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Mr Justice Meade concluded one of the European Moderna patents, labelled EP565, was “invalid”.
But the judge said a different patent, called EP949, was “valid” and was infringed by Pfizer and BioNTech.
https://finance.yahoo.com/news/covid-19-vaccine-patent-legal-123139810.html
full stop$$$$$$$
What happened to the NIH director
So many have yet
To be disclosed
With Pfizer hitting a stumbling block, Moderna’s COVID-19/influenza vaccine, mRNA-1083, could be the first such combination vaccine to reach the market. In June, the company posted results from a Phase III trial that showed mRNA-1083 produced a strong immune response against both COVID-19 and influenza. In releasing the results, Moderna also became the first and, due to Pfizer/BioNTech’s struggles, only company to date to post positive Phase III results for a combination COVID-19/influenza vaccine.
https://www.biospace.com/drug-development/5-late-stage-mrna-vaccines-to-watch
That's a clcikbait article, IMO. NVO's working with a small company who has some expertise in RNA does not make NOVO a competitor of MRNA.
Novo Nordisk Just Took a $530 Million Step Onto Moderna's Turf. Here's What It Means for Both Stocks
https://www.fool.com/investing/2024/09/19/novo-nordisk-just-took-a-530-million-step-onto-mod/
$RELAX
Buy the Fear, Sell the Greed$$$$$$
That is the question
Why does the NIH own half
Of all MRNA injections
I do not know, what do you think? "It has to bounce back"
Moderna was getting too big, too fast. "The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these 10 products to patients, slow down the pace of new R&D investment, and build our commercial business," said chief executive officer Stéphane Bancel.
This is after -- just last year -- forecasting the launch of as many as 15 new products over the next five years.
THE WRITING IS ON THE WALL
https://www.fool.com/investing/2024/09/14/after-moderna-shocking-news-is-stock-a-buy-or-sell/
https://www.oncologypipeline.com/apexonco/accelerated-path-closes-modernamercks-immunotherapy
The journey is long and full of dangers.
The FDA’s issue with mRNA-4157 is unclear but it’s possible that, with the melanoma sector already well served, the agency is waiting for a clear overall survival benefit.
Scientists are hailing a new dawn in cancer treatment after a groundbreaking vaccine stopped the growth of tumours and the development of new ones in half of patients in the first-in-human study.
The mRNA-4359 vaccine works by teaching the immune system to identify and attack cancer cells
The work
https://www.msn.com/en-gb/health/other/cancer-breakthrough-as-vaccine-revs-up-immune-system-to-stop-tumours-and-destroy-disease-in-world-first/ar-AA1qwwX1?apiversion=v2&noservercache=1&domshim=1&renderwebcomponents=1&wcseo=1&batchservertelemetry=1&noservertelemetry=1
Moderna is due to present the data from the first-in-human study of mRNA-4359 on 14 September at the European Society of Medical Oncology meeting, taking place between 13 September and 16 September in Barcelona, Spain.
What's in this vaccine?
That shows positive results
What makes it work
Otherwise
Why be a mouthpiece
Provided that the phase-3 trial is successful. MRNA acknowledged yesterday that FDA accelerated approval for mRNA-4147 based on phase-2 data is no longer under consideration
Moderna to launch skin cancer vaccine as soon as 2025: CEO
https://asia.nikkei.com/Business/Pharmaceuticals/Moderna-to-launch-skin-cancer-vaccine-as-soon-as-2025-CEO
Cancer vaccine breakthrough as tests show positive results on patients with tumours
The jab, known as mRNA-4359, is developed by Moderna
Researchers found tumours did not grow and no new tumours appeared in eight of the 16 patients who were evaluated
Scientists use a tumour sample, along with DNA sequencing and artificial intelligence, to create a jab specific to the patient’s tumour.
https://www.independent.co.uk/news/health/cancer-vaccine-jab-lung-mrna4359-b2611858.html
MRNA—(-17%)—cuts costs, pares pipeline—investors unimpressed:
https://finance.yahoo.com/news/moderna-r-d-day-highlights-100000130.html
Annual R&D expenses, expected to be $4.7B in 2024, will be reduced to $3.6-3.8B by 2027. Cumulatively, R&D expenses during the 2025-2028 period will be reduced by 20%. Such a cutback is apparently too little and too slow to placate investors.
Perhaps more important, MRNA now says it expects to reach break-even cash flow in 2028—two years later then the previous guidance.
Moreover, MRNA issued 2025 revenue guidance of $2.5-3.5B, which is down from the (previously reduced) 2024 guidance of $3.0-3.5B (#msg-174849487).
Please see #msg-175048423 for related info.
Focuses on ten product approvals through 2027
"Moderna now has five respiratory vaccines with positive Phase 3 results and expects to submit three for approval this year. In addition, we have five non-respiratory products in pivotal studies across cancer, rare diseases and latent vaccines with potential for approval by 2027. Our demonstrated probability of success in R&D has been higher than industry standards at every stage of development," said Stéphane Bancel, CEO of Moderna. "The size of our late-stage pipeline combined with the challenge of launching products means we must now focus on delivering these 10 products to patients, slow down the pace of new R&D investment, and build our commercial business."
Moderna's broad clinical success and recent commercial challenges necessitate a more selective and paced approach to its research and development investment. Through portfolio prioritization and cost efficiencies, the Company expects to reduce annual research and development expense by approximately $1.1 billion starting in 2027. During this time, Moderna will expand its commercial portfolio into oncology, rare diseases, and first-in-class non-respiratory vaccines. The Company expects this strategy to yield 10 product approvals over the next three years.
Cash and Investments: Year-end cash and investments for 2025 are projected to be approximately $6 billion.
Moderna plans to break even on an operating cash cost basis (which excludes stock-based compensation, depreciation and amortization expense) with $6 billion in revenue. The Company expects to achieve this in 2028. The Company has sufficient capital to fund its plans until achieving break even on a cash cost basis without raising additional equity.
https://investors.modernatx.com/news/news-details/2024/Moderna-RD-Day-Highlights-Progress-and-Strategic-Priorities/default.aspx
launch pad$$$$$$$$
So much noise
Can't pay attention
Suffering from
A medical coincidence
From the other side
Milestone marks a significant step toward producing mRNA vaccines in Canada by 2025
https://investors.modernatx.com/news/news-details/2024/Modernas-Canadian-Manufacturing-Facility-Receives-Drug-Establishment-License-From-Health-Canada/default.aspx
MRNA spends far too much, says WSJ’s “Heard-on-the-Street” column:
https://www.wsj.com/finance/stocks/pandemic-darling-moderna-needs-a-reality-check-3c375b0e
Cancer Vaccines Industry Research Report 2024: Market Poised for Exponential Growth with a Projected Value of $6.7 Billion by 2032
https://www.globenewswire.com/news-release/2024/09/05/2941536/0/en/Cancer-Vaccines-Industry-Research-Report-2024-Market-Poised-for-Exponential-Growth-with-a-Projected-Value-of-6-7-Billion-by-2032.html
Study shows that vaccination against RSV lowers the risk of hospitalization in people over 60
https://medicalxpress.com/news/2024-09-vaccination-rsv-lowers-hospitalization-people.html#google_vignette
Moderna’s First mRNA Mpox Vaccine Beats Licensed Rival Shots In Early Testing
https://www.forbes.com/sites/roberthart/2024/09/04/modernas-first-mrna-mpox-vaccine-beats-licensed-rival-shots-in-early-testing/
Do viruses exist?
The essence of science
Called the null hypothesis
What is the issue
Mother's RSV vaccine plea after baby's virus death-
https://www.bbc.com/news/articles/c5y3kvl9k0wo
Typo correction—The header of #msg-174969830 should say, "FDA approves PFE, MRNA COVID vaccines targeting KP.2 variant."
Patient in the UK is the first to receive a novel lung cancer vaccine
Unlike chemotherapy, the vaccine reduces the risk of toxicity to healthy, non-cancerous cells by enhancing the immune responses to target cancer cells, researchers said
$BNTX
https://www.insideprecisionmedicine.com/topics/oncology/global-trial-of-biontechs-mrna-based-lung-cancer-vaccine-launches/
Which was created through the vaccines
Coming Soon: The First mRNA Vaccine for Melanoma........
Moderna and Merck have presented promising results from their phase 2b clinical trial that investigated a combination of a messenger RNA (mRNA) vaccine and a cancer drug for the treatment of melanoma.
Is mRNA set to shake up the world of cancer treatment? This is certainly what Moderna seems to think; the pharmaceutical company has published the results of a phase 2b trial combining its mRNA vaccine (mRNA-4157 [V940]) with Merck's cancer drug KEYTRUDA. While these are not the final results but rather mid-term data from the 3-year follow-up, they are somewhat promising. The randomized KEYNOTE-942/mRNA-4157-P201 clinical trial involves patients with high-risk (stage III/IV) melanoma following complete resection.
Relapse Risk Halved
Treatment with mRNA-4157 (V940) in combination with pembrolizumab led to a clinically meaningful improvement in recurrence-free survival, reducing the risk for recurrence or death by 49%, compared with pembrolizumab alone. The combination of mRNA-4157 (V940) with pembrolizumab also continued to demonstrate a meaningful improvement in distant metastasis-free survival compared with pembrolizumab alone, reducing the risk of developing distant metastasis or death by 62%. "The KEYNOTE-942/mRNA-4157-P201 study was the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show a significant benefit over pembrolizumab alone in adjuvant melanoma", said Kyle Holen, MD, Moderna's senior vice president, after presenting these results.
Side Effects
The combined treatment also did not demonstrate more significant side effects than pembrolizumab alone. The number of patients reporting treatment-related adverse events of grade 3 or greater was similar between the arms (25% for mRNA-4157 [V940] with pembrolizumab vs 20% for KEYTRUDA alone). The most common adverse events of any grade attributed to mRNA-4157 (V940) were fatigue (60.6%), injection site pain (56.7%), and chills (49%). Based on data from the phase 2b KEYNOTE-942/mRNA-4157-P201 study, the US Food and Drug Administration and European Medicines Agency granted breakthrough therapy designation and recognition under the the Priority Medicines scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma.
Phase 3 Trial
In July, Moderna and Merck announced the launch of a phase 3 trial, assessing "mRNA-4157 [V940] in combination with pembrolizumab as adjuvant treatment in patients with high-risk resected melanoma [stages IIB-IV]." Stéphane Bancel, Moderna's director general, believes that an mRNA vaccine for melanoma could be available in 2025.
Moderna Receives European Commission Approval for RSV Vaccine mRESVIA(R)
https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-European-Commission-Approval-for-RSV-Vaccine-mRESVIAR/default.aspx
PFE/MRNA/NVAX—Street consensus sales for 2H24 COVID vaccines:
https://www.barrons.com/articles/fda-approves-updated-covid-19-shots-pfizer-moderna-5d1d1229
FDA approves PFE, COVID vaccines targeting KP.2 variant:
https://finance.yahoo.com/news/pfizer-biontech-receive-u-fda-181500674.html (PFE)
https://finance.yahoo.com/news/moderna-receives-u-fda-approval-174700629.html (MRNA)
NVAX’s updated COVID vaccine is not ready yet.
FDA approved RNA Drugs: 21
RNA therapeutics in targeting GPCRs
https://www.cell.com/action/showPdf?pii=S2162-2531%2824%2900082-9
Moderna was the most shorted healthcare company at July-end, with short interest at 6.69%
The good news about an mRNA vaccine is that if necessary, it could easily be adapted to work against any new
mpox variants that emerge and they can rapidly be manufactured.
mpox
Curious about the status of @moderna_tx’s #mRNA #vaccines for #mpox and #smallpox?
— Krutika Kuppalli, MD FIDSA (@KrutikaKuppalli) August 17, 2024
With the ongoing #mpox outbreak, it’s crucial to know how the Phase 1/2 Clinical Trial that began in the UK earlier this year is progressing. #vaccineshttps://t.co/NrSZPvoPv1
Cancer patients to join personalised vaccine trial
https://www.bbc.com/news/articles/c5yk7m9x8nmo
Cause unknown
Sudden death "epidemic"
Is "national security issue"
sometimes they come back
https://www.wsws.org/en/articles/2024/08/13/qmqx-a13.html
The math is not an opinion!
Funny, the population of the USA is 333.3 million (2022).
One million infected is 1 in 333 people.
That X poster for the Covid19 appears to have made a mistake........or they have terrible math skills.........or they have an agenda.
All labs cannot be wrong
Characteristics and behaviors distinguishing
(1:52:35)
Those in positions of power
BaggyPants
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2021 was a year of monumental impact and change for Moderna
Moderna entered 2021 with a strong cash position of approximately $5.25 billion. We have used this capital to invest in R&D and scale our development pipeline and manufacturing capabilities to maximize our impact on human health.
As we close our books for 2021, the company’s cash, cash equivalents and investments as of December 31, 2021, were more than $17 billion. We now have the resources to scale our investments and do even more to positively impact human health with mRNA medicines. This is just the beginning.
.
https://www.modernatx.com/newsroom/our-blog-coding-region/moderna-2021-shareholder-letter
Moderna is entering 2022 with a remarkable team poised to continue advancing mRNA vaccines and therapeutics into new areas for patients. We have a clear and exciting strategic path to do so, and a strong cash position.
Priority two is to go after the most important latent viruses and develop first-in-class vaccines against them. We want to protect our fellow human beings from suffering from the long-term damage caused by these viruses. Too many people have the quality of their health impacted because decades before, they were infected with a latent virus. We envision a world where vaccines against all the most important latent viruses are available to all.
Priority three is to bring to market therapeutics based on mRNA-encoded proteins, like our current pipeline in oncology, cardiology, rare genetic diseases and autoimmune diseases.
Priority four is to bring to market innovative therapeutics based on mRNA-encoded gene editing enzymes.
Moderna expects to enroll approximately 34,000 participants in multiple countries
RSV is a leading cause of severe respiratory illness in older adults (65+) and young children; there is no approved vaccine to prevent RSV
RSV illness in older adults results in an estimated $3 billion in annual medical costs in the U.S. each year
NOVEMBER, 18, 2021
https://investors.modernatx.com/news/news-details/2021/Moderna-Announces-First-Participant-Dosed-in-Phase-2-3-Study-of-its-mRNA-Respiratory-Syncytial-Virus-RSV-Vaccine/default.aspx
MODERNA ANNOUNCES POSITIVE DATA FROM PHASE 2 STUDY OF MRNA VEGF-A THERAPEUTIC IN PATIENTS UNDERGOING CORONARY ARTERY BYPASS GRAFTING SURGERY
Approval based on a comprehensive submission package including efficacy and safety data approximately six months after second dose
SPIKEVAX has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel
807 million doses of Moderna's COVID-19 vaccine shipped globally in 2021; approximately 25% of those doses shipped to low- and middle-income countries
https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-Full-U.S.-FDA-Approval-for-COVID-19-Vaccine-Spikevax/default.aspx
Q4 2021 revenues of $7.2 billion; GAAP net-income of $4.9 billion and GAAP diluted EPS of $11.29
Full year 2021 revenues of $18.5 billion; GAAP net-income of $12.2 billion and GAAP diluted EPS of $28.29
Moderna increased its 2022 signed advance purchase agreements to approximately $19 billion, with additional signed options of approximately $3 billion; numerous discussions ongoing with governments for the fall of 2022 and 2023
Moderna received full U.S. FDA approval for COVID-19 vaccine, Spikevax
Moderna announces new bivalent booster candidate (mRNA-1273.214) combining Omicron-specific booster candidate (mRNA-1273.529) and the Moderna COVID-19 vaccine (mRNA-1273)
Company now has 44 programs in development
Moderna announces a new $3 billion share repurchase plan
https://investors.modernatx.com/news/news-details/2022/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2021-Financial-Results-and-Provides-Business-Updates/default.aspx
Facility to manufacture drug substance with opportunity for fill/finish and packaging capabilities
Moderna investing up to $500 million to produce up to 500 million doses each year for the African continent
Moderna will invest in building mRNA capabilities in Africa
https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Memorandum-of-Understanding-with-the-Government-of-the-Republic-of-Kenya-to-Establish-its-First-mRNA-Manufacturing-Facility-in-Africa/default.aspx
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