Gilead and Novo Nordisk Present New Data from Proof-of-Concept Trial in NASH

Gilead and Novo Nordisk Present New Data from Proof-of-Concept Trial in NASH

— Results from First Phase 2 Trial Describing a Triple Combination Regimen Targeting NASH Presented at The Liver Meeting Digital Experience —

FOSTER CITY, Calif. & BAGSVÆRD, Denmark–(BUSINESS WIRE)–
Gilead Sciences, Inc. (Nasdaq: GILD) and Novo Nordisk A/S (NASDAQ Copenhagen: NOVO B) today announced results from a Phase 2 proof-of-concept trial. The five-arm trial evaluated combinations of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, with Gilead’s investigational FXR agonist cilofexor and/or Gilead’s investigational ACC inhibitor firsocostat over 24 weeks in 108 people with non-alcoholic steatohepatitis (NASH). The results were presented at The Liver Meeting Digital Experience™ (TLMdX), November 13–16, 2020 (Late Breaker #L02).

The trial met its primary endpoint by demonstrating that in people with NASH and mild to moderate fibrosis all regimens were well tolerated. The most common adverse events (AEs) were gastrointestinal. Minimal pruritus (itching) was observed in people treated with cilofexor. Across all groups, 5–14% of people discontinued any trial treatment due to AEs. Exploratory efficacy endpoints assessing biomarkers of liver health at 24 weeks in post-hoc analyses showed statistically significant improvements in hepatic steatosis (measured by magnetic resonance imaging proton density fat fraction; MRI-PDFF) and liver injury (measured by serum alanine aminotransferase; ALT) in the combination arms versus semaglutide alone. Although liver stiffness measured by vibration-controlled transient elastography (VCTE) and enhanced liver fibrosis (ELF) score declined in all groups, statistically significant differences between groups were not observed.

“These results offer novel insights around the multiple mechanisms that drive NASH and demonstrate the potential of combination approaches for patients in significant need of a treatment option for this condition,” said Naim Alkhouri, MD, Director of the Fatty Liver Program, Chief of Transplant Hepatology, Arizona Liver Health, Chandler. “We are encouraged that these data showcase the potential for combination approaches to elicit improvements in liver fat content, liver biochemistry, and certain non-invasive tests of fibrosis, all of which have been associated with meaningful histologic improvement in NASH.”

“Gilead is focused on delivering scientific advances that can improve the lives of people with liver disease, both through our own innovation and in partnership with companies with complementary expertise, such as Novo Nordisk,” said Mark Genovese, MD, Senior Vice President, Inflammation Clinical Development at Gilead Sciences. “These data offer new insights into potential therapeutic approaches to treating NASH, a disease which currently has limited treatment options.”

“This trial brings together Gilead and Novo Nordisk’s respective expertise and science to provide important insights into potential new combination therapies involving semaglutide to help people living with NASH,” said Martin Holst Lange, Senior Vice President, Global Development at Novo Nordisk. “We are now carefully evaluating next steps together based on a thorough assessment of data.”

The companies are also presenting preclinical data supporting the development of combination approaches in NASH. In the preclinical trial, semaglutide alone and in combination with cilofexor and/or GS-834356 (an analog of firsocostat) were administered daily for 12 weeks in a murine model of diet-induced NASH (n=15-16/group). The results demonstrated that while semaglutide significantly improved NASH and fibrosis-related endpoints, the addition of either cilofexor or the firsocostat analog further improved liver fat reduction. The combination of all three agents had the greatest impact on changes in the NAFLD Activity Score (NAS).

The safety and efficacy of firsocostat, GS-834356 and cilofexor have not been established. Firsocostat, GS-834356 and cilofexor are investigational compounds and are not approved by the FDA or any other regulatory authority. Semaglutide has not been approved by the FDA or any other regulatory authority for the treatment of people living with NASH, but has been approved for the treatment of type 2 diabetes.

About NASH

NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. The risk of progression to advanced liver disease, including liver decompensation (loss of liver function) and liver cancer, is higher in people with NASH than in the general population and NASH could become the leading reason for liver transplants in most countries. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few management options.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

About Novo Nordisk

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 44,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

Gilead Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing and additional clinical trials involving cilofexor, firsocostat and GS-834356 and the possibility that Gilead may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of cilofexor, firsocostat and GS-834356 and other investigational compounds, or that the parties may make a strategic decision to discontinue their collaboration at any time, and as a result, the compounds may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

GILEAD CONTACTS:

Douglas Maffei, PhD, Investors

+1 (650) 522-2739

Darcy Bowman, Media

+353 (87) 382-6777

NOVO NORDISK CONTACTS:

Daniel Muusmann Bohsen, Investors

+45 3075 2175

Mette Kruse Danielsen

+45 3079 3883

KEYWORDS: Europe Denmark United States North America California

INDUSTRY KEYWORDS: Health Hospitals Clinical Trials Research Science Pharmaceutical Biotechnology

MEDIA:

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Azul S.A. Statement on the Successful Settlement of Public Convertible Debentures

Knighthead Capital Management and Certares Management acted as anchor investors of the offering

PR Newswire

SAO PAULO, Nov. 15, 2020 /PRNewswire/ — Azul S.A. (B3: AZUL4, NYSE: AZUL) and its partners celebrate the successful settlement of its public offering of convertible debentures in Brazil.  The settlement took place on Nov 12 and the official settlement announcement can be found on the Azul Investor Relations website.  Financial advisors to the company included Seabury Securities LLC, a US investment banking firm and Itau BBA, a Brazilian investment bank which acted as sole underwriter for the public offer. 

“We want to thank all of our financial partners for their support during this process.  Together with our anchor investors Knighthead and Certares, we are setting the stage for a successful long-term partnership.  Azul’s strategic competitive advantages and unique business model, combined with the strong market recovery in Brazil, lead to us to be optimistic about our future.  The successful conclusion of this public offering ensures that we are in a position to be a long-term winner,” says John Rodgerson, Chief Executive Officer at Azul.

“Since its founding in 2008, Azul has executed one of the most creative and ambitious business plans in aviation,” said Tom Wagner, Founder of Knighthead Capital Management.  “Amidst uncertainty around COVID-19, this transaction provides the airline with one of the best liquidity positions in the global industry.  Brazil has been an excellent and resilient air travel market for several years, and Azul’s strong balance sheet and market position set the stage for its future success.  We are excited to partner with management as the company grows in the years ahead.”

“Azul is a premier airline that has been recognized globally for delivering great customer experiences and consistently strong financial performance,” said Tom Klein Senior Managing Director at Certares.  “That, coupled with Azul’s being strategically positioned for growth and a long term winner in Latin American aviation, makes partnering with its respected management team ideal for Certares.”

About Azul

Azul S.A. (B3: AZUL4, NYSE: AZUL), the largest airline in Brazil by number of flight departures and cities served, offers 916 daily flights to 116 destinations. With an operating fleet of 140 aircraft and more than 13,000 crewmembers, the Company has a network of 249 non-stop routes as of December 31, 2019. In 2020 Azul was awarded best airline in the world by TripAdvisor, the first time a Brazilian Flag Carrier ranked number one in the Traveler’s Choice Awards. Azul was also recognized in 2019 as best regional carrier in South America for the ninth consecutive year by Skytrax. Additionally, in 2019, Azul ranked among the top ten most on–time low-cost carriers in the world, according to OAG. For more information visit www.voeazul.com.br/ir.

About Knighthead

Established in 2008, Knighthead Capital Management’s credit platform combines bottom-up fundamental research with top-down macro analysis to identify investment opportunities across the capital structure.  Led by co-founders Tom Wagner and Ara Cohen, the experienced investment team seeks to achieve superior risk-adjusted returns in distressed investments via fundamental analysis and driving restructuring processes.  The $4.5 billion platform is diversified across Knighthead’s evergreen funds, closed end credit funds, real estate lending, and insurance asset management.

About Certares

Established in 2012, Certares focuses on direct investments in proprietary transactions, leveraging deep sector experience in the travel and hospitality industries, and with a consistent emphasis on partnership with management teams to drive growth. Certares brings together a team with decades of both operational and investment experience in private equity, travel, tourism, hospitality and travel-related business and consumer services. For more information, please visit www.certares.com.

Cision View original content:http://www.prnewswire.com/news-releases/azul-sa-statement-on-the-successful-settlement-of-public-convertible-debentures-301173258.html

SOURCE Azul S.A.

MyoKardia Presents Cardiac Imaging Data from 30-Week EXPLORER-HCM Study of Mavacamten

EXPLORER
-HCM
Cardiac Imaging Data Presented at AHA 2020 Scientific Session with Simultaneous Publication in Circulation

Mavacamten
T
reatment
Resulted in
Favorable Effect on
Cardiac Structure
— Significantly Reduced
Hypertrophy
in Patients with Hypertrophic Cardiomyopathy

BRISBANE, Calif., Nov. 15, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) announced results from its cardiac magnetic resonance imaging (CMR) substudy of mavacamten for the potential treatment of hypertrophic cardiomyopathy (HCM) showing that 30-week treatment with mavacamten has a favorable effect on cardiac structure, while maintaining contractile function within the normal range. These data were shared today in an oral presentation titled, “Mavacamten Favorably Impacts Cardiac Structure in Obstructive Hypertrophic Cardiomyopathy: EXPLORER-HCM CMR substudy” (Oral Session 18654), at the American Heart Association’s Scientific Sessions 2020 during the High Profile Clinical Science in CVD session. Data from the EXPLORER-HCM CMR substudy were also published simultaneously in Circulation.

The CMR substudy was conducted as part of MyoKardia’s pivotal Phase 3 EXPLORER-HCM clinical trial in patients with symptomatic, obstructive HCM to assess the impact of once-daily treatment with mavacamten on parameters of cardiac structure and function. Thirty-five patients were enrolled in the CMR substudy and randomized to mavacamten (n=17) or placebo (n=18) and had valid CMR assessments at day 1 and week 30 (end of treatment) which were analyzed centrally in a blinded manner. Statistically significant changes from baseline to Week 30 were observed in the mavacamten group vs. placebo for the primary endpoint of left ventricular mass index (p<0.0001), as well as exploratory endpoints of absolute intracellular myocardial mass index, maximum wall thickness, and maximum left atrial volume index (all p<0.001 for the difference from placebo). From baseline to Week 30, there was no worsening in myocardial fibrosis, another common characteristic of HCM.

“Hypertrophic cardiomyopathy is defined by the thickening of the heart muscle, so to see favorable remodeling of the heart indicating a lessening of hypertrophy within 30-weeks of treatment is a highly encouraging finding for the many patients struggling with HCM,” said Sara Saberi, M.D., Assistant Professor in the Division of Cardiovascular Medicine and member of the Inherited Cardiomyopathy Program at the University of Michigan Medical School, and lead author on the study. “The CMR substudy is the first randomized, controlled clinical trial of HCM patients to show that a once-daily oral therapeutic agent can reduce left ventricular wall thickness and mass, and positively impact several other parameters of cardiac structure and function. Left ventricular hypertrophy and left atrial volumes in particular are predictive of poor prognosis in HCM patients, so it will be exciting to see how mavacamten impacts cardiac function and disease progression as we continue to follow patients over time.”  

Changes in left ventricular hypertrophy and left atrial volumes were observed concurrently with reductions in levels of plasma biomarkers of myocardial stress and injury, consistent with echocardiographic observations from the overall EXPLORER-HCM population. Importantly, the reduction in left ventricular mass index correlated with a reduction in high-sensitivity cardiac troponin I.  

“Data from the CMR substudy complements and extends our observations of mavacamten’s positive benefits on cardiac function and symptom relief, providing us with encouraging evidence that mavacamten treatment may change the course of the adverse cardiac remodeling inherent to HCM. In directly targeting the proteins of the heart muscle that lead to the excessive contraction and impaired relaxation underlying HCM, we have a growing body of data showing that mavacamten is reducing hypercontractility and hypertrophy and reducing harm to the cardiac muscle while maintaining contractile function within the normal range,” said Jay Edelberg, M.D., Ph.D., MyoKardia’s Chief Medical Officer.  

As previously reported, results from EXPLORER-HCM demonstrated that patients treated with mavacamten experienced statistically significant and clinically meaningful improvements in symptoms, functional status and key aspects of quality of life. In addition to meeting the primary and all secondary endpoints, mavacamten was well tolerated with a safety profile similar to placebo. MyoKardia plans to submit a New Drug Application for mavacamten to the U.S. Food and Drug Administration (FDA) in the first quarter of 2021.

About EXPLORER-HCM

The EXPLORER-HCM Phase 3 trial enrolled a total of 251 patients with symptomatic (NYHA Class II or III), obstructive hypertrophic cardiomyopathy. All participants had measurable LVOT gradient (resting and/or provoked) ≥50 mmHg at baseline. Patients were randomized on a 1:1 basis to receive individualized once-daily dosing of mavacamten or placebo. Patients started on a dose of 5mg, with up to two opportunities for dose adjustments (to doses of 2.5mg – 15mg) based on a combination of residual LVOT gradient, drug plasma concentration and left ventricular ejection fraction (LVEF) levels.

The primary endpoint for EXPLORER-HCM was a composite functional analysis designed to capture mavacamten’s effect on both symptoms and function. The composite functional endpoint is defined by either (1) the achievement of a ≥1.5mL/kg/min improvement in peak VO2 accompanied by an improvement of ≥1 NYHA functional class, or (2) the achievement of a ≥3.0mL/kg/min improvement of peak VO2 with no worsening in NYHA functional class. In addition to the endpoints reported today, the EXPLORER-HCM study also assessed mavacamten’s effect on patient-reported outcomes, health-related quality-of-life and symptom severity assessments, changes from baseline to Week 30 in echocardiographic indices, circulating biomarkers, cardiac rhythm patterns and accelerometry.

About
MyoKardia

MyoKardia is a clinical-stage biopharmaceutical company discovering and developing targeted therapies for the treatment of serious cardiovascular diseases. The company is pioneering a precision medicine approach to its discovery and development efforts by 1) understanding the biomechanical underpinnings of disease; 2) targeting the proteins that modulate a given condition; 3) identifying patient populations with shared disease characteristics; and 4) applying learnings from research and clinical studies to inform and guide pipeline growth and product advancement. MyoKardia’s initial focus is on small molecule therapeutics aimed at the proteins of the heart that modulate cardiac muscle contraction to address diseases driven by excessive contraction, impaired relaxation, or insufficient contraction. Among its discoveries are three clinical-stage therapeutics: mavacamten (formerly MYK-461); danicamtiv (formerly MYK-491) and MYK-224.

MyoKardia’s mission is to change the world for people with serious cardiovascular disease through bold and innovative science.

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements regarding the clinical and therapeutic benefit and future potential of mavacamten, the ability of our long-term studies to provide further evidence of how mavacamten impacts cardiac function and disease progression over time, the ability of our long-term studies to provide further evidence of mavacamten’s potential to positively impact several other parameters of cardiac structure and function, that mavacamten treatment may change the course of the adverse cardiac remodeling inherent to HCM, and mavacamten’s ability to reduce harm to the cardiac muscle while maintaining contractile function within the normal range, reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks associated with the development and regulation of our product candidates and any ongoing effects of the COVID-19 pandemic, as well as those set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and our other filings with the SEC. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Michelle Corral
Executive Director, Corporate Communications and Investor Relations
MyoKardia, Inc.
650-351-4690
[email protected]

Hannah Deresiewicz (investors)
Stern Investor Relations, Inc.
212-362-1200
[email protected]

Julie Normant (media)
W2O
628-213-3754
[email protected]



ROSEN, A LEADING LAW FIRM, Reminds Golar LNG Limited Investors of Important November 23 Deadline in Securities Class Action – GLNG

NEW YORK, Nov. 15, 2020 (GLOBE NEWSWIRE) — Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Golar LNG Limited (NASDAQ: GLNG) between April 30, 2020 and September 24, 2020, inclusive (the “Class Period”), of the important November 23, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Golar investors under the federal securities laws.

To join the Golar class action, go to http://www.rosenlegal.com/cases-register-1958.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.

The complaint alleges throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose that: (1) certain employees, including the CEO of Hygo Energy Transition Ltd. f/k/a Golar Power Limited (“Hygo”), had bribed third parties, thereby violating anti-bribery policies; (2) as a result, the Company was likely to face regulatory scrutiny and possible penalties; (3) as a result of the foregoing reputational harm, Hygo’s valuation ahead of its IPO would be significantly impaired; and (4) 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. When the true details entered the market, the lawsuit claims that investors suffered damages.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 23, 2020. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1958.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at [email protected] or [email protected].

NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR’S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors. Attorney Advertising. Prior results do not guarantee a similar outcome.

——————————-

Contact Information:

        Laurence Rosen, Esq.
        Phillip Kim, Esq.
        The Rosen Law Firm, P.A.
        275 Madison Avenue, 40th Floor
        New York, NY 10016
        Tel: (212) 686-1060
        Toll Free: (866) 767-3653
        Fax: (212) 202-3827
        [email protected]
        [email protected]
        [email protected]
        www.rosenlegal.com



Arbutus Announces Presentation of Phase 1a/1b Clinical Trial Results for AB-729 in Chronic Hepatitis B Subjects at The Liver Meeting Digital Experience™, The American Association for the Study of Liver Diseases Meeting

Across all single-dose cohorts, mean HBsAg concentrations continuously declined up to week 12 before reaching a plateau
,
suggesting
dosing of AB-729 less frequently than every 4 weeks
may be warranted

        In the 60mg every 4 weeksmulti-dose cohort, HBsAg concentrations continued to decline steadily beyond week 12 with no plateau in response observed to date

          Both HBV RNA and HBcrAgconcentrations declined after single- and multi-dose administration of AB-729

          AB-729 was generally safe and well tolerated

C
onference Call and Webcast Scheduled
for Monday, November 16, 2020 at 8:00 am ET

WARMINSTER, Pa., Nov. 15, 2020 (GLOBE NEWSWIRE) — Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced the presentation of updated clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound. The presentation, entitled Safety and pharmacodynamics of the GalNAc-siRNA AB-729 in subjects with chronic hepatitis B infection, was presented by Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., Chief of Division of Gastroenterology and Hepatology, Department of Medicine, The University of Hong Kong, Hong Kong, during a virtual oral session: Hepatitis B: Therapeutics (New) at The Liver Meeting Digital ExperienceTM, The American Association for the Study of Liver Diseases Meeting.              

Summary of presented data

Single-doses of AB-729 studied to date, 60 mg, 90 mg and 180 mg, resulted in comparable mean HBsAg declines at week 12, followed by a sustained plateau phase. During the multiple-dose portion of the trial, 60 mg of AB-729 dosed every 4 weeks resulted in continuous declines in HBsAg, reaching a mean of –1.44 log10 IU/ML at week 16. Data beyond week 16 demonstrate further declines in HBsAg with no plateau seen to date. AB-729 also resulted in meaningful decreases in both HBV RNA and HBcrAg. AB-729 was generally safe and well tolerated. The presentation can be accessed through the Investors section under Events & Presentations of Arbutus’ website at www.arbutusbio.com.

Repeat dosing of AB-729 60 mg every 4 weeks results in continuous HBsAg declines beyond
w
eek 12

  Mean (SE) Week 12

N=7
Mean (SE) Week 16

N=7
Mean (SE) Week 20

N=3

Δlog10 HBsAg (IU/mL)
-1.10 (0.15) -1.44 (0.18) -1.73 (0.12)

Professor Yuen stated “These are the first multi-dose data for AB-729 and show continuous decline of HBsAg throughout the dosing period. Importantly, AB-729 was generally safe and well tolerated. These encouraging data support the continued development of AB-729 as a potential cornerstone of future combination regimens for the treatment of chronic hepatitis B infection.”

Summary of clinical trial design 

AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts:

In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.

In Part 2, non-cirrhotic, HBeAg positive or negative, chronic HBV subjects (N=6) on a background of nucleos(t)ide therapy with HBV DNA below the limit of quantitation received single-doses (60 mg to 180 mg) of AB-729. An additional cohort in Part 2 included 90 mg single-dose of AB-729 in HBV DNA positive chronic HBV subjects.

In Part 3, chronic HBV subjects, HBV DNA negative first and HBV DNA positive later, are receiving multi-doses of AB-729 for up to six months.

About AB-729 

AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. In an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About HBV

Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.

The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.

Conference Call and Webcast

Arbutus will hold a conference call and webcast on Monday, November 16, 2020 at 8:00 am Eastern Time to provide an AB-729 clinical update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 7791835.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 7791835.

About Arbutus

Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, please visit www.arbutusbio.com.

Forward-Looking Statements and Information

This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements regarding the Company’s expectation that AB-729 could be the cornerstone of future combination regimens for the treatment of chronic hepatitis B infection.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus’ clinical development programs.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Contact Information


Investors and Media

William H. Collier
President and CEO
Phone: 267-469-0914
Email: [email protected]

Pam Murphy
Investor Relations Consultant
Phone: 267-469-0914
Email: [email protected]

 



New Research Shows Gazelle Diagnostic Device Outperformed Rapid Diagnostic Test for P. Vivax Malaria, Detected Challenging Types of Malaria, and Provided Accurate Sickle Cell Disease Detection

Researchers to Present Five Scientific Posters at the 2020 American Society of Tropical Medicine and Hygiene Annual Meeting

PORTLAND, Ore., Nov. 15, 2020 (GLOBE NEWSWIRE) — Hemex Health, an innovator in point-of-care diagnostic technologies, announced today that researchers will present five scientific posters at the 2020 American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting showcasing the company’s Gazelle® platform – a novel approach to identifying malaria and sickle cell disease accurately within minutes.

Gazelle is a compact, rugged, battery-operated diagnostic device. Gazelle can be used inexpensively, with no cold chain requirements by entry level healthcare workers in areas with limited access, resources or electricity. Patient information and results are captured digitally for storage, printing, or later transmission to the cloud.

“Gazelle has a unique approach that uses hemozoin to find malaria accurately in about one minute,” said Patti White, co-founder and CEO of Hemex Health. “This research shows that when Gazelle was tested in the field, it accurately and quickly found malaria species that were not successfully identified by rapid diagnostic tests.”

Below are highlights of the clinical information supporting Gazelle that will be given at the 2020 ASTMH Annual Meeting:


Title

: Gazelle: A portable point-of-
c
are diagnostic with high accuracy and fast turnaround time for detecting

P. vivax

malaria

A study conducted in the Brazilian Amazon on P. vivax showed that Gazelle was more sensitive than RDTs and comparable in accuracy to expert microscopy, but significantly faster than RDTs, microscopy and PCR.


Title

: New diagnostic demonstrates improved limit of detection for

P. vivax

in multi-site testing

Research demonstrated that Gazelle had over six times lower limit of detection for P. vivax malaria than RDTs when evaluated in dilution testing in Cambodia, Brazil, and India.

[Full news release continues here.]

About Hemex Health

Hemex Health designs diagnostic technologies for the real world by listening to the needs of healthcare providers including in some of the most remote and challenging settings. The Gazelle technology was developed in collaboration with Case Western Reserve University.   Hemex Health is located in Portland, Oregon, USA. HemexDx, a subsidiary of Hemex Health, is located in Mumbai, India. More information can be found by going to www.hemexhealth.com.

CONTACT:         
David Sheon
[email protected]
202 422-6999



FINAL DEADLINE ALERT: ROSEN, A TOP RANKED LAW FIRM, Reminds Odonate Therapeutics, Inc. Investors of Important Monday Deadline in Securities Class Action – ODT

NEW YORK, Nov. 15, 2020 (GLOBE NEWSWIRE) — Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Odonate Therapeutics, Inc. (NASDAQ: ODT) between December 7, 2017 and August 21, 2020, inclusive (the “Class Period”), of the important November 16, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Odonate investors under the federal securities laws.

To join the Odonate class action, go to http://www.rosenlegal.com/cases-register-1946.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose to investors that: (1) tesetaxel was not as safe or well-tolerated as Odonate had led investors to believe; (2) consequently, tesetaxel’s commercial viability as a cancer treatment was overstated; and (3) as a result, defendants’ public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 16, 2020. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1946.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at [email protected] or [email protected].

NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR’S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors. Attorney Advertising. Prior results do not guarantee a similar outcome.

——————————-

Contact Information:

        Laurence Rosen, Esq.
        Phillip Kim, Esq.
        The Rosen Law Firm, P.A.
        275 Madison Avenue, 40th Floor
        New York, NY 10016
        Tel: (212) 686-1060
        Toll Free: (866) 767-3653
        Fax: (212) 202-3827
        [email protected]
        [email protected]
        [email protected]
        www.rosenlegal.com



Sienna Announces November Dividend

MARKHAM, Ontario, Nov. 15, 2020 (GLOBE NEWSWIRE) — Sienna Senior Living Inc. (“Sienna” or the “Company”) (TSX: SIA) today announced a dividend of $0.078 per common share of the Company (each, a “Common Share”) for the month of November 2020, representing $0.936 per Common Share on an annualized basis.

The dividend will be payable on December 15, 2020 to shareholders of record as at November 30, 2020.  

The Company’s dividends are designated as eligible dividends for Canadian tax purposes in accordance with subsection 89(14) of the Income Tax Act (Canada), and any applicable corresponding provincial and territorial legislation.

A
bout Sienna Senior Living

Sienna Senior Living Inc. (TSX:SIA) offers a full range of seniors’ living options, including independent living, assisted living, long-term care, and specialized programs and services. Sienna’s approximately 13,000 employees are passionate about helping residents live fully every day. For more information, please visit www.siennaliving.ca.

For further information, please contact:

Karen Hon
Chief Financial Officer & Senior Vice President
(905) 489-0254
[email protected]



FINAL DEADLINE REMINDER: ROSEN, LEADING INVESTOR COUNSEL, Reminds Nano-X Imaging Ltd. Investors of Important Monday Deadline in First Filed Securities Class Action Commenced by the Firm – NNOX

NEW YORK, Nov. 15, 2020 (GLOBE NEWSWIRE) — Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Nano-X Imaging Ltd. (NASDAQ: NNOX), between August 21, 2020 and September 15, 2020, inclusive (the “Class Period”), of the important November 16, 2020 lead plaintiff deadline in the securities class action commenced by the firm. The lawsuit seeks to recover damages for Nano-X investors under the federal securities laws.

To join the Nano-X class action, go to http://www.rosenlegal.com/cases-register-1945.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.

According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Nano-X’s commercial agreements and its customers were fabricated; (2) Nano-X’s statements regarding its “novel” Nanox System were misleading as the Company never provided data comparing its images with images from competitors’ machines; (3) Nano-X’s submission to the U.S. Food and Drug Administration admitted the Nanox System was not original; and (4) as a result, defendants’ public statements were materially false and/or misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than November 16, 2020. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1945.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at [email protected] or [email protected].

NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR’S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm or on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors. Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
[email protected]
[email protected]
[email protected]
www.rosenlegal.com



DEADLINE TOMORROW: The Schall Law Firm Announces it is Investigating Claims Against Nikola Corporation and Encourages Investors with Losses of $1,000,000 to Contact the Firm

DEADLINE TOMORROW: The Schall Law Firm Announces it is Investigating Claims Against Nikola Corporation and Encourages Investors with Losses of $1,000,000 to Contact the Firm

LOS ANGELES–(BUSINESS WIRE)–The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Nikola Corporation (“Nikola” or “the Company”) (NASDAQ: NKLA) for violations of the securities laws.

The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Nikola’s founder, Trevor Milton, materially misrepresented the Company’s technology and business. The Company’s profitability and business prospects were massively overstated. Based on these facts, the Company’s public statements were false and materially misleading throughout the class period. When the market learned the truth about Nikola, investors suffered damages.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 1880 Century Park East, Suite 404, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm’s website at www.schallfirm.com, or by email at [email protected].

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

The Schall Law Firm

Brian Schall, Esq.

310-301-3335

[email protected]

www.schallfirm.com

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Legal Professional Services

MEDIA:

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