the Company’s ability to meet its fiscal-year 2019 goals and outlook. These and other factors are identified and described in more detail in the Company's filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on May 31, 2018. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances or to reflect the occurrence of unanticipated events. 

CONTACT: Investor & Press Contact:

Steve Kunszabo         
Organovo Holdings, Inc.
+1 (858) 224-1092
skunszabo@organovo.com

RedHill Biopharma Announces Closing of $25 Million Underwritten Offering

TEL-AVIV, Israel and RALEIGH, N.C., Aug. 14, 2018 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today announced the closing of its previously announced underwritten offering of 4,166,667 American Depositary Shares (“ADSs”), each representing ten of its ordinary shares, at an offering price of $6.00 per ADS, for gross proceeds of approximately $25 million, before commissions and other offering expenses.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American: LTS), acted as the sole book-running manager for the offering.

The Company intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund clinical development programs, including preparations for a second Phase III study with RHB-104 for Crohn’s disease, initiation of a pivotal Phase III study with RHB-204 for NTM, for commercial operations including TALICIA® (H. pylori) launch preparations, acquisitions, and general corporate purposes.

The ADSs described above were issued pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on July 31, 2018. A final prospectus supplement and accompanying prospectus related to the offering was filed with the SEC and is available on the SEC’s website located at www.sec.gov. This offering was made only by means of a prospectus. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172, by calling (212) 409-2000.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About RedHill Biopharma Ltd.:     
RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company, primarily focused on the development and commercialization of late clinical-stage, proprietary drugs for the treatment of gastrointestinal diseases. RedHill commercializes and promotes four gastrointestinal products in the U.S.: Donnatal® - a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; Mytesi® - an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy; Esomeprazole Strontium Delayed-Release Capsules 49.3 mg - a prescription proton pump inhibitor indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal conditions, and EnteraGam® - a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s key clinical-stage development programs include: (i) TALICIA® (RHB-105) for the treatment of Helicobacter pylori infection with an ongoing confirmatory Phase III study and positive results from a first Phase III study; (ii) RHB-104, with positive top-line results from a first Phase III study for Crohn's disease; (iii) RHB-204, with a planned pivotal Phase III study for nontuberculous mycobacteria (NTM) infections; (iv) BEKINDA® (RHB-102), with positive results from a Phase III study for acute gastroenteritis and gastritis and positive results from a Phase II study for IBS-D; (v) YELIVA® (ABC294640), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase IIa study for cholangiocarcinoma; (vi) RHB-106, an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vii) RHB-107 (formerly MESUPRON), a Phase II-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully promote Donnatal®, Mytesi® and Esomeprazole Strontium Delayed-Release Capsules 49.3 mg and commercialize EnteraGam®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 22, 2018. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.

CONTACT: Company contact:
Adi Frish
Senior VP Business Development & Licensing 
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

IR contact (U.S.): 
Timothy McCarthy, CFA, MBA
Managing Director, Relationship Manager
LifeSci Advisors, LLC
+1-212-915-2564
tim@lifesciadvisors.com

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