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Biotech News

Oncology Vaccine Developer's Lead Programs 'On Track or Better'
May 23, 2019 (Investorideas.com Newswire) The biopharma's two assets are discussed and Q1/19 financial results are provided in a BTIG research report.

U.S. Biopharma's 'Biggest Stock Moving Event' Imminent
May 23, 2019 (Investorideas.com Newswire) With study results from this company due out shortly, an analysis of the possible outcomes was provided in a ROTH Capital Partners report.

Immuno-oncology Firm to Co-Develop Companion Diagnostic for Cervical Dysplasia
May 23, 2019 (Investorideas.com Newswire) The partnership news and upcoming data readouts are reviewed in an H.C. Wainwright & Co. report.

FDA Approval of Antibiotic for Bacterial Pneumonia Expected in Late Summer
May 17, 2019 (Investorideas.com Newswire) An update on this biopharma's two lead drug candidate programs was provided in an H.C. Wainwright report.

Why Did ImmunoGen Plummet 32%?
May 17, 2019 (Investorideas.com Newswire) This biotechnology company, which focuses on the treatment of cancer, received some feedback from the FDA that upset investors on Wednesday.

Pharma stocks: Biocure (CSE: CURE) (OTCQB: BICTF) Enters into Exclusive Joint R&D Agreement with Pharos Vaccine Inc. for Overseas Market of CAR T-Cell Products
Vancouver, British Columbia - May 16, 2019 (Newsfile Corp.) (Investorideas.com Newswire) Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (formerly Gravis Energy Corp.) (the "Company" or "Biocure") is pleased to announce that Biocure Pharm Corp.("BPK"), a subsidiary of the Company has entered into an agreement with Pharos Vaccine Inc. for the development of overseas market of CAR T-cell products on exclusive basis.

Trial Milestone Reached; U.K.-Based Biopharma Gets $15 Million
May 9, 2019 (Investorideas.com Newswire) The first patient has been treated in the second cohort of a Phase 2 study of a gene therapy targeting Parkinson's disease, explained an H.C. Wainwright & Co. report.

Shares of Plant-Based Meat Company Spike 53% (and It's Not Beyond Meat)
May 7, 2019 (Investorideas.com Newswire) This small-cap nutrascience stock hit a new 52-week high on May 6th, extending a run that has the stock up 147% over a five-day period.

US and Canada Clinical Laboratories to Strike the 100 Billion Market Cap
Santa Clara, Calif. - May 6, 2019 (Investorideas.com Newswire) The growing trend of decentralization has expanded the scope of testing beyond the traditional laboratory environment.

'Pivotal Topline Up Next' for Biotech's Phase 3 Cardiac Clinical Trial
May 2, 2019 (Investorideas.com Newswire) A study update and the next steps to advance the therapeutic were covered in a ROTH Capital Partners report.

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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 News from Newsfile

Beleave Receives Approval for Hamilton Facility Expansion from City Council

Beleave will add roughly 100,000 sq. ft. for cannabis extraction, processing, and cultivation.

Toronto, Ontario--(Newsfile Corp. - May 23, 2019) - Beleave Inc. (CSE: BE) (OTCQX: BLEVF) ("Beleave" or the "Company") is ready to move forward with the long-awaited expansion of its Hamilton facility after receiving approval from the Hamilton City Council.Last Tuesday, the Planning Committee unanimously authorized Beleave's request to rezone the Hamilton facility and allowed the application to proceed forward to last night's vote which marks the final step in the approval process and was ...

Vivera Pharmaceuticals Names Mr. Fred Jamee Vice President of Regulatory and Compliance
Newport Beach, California--(Newsfile Corp. - May 22, 2019) - Vivera Pharmaceuticals, Inc., a pharmaceutical company focused on non-addictive pain management, today announces the appointment of Mr. Fred Jamee as the Company's Vice President of Regulatory and Compliance. Within this role, Mr. Jamee will ensure Vivera meets and exceeds all compliance standards mandated by industry regulations and best practices."I was attracted to Vivera's mission of focusing on non-addictive therapies for patients," said Mr. Jamee. "I've been ...

PreveCeutical Granted Approval to Acquire and Use Human Mucosal Tissue for Final Phase of Sol-Gel Program
Vancouver, British Columbia--(Newsfile Corp. - May 21, 2019) - PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H) (the "Company" or "PreveCeutical"), announces that the Company's research team at the University of Queensland has been granted the necessary approvals from a local hospital's Human Ethics Committee to acquire and use human nasal mucosal tissue (mucosal membrane) for the final phase of the cannabinoid-based, soluble gel ("Sol-gel") drug delivery research and development program (the "Sol-gel Program"). ...

Vivera Pharmaceuticals' TVIA Kit Featured in AJ McLean's Hit Music Video 'Boy and a Man'
Newport Beach, California--(Newsfile Corp. - May 16, 2019) - Vivera Pharmaceuticals, Inc., a pharmaceutical company focused on non-addictive pain management, today announces the appearance of its TVIA Kit™ in the hit video for the best-selling single "Boy and a Man" by Backstreet Boys member AJ McLean. The video has been viewed over one million times since its debut last month, and the song will appear on the recording artist's upcoming debut solo country album, Long ...

Biocure Enters into Exclusive Joint R&D Agreement with Pharos Vaccine Inc. for Overseas Market of CAR T-Cell Products
Vancouver, British Columbia--(Newsfile Corp. - May 16, 2019) - Biocure Technology Inc. (CSE: CURE) (OTCQB: BICTF) (formerly Gravis Energy Corp.) (the "Company" or "Biocure") is pleased to announce that Biocure Pharm Corp.("BPK"), a subsidiary of the Company has entered into an agreement with Pharos Vaccine Inc. for the development of overseas market of CAR T-cell products on exclusive basis. The two Companies will work together in developing anti-CD19 CAR T-cell therapy products, conduct preclinical, ...

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Biotech News from GlobeNewswire

Santhera Submits Marketing Authorization Application to the European Medicines Agency for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy

Pratteln, Switzerland, May 27, 2019 - Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) for Puldysa® (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) to the European Medicines Agency (EMA). Santhera is seeking conditional marketing authorization (CMA).

Santhera reicht Zulassungsantrag bei der Europäischen Arzneimittelbehörde für Puldysa® (Idebenon) bei Duchenne-Muskeldystrophie ein

Pratteln, Schweiz, 27. Mai 2019 - Santhera Pharmaceuticals (SIX: SANN) gibt bekannt, dass das Unternehmen bei der Europäischen Arzneimittelbehörde (EMA) einen Antrag auf Marktzulassung (MAA) für Puldysa® (Idebenon) zur Behandlung von Atmungsfunktionsverlust bei Patienten mit Duchenne-Muskeldystrophie (DMD) eingereicht hat. Santhera strebt eine bedingte Marktzulassung (sog. conditional marketing authorization, CMA) an.

Aptose Biosciences Establishes New At-The-Market Facility

SAN DIEGO and TORONTO, May 24, 2019 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, today announced that it has entered into an “at-the-market” (“ATM”) sales agreement (the “Sales Agreement”) with Piper Jaffray and Canaccord Genuity (collectively “Co-Agents”). Under the terms of the Sales Agreement, the Company may, from time to time, issue and sell through the Co-Agents, common shares of the Company (the “Common Shares”) through ATM distributions (the “Offering”) on the NASDAQ Capital Market (“NASDAQ”). This ATM replaces the previous ATM that the Company entered into with Cantor Fitzgerald in 2018. Aptose will determine, at its sole discretion, the time, price and number of Common Shares to be sold under the Offering.

DBV Technologies Announces Results of its 2019 Ordinary and Extraordinary General Meeting and the Appointment of Viviane Monges to the Board of Directors

Montrouge, France, May 24, 2019

DBV Technologies annonce les résultats de son Assemblée générale ordinaire et extraordinaire 2019, ainsi que la nomination de Madame Viviane Monges en tant que membre du conseil d’administration

Montrouge, France, le 24 Mai 2019 (22h30 CET)

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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.

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