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The study enrolled melanoma patients who had undergone surgery to remove any signs of their cancer. Unlike vaccines the public is used to taking — mass-produced shots that aim to prevent people from catching a contagious disease like the flu or polio, Moderna’s cancer vaccine instead is intended to keep the disease from returning. It does that by training immune cells to recognize as dangerous proteins found on a patient’s own tumor cells.
Stephane Bancel told CNBC recently that the company is moving aggressively into Phase 3 studies with the belief that “anywhere Keytruda works, this should work.”
Keytruda, meanwhile, is approved to treat a long list of cancers beyond melanoma—so many, in fact, that it’s expected to bring in more than $24 billion in sales in 2023. Bancel suggested that the vaccine might even make possible responses in tumors where Keytruda has failed, either on its own or by acting synergistically with Merck’s drug.
Another immense challenge is the very high likely cost of a personalized therapy on top of Keytruda, which on its own carries a list price of around $185,000 per year. The only upside to that hefty price tag is that the companies will be motivated to answer these questions as quickly as possible. Indeed, Bancel has said that Moderna plans to aggressively invest in cancer.
So let's see what happens with this Beast.
Yes, I think so......
personalized mRNA vaccine reduced risk of recurrence or death in melanoma.
In the cancer vaccine, the mRNA encodes for tumor-specific mutations called neoantigens. The body creates copies of these neoantigens, learns to recognize them, and creates more immune cells that can target them, therefore fighting the cancer.
The shot, when combined with Merck’s checkpoint inhibitor Keytruda, reduced the risk of cancer recurrence or death by 44% compared to Keytruda alone over a period of 1 year. It was tested in people with stage 3/4 melanoma who had their tumors removed but had a higher chance of the cancer returning due to features of their melanoma
Moderna and Merck plan to initiate a Phase 3 study in people with melanoma in 2023.
So let's see what happens with this Beast.
Personalis and Moderna Sign New Agreement to Leverage NeXT Platform™ in Personalized mRNA Cancer Vaccine Clinical Trials
https://www.businesswire.com/news/home/20230203005108/en/Personalis-and-Moderna-Sign-New-Agreement-to-Leverage-NeXT-Platform%E2%84%A2-in-Personalized-mRNA-Cancer-Vaccine-Clinical-Trials
LOL.....LOL.....
Is Moderna (MRNA) a High Growth Stock: https://finance.yahoo.com/news/moderna-mrna-high-growth-stock-050325327.html
Moderna has roughly $18 billion of cash on its balance sheet as of December 31, 2022.....huge
mRNA-1345 was previously granted Fast Track designation by the FDA in August 2021. Moderna intends to submit a license application for regulatory approval in the first half of 2023.
A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
$MRNA winner
MODERNA GRANTED FDA BREAKTHROUGH THERAPY DESIGNATION FOR MRNA-1345, AN INVESTIGATIONAL RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE CANDIDATE
Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
https://investors.modernatx.com/news/news-details/2023/Moderna-Granted-FDA-Breakthrough-Therapy-Designation-for-mRNA-1345-An-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Candidate/default.aspx
The biotech has a total of 48 programs in development across many therapeutic areas. If even a handful are successful, we could be looking at major earnings down the road. All of this means Moderna's growth story may just be getting started. And now is the time to jump on board.
Moderna expects a post-pandemic vaccine market in the range of $12 billion to $24 billion. The company also has spoken of charging up to $130 for its vaccine; that's up from about $25 today.
The trial results were impressive:
On Jan. 17, Moderna announced that its RSV vaccine was highly effective in phase 3 trials in preventing the risk of lower respiratory disease (where there were at least two symptoms) in people aged 60 and over. The rate of efficacy was 83.7%. That's slightly higher than the 82.6% efficacy that GSK reported from its vaccine in October, and well above the 66.7% that rival Pfizer achieved when it announced its trial results a few months earlier in August.
The RSV market is an attractive one. Morgan Stanley analysts project that it could be worth between $7 billion and $10 billion....
Moderna is hiring 2,000 employees this year. Here's where they'll be.
https://www.bizjournals.com/boston/news/2023/01/23/moderna-2023-hiring-plans-2000-employees-massachu.html?utm_source=sy&utm_medium=nsyp&utm_campaign=yh
$MRNA winner
Our CEO Stéphane Bancel :
Our CEO Stéphane Bancel joins colleagues at @FlagshipPioneer to discuss digital first, growing R&D budget, #cancer breakthroughs, Moderna's progress in addressing respiratory illnesses, and a growing leadership in #genomics. #FlagshipJPM #JPM23 pic.twitter.com/fjRhROdcdp
— Moderna (@moderna_tx) January 20, 2023
Inhaled pulmonary therapeutics
Cystic fibrosis (CF)
Moderna's collaborator, Vertex Pharmaceuticals, announced that the U.S. Food and Drug Administration cleared its Investigational New Drug (IND) application for VX-522, an mRNA targeted at treating the underlying cause of cystic fibrosis for the approximately 5,000 people with CF who cannot benefit from a cystic fibrosis transmembrane conductance regulator (CFTR) modulator
VX-522 is delivered to the lung through inhalation of a CFTR mRNA encapsulated by a lipid nanoparticle. Once delivered to the target lung cells, the mRNA is designed to produce functional copies of the CFTR protein
relax$$$$$$
Moderna increases investments in R&D, manufacturing infrastructure, and company buildout, and pursues external investment opportunities (licenses and/or M&A). R&D investments in 2023 are estimated at $4.5 billion, up from approximately $3.3 billion (unaudited) for 2022.....
$MRNA big company!
Moderna Aims to Supply COVID Vaccine to China:
https://learningenglish.voanews.com/a/moderna-aims-to-supply-covid-vaccine-to-china/6923740.html
countdown$$$$$$$$$$
RNA : this is the future .......moderna Founder and pioneer....
$MRNA money machine $$$$$$$$$$$$
DAVOS, Switzerland, Jan 18 (Reuters) - Moderna chief executive Stephane Bancel said on Wednesday the U.S. company was in active discussions to supply COVID-19 vaccines to China.
Speaking to Reuters on the sidelines of the World Economic Forum annual meeting in Davos, he said the talks with Beijing also covered the topic of factories, and other products including cancer treatments
https://finance.yahoo.com/news/1-davos-2023-moderna-ceo-114557785.html
Moderna intends to submit for regulatory approval in the first half of 2023. The trial is ongoing, and additional efficacy analyses are planned as cases accrue, including for severe RSV..........
HUGE: mRNA-1345 demonstrated vaccine efficacy (VE) of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults...
MULTIBAGGER$
$MRNA
Richard Torbett, Chief Executive, ABPI, said:
“I’m delighted to welcome Moderna into membership as a world-leading pharmaceutical company that can help bring the UK closer to realising its ambitions to be a leading global centre for life sciences.
“With Moderna’s help we will be in an even stronger position to make the UK the best place in the world to research, develop and use new medicines and vaccines.”
$MRNA big company!
Moderna joins the Association of the British Pharmaceutical Industry:
https://www.abpi.org.uk/media/news/2023/january/moderna-joins-the-association-of-the-british-pharmaceutical-industry/
The Fly reports that on Wednesday, investment analysts at Deutsche Bank Aktiengesellschaft increased their price objective for Moderna (NASDAQ: MRNA), moving it from $185.00 to $225.00
Moderna CEO: 400% price hike on COVID vaccine “consistent with the value” nice!
https://arstechnica.com/science/2023/01/moderna-may-match-pfizers-400-price-hike-on-covid-vaccines-report-says/
The company reiterates 2023 expected minimum COVID-19 vaccine sales of approximately $5 billion, with more contracts coming in 2023.
Moderna increased investments with around $4.5 billion in 2023, up from approximately $3.3 billion in 2022. Moderna continues to scale with 48 programs in development, including 36 in ongoing clinical studies!
Moderna Inc. said it is considering pricing its Covid-19 vaccine in a range of $110 to $130 per dose in the U.S. when it shifts from government contracting to commercial distribution of the shots.
money machine$
With 65% ownership, Moderna, Inc.- boasts of strong institutional backing "up"
https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-mrna/moderna/news/with-65-ownership-moderna-inc-nasdaqmrna-boasts-of-strong-in
Repurchased 23 million shares (avg. price $143/share) for $3.3 billion in 2022, with $2.8 billion remaining for future repurchases from the $3.0 billion August authorization " winner"
huge: MODERNA ANNOUNCES ADVANCES ACROSS MRNA PIPELINE AND PROVIDES BUSINESS UPDATE
Company continues to scale with 48 programs in development, including 36 in ongoing clinical studies, and is increasing R&D investment to an expected $4.5 billion for 2023
"We enter 2023 in a great position, with significant momentum across our clinical pipeline, a highly energized team and a strong balance sheet of over $18 billion of cash and cash equivalents
https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Advances-Across-mRNA-Pipeline-and-Provides-Business-Update/default.aspx
https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Advances-Across-mRNA-Pipeline-and-Provides-Business-Update/default.aspx
anything is possible!
Proposal 6: Amendment of the Company's Certificate of Incorporation to increase the number of authorized common shares by 500 million. dilution maybe!
yes: Moderna signs $35 million deal with cancer drug developer CytomX
MODERNA TO ACQUIRE ORICIRO GENOMICS The company is located in Tokyo, Japan
today announced they have entered into a definitive agreement through which Moderna will acquire OriCiro for $85 million.
https://investors.modernatx.com/news/news-details/2023/Moderna-to-Acquire-OriCiro-Genomics/default.aspx
$80-90 buy zone!
Moderna 2022 Shareholder Letter- Preparations are underway for multiple vaccine launches globally between 2023 and 2026. : https://www.modernatx.com/media-center/all-media/blogs/moderna-2022-shareholder-letter
MODERNA TO PROVIDE BUSINESS AND PIPELINE UPDATES AT THE 2023 J.P. MORGAN HEALTHCARE CONFERENCE
https://investors.modernatx.com/news/news-details/2023/Moderna-to-Provide-Business-and-Pipeline-Updates-at-the-2023-J.P.-Morgan-Healthcare-Conference/default.aspx
Moderna/BioNTech: cancer vaccines will show mRNA not a one-trick pony
https://www.ft.com/content/218af626-243f-415d-a643-21aa7d39ccf3?ftcamp=traffic/partner/feed_headline/us_yahoo/auddev
$80-90 buy zone!
In 2023, drug companies will introduce the first vaccines for respiratory syncytial virus—known as RSV—and could roll out the first flu vaccine based on messenger RNA, or mRNA. It will also be a significant year for Covid-19 shots, which are expected to make their debut on the commercial market!!!!!!!!