European Medicines Agency Agrees with Pharnext’s Pediatric Investigation Plan for PXT3003
Pharnext SA (Paris:ALPHA) (FR0011191287 – ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drug combinations based on big genomic data and artificial intelligence, today announced that the European Medicines Agency (EMA) has agreed with its pediatric investigation plan (PIP) for PXT3003 in Charcot-Marie-Tooth disease type 1A (CMT1A).
“The EMA agreement with our PIP represents a significant step forward in our efforts to bring PXT3003 to patients in Europe,” said Prof. Daniel Cohen, M.D., Ph.D., Co-Founder and Chief Executive Officer of Pharnext. “Given that much of the progression of CMT1A occurs in the first two decades of patients’ lives, we believe that by intervening in childhood, we can have a greater impact on patients’ disease trajectory. In our Phase 2 study, PXT3003 was observed to stablilize and slow the progression of CMT1A, and also demonstrated clinical improvement in patients. We are dedicated to providing the estimated 14,000 children in Europe living with CMT1A a safe therapeutic option that may offer significant long-term relief.”
As part of the regulatory process for registering new medicines with the EMA, pharmaceutical companies are required to provide a PIP that outlines the clinical development strategy for studying the investigational product in children. EMA agreement with the PIP is required before a company can file a marketing authorization application (MAA) for any new medicinal product in Europe.
PXT3003 is being evaluated in an international pivotal Phase 3 clinical trial in adults with CMT1A, with top-line results expected by October 2018. The clinical study investigating the safety and efficacy of PXT3003 for CMT1A in children will be conducted in Europe, Canada and the United States.
Pharnext is an advanced clinical-stage biopharmaceutical company developing novel therapeutics for orphan and common neurodegenerative diseases that currently lack curative and/or disease-modifying treatments. Pharnext has two lead products in clinical development. PXT3003 is currently in an international Phase 3 trial for the treatment of Charcot-Marie-Tooth disease type 1A and benefits from orphan drug status in Europe and the United States. PXT864 has generated positive Phase 2 results in Alzheimer’s disease. Pharnext has developed a new drug discovery paradigm based on big genomic data and artificial intelligence: PLEOTHERAPY™. The Company identifies and develops synergic combinations of drugs called PLEODRUG™ offering several key advantages: efficacy, safety and robust intellectual property. The Company was founded by renowned scientists and entrepreneurs including Professor Daniel Cohen, a pioneer in modern genomics and is supported by a world-class scientific team.
Pharnext is listed on Euronext Growth Stock Exchange in Paris (ISIN code: FR0011191287).
For more information, visit http://www.pharnext.com/
René GoedKoop, +33 (0)1 41 09 22 30
Chief Medical Officer
Financial Communication (France)
Stéphane Ruiz, +33 (0)1 56 88 11 15
Investor Relations (U.S.)
Stern Investor Relations, Inc.
Matthew Shinseki, +1-212-362-1200
Investor Relations (Europe)
MC Services AG
Anne Hennecke, +49 211 529252 22
Media Relations (Europe)
Bruno Arabian, +33 (0)1 81 70 96 30
Media Relations (U.S.)
Kate L. Barrette, +1-212-223-0561
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Xilam: H1 2018 Revenue: +50%18.7.2018 19:00 | Tiedote
Regulatory News: The Xilam Group (Paris:XIL) posted consolidated H1 2018 revenue of EUR 13,866 thousand, an increase of 50%. This increase represents an excellent performance, as it follows on the heels of growth of 54% in H1 2017. Revenue for the first part of this financial year breaks down as follows. In thousands of euros 30.06.2018 (1) 30.06.2017 Change New productions 8,465 4,571 +85% Catalogue 5,385 4,652 +16% Other 16 16 +0% Revenue and subsidies 13,866 9,239 +50% (1) Unaudited data. Remarkable success for new releases +85% Excellent H1 growth was driven by the two main businesses, New Productions and Catalogue. In New Productions, H1 deliveries generated record revenue of EUR 8,465 thousand, an 85% increase compared with H1 2017, and confirmed Xilam’s position as a major European animation company. Catalogue revenue was up 16% compared with H1 2017, thanks again to traditional TV channels and digital platforms, in both France and abroad. A fast-paced delivery schedule Thanks t
Department for International Trade: Life Sciences at the Heart of UK Economy18.7.2018 15:38 | Tiedote
The Government will today (Wednesday 18 July) host the second in a series of roundtables with stakeholders from key life science businesses, demonstrating the importance of the sector to the UK economy. The Chancellor, International Trade Secretary, Business Secretary and Health and Social Care Secretary will be amongst those that meet with senior representatives from leading UK and international life sciences companies as the UK positions itself as the global home of health innovation, welcoming overseas investment and seeking to boost exports in the process. Discussions at the roundtable will focus on how the future of the Life Sciences sector will be supported by the delivery of our modern Industrial Strategy, ensuring that the UK is ‘open for business’ with a positive business environment, our ambitions for a comprehensive agreement with the EU on our future relationship and the development and implementation of our independent trade policy. To date, the government has engaged sign
Universal Laser Systems Expands Its Materials Database with 3M, Victrex and Dexmet Materials18.7.2018 15:05 | Tiedote
Universal Laser Systems (ULS) announces the addition of 3M™, Victrex® and Dexmet materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The 3M, Victrex and Dexmet materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: 3M™ Extreme Sealing Tape 4412N 3M™ Thermally Conductive Silicone Interface Pad 5516 Victrex® APTIV® PEEK Film Dexmet PolyGrid® 8PTFE10-125ST Expanded PTFE Dexmet MicroGrid® AL 25 Expanded Aluminum Laser processing notes, describing the results of the laser-material interaction for these materials, are also available in the Materials Library on the ULS website to help potential customers explore the advantages of deploying laser technology within their manufacturing, research and d
Sterigenics Expands European Capacity With New State-of-the-Art Gamma Sterilization Facility in the UK18.7.2018 15:00 | Tiedote
Sterigenics, a Sotera Health company and leading global provider of mission-critical sterilization solutions and expert advisory services, announced today it is building a new facility in Markham Vale North in Chesterfield/Derbyshire, UK. The facility will significantly expand Sterigenics’ footprint in Europe to help meet the growing sterilization needs of its customers and support the company’s mission of Safeguarding Global HealthTM. Scheduled for completion in the fourth quarter, 2018, the facility will include the installation of a state-of-the-art Nordion JS10000 gamma irradiator with a research loop. The new 60,000-square-foot facility will add gamma sterilization capabilities in the UK to complement Sterigenics’ existing ethylene oxide (EtO) facility based in Somercotes/Derbyshire. “Sterigenics is committed to being the world’s leading provider of sterilization services and partnering with our customers to eliminate threats to human health,” said Philip Macnabb, President of Ste
Smiths Detection Technology Chosen for Standard 3 Upgrade at Helsinki Airport18.7.2018 12:05 | Tiedote
Smiths Detection has been selected by Finnish airport operator, Finavia Corporation, to support the transition to Standard 3 at Helsinki Airport with approved hold baggage screening systems. Included in the contract are eight high-speed, HI-SCAN 10080 XCT scanners, which combine high resolution X-ray technology, computed tomography (CT) and advanced detection algorithms to increase both security and operational efficiency significantly. Security, speed and efficiency are critical to the extensive development programme underway at the airport, which will allow the airport to serve 30 million passengers annually and increase baggage handling capacity by 50%. “Any financial investment in upgrading security equipment has to be balanced against operational improvement, particularly when part of a major expansion. Airports need assurance that efficiencies will be gained and systems can be further updated as necessary to detect evolving explosive threats and handle ever higher volumes,” comme
Norsk Titanium Continues to Grow in the State of New York18.7.2018 10:00 | Tiedote
Norsk Titanium (Norsk), the world’s first FAA-approved supplier of aerospace-grade, additive manufactured, structural titanium components, announced another major milestone in qualified production. Norsk’s Plattsburgh Development and Qualification Center (PDQC) site was officially added to the Spirit AeroSystems Approved Suppliers List (ASL) in anticipation of the start of qualified production later this year. Partnered with the recent announcements of PDQC being added to the Boeing’s Qualified Producer’s List (QPL) list and its certification under AS9100D, this new qualification is key to furthering the availability of Norsk’s disruptive technology in the aerospace market. Spirit AeroSystems is the world’s largest independent aerostructures manufacturer. “These significant achievements have been made possible by the foresight and commitment made to Norsk by the State of New York and Empire State Development. We are extremely proud of our PDQC quality and operations teams and appreciat
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme