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To the moon??...GO Phil Go..
New tweet...GO PHIL
$PHIL Dear Valued Shareholders, we have received inquiries about broker notification, saying they will not allow purchasing of certain securities as of 8-13-21. We plan to file the remaining 10-Q's with the SEC in a matter of days to be current.This should not be a concern. GB!
— PHI GROUP INC (@PHIGROUP) July 13, 2021
Happy Father's Day to all. Let's show Henry our love, for the great work that he is doing by wishing him a great Father's Day, on Twitter...etc
Nice...thank you...GO PHIL
$PHIL$...???
Just send it to CBS and NBC New York...Go RLFTF
Price target $2.00...GO...RLFTF
https://moneymidnight.com/2020/10/relief-therapeutics-otc-rlftf-is-making-big-moves-2-price-target/
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Great news...GO MRNA
Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNA-1273) Against COVID-19
July 26, 2020 at 10:22 AM EDT
Additional funding to support expanded mRNA-1273 clinical development plan including 30,000 participant Phase 3 COVE study conducted in collaboration with the NIH
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul. 26, 2020-- Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late stage clinical development including the expanded Phase 3 study of the Company’s mRNA vaccine candidate (mRNA-1273) against COVID-19.
An earlier award from BARDA for up to $483 million was entered into to support the scale up of mRNA-1273 and clinical development, originally with a smaller anticipated number of participants in the Phase 3 clinical trial. Following discussions with the U.S. Food and Drug Administration (FDA) and consultations with Operation Warp Speed over the past several months, the Company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification. Under the terms of the revised contract, BARDA is expanding their support of the Company’s late stage clinical development of mRNA-1273, including the execution of a 30,000 participant Phase 3 study in the U.S. The total value of the award is now approximately $955 million.
“We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19.” said Stéphane Bancel, Moderna’s Chief Executive Officer. “Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”
The Phase 3 COVE study is being conducted in collaboration with National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and is expected to begin tomorrow, July 27. The Phase 3 study protocol has been reviewed by the U.S. Food and Drug Administration (FDA) and is aligned to recent FDA guidance on clinical trial design for COVID-19 vaccine studies. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2. The ClinicalTrials.gov identifier is NCT04470427.
Moderna is working closely with Operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network (CoVPN), to conduct the Phase 3 COVE study. Working together with collaborators like NIH, the Company hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at highest risk for COVID-19 and of our diverse society.
The Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company’s internal U.S. manufacturing site and strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the Company’s most recent public equity offering in May 2020.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00034.
About mRNA-1273
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on
GO MRNA...
The Trump administration has selected four potential vaccines as the most likely candidates, but the senior official said Monday that that list could grow. On the list are vaccines from biotech firm Moderna and Johnson & Johnson. The two companies are expected to begin late-stage human trials for potential vaccines by the end of this month. It’s a record-breaking time frame to produce a vaccine — even as scientists say there is no guarantee the vaccines will be effective.
https://www.cnbc.com/2020/07/13/drugmakers-will-start-coronavirus-vaccine-production-by-end-of-summer-trump-health-officials-say.html
Great news...GO MRNA
News out...GO MRNA
July 8th, 2020
Moderna Completes Enrollment of Phase 2 Study of its mRNA Vaccine Against COVID-19 (mRNA-1273)
Source: Business Wire
Cohorts of younger adults (n=300) and older adults (n=300) in Phase 2 study fully enrolled
Cohorts of older adults (ages 56-70, n=30) and elderly adults (ages 71 and above, n=30) in NIH-led Phase 1 study completed enrollment; results expected to be published once available
Pivotal Phase 3 study expected to begin in July; manufacture of vaccine required to start Phase 3 study completed
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has completed enrollment for both cohorts of the Phase 2 study of its vaccine candidate (mRNA-1273) against COVID-19. mRNA-1273 is Moderna’s second mRNA vaccine for an infectious disease to complete enrollment of a Phase 2 study, following the Company’s CMV Phase 2 study, which was fully enrolled on March 3, 2020.
On June 11, 13 days after the first participant was dosed, the Company announced that the cohort of healthy younger adults ages 18-55 (n=300) and the sentinel group of older adults ages 55 years and above (n=50) in the Phase 2 study of mRNA-1273 was complete. After reviewing the safety data from the sentinel cohort of older adults, on June 25, the Data and Safety Monitoring Committee of the study recommended Moderna to proceed with enrollment for the remainder of the Phase 2 study. The cohort of older adults (n=300) has now been fully enrolled. This Phase 2 placebo-controlled, dose-confirmation study is evaluating the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. Each participant is receiving placebo, a 50 µg or a 100 µg dose at both vaccinations.
The Company also announced that the cohorts of older adults (ages 56-70, n=30) and elderly adults (ages 71 and above, n=30) in NIH-led Phase 1 study have completed enrollment. Results are expected to be published once available.
“I would like to thank the healthy volunteer participants, our partners at clinical trial sites and the dedicated Moderna team for their support in completing enrollment of the Phase 2 study of mRNA-1273, our vaccine candidate against COVID-19,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “We are committed to helping address this ongoing public health emergency and continue to focus on our Phase 3 study, which remains on track to start in July, less than seven months from the sequencing of the virus.”
Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. and is expected to be conducted in collaboration with NIAID, subject to regulatory approval. Moderna has completed manufacture of vaccine required to start the Phase 3 study. With the Phase 3 dose at 100 µg, the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company’s internal U.S. manufacturing site and strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana.
About mRNA-1273
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,600 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.
Moderna currently has nine development candidates in its prophylactic vaccines modality, including:
Vaccines against respiratory infections
Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
RSV vaccine for young children (mRNA-1345)
Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
COVID-19 vaccine (mRNA-1273)
Influenza H7N9 (mRNA-1851)
Vaccines against infections transmitted from mother to baby
Cytomegalovirus (CMV) vaccine (mRNA-1647)
Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections
Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). Moderna’s CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine against the novel coronavirus, the parameters and timing of the Phase 2 and planned Phase 3 studies of mRNA-1273, and the Company’s potential manufacturing capabilities and projected vaccine dose production. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
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View source version on businesswire.com: https://www.businesswire.com/news
Most are back to work...GO IPIX
Great news....thank you...GO MRNA
Hedge Funds Have Never Been This Bullish On Moderna, Inc...GO MRNA
https://finance.yahoo.com/news/hedge-funds-never-bullish-moderna-133451306.html
Good news...GO MRNA
Moderna's Covid-19 Vaccine Enters Next Phase of Testing.
Goldman Sachs 9:07 AM ET 6/1/20
The biotech company Moderna has dosed the first of 600 volunteers in the next phase of testing for its vaccine against the Covid-19 virus, saying Friday that it gave the vaccine to people in each of the two groups it will test -- adults under 55 and those older.
Goldman Sachs analyst Salveen Richter expressed optimism about the vaccine in a Monday note. She reiterated her Buy recommendation on the stock and said she thinks the vaccine test has a 75% probability of success.
The Goldman analyst thinks Moderna shares (ticker: MRNA) are worth $105 apiece. In premarket trading Monday, the stock was up 2% to $62.90.
Moderna shares have ridden a roller coaster since it disclosed a bit of data two weeks ago on eight patients in the first phase of its vaccine's trials. It said that the patients developed antibodies to the SARS-CoV-2 virus that causes Covid-19, in amounts that were comparable to the levels that protected lab mice from the disease. The vaccine appeared safe.
"[W]e remain optimistic on the initial results," said Richter in her note. She expects Moderna's collaborators at the National Institutes of Health to publish a peer-reviewed report on the Phase 1 study this month.
The biotech company will host a "science day" on Tuesday to review its technology. Moderna's vaccine uses genetic instructions to cause human cells to express harmless pieces of the Covid virus, which then provoke antibodies that will, if all goes well, fend off the real thing. The company's product is the furthest advanced of several that use this novel approach. Other biopharma companies such as Merck (MRK) are developing more traditional vaccines against Covid.
The Phase 2 study of Moderna's vaccine will test two dose levels of the product on 300 volunteers in each of the two age groups. After a month, they'll get a booster shot. On a fast-track schedule, NIH and Moderna will start a pivotal Phase 3 trial in July, based on what they learn about dosing this month.
Moderna hopes to ask for approval from the U.S. Food and Drug Administration next year. To produce a vaccine in volumes of up to a billion doses a year, the little company has made arrangements with Swiss-based Lonza Group (LZAGY).
With other vaccines under development for Ebola and other viral diseases, Moderna could surpass $10 billion in revenue by 2022, predicts the Goldman analyst. That would yield earnings of $4.72 a share, she estimates.
Interesting information...GO MRNA
https://money.cnn.com/quote/shareholders/shareholders.html?symb=MRNA&subView=institutional
Moderna Institutional Holdings...GO MRNA
Institutional Ownership.............50.12%
Total Shares Outstanding (millions).389
Total Value of Holdings (millions)..$13,445
Total Shares Held...................194,861,000
https://www.nasdaq.com/market-activity/stocks/mrna/institutional-holdings
100% Buy...Go MRNA
https://www.barchart.com/stocks/quotes/MRNA/opinion
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This is their website....GO PTOP
http://www.thinklatitude.pro/meet-the-team/