Large swells batter Caribbean as Hurricane Lee churns waters nearby!

Moderna Recommends Shareholders Reject “Mini-Tender” Offer by TRC Capital Investment Corporation:

has been notified that TRC Capital Investment Corporation (TRC Capital) has made an unsolicited "mini-tender" offer to purchase up to 1,000,000 shares of Moderna's common stock, at an offer price of $107.56 per share. TRC Capital's offer price of $107.56 per share is approximately 4.44% lower than the closing price of Moderna common stock on the Nasdaq Global Select Market on September 1, 2023, the last trading day prior to the date of the offer, September 5, 2023.

Moderna does not endorse TRC Capital's unsolicited mini-tender offer and recommends that shareholders do not tender their shares in response to TRC Capital's offer because the offer is at a price below the current market value of Moderna common stock and is subject to numerous conditions. Per the terms of the offer, any shareholders who tender (or have already tendered) their shares can withdraw them prior to the expiration of the offer, currently scheduled for 12:01 a.m., New York City time, on October 4, 2023, in accordance with the offering documents, but subject to extension at TRC Capital's discretion.

Moderna is not affiliated or associated in any way with TRC Capital, its mini-tender offer or its mini-tender offer documents. Consistent with the cautionary guidance from the U.S. Securities and Exchange Commission (SEC) referenced below, Moderna urges investors to obtain a current market quotation for their shares, consult with their broker or financial advisor and exercise caution with respect to TRC Capital's offer.

TRC Capital's purported mini-tender offer seeks less than one percent of Moderna's outstanding common stock, thereby avoiding many disclosure and procedural requirements of the SEC that apply to offers for more than five percent of a company's outstanding shares. As a result, mini-tender offers do not provide investors with the same level of protections as provided by larger tender offers under U.S. securities laws.

SCIENTISTS DISCOVER STRANGE LINK BETWEEN INTERNET USE AND DEMENTIA.....

The FDA is advising people not to eat oysters harvested in that area between Aug. 28 and Aug. 30

COVID-19 certainly has not disappeared from our lives and it continues providing a revenue source for pharmaceutical companies!!!!!!!!!

Clinical trial data from research assay confirmed Moderna's updated COVID-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variants

https://investors.modernatx.com/news/news-details/2023/Moderna-Clinical-Trial-Data-Confirm-Its-Updated-Covid-19-Vaccine-Generates-Strong-Immune-Response-in-Humans-Against-BA.2.86/default.aspx

Self-Amplifying RNA Vaccines

https://sciencebasedmedicine.org/self-amplifying-rna-vaccines/

The only mRNA-based therapy candidate in the ongoing Phase III clinical trial for stage IIB-IV cutaneous melanoma, in combination with immune checkpoint inhibitor (ICI) pembrolizumab, is Moderna/Merck‘s mRNA-4157.

If successful, this trial will mark the first time an mRNA cancer vaccine and an immune checkpoint inhibitor have shown improved recurrence-free survival rates. It will open new opportunities to boost the potential of mRNA-based therapies by combining them with other ICIs and expanding to other solid tumours,

personalised mRNA vaccines are the most promising cancer vaccine type---Cancer vaccines are already a reality---Kyle Holen, head of Development, Therapeutics, and Oncology at Moderna, believes that while the process of developing personalized mRNA vaccines is “not for the faint of heart, it offers a wealth of opportunities.” The use of algorithms as part of the manufacturing process presents unique regulatory challenges, while logistical difficulties, such as shipping materials and obtaining specimens from pathology labs, impact the speed of vaccine production.

Despite these challenges, personalized mRNA vaccines are delivering promising results in clinical trials. Holen highlighted the results from ongoing clinical trials of two personalized mRNA cancer vaccines that were tailored to the antigens presented by individual patient tumors. The first, developed by BioNTech in partnership with Genentech for treating pancreatic cancer, was given alongside checkpoint blockade therapy after surgery, and resulted in almost no recurrence of tumors after 18 months of follow-up for patients who responded to the vaccine. The second vaccine, developed by Moderna in partnership with Merck, showed a 44 percent decrease in the recurrences of melanoma and a 65 percent decrease in distant metastases.

Thanks to AI, Moderna went from producing about 30 mRNAs a month to 1,000, chief AI officer Dave Johnson told MIT Sloan Management Review back in 2021.

This is significant because it allows Moderna to speed up its research and gain access to better-quality mRNA sequences. Moderna also has built its own AI models for tasks including asset data analysis and regulatory interactions, chief executive officer Stéphane Bancel said during the most recent earnings call.

R&D Day and Business Updates at 1:00 p.m. ET on Wednesday, September 13, 2023....ALERT$$$$$$$

REMENBER: Moderna and Merck's cancer vaccine, used in combination with Merck's Keytruda, reduced the risk of melanoma spreading to other parts of the body or death by 65% compared with Keytruda alone.

covid on the rise again....spinning wheel------

UK scientists have begun developing vaccines as insurance against a new pandemic caused by an unknown "Disease X". The work is being carried out at the government's high-security Porton Down laboratory complex in Wiltshire by a team of more than 200 scientists.

https://twitter.com/AndyGreensky/status/1697194259760193873?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1697194259760193873%7Ctwgr%5E0a8f990a01191b1ac18aac9e277cdc1ac3a750f9%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fwww.leggo.it%2Festeri%2Fnews%2Fmalattia_x_sintomi_vaccino_cosa_e_cosa_sappiamo_ultimissime_oggi_2_9_2023-7608177.html

I just want the greenbacks $$$$$$$$$$$

Biotechnology Market is Expanding USD 3,995.22 Billion By 2032

https://www.biospace.com/article/releases/biotechnology-market-is-expanding-usd-3-995-22-billion-by-2032/

R&D Day and Business Updates at 1:00 p.m. ET on Wednesday, September 13, 2023

stay tuned$$$$$$$$

A Synthetic RNA Export System Reveals the Dynamic Lives of Cells and Suggests Direction for New Therapeutics

https://www.caltech.edu/about/news/a-synthetic-rna-export-system-reveals-the-dynamic-lives-of-cells-and-suggests-direction-for-new-therapeutics

CARsgen and Moderna have initiated a collaboration agreement to investigate CT041 in combination with Moderna's investigational Claudin18.2 mRNA cancer vaccine.

Business Highlights

Collaboration agreement for zevor-cel commercialization in mainland China with Huadong Medicine.
CT041 has achieved IND clearance from the NMPA for the postoperative adjuvant therapy of Claudin18.2 positive pancreatic cancer (PC).
CT041 Phase 2 clinical trial has been initiated in the U.S. for the treatment of Claudin18.2 positive advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) in patients who have failed at least 2 prior lines of systemic therapies.

https://www.nasdaq.com/press-release/carsgen-announced-2023-interim-results-2023-08-22

news: https://www.biospace.com/article/releases/sapu-bioscience-and-cromos-pharma-initiating-p201-a-registrational-trial-for-ot-101-in-pancreatic-cancer/?keywords=pancreatic+cancer+phase+3

welcome back!!!!! we have a winner MRNA

everything is possible$$$$$$$$$

go pick tomatoes.....

Moderna, CARsgen Join Forces Combining mRNA Cancer Vaccine with CAR T.......


https://www.biospace.com/article/moderna-carsgen-join-forces-combining-mrna-cancer-vaccine-with-car-t/

Last month, Moderna initiated regulatory submissions for its mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States, Europe and Australia. A potential launch is expected next year. If approved, mRNA-1345 could be Moderna’s second product launch.

Earlier this month, Moderna announced that it completed enrolment in the phase III immunogenicity study (P303) evaluating an enhanced formulation of mRNA-1010, which is expected to improve immune responses againstthe influenza B strain. Data from the P303 study is also likely to support the company’s regulatory filing for the vaccine’s accelerated approval. Data from the P303 study is expected before September 2023-end. Given the company’s accelerated timetable for mRNA-1010, we expect mRNA-1010 to be the company’s third product launch, expected in the next year.

Data from the study showed that mRNA-4157combined with Merck’s Keytruda reduced the risk of distant metastasis or death by 65% compared with participants treated with Merck’s Keytruda alone. The study previously achieved its primary endpoint of recurrence-free survival.

the work continues$$$$$$$$$$

Moderna's updated COVID vaccine effective against 'Eris' variant in humans

https://finance.yahoo.com/news/moderna-clinical-trial-data-confirm-201500678.html

Revenue: Total revenue for the second quarter of 2023 was $344 million

https://investors.modernatx.com/news/news-details/2023/Moderna-Reports-Second-Quarter-2023-Financial-Results-and-Provides-Business-Updates/default.aspx

Moderna plots lung cancer trial for Merck-partnered vax, piggybacking on Keytruda's recent win

https://www.fiercebiotech.com/biotech/moderna-has-bold-ambitions-merck-partnered-cancer-vaccine-plans-launch-lung-cancer-trial

We expect Moderna MRNA to beat expectations when it releases second-quarter 2023 results on Aug 3, before the opening bell. In the last reported quarter, the company reported an earnings surprise of 110.73%.

The Zacks Consensus Estimate and our model estimate for second-quarter product sales is pegged at $233 million and $246 million, respectively.

Merck and Moderna Initiate Phase 3 Study Evaluating V940 (mRNA-4157) in Combination with KEYTRUDA® (pembrolizumab) for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma

Global recruitment in V940-001 has begun, and the first patients are now enrolling in Australia.

https://www.biospace.com/article/releases/merck-and-moderna-initiate-phase-3-study-evaluating-v940-mrna-4157-in-combination-with-keytruda-pembrolizumab-for-adjuvant-treatment-of-patients-with-resected-high-risk-stage-iib-iv-melanoma/?keywords=pancreatic+cancer+phase+3

GSK’s Arexvy to lead new RSV vaccines sales race with Moderna a close second:

https://www.fiercepharma.com/marketing/gsks-arexvy-lead-new-rsv-vaccines-sales-race-moderna-close-second-report

Alex Tabarrok writes about how:

I am dying of squamous cell carcinoma, and the treatments that might save me are just out of reach-

So what might help me? MRNA tumor vaccines. Head and neck squamous cell carcinomas (HNSCC) are notoriously treatment resistant, and mRNA vaccines have shown huge promise. Why aren’t they happening faster? Because the FDA is slow. There are some trials underway (here is one from Moderna; here is another), and, although I’m trying to enroll, I may be too late, since my cancer moves so aggressively. The FDA was loathe to approve initial mRNA human trials, even when those trials would have been full of people like me: those who are facing death sentences anyway.

https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-cell-carcinoma-and-the-treatments-that-might-save-me-are-just-out-of-reach/

BAVARIAN NORDIC PROVIDES UPDATE ON RSV VACCINE PROGRAM
Phase 3 study failed to meet one of the success criteria of the primary objective
RSV program to be discontinued

https://www.bavarian-nordic.com/investor/news/news.aspx?news=6808

Vir’s GSK-Backed Flu Vaccine Candidate Fails Phase II Trial..... "less competition"


https://www.biospace.com/article/vir-s-gsk-backed-flu-vaccine-candidate-fails-phase-ii-trial/

it is better to pick the flowers....-fast-

For more than a decade, we have been at the forefront of groundbreaking #mRNA research that holds immense potential to revolutionize healthcare. Hear more from @cleoabram about how we are studying mRNA to see if one day it can teach our bodies to make its own #medicine. pic.twitter.com/8emxT8yn2P

— Moderna (@moderna_tx) July 19, 2023

Moderna may become a biotech giant by 2030$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

https://www.fool.com/investing/2023/07/19/prediction-company-will-be-a-biotech-giant-by-2030/

we are here to make money!!!!!!!!

Flagship Pioneering and Pfizer Partner to Accelerate Development of Innovative Medicines Targeting Unmet Needs

Flagship Pioneering -He is also co-founder and Board Chairman of Moderna.:
Unity is strength$$$$$$$$$


https://www.pfizer.com/news/press-release/press-release-detail/flagship-pioneering-and-pfizer-partner-accelerate

in the end it will be a success---- cancer vaccine!

Merck, Moderna unveil phase 3 trial details for closely watched mRNA cancer vaccine

The vaccine is made by profiling each patient’s tumor mutational signature and is designed to induce an immune response against the corresponding antigens. If eventually successful, Merck and Moderna could open up an entirely new area of cancer treatment.

https://www.fiercebiotech.com/biotech/merck-moderna-post-phase-3-trial-closely-watched-mrna-cancer-vaccine

Moderna: Potential To Get Second Product To Market:
Moderna had $16.3 billion in total assets as of the quarter ending March 31, 2023.

The reason why I believe that its financial position should be strong in 2023 is because it still reiterates that its minimum sales for this period will be about $5 billion, thanks to previously announced Covid-19 vaccine Advanced Purchase Agreements. Not only that, but there is something else to consider as well, which is that it is expecting to negotiate new orders for its Covid-19 vaccine in the fall of 2023. Such negotiations that are taking place for this period are with the U.S., Japan, and Europe.

One thing to note is that should the RSV vaccine mRNA-1345 be approved, sales won't start until at least 2024. Still, this biotech is excellent to look into, because it is expecting six major vaccine launches from its respiratory franchise, with expected annual sales of $8 to $15 billion by 2027. The vaccine franchise that I'm talking about deals with Covid-19, RSV, Flu, and even possibly combinations thereof.

https://seekingalpha.com/article/4615604-moderna-potential-to-get-second-product-to-market