Morning Brew: October 20, 2020 U.S

Total Page:16

File Type:pdf, Size:1020Kb

Morning Brew: October 20, 2020 U.S PORTFOLIO STRATEGY | PUBLISHED BY RAYMOND JAMES & ASSOCIATES Michael Gibbs, Director of Equity Portfolio & Technical Strategy | (901) OCTOBER 20, 2020 | 8:50 AM EDT 579-4346 | [email protected] Joey Madere, CFA | (901) 529-5331 | [email protected] Richard Sewell, CFA | (901) 524-4194 | [email protected] Mitch Clayton, CMT, Senior Technical Analyst | (901) 579-4812 | [email protected] Morning Brew: October 20, 2020 U.S. FUTURES (BRIEFING.COM) The S&P 500 futures trade 25 points, or 0.7%, above fair value to recoup some of yesterday's decline, while investors assess the latest updates on stimulus, earnings, and a vaccine. After it was reported yesterday that a stimulus deal didn't look imminent, House Speaker Pelosi and Treasury Secretary Mnuchin came out of their meeting with news that they continued to narrow some differences. Both will speak again today, which is supposedly the last day a deal can be reached in order to pass it before the election. This stimulus development is accordingly being viewed as good news. Other good news includes commentary that Moderna's (MRNA 73.38, +2.42, +3.4%) vaccine could be available in December and earnings reports from Procter & Gamble (PG 143.75, +1.84, +1.3%) and Travelers (TRV 115.50, +3.66, +3.3%). IBM (IBM 122.00, -3.52, -2.8%) is a notable earnings laggard. On the data front, investors will receive Housing Starts (Briefing.com consensus 1.430 million) and Building Permits (Briefing.com consensus 1.510 million) for September at 8:30 a.m. ET. Longer-dated Treasuries have extended yesterday's losses, pushing yields to recent highs. The 2-yr yield is flat at 0.15%, and the 10-yr yield is up two basis points to 0.78%. The U.S. Dollar Index is down 0.2% to 93.26. WTI crude futures are up 0.1% to $41.11/bbl. U.S equity futures: ● S&P 500 Futures +22 @ 3445 ● DJIA Futures +172 @ 28272 ● Nasdaq Futures +71 @ 11721 Overseas: ● Europe: DAX -0.3%, FTSE +0.3%, CAC +0.6% . Sources: Briefing.com, FactSet, Raymond James Research, ● Asia: Nikkei -0.4%, Hang Seng +0.1%, Shanghai +0.5% Raymond James Equity Portfolio & Technical Strategy INTERNATIONAL HEADQUARTERS: THE RAYMOND JAMES FINANCIAL CENTER | 880 CARILLON PARKWAY | ST. PETERSBURG FLORIDA 33716 PORTFOLIO STRATEGY . Source: FactSet and RJ Equity Portfolio & Technical Strategy In U.S. Corporate news: ● Procter & Gamble (PG 143.75, +1.84): +1.3% after beating top and bottom-line estimates, guiding FY21 EPS mostly above consensus, and increasing the range for its share buyback plan. ● IBM (IBM 122.00, -3.52): -2.8% after reporting in-line results. ● Travelers (TRV 115.50, +3.66): +3.3% after beating top and bottom-line estimates. ● Parsley Energy (PE 11.25, +1.15): +11.4% on news that it's nearing a deal to be purchased by Pioneer Natural Resources (PDX 87.05, unch), according to TheWallStreetJournal. ● Moderna (MRNA 73.38, +2.42): +3.4% after its CEO said he believes the FDA could grant the company's vaccine emergency use authorization in December. Today’s U.S. Economic Data (Briefing.com) ● 08:30 ET: Housing Starts for September (Briefing.com Consensus 1430K; Prior 1416K) ● 08:30 ET: Building Permits for September (Briefing.com Consensus 1510K; Prior 1470K) OVERSEAS OVERNIGHT SUMMARY (BRIEFING.COM) ● Equity indices in the Asia-Pacific region ended Tuesday on a mixed note. Japan's Nikkei: -0.4%, Hong Kong's Hang Seng: +0.1%, China's Shanghai Composite: +0.5%, India's Sensex: +0.3%, South Korea's Kospi: +0.5%, Australia's ASX All Ordinaries: -0.6%. ○ In economic data: – China's September House Prices 4.6% yr/yr (last 4.8%) PAGE 2 OF 7 PORTFOLIO STRATEGY – Hong Kong's September Unemployment Rate 6.4% (last 6.1%) – New Zealand's Q3 NZIER Business Confidence -40% (last -63%) ○ In news: – The People's Bank of China left its one-year and five-year loan prime rates at their respective 3.85% and 4.65% for the sixth month in a row. – Standard & Poor's affirmed Australia's AAA rating with a Negative outlook. – The Reserve Bank of Australia is looking at ways of lowering its cash rate toward zero without taking the rate negative. ● Major European indices trade on a mostly higher note while Germany's DAX (-0.3%) lags. STOXX Europe 600: UNCH, Germany's DAX: -0.3%, U.K.'s FTSE 100: +0.3%, France's CAC 40: +0.6%, Italy's FTSE MIB: +0.7%, Spain's IBEX 35: +1.1%. ○ In economic data: – Eurozone's August Current Account surplus EUR19.90 bln (expected surplus of EUR17.20 bln; last surplus of EUR16.60 bln) – Germany's September PPI 0.4% m/m (expected -0.1%; last 0.0%); -1.0% yr/yr (expected -1.4%; last -1.2%) – Swiss September trade surplus CHF3.28 bln (expected surplus of CHF4.32 bln; last surplus of CHF3.54 bln) ○ In news: – Negotiators from the U.K. and the European Union have yet to make meaningful progress toward a trade deal. – The EU is set to sell EUR17 bln in 10- and 20-yr social bonds. – UBS and Logitech reported better than expected earnings. ● STOCK HEADLINES (BRIEFING.COM) Earnings/Guidance: ● Albertsons (ACI) beats by $0.37, reports revs in-line; guides FY21 EPS above consensus ● AMC Entertainment (AMC) reports prelim Q3 results; enters into 15 mln share Class A common stock equity distribution agreement ● BancorpSouth (BXS) beats by $0.15, net interest revenue increased 5.6% ● BHP Group (BHP) reports Q1 production; copper equivalent production increased by 2% ● Cadence Design (CDNS) beats by $0.09, beats on revs; guides Q4 EPS above consensus, revs above consensus; guides FY20 EPS above consensus, revs above consensus ● Centogene (CNTG) raises FY20 revenue guidance ● Comerica (CMA) beats by $0.60 ● Commerce Bancshares (CBSH) beats by $0.41, beats on revs ● Crown (CCK) beats by $0.38, beats on revs; guides Q4 EPS above consensus; guides FY20 EPS above consensus, announces plans to initiate a dividend ● Dover (DOV) beats by $0.28, beats on revs; guides FY20 EPS above consensus ● Equity Lifestyle Properties (ELS) beats by $0.02, beats on revs ● F.N.B. Corp (FNB) beats by $0.03 ● Golub Capital (GBDC) reports preliminary Q4 results ● Graphic Packaging (GPK) beats by $0.04, beats on revs ● Hexcel (HXL) misses by $0.36, misses on revs ● IBM (IBM) reports EPS in-line, revs in-line PAGE 3 OF 7 PORTFOLIO STRATEGY ● Ingevity (NGVT) reports prelim Q3 results above consensus; commences private offering of $550.0 million in aggregate principal amount of senior unsecured notes ● IQVIA (IQV) beats by $0.11, beats on revs; guides Q4 EPS below consensus, revs above consensus; guides FY21 EPS above consensus, revs above consensus ● Iridium Communications (IRDM) beats by $0.07, beats on revs; guides FY20 revs below consensus ● Jazz Pharma (JAZZ) announces publication of Phase 3 Xywav study in SLEEP ● Lockheed Martin (LMT) beats by $0.15, beats on revs; raises FY20 EPS guidance above consensus, revs above consensus ● Logitech Int'l SA (LOGI) beats by $1.33, beats on revs; guides FY21 revs above consensus ● Lowe's (LOW) to launch holiday deals in-store and online beginning Thursday, October 22 ● Manpower (MAN) beats by $0.55, beats on revs; guides Q4 EPS mostly above consensus ● Ocwen Fincl (OCN) reports prelim Q3 results; balance sheet optimization actions on track ● Pentair (PNR) beats by $0.19, beats on revs; guides FY20 EPS above consensus, revs above consensus ● Philip Morris International (PM) beats by $0.06, beats on revs; guides FY20 EPS in-line ● PPG Industries (PPG) beats by $0.01, beats on revs ● Procter & Gamble (PG) beats by $0.21, beats on revs; guides FY21 EPS mostly above consensus; ups buyback plan range ● Regions Fincl (RF) beats by $0.16, beats on revs ● Signature Bank (SBNY) misses by $0.09 ● Steel Dynamics (STLD) beats by $0.03, beats on revs ● Synchrony Financial (SYF) beats by $0.04, net interest income decreased 21% ● Synovus (SNV) beats by $0.37 ● Travelers (TRV) beats by $0.05, beats on revs ● UBS AG (UBS) beats by $0.16, beats on revs ● Vale S.A. (VALE) reports sales and production data for Q3 ● Zions Bancorp (ZION) beats by $0.12 General News: ● President Trump and Joe Biden will have their microphones muted during a portion of Thursday's presidential debate where each candidate will give opening statements on the topic, according to the NewYorkTimes ● House Speaker Nancy Pelosi (D-CA) and Treasury Secretary Steven Mnuchin have "narrowed" some differences on stimulus and will speak again today. Senate Republicans continue to be against a larger package, but will vote on extension of PPP funding today and a $500 bln package tomorrow, according to the Bloomberg ● Republicans have gained voter registration in key states of North Carolina, Florida, and Pennsylvania even though President Trump is trailing in the polls in those states, according to the NewYorkTimes ● Supreme Court will allow mail in ballots to be received three days after Election Day in Pennsylvania, according to TheHill ● Align Tech (ALGN) files new lawsuit against 3Shape in Texas Federal Court for patent infringement ● Aptinyx (APTX) reports "positive" top-line data from Phase 2 study of NYX-783 in patients with post-traumatic stress disorder; data support discussion with FDA and advancement into pivotal study ● AstraZeneca (AZN) receives Priority Review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer PAGE 4 OF 7 PORTFOLIO STRATEGY ● Canadian Pacific (CP) announces strategic, multi-year rail agreement with A.P.
Recommended publications
  • Uniqure N.V. Paasheuvelweg 25A 1105BP Amsterdam the Netherlands +1-339-970-7000
    uniQure N.V. Paasheuvelweg 25a 1105BP Amsterdam The Netherlands +1-339-970-7000 NOTICE OF EXTRAORDINARY GENERAL MEETING OF SHAREHOLDERS To be held on September 14, 2017 To the Shareholders of uniQure N.V.: Notice is hereby given that an Extraordinary General Meeting of Shareholders (the “Extraordinary Meeting”) of uniQure N.V., a public company with limited liability ( naamloze vennootschap ) under the laws of the Netherlands (the “Company,” “uniQure,” and “we”), will be held on September 14, 2017, at 9:30 a.m., Central European Summer Time, at the Company’s principal executive offices located at Paasheuvelweg 25a, 1105BP Amsterdam, the Netherlands, for the following purposes: I. Opening and announcements; II. Appointment of Jeremy P. Springhorn, Ph.D. as a non-executive director (voting proposal no. 1); III. Appointment of Madhavan Balachandran as a non-executive director (voting proposal no. 2); IV Any other business that may properly come before the meeting or any adjournment of the meeting; and V. Closing of the meeting. Each person authorized to attend the Extraordinary Meeting may inspect the Agenda at the office of uniQure. Our Board of Directors (our “Board”) recommends that you vote “FOR” each of the voting proposals noted above. The record date is set at the close of business on August 17, 2017 EST and, therefore, only the Company’s shareholders of record at the close of business on August 17, 2017 EST are entitled to receive this notice (this “Notice”) and to vote at the Extraordinary Meeting and any adjournment thereof. Only shareholders who have given notice in writing to the Company by September 12, 2017 of their intention to attend the Extraordinary Meeting in person are entitled to attend the Extraordinary Meeting in person.
    [Show full text]
  • Interim Recommendations for Use of the Moderna Mrna-1273 Vaccine Against COVID-19
    Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19 Interim guidance First issued 25 January 2021 Updated 15 June 2021 Background This interim guidance has been developed on the basis of the advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) at its extraordinary meeting on 21 January 2021 (1) and updated during its extraordinary meeting on 27 May 2021(2). Declarations of interests were collected from all external contributors and assessed for any conflicts of interest. Summaries of the reported interests can be found on the SAGE meeting website and SAGE Working Group website. The guidance is based on the evidence summarised in the Background document on the Moderna mRNA-1273 vaccine against COVID-19 (3) and the background paper on COVID-19 disease and vaccines (4). Annexes which include GRADE and evidence-to-recommendations (ETR) tables have also been updated to reflect the updated recommendations. All referenced documents are available on the SAGE COVID-19 webpage: https://www.who.int/groups/strategic- advisory-group-of-experts-on-immunization/covid-19-materials. These interim recommendations refer to the mRNA-1273 vaccine, manufactured by Moderna. The vaccine is also known as COVID-19 Vaccine Moderna. In the subsequent text the vaccine will be referred to as mRNA-1273. On 30 April 2021, mRNA-1273 was granted WHO’s Emergency Use Listing (EUL). Methods SAGE applies the principles of evidence-based medicine and has set in place a thorough methodological process for issuing and updating recommendations (5). A detailed description of the methodological processes as they apply to COVID-19 vaccines can be found in the SAGE evidence framework for COVID-19 vaccines (6).
    [Show full text]
  • Moderna Vaccine Day Presentation
    Zika Encoded VLP mRNA(s) RSV CMV + EBV SARS-CoV- RSV-ped 2 Flu hMPV/PIV3 H7N9 Encoded mRNA(s) Ribosome Protein chain(s) First Vaccines Day April 14, 2020 © 2020 M oderna Therapeutics Forward-looking statements and disclaimers This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning; the impact of the SARS-CoV-2 pandemic on the Company’s clinical trials and operations; the timing and finalization of a dose-confirmation Phase 2 study and planning for a pivotal Phase 3 study for mRNA-1647; the status and outcome of the Phase 1 clinical trial for mRNA-1273 being conducted by NIH; the next steps and ultimate commercial plan for mRNA-1273; the size of the potential market opportunity for mRNA-1273; the size of the potential commercial market for novel vaccines produced by Moderna or others; the potential peak sales for the Company’s wholly-owned vaccines; the probability of success of the Company’s vaccines individually and as a portfolio; and the ability of the Company to accelerate the research and development timeline for any individual product or the platform as a whole. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements.
    [Show full text]
  • The Covid–19 Pandemic and Haemoglobin Disorders
    THE COVID–19 PANDEMIC AND HAEMOGLOBIN DISORDERS VACCINATIONS & THERAPEUTIC DRUGS An Informational Guide from the Thalassaemia International Federation (TIF) Prepared by: Dr Androulla Eleftheriou, Executive Director, TIF Last Updated: 12 May 2020 VACCINATIONS & THERAPEUTIC DRUGS Introduction It is important to note that there are currently no FDA1 or EMA2-approved or even recommended agents for the treatment of the novel coronavirus (COVID-19), for which the World Health Organization (WHO) declared as pandemic on Wednesday 11th of March 2020. Any agent being used at this time is being administered in an experimental setting under controlled conditions. Thalassaemia International Federation (TIF) has made an effort to compile a list of studies/clinical trials for treatment and vaccines, which is by no means exhaustive as this situation is extremely labile and research in this area is dramatically intensified. New information is anticipated to be added to this guide which is prepared exclusively for TIF’s global thalassemia community. The viral genome was mapped very soon as rom early January 2020 and shared globally. In February 2020, the WHO published an overview of the potential therapeutic candidates for the treatment of COVID-19. The document outlines 76 regimens that have been proposed (as of February 17, 2020) for the treatment of patients infected with the virus. Thirty-eight of these candidates are in the preclinical state with minimal information available on their proposed mechanism, uses, doses routes, or planned trials. Sixteen of the remaining regimens contain an interferon-based product. The rest include a variety of antimicrobials, corticosteroids, convalescent plasma, and biologics. The Director-General of the WHO, Mr Tedros Adhanom, stated on the 10th of April 2020, that more than 70 countries have joined WHO’s trial to accelerate research on effective treatments and 20 Institutions and companies ‘are racing to develop a vaccine’.
    [Show full text]
  • Biopharma R&D on Treatment and Vaccines
    Biopharma R&D on Treatment and Vaccines Coronavirus: Gilead Readies For Remdesivir Ramp Up, Questions On Profit Motive Demand Could Be High For Antiviral Executive Summary “All of that is at risk in not knowing if the drug If clinical trials prove it effective against COVID-19, works or not – and that is really not with an eye to remdesivir could potentially help millions of commercial,” she added. patients - which raises big questions about funding and access. Mercier said the company was spending more time on considering issues of access to the drug once its safety and efficacy is established – especially in regions of the world with less As vaccines will take around 12 months to developed healthcare systems. develop, companies with antiviral treatments are now been pushed to the front line in the battle Nevertheless, Gilead is contemplating a possible against coronavirus, and Gilead Sciences Inc.’s commercial future for the drug. remdesivir is currently the biggest hope of a drug to treat infected patients. “I have to be honest, commercial opportunity might come if this becomes a seasonal disease The company had big news to talk about on 2 or if stockpiling comes into play, but that is much March at the Cowen Health Care conference, as it later down the line,” concluded Mercier. had announced earlier in the day the acquisition of oncology firm Forty Seven for $4.9bn. (Also see One precedent for a big commercial hit for an “Gilead Calls Forty Seven Buyout Complementary antiviral product is Roche’s Tamiflu (oseltamivir). To Kite, Other IO Efforts” - Scrip, 2 Mar, 2020.) The drug achieved peak revenues of $3bn in 2009, largely down to stockpiling in response to that Speaking at the investor conference, Gilead’s chief year’s H1N1 flu pandemic.
    [Show full text]
  • Effectiveness of Pfizer-Biontech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021
    Morbidity and Mortality Weekly Report Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021 Mark W. Tenforde, MD, PhD1; Samantha M. Olson, MPH1; Wesley H. Self, MD2; H. Keipp Talbot, MD2; Christopher J. Lindsell, PhD2; Jay S. Steingrub, MD3; Nathan I. Shapiro, MD4; Adit A. Ginde, MD5; David J. Douin, MD5; Matthew E. Prekker, MD6; Samuel M. Brown, MD7; Ithan D. Peltan, MD7; Michelle N. Gong, MD8; Amira Mohamed, MD8; Akram Khan, MD9; Matthew C. Exline, MD10; D. Clark Files, MD11; Kevin W. Gibbs, MD11; William B. Stubblefield, MD2; Jonathan D. Casey, MD2; Todd W. Rice, MD2; Carlos G. Grijalva, MD2; David N. Hager, MD, PhD12; Arber Shehu, MD12; Nida Qadir, MD13; Steven Y. Chang, MD, PhD13; Jennifer G. Wilson, MD14; Manjusha Gaglani, MBBS15,16; Kempapura Murthy, MPH15; Nicole Calhoun, LMSW, MPA15; Arnold S. Monto, MD17; Emily T. Martin, PhD17; Anurag Malani, MD18; Richard K. Zimmerman, MD19; Fernanda P. Silveira, MD19; Donald B. Middleton, MD19; Yuwei Zhu, MD2; Dayna Wyatt2; Meagan Stephenson, MPH1; Adrienne Baughman2; Kelsey N. Womack, PhD2; Kimberly W. Hart2; Miwako Kobayashi, MD1; Jennifer R. Verani, MD1; Manish M. Patel, MD1; IVY Network; HAIVEN Investigators On April 28, 2021, this report was posted as an MMWR Early ≥65 years. Vaccination is a critical tool for reducing severe Release on the MMWR website (https://www.cdc.gov/mmwr). COVID-19 in groups at high risk. Adults aged ≥65 years are at increased risk for severe outcomes Randomized clinical trials of vaccines that have received an from COVID-19 and were identified as a priority group to EUA in the United States showed efficacy of 94%–95% in receive the first COVID-19 vaccines approved for use under preventing COVID-19–associated illness (4,5).§ However, an Emergency Use Authorization (EUA) in the United States hospitalization is a rare outcome among patients with (1–3).
    [Show full text]
  • Comparing Three Covid-19 Vaccines: Pfizer, Moderna, J&J
    Comparing three Covid-19 vaccines: Pfizer, Moderna, J&J 3/1/21, 2:09 PM Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson By Helen Branswell Feb. 2, 2021 CVS registered pharmacist Ken Ramey prepares to give a Covid-19 vaccine at the Isles of Vero Beach assisted and independent senior living community in Vero Beach, Fla. Wilfredo Lee/AP In an ideal world, a pandemic vaccine could be delivered in a single shot, so supplies could be stretched to cover a lot of people. It would trigger no side effect more significant than a sore arm. And it would be easy to ship and store. https://www.statnews.com/2021/02/02/comparing-the-covid-19-vaccines-developed-by-pfizer-moderna-and-johnson-johnson/ Page 1 of 10 Comparing three Covid-19 vaccines: Pfizer, Moderna, J&J 3/1/21, 2:09 PM We now have one such vaccine. On Feb. 27, the Food and Drug Administration announced it had issued an emergency use authorization for Johnson & Johnson’s one-dose Covid vaccine. Developed by J&J’s vaccines division, Janssen Pharmaceuticals, it was shown to be 66% protective against moderate to severe Covid infection in a multi-country study. Importantly, it was 85% effective in protecting against severe disease. And there were no hospitalizations or deaths among people in the vaccine arm of a large clinical trial. Overall efficacy varied a bit geographically, especially in South Africa, where a new variant appears to evade to some degree the immunity induced both by infection and by Covid vaccines, which were designed to target earlier strains of the SARS-CoV-2 virus.
    [Show full text]
  • Biopharma Leaders Unite to Stand with Science
    Biopharma Leaders Unite to Stand with Science • Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines NEW YORK, September 8, 2020 (GLOBE NEWSWIRE) – The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech SE (NASDAQ: BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), known as MSD outside the United States and Canada, Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc. (Nasdaq: NVAX), Pfizer Inc. (NYSE: PFE), and Sanofi (NASDAQ: SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. All nine CEOs signed the following pledge: We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer- blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.
    [Show full text]
  • David Meline Joins Moderna As Chief Financial Officer
    David Meline Joins Moderna as Chief Financial Officer June 4, 2020 CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 4, 2020-- Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that David Meline has joined Moderna as Chief Financial Officer, effective Monday, June 8, 2020. He will serve on Moderna’s Executive Committee and report to Chief Executive Officer Stéphane Bancel. “I am pleased to welcome David to Moderna as our Chief Financial Officer and to the Executive Committee. As we prepare for the Phase 3 studies of our SARS-CoV-2 vaccine and our CMV vaccine, we are entering another critical phase for the Company. We have started to build commercial capabilities and started to set up commercial subsidiaries in several countries,” said Stéphane Bancel, Chief Executive Officer of Moderna. “David’s global biopharmaceutical industry and commercial experience along with his track record as CFO of Amgen for the last 6 years and before that, as CFO of 3M, make him a great addition to our team. I look forward to partnering with David to grow Moderna to a global enterprise focused on development and delivery of novel therapeutics and vaccines.” Mr. Meline joins Moderna from Amgen (Nasdaq: AMGN), where he served as Chief Financial Officer and EVP from 2014 through 2019. At Amgen, he was responsible for all finance, information systems and global business services activities across 100 countries. In this role, Mr. Meline led enterprise-wide transformation while increasing growth and productivity and reducing development cycle time.
    [Show full text]
  • Moderna COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older
    Moderna COVID-19 Vaccine Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older Purpose Inform recipients, especially males 12 through 29 years of age To reduce morbidity and mortality from coronavirus disease and their parents/legal representative (when relevant) of the 2019 (COVID-19) by vaccinating persons who meet the criteria possibility of myocarditis or pericarditis following receipt of mRNA COVID-19 vaccines and the need to seek care if symptoms of established by the Centers for Disease Control and Prevention’s ‡ Advisory Committee on Immunization Practices (ACIP). myocarditis or pericarditis develop after vaccination. For people who received a COVID-19 vaccine that is not Policy currently authorized in the United States, guidance can be Where authorized under state law, standing orders enable found at: https://www.cdc.gov/vaccines/covid-19/info-by- eligible nurses and other healthcare professionals (e.g., product/clinical-considerations.html#not-authorized-vaccines pharmacists) to assess and vaccinate persons who meet the Moderna COVID-19 vaccine may be coadministered with criteria in the "Procedure" section below without the need other vaccines - on the same day, as well as within 14 days of for clinician examination or direct order from the attending each other.§ provider at the time of the interaction. For recommendations for COVID-19 vaccination and Procedure SARS-CoV-2 infection, see https://www.cdc.gov/vaccines/ covid-19/clinical-considerations/covid-19-vaccines-us. Assess persons 18 years of age and older for vaccination with html#CoV-19-vaccination Moderna COVID-19 Vaccine based on the following criteria: Screen for contraindications and precautions.
    [Show full text]
  • Event Study: the Influence of COVID-19 Research and Development
    Event Study: The Influence Of COVID-19 Research and Development News on Pharmaceutical and Biotech Companies Lydia Chuyue Zhang1 College of Literature, Science, and the Arts University of Michigan – Ann Arbor [email protected] April 9, 2021 1 I thank Professor Pablo Ottonello, Professor Kathryn Dominguez, and Professor Linda Tesar for their helpful comments. Zhang 2 Abstract This event study estimates the influence of COVID-19 related research and development news on pharmaceutical and biotech companies and its impact on the stock market. Results show that companies can grow 4% to 63.92% from their development progress, except for Johnson & Johnson’s -2.96% loss on January 29th, 2021. Dynamics between vaccine and treatment drug developers were collaborative initially and more competitive later. The market prefers certain firms such as Moderna, CureVac, and Gilead, who are less likely to be defeated by others’ success and more likely to disrupt others with their progress. Private and public benefits from vaccine and drug developments mostly align, except when Novavax’s and Johnson & Johnson’s positive announcements collided. Lastly, positive market sentiment seems to influence small-cap and mid- cap firms more than large-caps, while negative events have less impact on them. Zhang 3 Ⅰ. Introduction This event study estimates the influence of COVID-19 related research and development news on pharmaceutical and biotech companies and its impact on the stock market. During COVID-19, the healthcare sector is attracting significant investments from governments and investors. The pandemic outbreak severely damaged the U.S economy and stock market during March 2020, which exacerbated domestic and external political conflicts.
    [Show full text]
  • Moderna COVID-19 Vaccine Storage and Handling Summary
    Moderna COVID-19 Vaccine Storage and Handling Summary Basics Store vaccine in a freezer or refrigerator. See guidance below for each storage unit. Use vaccine vials stored in the refrigerator before removing vials from frozen storage. Check and record storage unit temperature each workday. See guidance below for each type of temperature monitoring device. Save storage records for 3 years, unless your jurisdiction requires a longer time period. Deliveries Vaccine 1. The vaccine will arrive frozen between -50°C and -15°C (-58°F and 5°F). 2. Examine the shipment for signs of damage. 3. Open the box and remove TagAlert Temperature Monitor from box (placed in the inner box next to vaccine). 4. Check the TagAlert temperature monitoring device by pressing the blue “start and stop” button. Left arrow points to a green checkmark: The vaccine is ready to use. Store the vaccine at proper temperatures immediately. Right arrow points to a red X: The numbers 1 and/or 2 will appear in the display. Store the vaccine at proper temperatures and label DO NOT USE! Call the phone number indicated in the instructions or your jurisdiction's immunization program IMMEDIATELY! 5. The expiration date is NOT printed on the vaccine vial or carton. To determine the expiration date: Scan the QR code located on the outer carton, or Go to www.modernatx.com/covid19vaccine-eua/. Ancillary Supply Kit An ancillary kit with supplies will be provided for administering the vaccine. Administration supplies include needles, syringes, sterile alcohol prep pads, vaccination record cards (shot cards), and some PPE.
    [Show full text]