Day: November 21, 2020

REGN – Regeneron's REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

TARRYTOWN, N.Y., Nov. 21, 2020 /PRNewswire/ —

First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2

Authorized for recently diagnosed, mild to moderate COVID-19 in high-risk patients

Initial doses of REGEN-COV2 will be made available to approximately 300,000 patients, with no medication out-of-pocket costs, under U.S. government allocation program

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (also known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Casirivimab and imdevimab administered together are authorized for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

The criteria for ‘high-risk’ patients are described in the Fact Sheet for Health Care Providers. Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.  

“This FDA Emergency Use Authorization is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “The science and technology investments Regeneron has made over three decades positioned us to move rapidly to invent, study and maximize production of REGEN-COV2. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. In the first quarter of 2021, we expect to increase available REGEN-COV2 global supply as we continue our collaboration with Roche.”

“REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. “Data from approximately 800 non-hospitalized patients showed significant reductions in virus levels within days of receiving REGEN-COV2, which were associated with significantly fewer medical visits. This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors. We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. We are also very encouraged by recently announced promising vaccine results; however, there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination. Importantly, we continue to advance our rigorous clinical trial program evaluating the safety and efficacy of REGEN-COV2 for both the treatment and prevention of COVID-19, and we will share new results as available.”

Production of monoclonal antibodies is a complex, time- and labor-intensive process that requires deep expertise. Utilizing production and manufacturing platforms developed over decades, Regeneron rapidly scaled up REGEN-COV2, beginning in the early days of the pandemic with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Regeneron now expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021.

As part of Operation Warp Speed, in July the U.S. government and Regeneron signed an agreement for this initial supply of REGEN-COV2. The U.S. government will coordinate with state authorities to allocate REGEN-COV2 on a weekly basis based on the number of COVID-19 cases in each state. The government has committed to providing these 300,000 doses at no cost to patients, although healthcare facilities may charge fees related to administration. Regeneron will immediately begin shipping REGEN-COV2 to Amerisource Bergen, a national distributor, which will distribute the therapy as directed by the government.

Under the EUA, the recommended dose is 1,200 mg of casirivimab and 1,200 mg of imdevimab (2,400 mg total) administered as a single intravenous infusion. The authorization is based on positive Phase 2 data announced in September and October from the first 799 adults in an ongoing randomized, double-blind, placebo-controlled trial of non-hospitalized patients (“outpatients”) with COVID-19.

The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless terminated or revoked sooner. Casirivimab and imdevimab have not been approved by FDA and remain investigational. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. Data from these trials will be used to support a future BLA submission. Health care providers should review the Fact Sheet for detailed information on the authorized use and requirements of the EUA and may call 844-734-6643 for more information. Please see the Fact Sheet and FDA Letter of Authorization at http://www.regencov2.com/.

REGEN-COV2 continues to be evaluated in Phase 2/3 clinical trials for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients, the Phase 3 open-label RECOVERY trial of hospitalized patients in the UK, and a Phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals. To date, more than 7,000 people have participated in REGEN-COV2 clinical trials.

About REGEN-COV2
REGEN-COV2 is a cocktail of two monoclonal antibodies (casirivimab and imdevimab, also known as REGN10933 and REGN10987, respectively) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

To develop REGEN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGEN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

REGEN-COV2’s development and manufacturing has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. Regeneron continues to increase in-house production of REGEN-COV2, and the company has partnered with Roche to increase the global supply of REGEN-COV2 beginning in 2021. If REGEN-COV2 proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. and Roche will develop, manufacture and distribute it outside the U.S. Once both companies are at full manufacturing capacity in 2021, there are expected to be at least 2 million treatment doses available annually.

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION

Authorized Emergency Use

Casirivimab and imdevimab injection (REGEN-COV2) is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. Safety and effectiveness of casirivimab and imdevimab injection have not yet been established for the treatment of COVID-19.

This authorized use is only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564 (b)(1) of the Act, 21 U.S.C. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

Limitations of Authorized Use

  • Casirivimab and imdevimab injection is not authorized for use in patients:
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
  • Benefit of treatment with casirivimab and imdevimab injection has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.

Definition of High-Risk Patients

High-risk is defined as patients who meet at least one of the following criteria:

  • Have a body mass index (BMI) ≥35
  • Have chronic kidney disease
  • Have diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Are ≥65 years of age
  • Are ≥55 years of age AND have
    • cardiovascular disease, OR
    • hypertension, OR
    • chronic obstructive pulmonary disease/other chronic respiratory disease.
  • Are 12 – 17 years of age AND have
    • BMI ≥85th percentile for their age and gender based on CDC growth charts, OR
    • sickle cell disease, OR
    • congenital or acquired heart disease, OR
    • neurodevelopmental disorders, for example, cerebral palsy, OR
    • a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)

      OR
    • asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.

Warnings and Precautions: 

  • Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of casirivimab and imdevimab injection. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. Infusion-related reactions have been observed with administration of casirivimab and imdevimab injection. Signs and symptoms of infusion related reactions may include fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, and/or dizziness. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.
  • Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19: Benefit of treatment with casirivimab and imdevimab injection has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. Therefore, casirivimab and imdevimab injection is not authorized for use in who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

Adverse Reactions:

  • Serious adverse events (SAEs) were reported in 4 (1.6%) patients in the casirivimab and imdevimab injection 2,400 mg group, 2 (0.8%) patients in casirivimab and imdevimab injection 8,000 mg group and 6 (2.3%) patients in the placebo group. None of the SAEs were considered to be related to study drug. SAEs that were reported as Grade 3 or 4 adverse events were pneumonia, hyperglycemia, nausea and vomiting (2,400 mg casirivimab and imdevimab injection), intestinal obstruction and dyspnea (8,000 mg casirivimab and imdevimab injection) and COVID-19, pneumonia and hypoxia (placebo). Casirivimab and imdevimab injection are not authorized at the 8,000 mg dose (4,000 mg casirivimab and 4,000 mg imdevimab).

Patient Monitoring Recommendations: Clinically monitor patients during infusion and observe patients for at least 1 hour after infusion is complete.

Use in Specific Populations: 

  • Pregnancy: There is currently limited clinical experience in the use of casirivimab and imdevimab injection in COVID-19 patients who are pregnant. Casirivimab and imdevimab injection therapy should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
  • Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for casirivimab and imdevimab injection and any potential adverse effects on the breastfed child from casirivimab and imdevimab injection or from the underlying maternal condition.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune, which uses unique genetically-humanized mice to produce optimized fully-human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue to conduct research and clinical programs (including those discussed in this press release), Regeneron’s ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators (collectively, “Regeneron’s Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron’s Products and product candidates and research and clinical programs now underway or planned, including without limitation the development program relating to REGEN-COV2 (Regeneron’s investigational multi-antibody therapy for the treatment and prevention of COVID-19); how long the Emergency Use Authorization (“EUA”) granted by the U.S. Food and Drug Administration (the “FDA”) for REGEN-COV2 will remain in effect and whether the EUA is revoked by the FDA based on its determination that the underlying health emergency no longer exists or warrants such authorization or other reasons; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product candidates (such as REGEN-COV2) and new indications for Regeneron’s Products; safety issues resulting from the administration of Regeneron’s Products and product candidates (such as REGEN-COV2) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and product candidates in clinical trials (including those discussed in this press release); the ability of Regeneron to manufacture in anticipated quantities Regeneron’s Products and product candidates, including REGEN-COV2; the ability of Regeneron to manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and product candidates; uncertainty of market acceptance and commercial success of Regeneron’s Products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the trials discussed in this press release, on any potential regulatory approval (including with respect to REGEN-COV2) and/or the commercial success of Regeneron’s Products and product candidates; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and product candidates, including without limitation REGEN-COV2; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and product candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron’s collaboration with Roche relating to REGEN-COV2, to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), and Praluent® (alirocumab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).

Contacts:

Media Relations
Alexandra Bowie

Tel: +1 (914) 847-3407
[email protected]

Investor Relations
Mark Hudson

Tel: +1 (914) 847-3482
[email protected] 

SOURCE Regeneron Pharmaceuticals, Inc.

Related Links

http://www.regeneron.com

ROBT – Artificial Intelligence and Robotics ETF (ROBT) at a 52-Week High

For investors looking for momentum, First Trust Nasdaq Artificial Intelligence and Robotics ETF (ROBT Free Report) is probably a suitable pick. The fund just hit a 52-week high and is up 96.8% from its 52-week low price of $22.51/share.

Let’s take a look at the fund and its near-term outlook to gain an insight into where it might be headed:

ROBT in Focus

This ETF seeks investment results that correspond generally to the price and yield, before the fees and expenses of the Nasdaq CTA Artificial Intelligence and Robotics Index. It has AUM of $137.5 million and charges 65 basis points in annual fees.

Why the Move?

Due to the coronavirus outbreak, the robotics market is flooded with opportunities as robots are being used for jobs such as sanitizing hospitals, homes and workplaces along with monitoring, surveying, handling, and delivering food and medicines. The current conditions seem favorable for the robotic markets in government applications, such as health, security and defense. Also, with the reopening of the U.S. economy, it is believed that robots will see increased usage in industrial, manufacturing, healthcare, logistics, inspection and maintenance, automotive, electronics, and food and beverage areas. This is making funds like ROBT an attractive investment option.

More Gains Ahead?

It seems like the fund will remain strong, with a positive weighted alpha of 40.97, which gives cues of further rally.

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WU – Western Union Grabs 15% Stake In Saudi Digital Payments Business

The Western Union Company (NYSE: WU) has acquired a 15% stake in a Saudi Arabian digital payment business, Reuters reported.

What Happened: The $200 million stake is in a digital payment unit of Saudi Arabia’s STC Group, a telecom.

Why It Matters: Western Union is one of many companies vying for a lead in digital payments outside China, where Ant Financial’s Alipay app and Tencent Holding‘s (OTCMKTS: TCEHY) WeChat app are already well-entrenched.

This week, Alphabet Inc (NASDAQ: GOOG) relaunched an expanded version of its Google Pay app in a bid to grab more of the market. Google and Western Union are up against competitors such as PayPal Holdings Inc (NASDAQ: PYPL), Square Inc (NYSE: SQ) and Zelle.

Photo by Usien via Wikimedia

© 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

ZSAN – Rosen, A Top Ranked Law Firm, Reminds Zosano Pharma Corporation Investors of Important Deadline in Securities Class Action; Encourages Investors with Losses in Excess of $100K to Contact Firm – ZSAN

New York, New York–(Newsfile Corp. – November 21, 2020) – Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Zosano Pharma Corporation (NASDAQ: ZSAN) between February 13, 2017 and September 30, 2020, inclusive (the “Class Period”), of the important December 28, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Zosano investors under the federal securities laws.

To join the Zosano class action, go to http://www.rosenlegal.com/cases-register-1963.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com 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) the Company’s clinical results reflected differences in zolmitriptan exposures observed between subjects receiving different lots; (2) pharmocokinetic studies submitted in connection with the Company’s New Drug Application (“NDA”) included patients exhibiting unexpected high plasma concentrations of zolmitriptan; (3) as a result of the foregoing differences among patient results, the U.S. Food and Drug Administration (“FDA”) was reasonably likely to require further studies to support regulatory approval of Qtrypta; (4) as a result, regulatory approval of Qtrypta was reasonably likely to be delayed; and (5) as a result of the foregoing, 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 December 28, 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-1963.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 pkim@rosenlegal.com or cases@rosenlegal.com.

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
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/68703

info

GE – General Electric shares rise sharply but the business of the company is still under the pressure

General Electric (NYSE: GE) shares have advanced more than 50% since the beginning of October, mainly on speculation of what a vaccine could mean for GE’s aviation business. In less than several weeks, the price of the stock has advanced from $6.27 above $10 and the current price stands around $9.7.

Fundamental analysis: Revenues from the aviation segment have decreased by 38% in Q3

General Electric (GE) is an American company that operates through the following segments: healthcare, power, aviation, renewable energy, digital industry, additive manufacturing and finance. The price of the stock has weakened more than 60% since the 2016 year as the company continues to have a fall in revenues.

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It is also important to say that General Electric had a loss in 2017, 2018 and 2019 year. Despite this, the business of the company is not compromised and General Electric’s size will always attract potential investors.

General Electric had a 17% Y/Y decrease in revenues in Q3 but adjusted Q3 EPS came in at $0.06 (down from the $0.15 in 2019). Revenues from the aviation segment have decreased by 38% mainly due to the Covid-19 pandemic while revenues from Power and Renewable Energy have increased.

Positive information is that General Electric reduced debt by $2.6B in Q3 and the company expects to improve this even more in the fourth quarter.

“We are managing through a still-difficult environment with better operational execution across our businesses, and we are on track with our cost and cash actions. We are improving our profit and cash performance with organic margin expansion in every segment except Aviation,” said CEO Lawrence Culp.

COVID-19 cases in the US continue to rise and the US reported over 198K new cases in one day. The next year will be competitive for General Electric but the aviation segment is expected to benefit once the economy reopens.

The business of the company is still under the pressure and maybe now is not the best moment for buying General Electric shares. This stock is still risky in my opinion and the price of General Electric shares could weaken again.

Technical analysis: Bulls are focused on breaking the resistance level at $10

General Electric shares have been moving in the downtrend last several years but the price of this stock has seen a significant rise in the last forty days. In less than several weeks, the price of the stock has advanced from $6.27 above $10 and the current price stands around $9.7.

Data source: tradingview.com

The current support levels are $9 and $8, $10 and $11 represent the current resistance levels. Rising above $11 supports the continuation of the bullish trend for General Electric shares but if the price falls below $8 it would be a strong “sell” signal.

Summary

General Electric shares have advanced due to promising COVID-19 vaccines but this stock is still risky in my opinion. General Electric had a 17% Y/Y decrease in revenues in Q3 and the business of the company is still under the pressure. Revenues from the aviation segment have decreased by 38% mainly due to the Covid-19 pandemic while revenues from Power and Renewable Energy have increased.

MRNA – Is Moderna a Good Stock to Buy Right Now?

Moderna (NASDAQ:MRNA) recently announced an impressive efficacy of 94.5% from a late-stage study of coronavirus vaccine candidate mRNA-1273. The biotech stock jumped on the good news, but is it still a good pick to buy? That’s the question that Healthcare and Cannabis Bureau Chief Corinne Cardina and Fool.com writer Keith Speights address in this Motley Fool Live video recorded on Nov. 16, 2020.

Corinne Cardina: I don’t want to bury the lede, so I’m I go ahead and ask you what you think of Moderna as a potential investment today? The stock is up about $6 on the news of this interim analysis. Do you think that with Moderna, this expectation of safe and efficacious vaccine is already baked in? Will you cautiously say it’s a buy? What do you think?

Keith Speights: First of all, I think you’re exactly right. I think the expectation was, to a large extent, already baked into the price. This wasn’t a double-digit percentage gain from Moderna this morning. That’s just a reflection of investors anticipating this good news, especially in light of Pfizer‘s news last week.

First of all, I do think some of the news was already baked into the price, but I do think Moderna could be an intriguing investment opportunity for aggressive investors. There’s still risk with this stock, definitely. But the news for their interim results today was very good.

I think it looks likely at this point that they will be able to receive emergency use authorization for their vaccine and potentially approvals in other countries. But this is just the beginning for Moderna. They have a very loaded pipeline with other mRNA vaccines and therapeutics. I think the success of their COVID-19 vaccine could bode well for the rest of their pipeline.

Corinne Cardina: Absolutely, especially for Moderna, which I didn’t think I realized this until recently, but did you know that the mRNA is all in the name Moderna? Fun fact.

Keith Speights: And it’s their stock ticker as well. [Laughing]

Corinne Cardina: Of course. That is big news, proof of concept of basically their entire concept. There’s still some near-term catalyst for this stock. The emergency use authorization, if that happens, I could see the stock going up once it rolls out on the market. I could see that also propelling the stock forward. So I don’t think it reached an all-time high so far, but maybe not in the future. We’ll have to keep an eye on it for sure.

IDEX – IDEX Stock Price Increases 28.33%: Why It Happened

  • The stock price of Ideanomics Inc (NASDAQ: IDEX) increased by 28.33% on Friday, November 20. This is why the stock price likely increased.

The stock price of Ideanomics Inc (NASDAQ: IDEX) increased by 28.33% yesterday. Even though the company did not make any direct announcements on Friday, there were several external factors that sent the stock price up.

What does Ideanomics do? Ideanomics focuses on monetizing the adoption of commercial electric vehicles and associated energy consumption. The company’s Mobile Energy Global operations also offer financial services and incentives for commercial fleet operators, including group purchase discounts and battery buyback programs. This operation also offers solutions for procuring, financing, charging, and energy management needs for fleet operators of commercial electric vehicles. 

And the company’s Ideanomics Capital division offers financial services solutions. This unit is involved in the areas of capital markets like financial products advisory and creation with specific focus on the application of blockchain and artificial intelligence in financial technology. This division runs EKAR — an exchange traded fund that tracks the Innovation Labs Next Generation Vehicles Index. This Index comprises of global stocks that have exposure to the theme of electric and self driving/autonomous vehicles. It’s worth mentioning that the EKAR ETF is up 49.28% over the past year.

Earlier this month, Ideanomics revealed the Mobile Energy Global (MEG) division’s sales activities for the month of October. That division delivered 102 units — all of which were taxi / ride-hailing vehicles. And the 340 units that were invoiced during July through September 2020 are pending expected delivery. For the month of October, China had 2 major national holidays overlap — which resulted in fewer business days. And it was expected to be a lower delivery volume month as a result. 

“As we enter the final months of 2020, our sales efforts are focused on progressing opportunities for larger vehicle orders towards completion, and expanding our deliveries into battery systems and charging piles as part of testing programs with our customers and partners,” said said Alf Poor, CEO of Ideanomics. “As we look to round out Q4 and 2020, our goal is to deliver quarter over quarter growth while building our order book so that we can hit the ground running in 2021.”

A couple of weeks ago, Ideanomics also acquired 100% of a privately-held company called Timios Holdings in an all-cash deal. Timios is a a nationwide title and settlement solutions provider that offers freedom-of-choice-friendly solutions for real estate transactions, including residential and commercial title insurance and closing and settlement services, as well as specialized offerings for the mortgage industry. And Ideanomics expects that Timios will become one of the cornerstones of Ideanomics Capital.

Why Did Ideanomics Stock Price Increase On Friday?

This past week, the stock price increased a total of 29.41% as it went from $1.19 per share on November 16 to $1.54 on Friday November 20. And there was especially a rallying around companies in the electric vehicle space on Friday itself. The hype around the electric vehicle space was largely triggered by the better-than-expected earnings results reported by Nio, Xpeng, and Li Auto earlier this month. And Tesla was added to the S&P 500 (Tesla is up +20.95% this week), and Nikola is still having ongoing discussions with GM about a partnership (Nikola is up +19.91% this week).

Besides Ideanomics, there were several other electric vehicle companies that also saw a spike on Friday as well. Kaixin Auto Holdings — a China-based car dealership and e-commerce service — surged 101.33% on Friday alone. AYRO — a company that is building an all-electric mobile food cart — increased by 30.91% on Friday.  And Electrameccanica Vehicles — a company that is making a three-wheeled electric vehicle called the Solo — increased by 39.51% on Friday. Other companies in the electric vehicle space that increased on Friday also include Workhorse Group Inc (+13.17%), Hyliion Holdings (+3.29%), and Blink Charging (23.61%).

NVDA – Nvidia CEO Jensen Huang interview — Antitrust, openness, and the PC-console war

Nvidia had another stellar quarter, reporting this week it had revenues of $4.73 billion for its third fiscal quarter ended October 25, up 57% from a year earlier.

We talked to CEO Jensen Huang about those results, but we also strayed into other issues as well, such as the environment for antitrust. The tech giants like Apple, Google, Amazon, and Facebook are facing more scrutiny these days on antitrust, and I asked Huang if that affected Nvidia, especially as it attempts to acquire Arm for $40 billion. Nvidia also said its GeForce Now will debut on iOS via the web, with Fortnite coming soon, in a way that was constraining because of Apple’s rules about cloud gaming.

I also asked him if he thinks that Arm deal will also make Nvidia become more open than it otherwise might be. We also chattered about the PC versus the next-generation consoles and how Nvidia’s two big businesses, gaming graphics and AI/datacenter chips, are contending with each other to become the company’s biggest source of revenues.

We hope you enjoy the conversation. Here’s an edited transcript of our interview.

CEO Jensen Huang shows off GeForce RTX 3000 series graphics cards.

Above: CEO Jensen Huang shows off GeForce RTX 3000 series graphics cards.

Image Credit: Nvidia

GamesBeat: Congratulations on another good quarter. On anti-trust, I wondered — the regulators and Congress are all going after the tech giants now. Is that something that might affect Nvidia in some way, like with the ARM acquisition? What do you think about the environment for anti-trust?

Jensen Huang: There’s nothing on my radar. All the businesses we’re in are super competitive. ARM has giant customers. The new markets they want to grow into, they’re the severe underdog. There’s every reason to believe that by adding more horsepower to ARM, we’re going to increase customer choice and increase innovation in the marketplace. Our assessment is that regulatory is going to be quite favorable to this transaction.

GamesBeat: Do you think ARM can help Nvidia become more open than it ordinarily might be?

Huang: ARM and Nvidia are very similar. Nvidia’s architecture is available in every cloud, in every computer maker, in every shape and size. You can buy chips. You can buy systems. You can rent it for a dollar an hour. The reason why our platform is so well-adopted is because it’s open. People talk about even reverse-engineering our architecture, and that’s fine. The architecture is probably the most abundantly available architecture outside of the x86 in the world, for general-purpose programming.

ARM is the same way. Their architecture is available to anybody who wants to come and get it. Those are very similar, and we have very similar attitudes about the availability of our architecture to customers.

GamesBeat: The other side of this is, do you want other companies to be more open and allow you to do more? For example, Apple and GeForce Now. That cloud gaming app can’t really happen except on the web. How do you feel about others being open?

Huang: Our strategy is to be open, to have an open platform for everybody to use however they’d like to use it. But everybody has their own strategy. Ours just happens to be an open platform strategy.

Jensen Huang of Nvidia holds the world's largest graphics card.

Above: Jensen Huang of Nvidia holds the world’s largest graphics card.

Image Credit: Nvidia

GamesBeat: We have another console season here. What do you think of the PC versus console right now? There’s an interesting competition shaping up.

Huang: I don’t really think they’re competitors. The things you can do on a PC, you can’t do them on a console. But the thing that’s great is that all the content developers are having to raise the bar because the consoles are so powerful. Everyone is moving to raytracing, which is fantastic. All of that is good for gaming.

If you look at the way that people use PCs these days, as you know, gaming has gone well beyond just gaming. It’s used for art. It’s used for sport. It’s used for sharing and influencers. The PC is the best platform for doing all of that. Not to mention, you need a PC anyway for video conferencing and things like that. You might as well get an Nvidia GeForce with AI broadcasting and all that stuff. It’s good bang for the buck.

GamesBeat: I see gaming and the data center are trading the lead in your revenues back and forth. Do you expect that to keep happening in the foreseeable future?

Huang: I hope the two businesses will continue to trade leads in the size of the business. It’s a foregone conclusion that everybody in the world will be a gamer someday. There are only a billion active gamers today. Someday there will be 7 billion, 8 billion active gamers. The growth opportunity for gaming is still well ahead of us. Gaming is the only entertainment that can be any entertainment. You and I both know that when the metaverse, we’re going to spend a lot more time in game worlds, not just to game, but just to hang out, to be with people, to interact with people. The gaming market has a great future ahead of it.

Nvidia CEO Jensen Huang at the new robotics research lab in Seattle, Washington

Above: Nvidia CEO Jensen Huang at the new robotics research lab in Seattle, Washington

Image Credit: Nvidia

On the other hand, I also know that AI is a new way of writing software, and this way of writing software is going to impact every industry. Because we can now write software that we otherwise could not before, computing could reach more places that we otherwise could not before. For example, who would have thought that on the roads of the future, a billion computers could be just driving around? Who would have thought that, in the future, there will be thousands of computers roaming around warehouses and factories? Those are all new applications that otherwise wouldn’t have been possible without AI.

Every building will be an AI. Everything will be an AI. That’s going to generate a lot of data, a lot more computing. The computer industry is going to be gigantic because of AI. It’s the catalyst that’s been missing. It’s the final piece of the puzzle, to write the software. If someone can write the software, we can sell a computer. Now we can have computers write software. Those two businesses are long-term secular opportunities.

RETA – Rosen, Global Investor Counsel, Reminds Reata Pharmaceuticals, Inc. Investors of Important December 14 Deadline in Securities Class Action; Encourages Investors with Losses in Excess of $100K to Contact Firm – RETA

New York, New York–(Newsfile Corp. – November 21, 2020) – Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Reata Pharmaceuticals, Inc. (NASDAQ: RETA) between October 15, 2019 and August 7, 2020, inclusive (the “Class Period”), of the important December 14, 2020 lead plaintiff deadline in the securities class action. The lawsuit seeks to recover damages for Reata investors under the federal securities laws.

To join the Reata class action, go to http://www.rosenlegal.com/cases-register-1970.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com 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) the MOXIe Part 2 study results were insufficient to support a single study marketing approval of omaveloxolone for the treatment of Friedreich’s ataxia (“FA”) in the U.S. without additional evidence; (2) as a result, it was foreseeably likely that the FDA would not accept marketing approval of omaveloxolone for the treatment of FA in the U.S. based on the MOXIe Part 2 study results; and (3) as a result, Reata’s 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 December 14, 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-1970.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 pkim@rosenlegal.com or cases@rosenlegal.com.

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
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www.rosenlegal.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/68701

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MRNA – The Big Thing to Know About Moderna's COVID Vaccine Results

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) were the first drugmakers to announce interim efficacy results from a late-stage study of their coronavirus vaccine candidate. Moderna (NASDAQ:MRNA) had its turn last week. And — like Pfizer and BioNTech — the company had some very good news. In this Motley Fool Live video recorded on Nov. 16, 2020, Healthcare and Cannabis Bureau Chief Corinne Cardina talks with Fool.com writer Keith Speights about the big story from Moderna’s exciting update.

Corinne Cardina: Turning now, we have Keith Speights coming on. A longtime Fool.com writer. Fools, we’re going to talk about the exciting news that we got today from Moderna.

Before we do that, I do want to remind everyone that we are using a question-and-answer service called Slido. So open that up on your browser. There’s also an app. The code is “MFlive”. We are hoping to get to some of your questions at the end of this 30 minutes. Please throw those in there, and we will just go ahead and start by having Keith share the headline today. Keith, what did we learn from Moderna this morning?

Keith Speights: Hi, Corinne. It’s a little like deja vu. It was just a week ago we were talking about Pfizer and BioNTech. Great news with their interim efficacy for their COVID-19 vaccine candidate. Today, we’re talking about Moderna, and again, it’s great news.

Moderna this morning announced their interim efficacy results, and they announced a 94.5 percent vaccine efficacy, which is outstanding. Let’s see. Corinne, I think they had maybe a 100 or 95 cases in this interim analysis, 90 of those were in the placebo group and five were in the group that received Moderna’s vaccine candidate. And so really only five people who took the vaccine experienced a case of COVID-19 whereas 90 people in the placebo group experienced COVID-19. So that’s a very good interim result.

Corinne Cardina: Absolutely, and just for clarity, this is not one of those trials where folks are exposed to the coronavirus intentionally, they go about their daily lives as usual?

Keith Speights: Exactly. At least, so far, and I actually don’t anticipate we will have any of those challenge studies where humans are intentionally exposed to the coronavirus. There’s just really no need for it.

But yes, that’s what happened. They had thousands of people enrolled in the study. After receiving either placebo or the actual vaccine, then they wait and see who is going to be infected or not. And when they hit a certain threshold, then the independent data monitoring board that oversees the study does an interim analysis, turns that data over to the company, in this case, Moderna. We heard those results this morning.