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Two key economic events take place next week, including the release of the November consumer price index report and the Federal Reserve's December meeting........
$MRNA "I do believe in the next five to 10 years, almost every health care company will be in the in cloud," he said.
https://finance.yahoo.com/news/almost-every-health-care-company-will-be-in-the-in-cloud-in-the-next-10-years-aws-exec-214612722.html
winner!
STOMP is a NIAID-funded clinical trial led by the ACTG to evaluate the effectiveness of the antiviral tecovirimat, also know as TPOXX, for the treatment of human monkeypox infection.
stomptpoxx.org/main
MODERNA RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR OMICRON-TARGETING BIVALENT COVID-19 BOOSTER VACCINE IN CHILDREN 6 MONTHS THROUGH 5 YEARS OF AGE
https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-FDA-Emergency-Use-Authorization-for-Omicron-Targeting-Bivalent-COVID-19-Booster-Vaccine-in-Children-6-Months-Through-5-Years-of-Age/default.aspx
Moderna is expecting primary data from the 157-participant KEYNOTE-942 trial this quarter. Patients in the study received up to nine doses of mRNA-4157 at 21-day intervals.
RELAX$
cancer: we are getting close to a preliminary data readout here.
Pfizer-BioNTech And Moderna mRNA Vaccines Are Not Gene Therapies "anti Vaxers"
mRNA vaccines
On the other hand, mRNA vaccines will not enter a cell’s nucleus that is home to a person’s DNA genome. As a consequence, vaccines don’t integrate into the DNA genome and alter our genetic makeup. Rather, the mRNA vaccines are genetic-based therapies that do not genetically modify humans. Using a metaphorical set of instructions, mRNA vaccines teach our cells how to make a protein that will trigger an immune response inside our bodies.
Ideally, the antibodies are what protects us from getting infected if the real virus enters our bodies. But, as we’ve learned, the Covid-19 vaccines aren’t nearly as good at reducing transmission of the coronavirus as they are at preventing severe disease.
And so, while mRNA vaccines are viewed as genetic-based therapy because they use genetic code from Covid-19, they are not gene therapies and they don’t stay in a person’s body for more than a few days.
https://www.forbes.com/sites/joshuacohen/2022/01/04/pfizer-biontech-and-moderna-mrna-vaccines-are-not-gene-therapies/?sh=6004aa6e229a
float 76.39M
The team hopes results may be available before Christmas
Oxford University launch new clinical trial to test a treatment for monkeypox
https://www.ox.ac.uk/news/2022-08-24-oxford-university-launch-new-clinical-trial-test-treatment-monkeypox
alert!
Experimental flu vaccine, developed using mRNA, seen as potential game changer
https://www.statnews.com/2022/11/24/experimental-flu-vaccine-developed-using-mrna-seen-as-potential-game-changer/
$MRNA
BERLIN — The German government gave a piece of advice to China on Monday as the country faces historic protests against its rigid zero-COVID and lockdown policies : just start using Western mRNA vaccines to find a way out of the pandemic.
https://www.politico.eu/article/germany-to-china-use-western-covid-coronavirus-mrna-vaccines-duh/
The Worst Mistake Moderna Investors Can Make in 2023 $$$$$$$$$$
40 programs in development and three non-coronavirus candidates in phase 3 trial!!!!!!!!.
In 2023, it's a great idea to buy Moderna shares or add to your position for the company's long-term potential
https://www.fool.com/investing/2022/11/26/the-worst-mistake-moderna-investors-can-make-in-20/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
Monkeypox infection and resolution after treatment with tecovirimat in two patients with HIV disease
https://journals.sagepub.com/doi/10.1177/20499361221138349
$SIGA
In vitro and in vivo efficacy of Tecovirimat against a recently emerged 2022 Monkeypox virus isolate
approval coming soon$$$$$$$
https://pubmed.ncbi.nlm.nih.gov/36318038/
Moderna Tops BioSpace's Best Places to Work Ranking for Second Consecutive Year
https://www.biospace.com/best-places-to-work/
CHRISTINA HUTSON, CDC [00:20:10]
Because of these findings, from the start of the outbreak, we have been monitoring the F13L gene within sequenced isolates. At this time, CDC has analyzed sequence data for more than 4,000 specimens from across the United States, of which 11 were found to have genetic changes in the F13L gene during those sequence surveillance efforts.
When tested within the lab, using a cell culture based sensitivity assay, those 11 isolates were sensitive to tecovirimat, showing no evidence of resistance.
We’re currently working on a health advisory related, in part, to development of tecovirimat resistance virus during prolonged tecovirimat treatment. We wanted to let everyone know that this would be coming out soon, and there’ll be more information for providers about the potential for tecovirimat resistance.
-And we hope to have that HAN out by the middle of next week-
https://www.getrevue.co/profile/alexander_tin/issues/notes-for-11-14-2022-1459787
As published in the New England Journal of Medicine (NEJM), a 50 µg booster dose of mRNA-1273.214 elicited a superior neutralizing antibody response against Omicron BA.1 and Omicron BA.4/BA.5 compared to the booster dose of mRNA-1273, with superiority lasting through at least three months. In both groups, participants received the booster dose approximately 4.5 months after prior vaccination.
The frequency of adverse reactions with mRNA-1273.222 and mRNA-1273.214 were similar or lower than that of either a second or third dose of the original vaccine. Additionally, no new safety concerns were identified after approximately one month and three months of follow-up, respectively. These safety and immunogenicity data will be submitted for peer-reviewed publication and shared with regulators globally. These safety data are consistent with those recently published by the U.S. CDC and FDA in an analysis of over 211,000 individuals in the v-safe database1.
MODERNA'S BA.4/BA.5 TARGETING BIVALENT BOOSTER, MRNA-1273.222, MEETS PRIMARY ENDPOINT OF SUPERIORITY AGAINST OMICRON VARIANTS COMPARED TO BOOSTER DOSE OF MRNA-1273 IN PHASE 2/3 CLINICAL TRIAL
https://investors.modernatx.com/news/news-details/2022/Modernas-BA.4BA.5-Targeting-Bivalent-Booster-mRNA-1273.222-Meets-Primary-Endpoint-of-Superiority-Against-Omicron-Variants-Compared-to-Booster-Dose-of-mRNA-1273-in-Phase-23-Clinical-Trial/default.aspx
Moderna announced a $3 billion buyback program earlier in 2022 and then another $3 billion in August, which it's working on now. Combined, these represent roughly 10% of Moderna's entire market cap.
$MRNA is in a new major uptrend.
The reason for all this: Moderna is on the cusp of creating an infinite series of mRNA vaccines, to prevent HIV, various cancers, respiratory diseases, heart disease, any new Covid-19 variants, etc, etc, etc. All this, by using their patents that protect their quasi-robotic design and manufacturing method - yes, BionTech will lose in the courts, and will need to pay retroactive royalties to Moderna-
Moderna's appetite for antibody tech spurs $6M bet on Nona's heavy chain only platform
https://www.fiercebiotech.com/biotech/modernas-appetite-antibody-tech-spurs-6m-bet-nonas-heavy-chain-only-platform
Celebrating the 10th Anniversary of the International mRNA Health Conference
https://www.modernatx.com/media-center/all-media/blogs/mRNA-health-conference?tc=soc_fbe607&cc=1009
The fact the Merck invested and basically validated what they saw at moderna's labs, says it all. The cancer trials will yield positive results as will the stick price. moderna will have a different story then.
https://www.merck.com/news/merck-and-moderna-announce-exercise-of-option-by-merck-for-joint-development-and-commercialization-of-investigational-personalized-cancer-vaccine/
How mRNA vaccines could fight Ebola
https://www.nature.com/articles/d41586-022-03661-0
Quebec :
It was a wonderful day in la Belle Province of #Quebec as we celebrated the groundbreaking of our #mRNA #vaccine manufacturing facility in Laval with @JustinTrudeau @FP_Champagne @Cskeete @StphanBoyer and our distinguished guests. pic.twitter.com/TmuqUbm6mW
— Moderna (@moderna_tx) November 10, 2022
Nearly 2% of healthy infants hospitalized with RSV before first birthday, study finds
https://www.cnbc.com/2022/11/10/healthy-infants-face-significant-risk-of-rsv-hospitalization-study.html
$MRNA
Harbour BioMed Enters into a License and Collaboration Agreement with Moderna
he strategic collaboration will focus on discovering and developing nucleic acid-based immunotherapies for select oncology targets using the Company's proprietary heavy chain only antibody discovery platform (HCAb).
https://www.prnewswire.com/news-releases/harbour-biomed-enters-into-a-license-and-collaboration-agreement-with-moderna-301675149.html
Candel Therapeutics Reports Third Quarter 2022 Financial Results and Recent Corporate Highlights
Nov 10, 2022
https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-reports-third-quarter-2022-financial-results
On December 6, the Company will hold its virtual R&D Day with leadership and renowned oncology experts to present an in-depth overview of the Company’s viral immunotherapy platforms and clinical pipeline including additional data from its phase 2 clinical trial of CAN-2409 in combination with anti-PD-1 or PD-L1 agents in patients with stage III/IV non-small cell lung cancer.
Moderna, new headquarters in Italy at the beginning of 2023 (and starting with 20 hires)
https://news.italy24.press/local/amp/179844
President Joe Biden and Democrats will no longer have full control of the White House and Congres,,,,,,,
So a split Congress could be a positive for Wall Street, and could be good news for defense firms, private prisons and drugmakers. Then again, markets may have already priced some that in.
Feds hold groundbreaking ceremony for Moderna's mRNA vaccine factory in Montreal area
https://montreal.ctvnews.ca/feds-hold-groundbreaking-ceremony-for-moderna-s-mrna-vaccine-factory-in-montreal-area-1.6142301
I want to see who the winner is ;> Patent wars: Moderna’s battle for the spoils of Covid vaccines
Ending of pharma group’s IP truce spells fight for future of mRNA technology
https://www.ft.com/content/5769f077-641e-4d37-adc6-7634c59b6d5d?ftcamp=traffic/partner/feed_headline/us_yahoo/auddev
A combination vaccine for flu and COVID-19 is in the works. Here's what to know.
huge news: Human trials are underway to assess the safety and efficacy of a flu-COVID combination vaccine.
Moderna has finished enrolling trial participants while Pfizer-BioNTech isn't too far behind.
Health experts say these combination vaccines could be available as early as next flu season.
https://eu.usatoday.com/story/news/health/2022/11/07/flu-covid-vaccine-pfizer-moderna/8257444001/
REV 3.4B, EPS 2.53
-2022 est 18 - 19B$
-Pipeline 48 programs, 45 categories, 35 are in clinical trials
-PVC PII data expected 4Q22
-RSV PIII data expected this winter
-FLU PIII data 1Q23
Cash/cash equivalent at end of 3Q, 17B$
How money was spent
-Repurchase 24M share for 2.9B$ (complete) reduces outstanding shares (405M to 387M)
-Started a 2d buyback plan (3B$) as announced in AUG22
-Reinvested 820M$ in R&D (pipeline)
-Losses, 333M$ write off on CV19 product, and 102M$ from canceled purchase agreements
$MRNA multibaggers
Tecovirimat is effective against human monkeypox virus in vitro at nanomolar concentrations
https://www.nature.com/articles/s41564-022-01269-8
November and December news in release!!!! Oral Presentation Title: First efficacy and multi-omic analysis data from phase 1 clinical trial of oncolytic viral immunotherapy with CAN-2409 + valacyclovir in combination with nivolumab and standard of care in newly diagnosed high-grade glioma
CAN-2409 is also being evaluated in multiple phase 2 and phase 3 clinical trials for lung, brain, pancreatic, and prostate cancers.
but we will have more new data and a new cohort of 11 patients in December this year."
https://www.healthleadersmedia.com/pharma/just-two-years-helm-ceo-paul-peter-tak-transforms-candel-and-cancer-treatment
The U.S. is officially in a flu epidemic, federal health officials say. They’re preparing to deploy troops and ventilators if necessary
https://fortune.com/well/2022/11/04/us-united-states-in-flu-epidemic-federal-health-officials-say-cdc-hhs-rsv-covid-omicron-2022/
2023 Advanced Purchase Agreements
BIG COMPANY,,,,,,,,,
Confirmed APAs, as well as previously deferred product sales, currently represent $4.5-$5.5 billion in anticipated product sales in 2023. The Company expects additional sales in key markets, including the U.S., E.U., Japan, Middle East, Latin America and Asia Pacific in 2023.
From the end of the third quarter of 2021 to the end of the third quarter of 2022, the Company repurchased 24 million shares, reducing the number of common shares outstanding from 405 million to 387 million, more than offsetting 5 million shares of common stock issued in connection with equity compensation over this period.
CMV vaccine (mRNA-1647) pivotal Phase 3 study, known as CMVictory, is ongoing.
$MRNA
The good news is that RSV vaccines are on the way:
Moderna Inc. says its vaccine for respiratory syncytial virus, better known as RSV, could be ready for commercialization as soon as next year.
The Cambridge drugmaker is currently running a Phase 3 trial of its mRNA-based RSV vaccine. Data is expected sometime this winter; if it meets expectations, then Moderna could launch it before the fall 2023 sick season, executives said on the company's third-quarter earnings call Thursday morning.
$MRNA