Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 34 n° 349

Posts Tagged ‘therapeutics’

Angelini Pharma acquisisce Arvelle Therapeutics

Posted by fidest press agency su martedì, 5 gennaio 2021

Angelini Pharma – azienda farmaceutica internazionale di proprietà di Angelini Holding – comunica di aver acquisito Arvelle Therapeutics – società biofarmaceutica con sede in Svizzera, focalizzata sullo sviluppo di trattamenti innovativi destinati a pazienti affetti da disturbi del SNC. Secondo l’accordo Angelini Pharma acquisirà Arvelle Therapeutics nell’ambito di una transazione basata su una valutazione complessiva aggregata fino ad un massimo di $ 960 milioni.Questa acquisizione è stata possibile grazie alla visione internazionale di lungo termine della nuova generazione di azionisti, Thea Paola Angelini e Sergio Marullo di Condojanni, rispettivamente Vice Presidente e Amministratore Delegato Angelini Holding. La nuova governance Angelini, incaricata della trasformazione del Gruppo, è alla base del successo degli ultimi anni, sia in termini di acquisizioni che in termini di buona gestione del Gruppo.Con questa acquisizione Angelini Pharma diventa uno dei leader europei nell’innovazione dei trattamenti per i disturbi del sistema nervoso centrale (SNC) e per la salute mentale.

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Almirall enters into an option agreement to acquire Bioniz Therapeutics

Posted by fidest press agency su giovedì, 9 gennaio 2020

Almirall, S.A. (ALM) has announced today the execution of an option agreement to acquire Bioniz Therapeutics, Inc. a clinical stage biopharmaceutical company based in Irvine, California, which develops first-in-class peptide treatments that selectively inhibit multiple cytokines to treat immuno-inflammatory diseases and T-cell malignancies. If Almirall exercises the option, it will also enter into a broader research agreement with Bioniz NewCo, using its multiple cytokine inhibitor platform with the objective to deliver at least 3 IND-approved candidates.Through this collaboration, Almirall executes its strategy to develop and expand its R&D pipeline with new treatment modalities with the objective to address highly underserved diseases within oncodermatology and immunodermatology.
Under the terms of the agreement, Almirall will strengthen its medical dermatology pipeline. If Almirall opts-in, Almirall will have access to a clinical stage asset in development for several indications and will start a research collaboration to expand the early stage pipeline:
BNZ-1, a novel multicytokine inhibitor in development for: i) refractory Cutaneous T-cell Lymphoma (CTCL), an orphan disease with high unmet medical need and ii) alopecia areata, an autoimmune hair disorder with no approved treatments.
Research collaboration using Bioniz multiple cytokine inhibitor platform technology with the objective to deliver at least 3 IND-approved candidates. During the option collaboration period, Bioniz will complete the current ongoing phase 1/2 clinical trial in CTCL and the parties will collaborate to define future CTCL development activities. After opting-in, Bioniz will spin off other assets than BNZ-1 as well as the proprietary platform technology to a NewCo. and Almirall will continue with the development of BNZ-1.Under the terms of the agreement, Almirall will make an initial payment of $15 MM to Bioniz in exchange for an option to acquire all Bioniz outstanding shares. Following the availability of phase 1/2 results in CTCL, certain human biomarkers laboratory data and the official FDA End of Phase 2 meeting minutes, Almirall will have 60 days to exercise its option. If Almirall elects to exercise its option, the company will pay an option exercise fee of $47 MM in different instalments in the following years. Almirall will make additional payments upon the achievement of certain development, regulatory and commercial milestones.

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TherapeuticsMD Announces Amendment to Term Loan Financing Facility with TPG Sixth Street Partners

Posted by fidest press agency su martedì, 31 dicembre 2019

TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced that the Company and TPG Sixth Street Partners (“Sixth Street”) have amended the terms of the Company’s existing term loan financing facility to revise the draw trigger for one of the two $50 million delayed draw loan tranches thereunder.The terms of the amendment no longer require that ANNOVERA be designated as a new category of birth control by the U.S. Food and Drug Administration for the Company to draw the loan tranche. As amended, the $50 million loan tranche may be made available to the Company at Sixth Street’s sole and absolute discretion either contemporaneously with the delivery of the Company’s financial statements for the fiscal quarter ending June 30, 2020 or at such earlier date as Sixth Street may consent to.All other terms and conditions of the facility remain in full force and effect, including the conditions for the Company to draw the other $50 million loan tranche thereunder upon the Company achieving $11 million in net revenues from IMVEXXY®, BIJUVA® and ANNOVERA for the fourth quarter of 2019.“We are pleased that our lenders continue to be supportive and demonstrate confidence in our business as we progress toward the full commercial launch of ANNOVERA in the first quarter of 2020,” said Robert G. Finizio, CEO of TherapeuticsMD.

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Sage Therapeutics to Present at J.P. Morgan Healthcare Conference

Posted by fidest press agency su giovedì, 26 dicembre 2019

Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced that the Company will present at the J.P. Morgan 2020 Healthcare Conference in San Francisco, Calif. on Monday, January 13, 2020 at 1:30 p.m. PST (4:30 p.m. EST), followed by a Q&A session. A live webcast of the presentation and Q&A session can be accessed on the investor page of Sage’s website at A replay of the webcast will also be archived for up to 30 days on Sage’s website following the conference.
Sage Therapeutics is a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain. We are pursuing new pathways with the goal of improving brain health, and our depression, neurology and neuropsychiatry franchise programs aim to change how brain disorders are thought about and treated. Our mission is to make medicines that matter so people can get better, sooner.

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Sale of Bionomics’ French Subsidiaries to Domain Therapeutics

Posted by fidest press agency su domenica, 15 dicembre 2019

Bionomics Limited (ASX:BNO, OTCQB:BNOEF), a global, clinical stage biopharmaceutical company leveraging proprietary platform technologies to discover and develop a deep pipeline of novel drug candidates targeting ion channels, is pleased to announce that the Company has accepted an offer from Domain Therapeutics (“Domain”) for its two wholly owned subsidiaries, Neurofit SAS (“Neurofit”) and PC SAS “(“Prestwick Chemical”), which operate as contract research companies in France.The sale price of €1,810,028.97 is the amount of intercompany debt owed by Bionomics to the subsidiaries for the scientific research conducted by them on Bionomics drug candidates and this debt will be assumed by Domain upon acquisition of the Companies.
“We are pleased with the outcome of the sale of our French subsidiaries which is part of our ongoing cost reduction process, consolidation of our operations in Adelaide and focus on the clinical development of BNC210 for post-traumatic stress disorder,” said Dr. Errol De Souza, Executive Chairman of Bionomics. “We thank Neurofit and Prestwick Chemical for their key contributions to our previous research efforts resulting in several development candidates including our collaboration assets with Merck and our out-licensing assets in other ion channel programs.” The offer from Domain is subject to satisfaction of a number of conditions precedent, including entering into definitive contractual documentation satisfactory to both parties and regulatory approval. Subject to satisfaction of the conditions precedent, the parties anticipate being in a position to complete the transaction on or about 31 January 2020.

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Company Profile for Jasper Therapeutics, Inc

Posted by fidest press agency su giovedì, 12 dicembre 2019

Jasper Therapeutics is a biotechnology company focused on enabling safer conditioning agents and therapeutics to allow for expanded use of curative hematopoietic stem cell transplants and gene therapies. Jasper Therapeutics’ lead compound, JSP191, is in clinical development as a conditioning antibody that clears hematopoietic stem cells from bone marrow in patients undergoing a stem cell transplant. For more information, please visit us at

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Magenta Therapeutics to Present at the Evercore ISI HealthCONx Conference

Posted by fidest press agency su domenica, 1 dicembre 2019

Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, today announced that the Company is scheduled to participate in a fireside chat at the Evercore ISI HealthCONx Conference on December 3, 2019 at 1:15 p.m. ET at the Four Seasons Hotel in Boston. A live webcast of the presentation can be accessed under “Events & Presentations” in the Investors and Media section of the Company’s website at A replay of the webcast will be archived on the Magenta website for 60 days.

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Pear Therapeutics to Present at Evercore ISI HealthCONx Conference

Posted by fidest press agency su domenica, 24 novembre 2019

Pear Therapeutics, Inc., the leader in prescription digital therapeutics (PDTs), today announced that Christopher D.T. Guiffre, J.D., M.B.A., Chief Financial Officer and Chief Operating Officer, will participate in a fireside chat at the Evercore ISI HealthCONx Conference on Thursday, December 5 at 10:15 a.m. Eastern Time in Boston.Pear Therapeutics is a privately held, prescription digital therapeutics company developing clinically validated, FDA-authorized software applications to treat serious disease.Pear Therapeutics, Inc. is the leader in prescription digital therapeutics. We aim to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurological conditions. Our lead product, reSET®, for the treatment of Substance Use Disorder, was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, received marketing authorization from the FDA in December 2018.

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Company Profile for Immune-Onc Therapeutics, Inc.

Posted by fidest press agency su domenica, 24 novembre 2019

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a privately held cancer immunotherapy company dedicated to the discovery and development of novel biologic treatments for cancer patients. The company aims to translate unique scientific insights in myeloid cell biology and immune inhibitory receptors to discover and develop first-in-class biotherapeutics that disarm immune suppression in the tumor microenvironment. Immune-Onc has a promising pipeline built upon strategic collaborations and cutting-edge research from The University of Texas, Albert Einstein College of Medicine, and Memorial Sloan Kettering Cancer Center. Its lead program, an antibody targeting LILRB4, is being developed to treat acute myeloid leukemia and other cancers. Headquartered in Palo Alto, California, Immune-Onc has assembled a diverse team with deep expertise in drug development and proven track records of success at leading biotechnology companies. For more information, please visit

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HiFiBiO Therapeutics Establishes World-Class Scientific Advisory Board

Posted by fidest press agency su giovedì, 31 ottobre 2019

HiFiBiO Therapeutics, a pioneer in innovative biotherapeutics with a unique single-cell analytics platform for extensive immune profiling, today announced the formation of a Scientific Advisory Board (SAB) comprised of experts in immunology, oncology and cell therapy, as well as drug discovery and development. The SAB will work with the company as it continues to rapidly discover and advance its pipeline of novel antibody programs to treat cancer and autoimmune disorders. “We are privileged to have the opportunity to work closely with these internationally recognized thought leaders in our space,” said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics. “They bring tremendous biological understanding of cancer, autoimmune disorders and other unmet medical needs to our organization. We look forward to their contributions as we continue to refine our scientific strategy, advance our unique single-cell platform and develop more innovative antibody drugs.”

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Avacta Group plc Enters Collaboration and Option Agreement With ADC Therapeutics

Posted by fidest press agency su sabato, 12 ottobre 2019

Avacta Group plc (AIM: AVCT), a biotechnology company developing novel cancer immunotherapies based on its proprietary Affimer® platform, today announced that it has entered a collaboration and option agreement with ADC Therapeutics SA, a clinical-stage oncology-focused biotechnology company pioneering the development of highly potent and targeted antibody-drug conjugates for patients suffering from haematological malignancies and solid tumours. The agreement is to develop Affimer-drug conjugates combining Avacta’s Affimer technology with ADC Therapeutics’ pyrrolobenzodiazepine (PBD)-based warhead and linker technologies.As part of the multi-target collaboration Avacta will generate and optimise Affimer binders against three undisclosed cancer targets and provide these to ADC Therapeutics to target its proprietary cytotoxic warheads (PBDs) to the site of the tumour. ADC Therapeutics will carry out pre-clinical research and development programmes to evaluate each of the Affimer-drug conjugates with a view to generating clinical candidates.The commercial agreement between the two companies provides ADC Therapeutics with options, on a target by target basis, to obtain exclusive licenses to the Affimer proteins for clinical development and commercialisation.Under the terms of the agreement, ADC Therapeutics will cover all Avacta’s costs during the collaboration. Upon ADC Therapeutics entering into each of the commercialisation licenses and successfully bringing new Affimer-drug conjugates to market, Avacta will receive option fees, development and commercialisation milestones, as well as a single-digit royalty on sales. Further financial details are not disclosed.

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Development of novel therapeutics to address global unmet medical needs

Posted by fidest press agency su giovedì, 12 settembre 2019

Aptorum Group Limited (Nasdaq: APM) (“Aptorum Group”), a biopharmaceutical company announces that it has initiated investigational new drug (IND)-enabling studies for ALS-4, a small drug molecule candidate indicated for the treatment of infections caused by Staphylococcus aureus (or “S. aureus”) including methicillin-resistant Staphylococcus aureus (MRSA, i.e., one of the commonly known “super-bugs”) based on a novel anti-virulence approach.The ALS-4 candidate has been progressing well and the first series of GLP toxicology studies have been completed through an appointed North American based contract research organization (CRO). In particular, ALS-4 candidate did not show any mutagenicity in the in vitro Ames tests. ALS-4 development is on track and the company targets to submit the related IND in the first half year of 2020 and a hybrid Phase 1 clinical study is currently planned in North America with both healthy volunteers and patients to obtain preliminary efficacy readout.
S. aureus is a bacteria which is a leading cause of blood, lung, skin, bone and device-related infections, as well as toxin-related diseases1. It is estimated that patients with S. aureus bacteremia have an average mortality rate of 30%2 and that it is responsible for causing more deaths than AIDS, tuberculosis and viral hepatitis combined3. MRSA and vancomycin-intermediate and resistant S. aureus have also been classified by the World Health Organization (WHO) as high priority pathogens for research and development

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EdiGENE Changes Name to Modalis Therapeutics

Posted by fidest press agency su sabato, 31 agosto 2019

EdiGENE Corporation today announced that the company has changed its name to Modalis Therapeutics Corporation. Modalis (pronounced “MO-DA-LIS”) is an original name that the Company has chosen to hope Company’s proprietary gene modulation technology, CRISPR-GNDM, to be a new modality (therapeutic technology) to assist patients fighting with genetic disorders.”Our goal is to create CRISPR based gene therapies for genetic disorders, most of which fall into orphan disease. We think there should be no disease that can be ignored because of the small patient population and that our belief, ’Every Life Deserve Attention’, is achievable with power of our new technology. We are proud to be a front runner of CRISPR based gene modulation therapy,” said Haru Morita, chief executive officer at Modalis Therapeutics. “We decided to change our company name because the Modalis better reflects the emerging gene modulation technology that Company established and provides to the industries”. In conjunction with the corporate name change, the Company will have a new domain name

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ROMEG Therapeutics Secures Two Additional U.S. Patents

Posted by fidest press agency su venerdì, 23 agosto 2019

ROMEG Therapeutics, an innovative drug development company focused on alternative formulations to better meet clinical and patient needs, today announced that the United States Patent and Trademark Office has issued two additional U.S. patents that are directed to the formulation, methods of use and administration of ROMEG’s proprietary colchicine oral solution, which will be marketed as GLOPERBA® and is currently indicated for prophylaxis of gout flares in adults.U.S. patent numbers 10,383,820 and 10,383,821 are the third and fourth patents ROMEG has been granted for its colchicine oral solution and will join the first two patents already listed in the U.S. Food and Drug Administration’s Orange Book, the guide to drugs classified by the agency as safe and effective and that are protected by a patent. Specifically, the two patents will broaden the composition claims of the colchicine oral solutions and cover methods to potentially enable additional indications.“We are extremely pleased with the continued development of our patent portfolio, as it reflects our strategy to broaden and diversify our intellectual property,” said Naomi Vishnupad, Ph.D., ROMEG’s Chief Scientific Officer and a partner in the company. “In this case, we believe our product technology offers a novel and potentially superior treatment option for diseases such as gout and other diseases that represent significant unmet medical needs and a large market opportunity.” GLOPERBA®, approved by the FDA earlier this year, was recently licensed to Avion Pharmaceuticals, LLC of Alpharetta, Ga., for exclusive commercialization within the United States. The current U.S. market for gout is about $650 million annually.

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Nimbus Therapeutics and Celgene Expand Alliance to Immunotherapy in Oncology

Posted by fidest press agency su giovedì, 11 luglio 2019

Nimbus Therapeutics, a biotechnology company applying deep computational expertise throughout drug discovery and development, today announced the expansion of its long-term strategic alliance with Celgene Corporation to include Nimbus’ HPK1 inhibitor program.
Under the terms of the agreement, Celgene will receive an option to acquire the program up through a clinical inflection point. Nimbus will retain full control of research and development activities for the program prior to the program’s option point. Financial terms will remain undisclosed until Celgene exercises its option to acquire the program.
Hematopoietic Progenitor Kinase 1 (HPK1), a member of the MAP4K family, is an intracellular negative regulator of T cell proliferation and signaling and plays a key role in dendritic cell activation. The challenge with HPK1 thus far has been the ability of small molecules to achieve potency and selectivity profiles that do not inhibit other T cell kinases or MAP4K family members. Given its role in both T cells and dendritic cells, and an opportunity for working synergistically in upregulating immune system surveillance of cancer, HPK1 has been a highly prized target in immuno-oncology. Nimbus will continue to own and develop its potent small molecule HPK1 inhibitors that are highly selective against relevant off targets and possess robust cellular activity.

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Lyndra Therapeutics and Gilead Sciences to Collaborate on Development of Ultra-Long-Acting HIV Therapeutics

Posted by fidest press agency su giovedì, 11 luglio 2019

Lyndra Therapeutics, the company making daily pills a thing of the past, has announced a partnership with Gilead Sciences, Inc. to develop and commercialize ultra-long-acting oral HIV therapies. Gilead will have exclusive rights to Lyndra’s therapeutics platform for ultra-long-acting formulations related to HIV.Lyndra’s ultra-long-acting dosage form has the potential to improve medication adherence by allowing patients to take a pill once a week, or even less frequently, rather than daily.“Gilead has led the way in HIV prevention and treatment by focusing on reducing pill burden through the development of single-tablet oral regimens for their therapies, addressing an epidemic that affects nearly 40 million people globally*,” said Amy Schulman, CEO and co-founder of Lyndra Therapeutics. “At Lyndra, our commitment to HIV is foundational and we are delighted to continue to work with strong research and development partners such as the Bill & Melinda Gates Foundation and, now, Gilead.” “Gilead is committed to advancing therapies for all people living with or at risk for HIV, including potential strategies for long-acting regimens that would reduce pill burden. This early partnership with Lyndra is the latest step in our ongoing investment in HIV research and development,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences.

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Five Prime Therapeutics to Present at Two Upcoming Healthcare Conferences

Posted by fidest press agency su martedì, 11 giugno 2019

Montreal Wednesday, June 19th at 1:15pm ET / 10:15am PT. The 2019 Bank of Montreal Prescriptions for Success Healthcare Conference on Tuesday, June 25th at 3:00pm ET / 12:00pm PT. Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics announced that Aron Knickerbocker, Chief Executive Officer, is scheduled to present at the two investor conferences.
The presentations will be webcast and may be accessed at the “Events & Presentations” section of the Company’s website at: Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.
Five Prime Therapeutics, Inc. discovers and develops innovative protein therapeutics to improve the lives of patients with serious diseases. Five Prime’s product candidates have innovative mechanisms of action and address patient populations in need of better therapies. The company focuses on researching and developing immuno-oncology and targeted cancer therapies paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime’s product candidates. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development. For more information, please visit or follow us on LinkedIn, Twitter and Facebook.

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A New Strategy at Knight Therapeutics

Posted by fidest press agency su domenica, 28 aprile 2019

Medison Biotech (1995) Ltd. (“Medison”), which together with its affiliates owns more than 10.4 million shares or 7.3% of Knight Therapeutics, Inc. (TSX:GUD) (“Knight” or the “Company”), today announced that Glass Lewis & Co., LLC, a leading independent proxy advisory firm, has noted the underperformance of Knight, severe conflicts of interest among the directors, management and the Goodman family and the need for change to the Knight Board of Directors. Glass Lewis recommends that shareholders vote for change by using the GOLD proxy card and vote FOR the election of Medison nominees Michael Cloutier and Bob Oliver.Institutional Shareholder Services (“ISS”) has also recently recommended Knight shareholders support change and vote using the GOLD proxy card to elect Elaine Campbell and Christophe Robert Jean.Commenting on the report, Medison said, “The Glass Lewis report exposes the severity of the issues at Knight – inferior returns, lack of an operating business, a failed strategy, conflicted directors and a campaign to try to fool shareholders. The independent report also calls on Jonathan Goodman to divest his conflicted holdings or resign immediately as CEO. In addition, Knight’s Chairman, James Gale, is exposed for related party transactions and conflicts of interest.”Added Medison, “We are very pleased that shareholders are finally able to see, in detail, the issues with this board, but to also have the opportunity to vote for new, skilled directors that have a real plan to create value for all. This is an important time for Knight and we urge shareholders to vote FOR all of the Medison nominees on the GOLD proxy today.”

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Company Profile for Novus Therapeutics, Inc.

Posted by fidest press agency su mercoledì, 20 febbraio 2019

Novus Therapeutics, Inc. (“Novus”) is a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat (“ENT”). Novus has two technologies, each that has the potential to be developed for multiple ENT indications. Novus’ lead product candidate (OP0201) is a surfactant-based, drug-device combination product being developed as a potential first-in-class treatment option for patients at risk for, or with, otitis media (“OM” or middle ear inflammation with or without infection). Globally, OM affects more than 700 million adults and children every year, with over half of the cases occurring in children under five years of age. OM is one of the most common disorders seen in pediatric practice, and in the United States is a leading cause of health care visits and the most frequent reason children are prescribed antibiotics or undergo surgery. Novus also has a foam-based drug delivery technology (OP0102), which may be developed in the future to deliver drugs into the ear, nasal, and sinus cavities. For more information please visit

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Tenax Therapeutics to Present at 2019 BIO CEO & Investor Conference

Posted by fidest press agency su mercoledì, 6 febbraio 2019

Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying and developing drugs that address diseases with high unmet medical need, today announced that management is scheduled to present and conduct one-on-one meetings at the 2019 BIO CEO & Investor Conference to be held in New York, NY on February 11th and 12th. Anthony DiTonno, Chief Executive Officer, is scheduled to present on Tuesday, February 12th at 2:15 p.m. Eastern Time.Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying and developing drugs that address diseases with high unmet medical need. The Company has a world-class scientific team including recognized global experts in pulmonary hypertension. The Company owns the North American rights to develop and commercialize levosimendan and has initiated a Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit

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