Moderna Inc (MRNA) Quote

Why is this being allowed

With no choice of informed consent

Based on the evidence gathered

Pfizer and Moderna have admitted in federal filings

That their vaccines

Are gene therapy

This goes so much deeper then Moderna

Moderna CEO Stéphane Bancel walks us through Moderna and Merck's 3-year individual neoantigen therapy + Keytruda adjuvant melanoma data at #ASCO24 and Moderna's broader oncology pipeline

https://www.biotechtv.com/post/moderna-june-3-2024

Looking ahead, Holen discussed the ongoing phase 3 INTerpath-001 trial and Moderna's commercialization plans.
Holen also expressed optimism about the potential of INT to treat a wide range of cancers.

"INT is not limited to any specific type of cancer,” he said. “We are exploring its use in cutaneous squamous cell carcinoma, bladder cancer, renal cell carcinoma, lung cancer, and more.”
It's possible that future studies might reveal a subgroup that does not respond as well, but our current data is very promising," Holen said.




https://www.koreabiomed.com/news/articleView.html?idxno=24203

Moderna, IBM Quantum Researchers Use Quantum Computers For Critical Step In RNA-Based Therapeutic Design

https://thequantuminsider.com/2024/06/03/moderna-ibm-quantum-researchers-use-quantum-computers-for-critical-step-in-rna-based-therapeutic-design/

NEWS OUT At a median planned follow-up of the Phase 2b study at 34.9 months, mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% compared to KEYTRUDA alone in these patients

The 2.5-year recurrence-free survival rate of mRNA-4157 (V940) in combination with KEYTRUDA was 74.8% as compared to 55.6% for KEYTRUDA alone, with the benefit observed across exploratory subgroups

Moderna & Merck Announce 3-Year Data For mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated Sustained Improvement in Recurrence-Free Survival & Distant Metastasis-Free Survival Versus KEYTRUDA in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection

https://finance.yahoo.com/news/moderna-merck-announce-3-data-120000800.html

The company is sitting on a lot of cash, but it's also in expensive late-stage clinical development with several vaccine programs. On March 31, it had $12.2 billion in cash and investments, or $1.1 billion less than it had a year earlier.

A potential RSV leader
And even though Moderna's product is entering the market later, it could even become a leader. First, its RSV vaccine wasn't linked to any cases of Guillain-Barré syndrome in late-stage clinical trials (the Pfizer and GSK vaccines were). Though cases of the neurological disorder (which causes muscle weakness) were rare, the point still might prompt some healthcare providers to favor the Moderna jab.

Second, Moderna's vaccine is the only one to come in a pre-filled syringe. This might seem like a detail, but it's actually pretty important. A pre-filled syringe makes administration faster and safer: Since the shot is ready to use, there's a much lower risk of error in administering it.

The Moderna vaccine could make busy pharmacies more efficient during vaccination season, too, allowing them to complete more vaccinations -- saving them time and even boosting their profits. These two points could help Moderna win over healthcare providers and eventually become a leader in the RSV market.

Why the New Human Case of Bird Flu Is So Alarming
The emergence of respiratory symptoms is disconcerting because it indicates a potential shift in how the virus affects humans. Coughing can spread viruses more easily than eye irritation can.
New symptoms should be expected as the virus continues to spread and adapt to humans. Yet our response to this looming danger has been woefully inadequate, particularly in the area of testing.

https://www.nytimes.com/2024/06/02/opinion/bird-flu-case-respiratory.html

Exciting updates are expected at ASCO 2024
New melanoma treatments

Moderna and MSD’s co-developed mRNA-4157 vaccine the world’s first personalised mRNA cancer immunotherapy for resected melanoma, could be a game changer. The companies previously reported positive data from the KEYNOTE-942 Phase II trial with Keytruda (pembrolizumab) and the vaccine at last year’s annual meeting and will look to prove long-lasting effectiveness as they unveil three-year follow-up data on 3 June (LBA9512)

https://www.pharmaceutical-technology.com/news/top-ten-late-breaking-data-to-look-for-at-asco-2024/

mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes

MRNA—FDA approves mResvia RSV vaccine_for_adults 60+:

https://www.accesswire.com/870069/moderna-receives-us-fda-approval-for-rsv-vaccine-mresvia

This is the third approved RSV vaccine for the US adult market, the other two being GSK’s Arexvy (#msg-171831470) and PFE’s Abrysvo (#msg-172028729), both of which were approved in May 2023 and are indicated for adults 60+. (PFE’s Abrysvo is separately approved for maternal use to provide short-term protection for newborns.)

MRNA’s mResvia is the only RSV vaccine that comes in a prefilled syringe, but its efficacy appears to be somewhat less than Arexvy and Abrysvo based on cross-trial comparisons.

Commercial uptake of mResvia will depend to a large degree on the recommendations from CDC’s ACIP* regarding the patient population to be treated and the re-dosing schedule of each of the vaccines. If ACIP recommends biennial boosting with Arexvy and Abrysvo and annual boosting with MRNA’s mResvia, that would be a pretty big blow to mResvia’s commercial prospects, IMO. I’m not saying such an outcome is likely, but it is possible.

ACIP’s recommendations generally dictate reimbursement policy in the US market. ACIP’s meeting is Jun 26-27.

*Advisory Committee on Immunization Practices.

A Third Person in the U.S. Has Bird Flu. This Time, It’s Different

The farmworker, from Michigan, was exposed to infected cows and is the first of the three recently confirmed cases to have respiratory symptoms, according to the Michigan Department of Health and Human Services. The previous two people—another in Michigan and one in Texas—did not show any respiratory symptoms but experienced discharge from the eyes. The dairy worker in the latest case worked on a different farm in Michigan than the previous case reported in the state.

https://time.com/6983927/bird-flu-outbreak-person-infected/

let's see what happens

Funding from the government's Biomedical Advanced Research and Development Authority, known as BARDA, could come as soon as next month, according to Financial Times, which cited people familiar with the matter.

The agreement is expected to be for several tens of millions of dollars and could include a commitment to buy doses if the final-phase studies are successful.....

https://www.modernatx.com/en-US/media-center/all-media/blogs/types-of-viruses

It is all based on a lie

That keeps on giving

This makes no sense

Given the facts

RELAX$ A Moderna spokeswoman confirmed the company is in discussions with the U.S. government to move forward with the pandemic flu candidate, dubbed mRN-1018. The company has already finished dosing healthy participants in a Phase 1 and Phase 2 study. Data are expected soon.

US nears deal to fund Moderna's bird flu vaccine trial

https://www.forbes.com/sites/siladityaray/2024/05/30/us-government-nears-deal-to-fund-moderna-mrna-bird-flu-shot-trial-report-says/?sh=66778fb033ec

$MRNA

I wanted to highlight this recent paper because it's a look at a subject of great interest: can RNA be used as a disease therapy, outside of its use in vaccines? Vaccination, after all, takes advantage of the built-in amplification (and built-in memory) of the immune system, whereas most other diseases are going to need larger doses of RNA constructs for a much longer time (in some cases, for the lives of the patients). Is this going to work out? I've gone into this topic before in a general way here and with more specific examples here and here.

In this case, Moderna and co-workers were looking at patients with the genetically-driven disease propionic acidemia. This is generally a result of a mutation in one of the genes that code for subunits of the enzyme propionyl CoA carboxylase (PCC), and it leads to a buildup of propionic acid itself in the bloodstream and tissues. This has all sorts of harmful effects, both directly and downstream of the body's attempts to deal with the problem, and the end result is major trouble in the heart, liver, kidneys, nervous system, and more. Life expectancy is shortened drastically, even with attempts to manage the condition by extreme low-protein diets and other measures. (Propionyl CoA carboxylase is a key player in the breakdown of several essential amino acids, among other species, and having excess amounts of these in the diet just makes everything worse).

So this is a great candidate for an intervention at a fundamental level (gene therapy on patient DNA or RNA therapy to affect protein expression): the cause of the disease is clear, it's extremely serious and incurable, and existing options for treatment are truly inadequate. The Mayo Clinic and the NCATS team at NIH are both working on gene therapies in this area (both hoping to deliver working genes through an AAV vector). And Moderna's mRNA-3927 is a lipid-nanoparticle-formulated mixture of two mRNA species that code for the two subunits of propionyl CoA carboxylase. If things go according to plan, dosing patients with this therapy should cause their cells to produce the working version of the enzyme (for the first time!) and likewise directly ameliorate the disease at its very source. A gene therapy has the potential to be longer-lasting, although it comes with higher risk if things go wrong as you go in to alter the genomes of the affected cells (as opposed to just stopping the RNA therapy after signs of trouble and letting it be cleared out by the body). But the RNA therapy is easier to get off the ground, and that's why we're seeing interim trial results now.

A total of sixteen patients were dosed, ages ranging from 1 to 27. Twelve of them completed the dose-optimization stage and continued to receive the mRNA therapy in an open-label period afterwards. Five of those had their doses increased during that stage, with one patient (who had a history of recurring pancreatitis due to the disease) having the dose decreased. Virtually all of them showed side effects of the treatment (mainly fever and GI effects, and generally after the earlier doses). One patient showed development of antibodies to the PEG present in the lipid nanoparticle formulations, but was able to continue treatment without further effects.

Most of the patients showed decreased amounts of propionyl biomarkers in the blood. And the key marker of efficacy looks promising: patients with this disorder undergo frequent "metabolic decompensation events" as these propionyl metabolites build up, and these attacks can be severe and require hospitalization. Looking at the paper's Figure 4, it seems that these were quite common among the patient groups before dosing, but during the dose-finding and open-label stages they decreased markedly - and especially, it seems, in the higher-dose cohorts. This is a small number of patients, though, and you'd have to call the results so far "promising but in need of shoring up". That's just where the trial is heading as we speak, with an optimum dose identified and further dosing for at least a year. More patients will be needed as well, since the disease can be rather heterogeneous depending on the particular mutations that lead to it.

But this is a good sign: the mRNA therapy itself seems to be tolerable so far, and there are definite signs of it working. "So far, so good" about sums it up. There still are a lot of things that can go wrong over a more extended dosing period and as more patients receive this therapy, but it looks like the idea has passed its first test. Let's hope that things continue to work

https://www.science.org/content/blog-post/rna-therapy-trial-reads-out

impatient dummies.......

An Experimental mRNA Vaccine Targets H5N1 Bird Flu
The news comes as US officials are considering requiring vaccines for farm workers vulnerable to infection

https://gizmodo.com/mrna-bird-flu-vaccine-upenn-1851503662

Moderna Makes Big Play for Big Tech Talent.......

https://www.wsj.com/articles/moderna-makes-big-play-for-big-tech-talent-0b349371

Words have meaning

Beyond

The superficial

As time passes

next week, drugs approval $$$$$$

MRNA new 52 week high

"catalyst" three abstracts on mRNA-4157 (V940), an investigational mRNA individualized neoantigen therapy, have been accepted for presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held May 31 - June 4 in Chicago, IL. mRNA-4157 (V940) is being jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.

" catalyst" The FDA has informed Moderna that it is working to conclude the review by the end of May 2024.
respiratory syncytial virus (RSV)



https://investors.modernatx.com/news/news-details/2024/Moderna-Announces-Data-to-be-Presented-at-2024-ASCO-Annual-Meeting/default.aspx

no, it is early the best is yet to come......

Have you sold any on this pump?

Roy Buchanan – a Citizens JMP analyst expects the news to be significant for $MRNA particularly if the H5N1 strain turns into a worldwide concern.

That’s because the biotech giant has a vaccine currently in a Phase 2 trial that “targets the same evolutionary group as the avian influenza virus” – and it’s convinced that vaccine can be easily adapted to new mutations as well.

https://www.cdc.gov/media/releases/2024/s0522-human-case-h5.html

Moderna and Pfizer In Talks With U.S. To Make a Bird Flu Vaccine.

O'Connell added that active discussions are under way across federal agencies about what the key triggers would be for deploying H5N1 vaccine doses. She also said discussions are still under way with mRNA vaccine makers Pfizer and Moderna, with an announcement expected soon on how the companies might be involved in vaccine development.

https://www.cidrap.umn.edu/avian-influenza-bird-flu/hhs-advances-plan-produce-48-million-h5n1-vaccine-doses

For_some_reason, COVID-related stocks_are_up_today:

MRNA +11%
BNTX +9%
NVAX +8%
AVIR +5%
PFE +3%

" news coming soon" today announced that three abstracts on mRNA-4157 (V940), an investigational mRNA individualized neoantigen therapy, have been accepted for presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held May 31 - June 4 in Chicago, IL. mRNA-4157 (V940) is being jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.

https://investors.modernatx.com/news/news-details/2024/Moderna-Announces-Data-to-be-Presented-at-2024-ASCO-Annual-Meeting/default.aspx

https://www.modernatx.com/en-US/media-center/all-media/blogs/three-things-about-skin-cancer

PPS is moving up in anticipation now

We're almost there now---- mRNA-1345 Agency has indicated it expects to complete the review by end of May.

Does that make Moderna

More liable

While taking the heat off of Pfizer

Variable chess game

Where it ends up

It's all going down

Moderna wins Covid jab patent dispute over Pfizer and BioNTech

https://www.ft.com/content/50c5078c-c9f0-4b35-b916-3475b641c773

What does money mean

Where does it come from

To enable

Its demise

$MRNA money machine.....

Until the cartel

Gets taken down

And reality

Sets in

No way. This is a quasi-governmental corporation. It will continue to go higher and higher, until it see new all time highs in due time. Won’t even make anyones watchlist until it’s over $200, then it will really take off

Has been all year and will continue to be a BUY

Time for critical thought

Is there anybody out there

What is the intent

Why is this so revolutionary

When RNA can rule

Humans' genome

Revolutionary Genetics Research Shows RNA May Rule Our Genome

https://www.scientificamerican.com/article/revolutionary-genetics-research-shows-rna-may-rule-our-genome/

A potential approval will also show that Moderna isn't just a one-product company and instead can build a billion-dollar respiratory vaccine portfolio, including several game-changing products!

$MRNA This is an easy buy if I ever saw one.