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Moderna seeking Hong Kong regulatory approval for Omicron-targeted Covid-19 booster vaccine
https://www.scmp.com/news/hong-kong/health-environment/article/3183127/moderna-seeking-hong-kong-regulatory-approval
Taiwan in talks to buy vaccine, medication for monkeypox
https://focustaiwan.tw/society/202206270023
WHO making same mistake as with Covid19, delay in calling Mockeypox a pandemic all but ensures that the situation will get much worse. Mockeypox cases are SOARING around the world. By the time WHO wakes up, we have a PANDEMIC.
RELAX MULTIBAGGER $SIGA
THE COMPANY is well-positioned for decades to come thanks to its cash hoard and rich pipeline. At current levels, this biotech stock can indeed make investors richer$$$$$$$$$$$
Moderna has the funds to advance its pipeline programs thanks to its success in the coronavirus market!
Expect the company to record key clinical wins in the next two years....
the flu, cytomegalovirus, Zika virus, and several forms of cancer.
The green flag: A booster that works
Moderna recently reported that its booster candidate offers "superior" performance against the omicron variant. The vaccine lifted a measure of neutralizing antibody activity eight-fold one month after vaccination, trial data show. This means the booster candidate handles the omicron variant even better than Moderna's coronavirus vaccine. And the candidate also protects against the original coronavirus. Moderna said this potential product is effective against omicron subvariants BA.4 and BA.5 too.
The biotech company is submitting the data to the U.S. Food and Drug Administration (FDA) for consideration. An FDA advisory committee is set to meet on June 28 to discuss whether it's necessary to update current vaccines for fall to target new strains -- or just stick with those original vaccines. Strong data from Moderna could weigh in favor of an update. This would be excellent news for the company. That's because Moderna appears to be closest to the finish line compared to rivals. Pfizer, too, is working on an updated shot -- but the big pharma player hasn't yet released data.
D.E.Shaw takes 5% ownership in SIGA. Shared Dispositive Power 3,634,392
Great firm well respected!
$SIGA
new:
https://fintel.io/doc/sec-d-e-shaw-co-lp-1010086-sc-13g-2022-june-24-19167-4003
Covid-19 vaccines prevented nearly 20 million deaths in a year, study estimates
https://www.statnews.com/2022/06/23/covid19-vaccines-prevention-global-deaths/#:~:text=Health-,Covid%2D19%20vaccines%20prevented%20nearly%2020%20million,in%20a%20year%2C%20study%20estimates&text=Covid%2D19%20vaccines%20cut,in%20The%20Lancet%20Infectious%20Diseases.
9.42% % of Shares Held by All Insider
64.00% % of Shares Held by Institutions
70.66% % of Float Held by Institutions
Shares
Owned CEO 29,881,508
BIG COMPANY
CDC panel endorses Moderna two-dose COVID vaccine for kids ages 6 to 17
https://thehill.com/policy/healthcare/3534860-cdc-panel-endorses-moderna-two-dose-covid-vaccine-for-kids-ages-6-to-17/
MRNA manufacturing variant vaccine ahead of regulatory approval shows a lot of confidence they will get contracts from many countries. Again, the company has the capability to mass produce and is creating a moat by having a physical presence in key countries. Cannot emphasize enough that manufacturing and distributing is key and Moderna has the dollars to invest in this.
This is at least another 50 billion sales!!!!!!!!
Moderna's COVID-19 variant vaccine will be ready to ship in August as the company has been making shots ahead of approval, Chief Executive Stephane Bancel told Reuters on Wednesday, adding that the only bottleneck to supply was a regulatory one.
"Our goal is as early as August given we're going to file all the data in June, by the end of June... hopefully in the August timeframe, the vaccine is authorised," Bancel said in an interview.
"We can start shipping in the August timeframe. Some countries might be September, but that will really be a regulatory decision. Because what is (the) bottleneck now is regulatory. From a manufacturing standpoint, we are making the vaccine."
Remember, UK is only announcing numbers on Tuesday and Friday now. Tomorrow’s number could be 350-400 new cases in just the UK alone. Tuesday’s number was 219...
Do not sell this stock trades its whole float of 38 M (about) every four days. It would be an insane squeeze if everyone held.
The hunt for more monkeypox antiviral , Siga, the small company that makes the antiviral tecovirimat, has been talking with Biden administration officials about expanding manufacturing capacities, including possibly opening a second manufacturing site, CEO Phillip Gomez told Global Pulse.
https://www.politico.com/newsletters/global-pulse/2022/06/23/the-hunt-for-more-of-a-monkeypox-antiviral-00041539
it’s going to pop big soon..can’t be contained....
The World Health Network (WHN) has announced Monkeypox outbreak a pandemic.
The WHO would hold an emergency meeting on June 23 to determine whether to classify the global monkeypox outbreak as a public health emergency of international concern.
$SIGA
If tomorrow the monkeypox is declared a global pandemic, this will touch the sky of the apes!
SIGA Announces $13 Million of International Procurement Orders for Oral TPOXX® (Tecovirimat)
https://finance.yahoo.com/news/siga-announces-13-million-international-120000887.html
THE WORLD HEALTH NETWORK DECLARES MONKEYPOX A PANDEMIC - PRESS RELEASE:
The WHN announcement comes ahead of the The World Health Organization’s (WHO) meeting on June 23, 2022 to decide on their monkeypox outbreak designation. The WHN urges all local public health authorities to apply the precautionary principle and use the available, necessary, and proven interventions to contain and stop the spread.
https://www.worldhealthnetwork.global/monkeypoxpressrelease
Dr Burton added that Moderna is due to file for regulatory approval for the variant jab 'within days' and this included the UK.
The stage is set. Time to rise. Mode RNA
Once again, confirms my belief that this company really knows what it's doing.
'We’ve talked with public health bodies in the UK, I think there is definite interest in 214 (the variant vaccine),' he said.
The new jab is a bivalent vaccine meaning it contains material from both the original Covid strain and the Omicron variant.
Moderna has already created hundreds of millions of doses of its vaccine, meaning if approved it could be rapidly distributed.
Responding to the Moderna data Professor Penny Ward, pharmaceutical expert at King's College London, welcomed the findings.
'The data suggest that the bivalent booster might confer greater protection against the BA.4 and BA.5 omicron strains than re-administering the original vaccine to increase protection across the population,' she said.
While she added the full data of the study needs to be seen, the new jab could prove a vital tool against Covid in the coming months.
'As we head towards the autumn with Omicron variants dominating the Covid infection landscape, it certainly makes sense to consider use of this new bivalent vaccine, if available, for the UK autumn Covid booster campaign,' she said.
Moderna has also said it is preparing the data from the trial for peer review.
The data comes as the NHS urged people who had not yet come forward for their spring booster to get their jab.
More than five million invited were sent out to people over the age of 75, care home residents or people aged 12 and over who have a weakened immune system.
ENTIRE BRITISH AIRWAYS CREW IN QUARANTINE IN SINGAPORE AFTER MONKEYPOX CASE DETECTED
https://www.independent.co.uk/travel/news-and-advice/british-airways-monkeypox-crew-isolation-quarantine-b2106622.html
$SIGA
SIGA to Participate in Alliance Global Partners’ Monkeypox Panel on Thursday, June 23rd 2022
https://www.stocktitan.net/news/SIGA/siga-to-participate-in-alliance-global-partners-monkeypox-panel-on-q65ajcdqmhv5.html
SIGA Technologies, Inc.(NasdaqGM:SIGA) added to S&P Pharmaceuticals Select Industry Index
https://www.marketscreener.com/quote/stock/SIGA-TECHNOLOGIES-INC-10830/news/SIGA-Technologies-Inc-NasdaqGM-SIGA-added-to-S-P-Pharmaceuticals-Select-Industry-Index-40774116/
One month after administration in previously vaccinated and boosted participants, a 50 µg booster dose of mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 in all participants regardless of prior infection
$MRNA
MODERNA ANNOUNCES BIVALENT BOOSTER MRNA-1273.214 DEMONSTRATES POTENT NEUTRALIZING ANTIBODY RESPONSE AGAINST OMICRON SUBVARIANTS BA.4 AND BA.5
https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Bivalent-Booster-mRNA-1273.214-Demonstrates-Potent-Neutralizing-Antibody-Response-Against-Omicron-Subvariants-BA.4-And-BA.5/default.aspx
A reinfection red flag
Why a new report is so troubling:
For those thinking Covid is done.......
Hopefully Moderna is testing against BA.5
https://erictopol.substack.com/p/a-reinfection-red-flag
https://www.researchsquare.com/article/rs-1749502/v1
UK signs £1bn deal with Moderna for new vaccine centre:
The government is aiming to secure homegrown supplies of a technology that has proved a crucial weapon in the fight against Covid-19 and offers the prospect of transforming treatment for other conditions such as cancer.
https://www.ft.com/content/aab5de46-6a30-44fb-9e9d-08b915059b6f?ftcamp=traffic/partner/feed_headline/us_yahoo/auddev
$MRNA
Covid Israel, over 10 thousand infections in 24 hours: never so many since April
Following the growth of infections, the authorities have ordered hospitals to reopen the Covid wards that have been closed for months.
https://www.timesofisrael.com/israel-sees-over-10000-new-coronavirus-cases-highest-daily-number-since-april/
White House COVID adviser touts Moderna, Pfizer shots as ‘good choices’ for parents of kids under 5:
https://thehill.com/policy/healthcare/3529684-white-house-covid-adviser-touts-moderna-pfizer-shots-as-good-choices-for-parents-of-kids-under-5/
More than 800 days into the Covid-19 pandemic, 17 million US kids are finally eligible for vaccination!
$MRNA
CDC Recommends COVID-19 Vaccines for Young Children:
https://www.cdc.gov/media/releases/2022/s0618-children-vaccine.html
EU DRUGS WATCHDOG BEGINS REVIEW OF MODERNA’S VARIANT COVID VACCINE
https://www.pharmalive.com/eu-drugs-watchdog-begins-review-of-modernas-variant-covid-vaccine/
MODERNA RECEIVES FDA AUTHORIZATION FOR EMERGENCY USE OF ITS COVID-19 VACCINE FOR CHILDREN 6 MONTHS OF AGE AND OLDER
https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-FDA-Authorization-for-Emergency-Use-of-Its-COVID-19-Vaccine-for-Children-6-Months-of-Age-and-Older/default.aspx
Share Repurchase Program: As announced last quarter, the Board of Directors authorized a share repurchase program for $3 billion in February 2022 to return excess capital to shareholders. The previous program of $1 billion announced in August 2021 has been fully utilized as of the end of January 2022.
is in progress$$$$$$$$$$
The moderna series for toddlers only requires one month versus 3 months for pfizer. Think about return to school. Moderna will be the winner here by far. Two shots versus three for pfizer
US government advisers have recommended administering Covid-19 vaccines to babies and toddlers, paving the way for the nationwide rollout of jabs from as early as next week!
https://www.ft.com/content/9dd04cfb-e262-4242-988f-0f2f9f86b0a3?ftcamp=traffic/partner/feed_headline/us_yahoo/auddev
Moderna, Inc. (MRNA) Management Presents at 43rd Annual Goldman Sachs Global Healthcare Conference (Transcript)
Salveen Richter
On your pipeline outside of the infectious disease vertical, you have a personalized cancer vaccine drug with Merck, and we are going to see data in the second half. Maybe frame for us how we should be thinking about this data, because to-date, with cancer vaccines, it’s just been viewed as early proof of concept. So, is this meaningful? What are you looking for? And then what does it mean for that vertical as a whole?
Lavina Talukdar
Yes. Great question. So, you are right. We will be looking for data coming out of our Phase 2 PCV study. So, let me just explain what we are looking for in that data set. So, this is a landmark-type study that is head-to-head against KEYTRUDA as a standalone medicine for patients with adjuvant melanoma. And we are looking to show that the combination of our PCV plus KEYTRUDA shows higher percentage of people who are living recurrence-free from their adjuvant melanoma at the 12-month mark, which is why we can say that it’s – since it’s a timed endpoint, that we will have that data available in the fourth quarter of this year. And so we know that KEYTRUDA, which is already approved in that setting, shows somewhere between 60% and 70% recurrence-free survival rate at the 12-month mark. So, what we will look to do there is increase the percentage of people who are living recurrence-free at 12 mark – at the 12-month mark when they are getting PCV plus KEYTRUDA. So, it’s proof-of-concept because this will be the first instance where we can show the additive value of PCV to KEYTRUDA because it is a head-to-head study. And then once we show that data set, because we know KEYTRUDA works in many other cancers and because, by this data set, we will know if the mechanism of action is complementary, it will beg the question, where else can this mechanism of action, that’s synergistic between PCV as well as KEYTRUDA, work. And as I just mentioned, KEYTRUDA works in many other cancers, so it has the potential of really unlocking PCV working in other cancers. But first, let’s see what the data shows. I won’t get ahead of our skis here.
https://seekingalpha.com/article/4518530-moderna-inc-mrna-management-presents-43rd-annual-goldman-sachs-global-healthcare-conference?utm_source=stck.pro&utm_medium=referral
Moderna to invest 500 mln euros in Spain, PM Sanchez says:
Magníficas noticias. España liderará la producción de vacunas ARNm con un nuevo laboratorio y una inversión de más de 500 M€. Hoy me he reunido con el vicepresidente de @moderna_tx Dan Staner, quien me ha expuesto los planes de expansión de la farmacéutica en nuestro país. pic.twitter.com/YpgL1gWvx6
— Pedro Sánchez (@sanchezcastejon) June 14, 2022
The World Health Organization is convening its emergency committee next week to decide whether the monkeypox outbreak is a public health emergency of international concern — the world’s highest health alert:
https://www.politico.com/news/2022/06/14/monkeypox-world-health-organization-00039428
South Korea buys "about" 500 courses, will consider additional purchase if necessary.
https://n.news.naver.com/article/001/0013244730?sid=100
U.S. FDA advisers back authorization of $MRNA COVID vaccine for ages 6-17
For the first time, $MRNA could compete with Pfizer for older kids' vaccines:
https://www.bizjournals.com/boston/news/2022/06/14/moderna-childrens-vaccines-fda-adcomm.html?utm_source=sy&utm_medium=nsyp&utm_campaign=yh
big company!
Goldman Sachs Likes These 2 Beaten-Down Stocks for Triple-Digit Upside:
“We expect shares to rise on an announcement of US government purchasing of new vaccines for the fall as it would show the potential for upside to MRNA’s estimated ~$21bn in Advance Purchase Agreements (APAs),” the 5-star analyst explained. “Broadly, we believe investors are underestimating the optionality of MRNA’s platform which has been significantly de-risked by the billions of vaccinations given over the past two years using mRNA technology.”
Richter, though, is anticipating a meaningful recovery; the analyst has a Buy rating for the shares backed by a $290 price target.
https://finance.yahoo.com/news/goldman-sachs-likes-2-beaten-223920027.html