Market Newsdesk

GRAND BLANC, Mich., Dec. 2, 2020 /PRNewswire/ — Leveraging technology building blocks from its parent companies Nexteer Automotive and Continental, CNXMotion announces Brake-to-Steer (BtS) – a technology that provides driver safety through an additional layer of directional control for highly automated and autonomous vehicles.

In highly automated vehicle applications, steering systems feature multiple protective layers to ensure the steering safety net is always on. In addition, BtS adds yet another layer by using the electronic brake system to safely steer the vehicle while simultaneously controlling its speed. In a fully autonomous vehicle with no steering wheel present, BtS will negotiate a commanded path until a safe pull-over can be achieved.

“Perhaps the most critical challenge in highly automated and autonomous driving is ensuring the robustness of system redundancies to keep drivers, passengers and road users safe,” explained Alan Davis, general manager of CNXMotion. “CNXMotion’s Brake-to-Steer technology offers another steering safety layer for a wide range of automated driving conditions.”

CNXMotion’s BtS technology offers a cost-effective way for automakers to achieve safety needs by leveraging the vehicle’s existing braking and steering systems.

“As we progress toward higher levels of automation in vehicles, secondary and tertiary redundancy becomes crucial in executing successful minimum risk maneuvers. This helps keep vehicle occupants and road users safe,” said Hiren Desai, Head of Strategy, Autonomous Mobility and Safety, Continental North America. “Cross-domain functionalities such as Brake-to-Steer are enabled by, and housed on, existing hardware, like Continental’s MKCx brake-by-wire systems, eliminating the need for additional, costly components.”

“While steering traditionally manages the lateral control of a vehicle, Brake-to-Steer enables braking to contribute to lateral control as well,” said Robin Milavec, Senior Vice President, Executive Board Director, Chief Technology Officer (CTO) and Chief Strategy Officer (CSO), Nexteer Automotive. “When combined with advanced steering systems like Nexteer’s High Availability Electric Power Steering or Steer-by-Wire, Brake-to-Steer gives an additional layer of redundancy – further enhancing the safety net.”

How Brake-to-Steer Works

The BtS function resides in the Motion Control System (MCS), which acts as an intermediary between the vehicle’s path planner (the automated driving system) and the actuators (steering, brakes and powertrain) to determine the best path forward.

Integrated with a Performance Manager, the vehicle’s intended path is compared to the system’s ability to steer the vehicle via BtS, while constantly negotiating the safest route ahead.

In the event that BtS needs to engage, BtS reacts in one of three ways:  

1. Continues on the intended path before ultimately moving to the first or second option,
2. Performs a minimum risk maneuver, such as slowing and braking to steer the vehicle to the side of the road, or
3. Stops in the lane.

Originally developed for steering redundancy in Level 4+ autonomy, the feature can be adapted to assist a driver in multiple scenarios for lower levels (Lane Keep, Obstacle Avoidance, etc.) while a driver is still present, following the intentions provided from the driver’s steering input.

ABOUT CNXMOTION (Pronounced: Con-nex-motion)
CNXMotion was established as a joint venture between Continental and Nexteer Automotive in 2017 to innovate motion control solutions for advanced applications and accelerate R&D activities for the parent companies. CNXMotion employs about 30 people in its state-of-the-art facility located in Grand Blanc, Michigan.

Nexteer and Continental hold an equal 50-50 percent ownership position in the joint venture. CNXMotion focuses on R&D activities, including rapid evaluation, design and prototyping. Capitalizing on Continental and Nexteer’s history of innovation and leadership in advanced braking and steering respectively, the joint venture combines global resources and expertise to deliver advanced motion control systems solutions for the challenges in a quickly evolving mobility landscape.

ABOUT CONTINENTAL
Continental develops pioneering technologies and services for sustainable and connected mobility of people and their goods. Founded in 1871, the technology company offers safe, efficient, intelligent, and affordable solutions for vehicles, machines, traffic and transportation. In 2019, Continental generated sales of €44.5 billion and currently employs more than 233,000 people in 59 countries and markets.

ABOUT NEXTEER
Nexteer Automotive (HK 1316), a global leader in intuitive motion control, is a multi-billion dollar global steering and driveline business delivering electric and hydraulic power steering systems, steering columns, driveline systems, as well as advanced driver assistance systems (ADAS) and automated driving enabling technologies for original equipment manufacturers (OEMs). The company has 27 manufacturing plants, three technical centers and 13 customer service centers strategically located in North and South America, Europe, Asia and Africa. The company serves more than 60 customers in every major region of the world including BMW, Fiat Chrysler, Ford, GM, PSA Groupe, Toyota and VW, as well as automakers in India and China. www.nexteer.com

 

View original content:http://www.prnewswire.com/news-releases/nexteer-and-continental-joint-venture-cnxmotion-develops-brake-to-steer-technology-301183506.html

SOURCE CNXMotion

First-of-its-kind trial in Canada will pave the way for expanded MDMA-assisted treatment to support patients with posttraumatic stress disorder

VANCOUVER, BC, Dec. 2, 2020 /PRNewswire/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies, and the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), are pleased to announce a collaboration agreement that will seek approval to deliver MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) through a single-arm, open-label, compassionate access¹ trial. This clinical trial will be the first-of-its-kind in Canada and will take a meaningful step in furthering the accessibility of MDMA-assisted treatment options for those experiencing PTSD around the world. 

Through the completion of six Phase 2 trials and ongoing Phase 3 trials, MAPS and MAPS PBC have undertaken ground-breaking research demonstrating that MDMA-assisted psychotherapy — which recently received “breakthrough therapy” status from the U.S. Food and Drug Administration (FDA) — may provide sufficient benefit to patients experiencing PTSD to support approval from the FDA. 

This compassionate access trial, if approved, will be conducted at Numinus’ Vancouver clinic, providing MDMA-assisted psychotherapy to an initial 20 individuals experiencing PTSD and collecting outcome and safety data for Health Canada. Numinus’ physicians, therapists and staff will be trained to deliver the treatment under MAPS’ clinically-tested PTSD treatment protocol prior to approval by Health Canada.

“I am delighted to announce this collaboration agreement which, leveraging MAPS’ evidence-based treatment protocol and Numinus’ clinical infrastructure, will open the door to MDMA-assisted psychotherapy in Canada,” said Dr. Devon Christie, Medical Director at Numinus and a MAPS-trained therapist for the delivery of MDMA-assisted psychotherapy.

“Training Numinus therapists in the MDMA-assisted psychotherapy protocol for PTSD will provide a meaningful expansion of access to the ongoing research program for this promising treatment,” said Amy Emerson, CEO of MAPS PBC. “Though this treatment is still investigational, if approval is granted through the regulatory pathway this collaboration will bolster our shared goal of addressing the enormous — and growing — need for improved proven treatments for people suffering from PTSD.” 

Dr. Rick Doblin, Founder and Executive Director of MAPS, adds, “Our commitment to open science is rooted in our mission to develop the cadre of qualified practitioners who will provide this world-class therapy. We’re excited to work with Numinus to build the case for regulatory approval through this compassionate access trial and expand best practice clinical infrastructure.” 

“We are thrilled to collaborate with MAPS and deliver the meaningful framework that they have spent decades building to better support those experiencing PTSD,” said Payton Nyquvest, CEO of Numinus. “At Numinus, our mandate is to explore and expand patient access to psychedelic-assisted psychotherapies. We are proud to work alongside MAPS in furthering the regulatory landscape for psychedelic-assisted therapies, including MDMA, and setting the stage for the healthcare system of tomorrow.”

NOTE 

The safety and efficacy of MDMA-assisted psychotherapy is currently under investigation. It has not yet been approved by Health Canada or the FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted psychotherapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.

¹ Health Canada recommends compassionate access open-label clinical trials when drug manufacturers anticipate exceptional demand for a drug, “to meet the needs of patients not eligible for enrollment in other pivotal trials” (Special Access Program for Drugs: Guidance document for industry and practitioners, Published 2020-10-14). This program is not related to the U.S. FDA Expanded Access program, sometimes referred to as “compassionate use” or the Breakthrough Therapy designation.

ON BEHALF OF THE BOARD OF NUMINUS WELLNESS INC.
Payton Nyquvest
President, Chief Executive Officer and Chair

About Numinus
Numinus Wellness Inc. (TSXV: NUMI) is a mental health and wellness company creating an ecosystem of solutions centred around safe, evidence-based, accessible psychedelic-assisted psychotherapy to help people heal and be well.
Numinus Health is dedicated to delivering innovative treatments to address physical, mental, and emotional health, through clinics and virtual services.
Numinus R&D is conducting implementation science and leveraging partnerships to beta-test and refine optimal models of psychedelic-assisted psychotherapy delivery, setting the stage for approved routine use in mental health and wellness care.
Numinus Bioscience is focused on developing testing methods and effective formulas for the evolving psychedelics space. Health Canada licences, scientific expertise, and new technologies facilitate ongoing innovation, and high-throughput contract services generate established revenue.

Learn more at numinus.ca, and follow us on Facebook, Twitter, and Instagram.

ABOUT MAPS
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $100 million for psychedelic therapy and medical marijuana research and education.
www.maps.org
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization

www.mapspublicbenefit.org

Forward Looking Statements

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking statements.” Forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licences and any inability to obtain all necessary governmental approvals licences and permits to operate and expand the Company’s facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use and adult-use marijuana industry, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.

View original content to download multimedia:http://www.prnewswire.com/news-releases/numinus-and-maps-public-benefit-corporation-announce-collaboration-agreement-to-seek-approval-of-mdma-assisted-psychotherapy-for-ptsd-single-arm-open-label-trial-301183224.html

SOURCE Numinus Wellness Inc.

CHICAGO, Dec. 2, 2020 /PRNewswire/ — Aon plc (NYSE: AON), a leading global professional services firm providing a broad range of risk, retirement and health solutions, today announced the launch of a digital insurance solution for small and middle market businesses. With this new offering, businesses across a wide spectrum of industries can go through the full end-to-end process of buying and managing cyber and professional liability insurance online. They also have access to an insurance specialist to walk through the application process and coverage details.

This digital insurance solution is designed for any business generating up to $100 million in annual revenue across sectors including retail, technology, professional services, manufacturing, and more. The new offering builds on other insurance products that Aon has recently introduced to middle market businesses, providing clients with access to a seamless platform to help manage all of their insurance coverages under this offering in one place.

“As the world becomes increasingly interconnected online, cyber risks pose a growing threat to small and middle market businesses, which may have limited technology and security resources,” said Christian Hoffman, CEO, Cyber Solutions North America at Aon. “With our online platform, we are making cyber insurance coverage incredibly accessible. We can also help businesses of various sizes protect themselves against risks including data breach, ransomware, contractual liability, media liability, business interruption, social engineering, and more.”

By leveraging CoverWallet, the insurtech startup Aon acquired in January 2020, Aon is further expanding the solutions and services it provides to 30 million small and medium-sized U.S. businesses. New and existing clients now benefit from a dedicated team for small and middle market businesses, a user-friendly digital platform, and self-service tools.

To learn more about Aon’s digital insurance solutions for small and middle market businesses, where clients can speak with a cyber specialist, or get an instant quote, please visit www.aoncover.com.

About Aon


Aon plc
 (NYSE: AON) is a leading global professional services firm providing a broad range of risk, retirement and health solutions. Our 50,000 colleagues in 120 countries empower results for clients by using proprietary data and analytics to deliver insights that reduce volatility and improve performance.

Follow Aon on Twitter and LinkedIn 
Stay up to date by visiting the Aon Newsroom and hear from Aon’s expert advisors in The One Brief.
Sign up for News Alerts here

About CoverWallet, an Aon company


CoverWallet
, an Aon company, is dedicated to making commercial insurance simple, fast and convenient. With leading carriers as partners, CoverWallet helps customers around the world quickly get the insurance coverage they need so that they can get back to what matters – growing and managing their business. Powered by deep analytics, thoughtful design and state-of-the-art technology, CoverWallet is reinventing the $200 billion commercial insurance market for small and medium-sized businesses.

Media Contacts

Hally Peck

+1 646 453 4168
[email protected] 

Matt Taylor

+1 312 783 5837
[email protected]

View original content to download multimedia:http://www.prnewswire.com/news-releases/aon-launches-digital-cyber-insurance-for-small-and-middle-market-businesses-301183472.html

SOURCE Aon plc

NORTH CHICAGO, Ill. and SOUTH SAN FRANCISCO, Calif., Dec. 2, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Frontier Medicines, Corp., a precision medicine company drugging challenging protein targets to develop breakthrough medicines that change the course of human diseases, today announced a global strategic collaboration to discover, develop and commercialize a pipeline of innovative small molecule therapeutics against high-interest, difficult-to-drug protein targets.

Under the multi-year collaboration, AbbVie and Frontier will utilize Frontier’s proprietary chemoproteomics platform to identify small molecules for programs directed to novel E3 ligases and certain oncology and immunology targets. Whereas conventional drug discovery methodologies have been primarily successful against a relatively discrete set of target classes, chemoproteomics-based screening in relevant cellular contexts has the potential to enable targeting of a significantly broader range of proteins. By selecting certain immunology and oncology targets for the collaboration that are considered well validated but to date, inaccessible, the collaboration has the potential to develop highly differentiated and efficacious therapeutics.

Under the terms of the agreement, AbbVie will pay Frontier an upfront cash payment of $55 million, and Frontier is eligible to receive additional milestone payments. In addition, AbbVie will reimburse Frontier’s R&D costs through defined stages of pre-clinical development. The companies will collaborate on the research and pre-clinical development of programs directed against E3 ligase, immunology and oncology targets. Upon successful completion of defined stages of pre-clinical development, AbbVie will assume full responsibility for global development and commercialization activities and costs for the programs. Frontier will retain an option to share development activities and expenses for certain oncology programs through the completion of Phase 2. Frontier will be eligible to receive success-based development and commercial milestone payments that could potentially exceed $1 billion, in addition to royalty payments on commercialized products. AbbVie retains the right to expand the collaboration in the future by exercising options to a defined number of additional targets. The collaboration excludes all of Frontier’s internal programs for which Frontier retains exclusive global rights.

“AbbVie is focused on making investments in promising new technologies that assist us in our mission to develop innovative medicines,” said Jose-Carlos Gutiérrez-Ramos, Ph.D., vice president, Discovery, AbbVie. “One of our key strategic focus areas is targeted protein degradation and chemoproteomics, and this collaboration with Frontier Medicines will be highly synergistic and complementary to our ongoing efforts.”

“AbbVie’s commitment to innovative therapies makes them an ideal partner in the development and commercialization of new medicines for cancer and immunological diseases,” said Chris Varma, Ph.D., Frontier’s co-founder, chairman, and CEO. “With our powerful chemoproteomics platform, we are greatly expanding the universe of therapeutic targets that can be accessed with small molecule drugs. This partnership enables us to build a shared pipeline of novel therapeutics with AbbVie, while Frontier continues to independently advance our internal programs into the clinic.”

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

About Frontier Medicines
Frontier Medicines is a precision medicine company that has pioneered a proprietary discovery and development platform to develop medicines against disease-causing proteins previously considered undruggable. The company is deploying its groundbreaking scientific approaches in chemoproteomics, covalent drug discovery, and machine learning to develop medicines to treat a number of debilitating diseases, starting with cancer. In its quest to “drug the undruggable,” Frontier Medicines seeks to significantly broaden the therapeutic landscape with novel small molecule alternatives to change the course of a broad range of diseases. For more information, visit www.frontiermeds.com and follow us on LinkedIn.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of Allergan plc (“Allergan”), failure to promptly and effectively integrate Allergan’s businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

 

View original content:http://www.prnewswire.com/news-releases/abbvie-and-frontier-medicines-establish-global-partnership-to-discover-and-develop-novel-therapies-and-e3-degraders-against-difficult-to-drug-targets-301183159.html

SOURCE AbbVie

BRIDGEWATER, N.J., Dec. 2, 2020 /PRNewswire/ — Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the first patient has been dosed in the Phase 3 ASPEN study of brensocatib in patients with bronchiectasis. Brensocatib is a novel, first-in-class, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of bronchiectasis and other inflammatory diseases.

“There is an urgent need for an approved therapy for the treatment of bronchiectasis that has the potential to reduce exacerbations—the major driver of morbidity and mortality in these patients,” said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. “Building on the strength of data from our Phase 2 WILLOW study, which showed that treatment with brensocatib both prolonged the time to first exacerbation and reduced the risk of exacerbation over the 24-week treatment period, we are very pleased to initiate the registrational ASPEN trial. We believe this is a significant step toward enabling regulatory submissions and potentially bringing brensocatib to patients in need.”  

ASPEN is a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with bronchiectasis. Patients with bronchiectasis due to cystic fibrosis may not be enrolled in the study. Patients will be randomized to receive brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks. The primary endpoint is the rate of pulmonary exacerbations over the 52-week treatment period. Secondary endpoints include time to first pulmonary exacerbation, percentage of subjects who remain pulmonary exacerbation-free, change from baseline in post-bronchodilator FEV1, rate of severe pulmonary exacerbations, change from baseline in the Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score, and incidence and severity of treatment-emergent adverse events.

The study is expected to enroll approximately 1,620 patients (540 in each arm) at approximately 480 sites in 40 countries. More information on this study is available at clinicaltrials.gov (NCT04594369).

Brensocatib has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration as well as Priority Medicines (PRIME) designation from the European Medicines agency for patients with bronchiectasis.

About Brensocatib

Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs.

About Bronchiectasis

Bronchiectasis is a severe, chronic pulmonary disorder in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. Bronchiectasis affects approximately 340,000 to 520,000 patients in the U.S. Today, there are no approved therapies specifically targeting bronchiectasis in the U.S., Europe, or Japan.

About Insmed

Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed’s first commercial product is a first-in-disease therapy approved in the United States and the European Union to treat a chronic, debilitating lung disease. The Company is also progressing a robust pipeline of investigational therapies targeting areas of serious unmet need, including neutrophil-mediated inflammatory diseases and rare pulmonary disorders. Insmed is headquartered in Bridgewater, New Jersey, with a growing footprint across Europe and in Japan. For more information, visit www.insmed.com.

Forward-looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. “Forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

The forward-looking statements in this press release are based upon the Company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to obtain, or delays in obtaining, regulatory approvals for ARIKAYCE outside the U.S. or European Union or for the Company’s product candidates in the U.S., Europe, Japan or other markets, including the United Kingdom as a result of the United Kingdom’s exit from the European Union; failure to successfully commercialize ARIKAYCE, the Company’s only approved product, in the United States or European Union (amikacin liposome inhalation suspension and Liposomal 590 mg Nebuliser Dispersion, respectively), or to maintain U.S. or EU approval for ARIKAYCE; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; impact of the novel coronavirus (COVID-19) pandemic and efforts to reduce its spread on the Company’s business, employees, including key personnel, patients, partners and suppliers; the risk that brensocatib does not prove to be effective or safe for patients in ongoing and future clinical studies, including the ASPEN and STOP-COVID19 studies; uncertainties in the degree of market acceptance of ARIKAYCE by physicians, patients, third-party payors and others in the healthcare community; the Company’s inability to obtain full approval of ARIKAYCE from the FDA, including the risk that the Company will not timely and successfully complete the study to validate a PRO tool and the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE; inability of the Company, PARI Pharma GmbH (PARI) or the Company’s other third-party manufacturers to comply with regulatory requirements related to ARIKAYCE or the Lamira^® Nebulizer System; the Company’s inability to obtain adequate reimbursement from government or third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE; development of unexpected safety or efficacy concerns related to ARIKAYCE or the Company’s product candidates; inaccuracies in the Company’s estimates of the size of the potential markets for ARIKAYCE or its product candidates or in data the Company has used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company’s inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of the Company’s product candidates that are approved in the future; failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, treprostinil palmitil inhalation powder (TPIP) and the Company’s other product candidates due to the Company’s limited experience in conducting preclinical development activities and clinical trials necessary for regulatory approval and its potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that the Company’s clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE or the Company’s product candidates for commercial or clinical needs, to conduct the Company’s clinical trials, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business or agreements with the Company; the Company’s inability to attract and retain key personnel or to effectively manage the Company’s growth; the Company’s inability to adapt to its highly competitive and changing environment; the Company’s inability to adequately protect its intellectual property rights or prevent disclosure of its trade secrets and other proprietary information and costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on the Company by its agreements related to ARIKAYCE or the Company’s product candidates, including its license agreements with PARI and AstraZeneca AB, and failure of the Company to comply with its obligations under such agreements; the cost and potential reputational damage resulting from litigation to which the Company is or may become a party, including product liability claims; the Company’s limited experience operating internationally; changes in laws and regulations applicable to the Company’s business, including any pricing reform, and failure to comply with such laws and regulations; inability to repay the Company’s existing indebtedness and uncertainties with respect to the Company’s ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.

The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company’s forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company’s business, please see the factors discussed in Item 1A, “Risk Factors,” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, the Company’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020 and September 30, 2020, and any subsequent Company filings with the Securities and Exchange Commission (SEC).

The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Contact:

Investors:

Argot Partners
Laura Perry or Heather Savelle
(212) 600-1902 
[email protected] 

Media:

Mandy Fahey 
Senior Director, Corporate Communications 
Insmed 
(732) 718-3621 
[email protected]

 

View original content to download multimedia:http://www.prnewswire.com/news-releases/insmed-announces-initiation-of-phase-3-aspen-study-of-brensocatib-in-patients-with-bronchiectasis-301183121.html

SOURCE Insmed Incorporated

ROUND ROCK, Texas, Dec. 2, 2020 /PRNewswire/ — Dell Technologies (NYSE: DELL) announces that Matt Baker, senior vice president of Infrastructure Solutions Group strategy and planning, Yvonne McGill, corporate controller and chief financial officer of Infrastructure Solutions Group, and Dennis Hoffman, senior vice president of corporate strategy, will each present at the following virtual conferences during the second week of December:

UBS Global TMT Conference 2020
Monday, December 7, 2020
11:05 a.m. CT / 12:05 p.m. ET
Speaker: Matt Baker

Raymond James 2020 Technology Investors Conference
Tuesday, December 8, 2020
2:20 p.m. CT / 3:20 p.m. ET
Speaker: Yvonne McGill

Barclays Global TMT Conference 2020
Wednesday, December 9, 2020
2:30 p.m. CT / 3:30 p.m. ET
Speaker: Dennis Hoffman

A live audio-only webcast of each presentation will be available on Dell Technologies’ Investor Relations page at investors.delltechnologies.com. Webcast replays will be available for six months.

About Dell Technologies

Dell Technologies (NYSE:DELL) helps organizations and individuals build their digital future and transform how they work, live and play. The company provides customers with the industry’s broadest and most innovative technology and services portfolio for the data era.

Copyright © 2020 Dell Inc. or its subsidiaries. All Rights Reserved. Dell Technologies, Dell, EMC and Dell EMC are trademarks of Dell Inc. or its subsidiaries. Other trademarks may be trademarks of their respective owners.

 

View original content:http://www.prnewswire.com/news-releases/dell-technologies-to-present-at-investor-conferences-the-week-of-december-7th-301183470.html

SOURCE Dell Technologies