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Inari Medical Announces Presentation of Positive 30-Day Follow-Up Results from First Patients in Real World FLASH Registry

IRVINE, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today announced follow-up results of the first 230 patients enrolled in its FLASH study.  FLASH is a real world registry to study the FlowTriever system in intermediate- and high-risk pulmonary embolism (“PE”) patients.  The results were strongly positive.  Just one death (0.4%) was reported at 30 days.  By contrast, the national PERT Consortium® Quality Database recently showed 30-day mortality rates of 25.9% and 6.1% for high- and intermediate-risk PE patients.  In addition, the FLASH Registry showed a readmission rate of 6.7%, compared to the nearly 25% readmission rate shown in the PERT Database.  Efficacy data were equally compelling, showing normalization or near normalization in a battery of hemodynamic variables like pulmonary artery pressure, RV/LV ratio, and heart rate, as well as dyspnea (shortness of breath) metrics.   

FLASH is a 500-patient prospective, multicenter, single-arm registry evaluating real world patient outcomes after treatment of PE with FlowTriever. Interim data were obtained across 19 US sites, and results were presented virtually by National Principal Investigator, Catalin Toma, MD, Director of Interventional Cardiology at UPMC Heart & Vascular Institute in Pittsburgh, PA at the American Heart Association (“AHA”) Scientific Sessions 2020.

These data follow the presentation of equally compelling acute data from the same patient set delivered two weeks ago at the annual TCT meeting.  The acute results showed, at 48 hours, no deaths, no cardiac injuries, no pulmonary injuries, no procedure-related clinical deteriorations, and no intracranial hemorrhages in this highly compromised PE patient population.  The TCT data also showed clinically and statistically significant improvement in hemodynamic parameters while the patient was still on the table.  Post-procedure median ICU stay was 0 days.  The new FLASH data released at AHA extends the study follow-up period to 30 days and demonstrates the durability of these acute results with continued improvement in outcomes over time.

“FLASH has shown us that PE patients experience symptom relief and improved cardiac function immediately upon removal of significant clot burden.  These outcomes continue to improve over time.  In fact, for a high percentage of these patients, measurements for dyspnea, right heart strain, pulmonary artery pressure and heart rate actually normalized after FlowTriever thrombectomy.  We believe this suggests that removal of large clot burden with the FlowTriever system not only has an important impact acutely, but might have an important positive effect on long term implications of PE, like CTED and CTEPH,” said Dr. Toma.

“With over 60% of patients in FLASH having no contraindication to lytics, the study data suggests that FlowTriever is emerging as a frontline therapy for intermediate and high-risk PE patients, regardless of patient eligibility for other treatment options.  PE care pathways are evolving,” said Thomas Tu, MD, Chief Medical Officer of Inari Medical. “Venous thromboembolism (“VTE”) patients are central to everything that we do at Inari, and we remain committed to advancing the treatment of this disease through clinical research and the continued development of purpose-built devices.”

About Inari Medical, Inc.

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases. Inari has developed two minimally-invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k)-cleared by the FDA for the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by the FDA for the treatment of pulmonary embolism.

Investor Contact:

Westwicke Partners
Caroline Corner
Phone +1-415-202-5678
[email protected]

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InCarda Therapeutics Presents Positive New Data from Phase 2 Study of InRhythm™ in Patients with Paroxysmal Atrial Fibrillation at American Heart Association Scientific Sessions 2020

Data Demonstrate Achievement of Rapid Conversion
s
from Atrial Fibrillation to Normal Sinus Rhythm

Study Findings Provide Proof
of
Concept for
First-of-its-Kind Inhaled Antiarrhythmic for Treatment of Paroxysmal Atrial Fibrillation
(PAF)  

Provides Roadmap for
Start of
Pivotal Phase 3 in Medically Supervised Setting in 2021

SAN FRANCISCO, Nov. 13, 2020 (GLOBE NEWSWIRE) — InCarda Therapeutics, Inc. (“InCarda”), a privately-held biopharmaceutical company developing first-of-their-kind inhaled therapies for cardiovascular diseases today announced the presentation of positive data from the open-label, dose-escalation Part A portion of the company’s multinational INSTANT Phase 2 clinical trial of InRhythm™ (flecainide for inhalation) in patients with recent-onset paroxysmal atrial fibrillation (PAF) at the American Heart Association’s (AHA) Scientific Sessions 2020. The positive study results reported today during the AHA conference provide the first proof of concept for inhaled flecainide as a potentially safe and effective therapeutic option for rapidly converting PAF to normal sinus rhythm (NSR).

InRhythm is a novel inhaled therapeutic candidate designed to rapidly deliver flecainide, a well-established antiarrhythmic agent, to the heart via the lungs to restore NSR and to relieve symptoms associated with acute episodes of PAF. The therapy is being developed initially for its use under medical supervision in a hospital, emergency room or physician office and subsequently as a portable treatment that can be self-administered by patients in a non-medically supervised setting (such as the home) to rapidly achieve conversion of PAF to NSR.

Dr. Harry J.G.M. Crijns, professor, chair of cardiology and board member of the Cardiovascular Research Institute Maastricht (CARIM) at Maastricht UMC+, and co-principal investigator of the INSTANT trial, presented data from Part A of the INSTANT trial. The results demonstrated the rapid achievement of therapeutic plasma levels (Cmax > 200 ng/mL) of flecainide via oral inhalation with InRhythm. Approximately 80% of patients who received the study’s highest administered dose (120 mg) achieved a flecainide Cmax > 200 ng/mL. For all study participants who reached these therapeutic plasma levels, nearly 50 percent achieved a successful conversion from PAF to NSR. Importantly, those successful conversions occurred rapidly, with a median time to conversion of 3.6 minutes after the end of the administration of InRhythm (total inhalation time for InRhythm administration is eight minutes). The treatment was shown to be safe and well tolerated, and the majority of adverse events were transient, mild in severity and resolved without treatment.

“There is growing clinical and scientific evidence to support the importance of rhythm control in the overall management of atrial fibrillation,” said Jeremy N. Ruskin, M.D., professor of medicine at Harvard Medical School and founder and director emeritus of the Cardiac Arrhythmia Service at Massachusetts General Hospital and co-principal investigator of the INSTANT study. “Currently available treatment options for the acute conversion of atrial fibrillation to normal sinus rhythm are limited and do not fully address the unmet needs of improving patients’ symptoms and quality of life and reducing healthcare costs. This novel therapy for rapid restoration of normal rhythm, if successful in pivotal clinical trials, has the potential to play a significant role in addressing these unmet clinical needs.”

Based on these positive study results, InCarda has commenced enrollment of Part B of the INSTANT study which includes a confirmatory cohort using the selected optimal therapeutic dose (120 mg) and a pilot study referred to as the “Patient-led Sub-study.” In this latter study patients who have already experienced a safe cardioversion with InRhythm will receive training so that they can self-administer InRhythm under medical supervision when another (“recurrent”) episode of PAF occurs. In addition to current study sites in the Netherlands and Belgium, InCarda will start recruiting patients in the US later this year.

“The data presented today from the INSTANT study provide the first proof of concept of this novel strategy to deliver flecainide via oral inhalation to rapidly restore NSR in patients with symptomatic episodes of recent-onset PAF. These data will be used to finalize the design of a multinational, Phase 3 trial of InRhythm to support marketing approval for in-hospital, medically supervised use. We expect to initiate this study in the first half of 2021,” said Luiz Belardinelli, M.D., chief medical officer of InCarda.

“With six million atrial fibrillation patients in the US contributing to over $26B in annual healthcare expenditures, and more than 30 million atrial fibrillation patients worldwide, there is a tremendous opportunity for InCarda to uniquely address this important and growing need,” said Grace E. Colon, Ph.D., chief executive officer of InCarda. “We look forward to the next steps in the development of this important new therapy and reporting on several key company milestones over the next year.”


About


Atrial Fibrillation (AF)

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia (abnormal heart rhythm) and is characterized by rapid and irregular heartbeats often resulting in palpitations and other symptoms that can be debilitating. A chronic, progressive condition, AF is estimated to affect six million people in the U.S., with that number expected to double by 20501. This expected increase is partially due to the correlation between AF prevalence and an aging population, with approximately 9% of those aged 65 and older affected by the condition1. AF is associated with significant morbidity and a substantial reduction in quality of life, with the condition potentially resulting in exercise intolerance, congestive heart failure, tachycardia-induced cardiomyopathy and stroke. The annual cost of AF to the U.S. healthcare system is estimated at more than $26 billion1.

Paroxysmal AF (PAF) is a type of AF in which episodes occur intermittently and resolve spontaneously in fewer than seven days. Approximately 25% of PAF patients progress to the permanent form of AF within five years2. Common symptoms of PAF can include racing heartbeat, chest pain or pressure, a fluttering feeling in the chest, weakness, fatigue, dizziness, sweating and lightheadedness. Current treatments for patients with PAF rely upon either chronic administration of oral antiarrhythmic drugs or acute hospital-based procedures such as intravenous drug administration and electrical cardioversion, neither of which fully address the unmet need of patients for a rapid-acting treatment that can be administered whenever an episode of PAF occurs. There are currently no approved treatments that can be patient self-administered whenever an episode of PAF occurs.


About InRhythm



™

InRhythm (flecainide for inhalation) is a novel inhaled therapeutic candidate designed to rapidly deliver flecainide, a well-established antiarrhythmic agent, to the heart via the lungs, to restore normal sinus rhythm (NSR) and relieve the patient’s symptoms following the onset of an episode of PAF. InRhythm is intended to address the unmet need for a non-invasive, rapid-acting treatment that can be administered in a medically supervised setting (initial indication) and, ultimately, self-administered by patients anywhere they happen to be, whenever they experience an episode of PAF. Phase 1 clinical results in healthy volunteers demonstrated that InRhythm rapidly and safely delivered flecainide resulting in ECG changes consistent with the potential to restore NSR in patients with PAF. InCarda is currently conducting the INSTANT Phase 2 trial of InRhythm in patients with recent-onset PAF. InRhythm represents a first-in-class, multi-billion dollar global opportunity to address a significant unmet medical need.


About


InCarda Therapeutics

InCarda Therapeutics, Inc. is a privately-held, clinical-stage biopharmaceutical company developing first-of-their-kind inhaled therapies for acute cardiovascular diseases and conditions. The company is leveraging the ability of inhaled therapy to deliver medicine in the “first pass” to cardiac tissue, presenting a small, but effective dose of drug directly to affected regions of the heart. This permits rapid-onset, lower off-target tissue exposure of the drug, lower exposure to cardiac tissue and, more importantly, has the potential to be patient self-administered in a non-medical setting (e.g., home). InCarda employs a de-risked approach by using approved drugs with a long history of efficacy and safety as candidates for the new dosing paradigm via inhalation. The company’s lead development product, InRhythm, is in Phase 2 development to treat acute episodes of PAF, a prevalent atrial arrhythmia. For more information, please visit: www.incardatherapeutics.com.

LinkedIn: https://www.linkedin.com/company/incarda-therapeutics/

Twitter: @InCardaThera

References:


1

J Am Coll Cardiol. 
2014
 Dec 2;64(21):2305-7


2

Am Heart J. 2005 Mar;149(3):489-96 

Contact Information:

Tim Brons 
Vida Strategic Partners (media)
646-319-8981
[email protected]

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Halozyme Announces CHMP Recommends EU Approval Of Roche’s Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme’s ENHANZE® Technology For HER2-Positive Breast Cancer

– Phesgo® Can be Administered in 5 to 8 Minutes Compared with 1-2.5 Hours for the Standard Sequential IV Administration of Perjeta® and Herceptin®[1,2,3] –

– Phesgo® is the First Subcutaneous Fixed-dose Combination of Two Monoclonal Antibodies Utilizing Halozyme’s ENHANZE® Technology –

PR Newswire

SAN DIEGO, Nov. 13, 2020 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche’s Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) utilizing ENHANZE®, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future.

“We are delighted that Phesgo®, the first combination of two established monoclonal antibodies with our ENHANZE® technology, administered in just 5-8 minutes, is one step closer to becoming available for patients with HER-2 positive breast cancer in the EU,” said Dr. Helen Torley, president and chief executive officer.

Phesgo® can be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose1. This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta® and Herceptin® using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines2,3.

The recommendation from the CHMP is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo® showing non-inferior levels of Perjeta® in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta®. The safety profile of Phesgo® with chemotherapy was comparable to IV administration of Perjeta® plus Herceptin® and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhea and anemia1,4.

The U.S. Food and Drug Administration recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer. Based on the decision of the treating physician and the preference of the patient, it can be administered by a healthcare professional in a treatment center or in a patient’s home.

About ENHANZE® Technology 
Halozyme’s proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients’ lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme’s commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme’s proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company’s partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

Halozyme Safe Harbor Statement 
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development and regulatory approval efforts of Halozyme’s ENHANZE® partner. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the  ENHANZE® co-formulated product referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme’s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

References:

[1] US Food and Drug Administration. Prescribing information for Phesgo. [Internet; cited October 2020]. Available from:  https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf.
[2] European Medicines Agency. Summary of Product Characteristics for Perjeta. [Internet; cited October 2020]. Available from: https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf. 
[3] European Medicines Agency. Summary of Product Characteristics for Herceptin. [Internet; cited October 2020]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf 
[4] Tan A, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS, 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07.

Contact:

Al Kildani

Vice President, Investor Relations and Corporate Communications
858-704-8122
[email protected]

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/halozyme-announces-chmp-recommends-eu-approval-of-roches-phesgo-fixed-dose-combination-of-perjeta-and-herceptin-for-subcutaneous-injection-utilizing-halozymes-enhanze-technology-for-her2-positive-breast-cancer-301172817.html

SOURCE Halozyme Therapeutics, Inc.

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BMRN UPCOMING DEADLINE: Zhang Investor Law Alerts Investors to Imminent Deadline in Securities Class Action Lawsuit Against  BioMarin Pharmaceutical Inc. – BMRN

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Zhang Investor Law announces a class action lawsuit on behalf of shareholders who bought shares of BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) from February 28, 2020 through August 18, 2020. If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 24, 2020 DEADLINE.

To join the class action, go to http://zhanginvestorlaw.com/join-action-form/?slug=biomarin-pharmaceutical-inc&id=2428 or call Sophie Zhang, Esq. toll-free at 800-991-3756 or email [email protected] for information on the class action.

如果您想加入这个集体诉讼案，请在这里提交您的信息。http://zhanginvestorlaw.com/join-action-form/?slug=biomarin-pharmaceutical-inc&id=2428

If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 24, 2020 DEADLINE.  A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. 

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose, among other things:  differences between the Phase 1/2 and Phase 3 study of valoctocogene roxaparvovec limited the reliability of the Phase 1/2 study to support valoctocogene roxaparvovec’s durability of effect; as a result, it was foreseeable that the U.S. Food and Drug Administration would not approve the Biologics License Application for valoctocogene roxaparvovec without additional data; and as a result, the Company’s public statements were materially false and misleading at all relevant times.

Lead plaintiff status is not required to seek compensation.  You may retain counsel of your choice.  You may remain an absent class member and take no action at this time.

Zhang Investor Law represents investors worldwide. Attorney Advertising. Prior results do not guarantee similar outcomes.

Zhang Investor Law P.C.
99 Wall Street, Suite 232
New York, New York 10005
[email protected]
tel: (800) 991-3756



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FLDM LOOMING DEADLINE: Zhang Investor Law Alerts Investors to Imminent Deadline in Securities Class Action Lawsuit Against  Fluidigm Corporation – FLDM

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Zhang Investor Law announces a class action lawsuit on behalf of shareholders who bought shares of  Fluidigm Corporation (NASDAQ: FLDM) between February 7, 2019 and November 5, 2019, inclusive. If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 20, 2020 DEADLINE.

To join the class action, go to http://zhanginvestorlaw.com/join-action-form/?slug=fluidigm-corporation&id=2433 or call Sophie Zhang, Esq. toll-free at 800-991-3756 or email [email protected] for information on the class action.

如果您想加入这个集体诉讼案，请在这里提交您的信息。http://zhanginvestorlaw.com/join-action-form/?slug=fluidigm-corporation&id=2433

If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 20, 2020 DEADLINE.   A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. 

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose, among other things:  Fluidigm was experiencing longer sales cycles; as a result, Fluidigm’s revenue was reasonably likely to decline and Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Lead plaintiff status is not required to seek compensation.  You may retain counsel of your choice.  You may remain an absent class member and take no action at this time.

Zhang Investor Law represents investors worldwide. Attorney Advertising. Prior results do not guarantee similar outcomes.

Zhang Investor Law P.C.
99 Wall Street, Suite 232
New York, New York 10005
[email protected]
tel: (800) 991-3756



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Urovant Merger Investigation: Halper Sadeh LLP Announces Investigation Into Whether the Sale of Urovant Sciences Ltd. Is Fair to Shareholders; Investors Are Encouraged to Contact the Firm – UROV

Urovant Merger Investigation: Halper Sadeh LLP Announces Investigation Into Whether the Sale of Urovant Sciences Ltd. Is Fair to Shareholders; Investors Are Encouraged to Contact the Firm – UROV

 

NEW YORK–(BUSINESS WIRE)–
Halper Sadeh LLP, a global investor rights law firm, is investigating whether the sale of Urovant Sciences Ltd. (NASDAQ: UROV) to Sumitovant Biopharma Ltd. for $16.25 per share is fair to Urovant shareholders. On behalf of Urovant shareholders, Halper Sadeh LLP may seek increased consideration for shareholders, additional disclosures and information concerning the proposed transaction, or other relief and benefits.

If you are an Urovant shareholder and would like to discuss your legal rights and options, please visit Urovant Merger or contact Daniel Sadeh or Zachary Halper at (212) 763-0060 or [email protected] or [email protected].

The Urovant merger investigation concerns whether Urovant and its board of directors violated the federal securities laws and/or breached their fiduciary duties to shareholders by failing to: (1) obtain the best possible price for Urovant shareholders; (2) determine whether Sumitovant is underpaying for Urovant; and (3) disclose all material information necessary for Urovant shareholders to adequately assess and value the merger consideration.

If you are an Urovant shareholder and would like to discuss your legal rights and options, please visit https://halpersadeh.com/actions/urovant-sciences-ltd-urov-merger-stock-sumitovant/ or contact Daniel Sadeh or Zachary Halper at (212) 763-0060 or [email protected] or [email protected].

Halper Sadeh LLP represents investors all over the world who have fallen victim to securities fraud and corporate misconduct. Our attorneys have been instrumental in implementing corporate reforms and recovering millions of dollars on behalf of defrauded investors.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Halper Sadeh LLP

Daniel Sadeh, Esq.

Zachary Halper, Esq.

(212) 763-0060

[email protected]

[email protected]

https://www.halpersadeh.com

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Legal Professional Services

MEDIA:

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Cooper Tire to Donate 10,000 Toy Vehicles to Toys for Tots this Holiday Season

Cooper Tire to Donate 10,000 Toy Vehicles to Toys for Tots this Holiday Season

Gift is one of multiple ways Cooper will support Toys for Tots to help meet increased need in communities across America

FINDLAY, Ohio–(BUSINESS WIRE)–
Cooper Tire Foundation, the philanthropic arm of Cooper Tire & Rubber Company, today announced it has selected Toys for Tots as its national charity for the 2020 holiday season. Toys for Tots is run by the U.S. Marine Corps Reserve with the mission of providing happiness and hope to disadvantaged children nationwide during the holiday season.

In addition to making a cash gift to Toys for Tots, the Cooper Foundation is donating 10,000 miniature cars, trucks and other vehicles that will be distributed through Toys for Tots to children in need across the United States.

“This holiday season will look and feel different for many families this year, and the need for assistance will be significant,” said Chris Ball, Cooper Tire President—Americas. “We believe everyone deserves to travel life’s journeys with confidence, and Cooper is there at every turn. That is our company purpose, and it is even more important as life has taken unexpected turns for so many this year. We are pleased to help Toys for Tots bring much needed joy to kids this holiday. Santa has his sleigh, but as a tire company, it’s even better for us at Cooper to share our passion for driving by giving toy cars, trucks and buses to children across America this holiday season. Oh what fun!”

Cooper will also collect a variety of toys at its offices, manufacturing plants and technical centers in the U.S., giving employees the opportunity to donate directly. To mark global “Giving Tuesday,” which is December 1, the Cooper Foundation will increase the match for its employee charitable matching gift program from a dollar-for-dollar match to two dollars for every dollar donated by employees who designate gifts to Toys for Tots. The increased match will be in effect for the month of December.

About Cooper Tire & Rubber Company

Cooper Tire & Rubber Company (NYSE: CTB) is the parent company of a global family of companies that specializes in the design, manufacture, marketing and sale of passenger car, light truck, medium truck, motorcycle and racing tires. Cooper’s headquarters is in Findlay, Ohio, with manufacturing, sales, distribution, technical and design operations within its family of companies located in more than one dozen countries around the world. For more information on Cooper, visit www.coopertire.com, www.facebook.com/coopertire or www.twitter.com/coopertire.

Anne Roman

419-429-7189

[email protected]

KEYWORDS: United States North America Ohio

INDUSTRY KEYWORDS: Aftermarket Automotive General Automotive Automotive Manufacturing Manufacturing Philanthropy Tires & Rubber Other Philanthropy Foundation

MEDIA:

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GOCO STOCK DEADLINE: Zhang Investor Law Reminds Investors With Losses of Deadline in Securities Class Action Lawsuit Against GoHealth, Inc. – GOCO

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Zhang Investor Law announces a class action lawsuit on behalf of shareholders who bought shares of GoHealth, Inc. (NASDAQ: GOCO) pursuant and/or traceable to the registration statement issued in connection with the Company’s July 2020 initial public offering (the “IPO”). If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 20, 2020 DEADLINE. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. 

To join the class action, go to http://zhanginvestorlaw.com/join-action-form/?slug=gohealth-inc&id=2439 or call Sophie Zhang, Esq. toll-free at 800-991-3756 or email [email protected] for information on the class action.

如果您想加入这个集体诉讼案，请在这里提交您的信息。http://zhanginvestorlaw.com/join-action-form/?slug=gohealth-inc&id=2439

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:  the Medicare insurance industry was undergoing a period of elevated churn, which had begun in the first half of 2020; GoHealth suffered from a higher risk of customer churn as a result of its unique business model and limited carrier base; GoHealth suffered from degradations in customer persistency and retention as a result of elevated industry churn, vulnerabilities that arose from the Company’s concentrated carrier business model, and GoHealth’s efforts to expand into new geographies, develop new carrier partnerships and worsening product mix; GoHealth had entered into materially less favorable revenue sharing arrangements with its external sales agents; and these adverse financial and operational trends were internally projected by GoHealth to continue and worsen following the IPO. When the true details entered the market, the lawsuit claims that investors suffered damages.

Lead plaintiff status is not required to seek compensation.  You may retain counsel of your choice.  You may remain an absent class member and take no action at this time.

Zhang Investor Law represents investors worldwide. Attorney Advertising. Prior results do not guarantee similar outcomes.

Zhang Investor Law P.C.
99 Wall Street, Suite 232
New York, New York 10005
[email protected]
tel: (800) 991-3756



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GLNG STOCK DEADLINE: Zhang Investor Law Reminds Investors with Losses of the Deadline in Securities Class Action Lawsuit Against Golar LNG Limited – GLNG

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Zhang Investor Law announces a class action lawsuit on behalf of shareholders who bought shares of Golar LNG Limited (NASDAQ: GLNG) between April 24, 2020 and September 24, 2020, inclusive (the “Class Period”). If you wish to serve as lead plaintiff, you must move the Court before the NOVEMBER 23, 2020 DEADLINE. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. 

To join the class action, go to http://zhanginvestorlaw.com/join-action-form/?slug=golar-lng-limited&id=2441 or call Sophie Zhang, Esq. toll-free at 800-991-3756 or email [email protected] for information on the class action.

如果您想加入这个集体诉讼案，请在这里提交您的信息。http://zhanginvestorlaw.com/join-action-form/?slug=golar-lng-limited&id=2441

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: certain employees, including Hygo’s CEO, had bribed third parties, thereby violating anti-bribery policies; as a result, the Company was likely to face regulatory scrutiny and possible penalties; as a result of the foregoing reputational harm, Hygo’s valuation ahead of its IPO would be significantly impaired; and as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Lead plaintiff status is not required to seek compensation.  You may retain counsel of your choice.  You may remain an absent class member and take no action at this time.

Zhang Investor Law represents investors worldwide. Attorney Advertising. Prior results do not guarantee similar outcomes.

Zhang Investor Law P.C.
99 Wall Street, Suite 232
New York, New York 10005
[email protected]
tel: (800) 991-3756



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Inland Cellular Brings Critical 4G Broadband to Rural Areas Using Intelsat CellBackhaul

Inland Cellular Brings Critical 4G Broadband to Rural Areas Using Intelsat CellBackhaul

Intelsat managed service helps Inland Cellular extend broadband connectivity to underserved customers in remote areas of Washington state

MCLEAN, Va. & SPOKANE, Wash.–(BUSINESS WIRE)–Intelsat, operator of the world’s largest integrated satellite and terrestrial network, and Inland Cellular, a regional mobile network operator (MNO) serving communities in the U.S. Pacific Northwest, are partnering to bring reliable 4G LTE broadband coverage to people in rural areas of Washington state.

Inland Cellular needed an efficient way to extend its high-performance service to customers no matter where they live, work or travel – particularly customers in rural areas and at remote construction, mining and camping sites. Intelsat CellBackhaul, an end-to-end managed service launched earlier this year, proved an ideal solution because it overcomes the technical, but mostly importantly, the economic challenges often associated with traditional, terrestrial backhaul deployments for rural coverage.

Intelsat CellBackhaul delivers a fully managed end-to-end cellular backhaul service that provides connectivity over Intelsat’s global network. The service includes on-site installation and maintenance of equipment, such as antennas and modems, and is available through a number of flexible service plans configured to meet differing MNO business needs.

“Our partnership with Intelsat helps increase our speed to market and more efficiently meet peak seasonal demand for connectivity in the areas we serve,” said Inland Cellular President Nathan Weis. “We are a small company that differentiates itself through exceptional customer service, so ensuring our subscribers can stay connected wherever they may go is of the utmost importance to us. With Intelsat CellBackhaul as part of our comprehensive network strategy, we can do just that.”

Today, 97% of the U.S. is considered rural, with low levels of population density, and large parts are still without 4G coverage, a need which has been exacerbated by the COVID-19 pandemic. While traditional terrestrial backhaul approaches work well for urban and suburban coverage, the business case for rural expansion breaks down when factoring in the high cost of building out fiber or microwave, the deployment of which also takes a lot of time, disruption and planning.

Intelsat CellBackhaul is uniquely positioned to enable MNOs of any size to quickly and economically backhaul high-quality, reliable mobile broadband coverage in rural, low-population density regions, and hard-to-reach areas of the U.S.

“That’s precisely why we launched Intelsat CellBackhaul, so mobile operators like Inland Cellular, who serve large rural areas, can quickly and efficiently expand their coverage to travelers, vacationers, rural businesses, tourist operations and IoT integrators — ultimately connecting more people and places,” said Intelsat Regional Vice President of North America Tim Schermerhorn. “We look forward to a long and productive partnership with Inland Cellular, helping them grow their business by expanding their coverage beyond the limits of terrestrial backhaul.”

On the Inland Cellular deployment, Intelsat partnered with U.S.-based equipment providers Comtech EF Data and Trilogy Networks.

To learn more about the Intelsat CellBackhaul managed service visit: www.intelsat.com/cellbackhaul.

About Intelsat

As the foundational architects of satellite technology, Intelsat operates the world’s largest and most advanced satellite fleet and connectivity infrastructure. We apply our unparalleled expertise and global scale to connect people, businesses, and communities, no matter how difficult the challenge. Intelsat is uniquely positioned to help our customers turn possibilities into reality – transformation happens when businesses, governments, and communities use Intelsat’s next-generation global network and managed services to build their connected future. Imagine here, with us, at Intelsat.com.

About Inland Cellular LLC

Inland Cellular LLC, doing business as Inland Cellular and Emerge Technologies, has been providing wireless technology communications services since 1989. Inland Cellular provides mobile voice, messaging and data service, fixed wireless, and fiber to the premises, as well as services such as VoIP for business, fleet management, surveillance cameras, and other small business services in Eastern Washington and Northern Idaho. Inland Cellular has over 120 employees, and our staff has expertise in every aspect of providing fixed wireless internet service, including 160 towers, tower construction, and maintenance; licensed tower climbers; microwave and fiber backhaul; routing and network security; customer premises installation; radio frequency testing and troubleshooting; customer technical support; customer billing and service; and, project management. Inland Cellular’s coverage area for mobile service is expanding, and currently includes 18 counties. Learn more: inlandcellular.com.

About Comtech EF Data

Comtech EF Data is providing its high performance and high availability Heights™ Networking Platform including Remote Gateways at Inland Cellular cell sites. Cellular backhaul over Heights provides the industry’s lowest latency and jitter enabling a terrestrial, fiber-like look and feel for end users and superior Key Performance Indicators (KPIs) for MNOs. To learn more, please visit www.comtechefdata.com/.

About Trilogy

Trilogy is an established leader in the emerging Edge Compute ecosystem with the deployment of Metro, Regional, and On-Premise Cloud installations across the United States. Trilogy recently founded the Rural Cloud Initiative, a coalition of network operators and technology providers committed to promoting and accelerating the digital transformation of rural America. In conjunction with network operators and edge innovation partners, Trilogy is utilizing its LinX™ virtual private network and ConEx infrastructure platform to build a unified, distributed multi-tenant cloud capability on a single network fabric to provide 1.5 million square miles of edge compute capability across rural America, delivering the essential infrastructure for 5G, agriculture, and energy solutions. To learn more, please visit www.ruralcloud.com or www.trilogynet.com.

Media:

Melissa Longo – [email protected]; 240-308-1881

KEYWORDS: United States North America Alabama Washington Virginia

INDUSTRY KEYWORDS: Other Defense Contracts Security Aerospace Satellite Manufacturing Technology Defense Infectious Diseases Other Technology Other Manufacturing Telecommunications Networks Health Mobile/Wireless

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