MRNA 23$ IPO
- BNTX: ca. 3,28 Mrd. $
- MRNA: ca. 2,8 Mrd. $
EPS Q2/2021: hier ergeben sich >100% Unterschied
- BNTX: ca. 13,50 $
- MRNA: ca. 6,46 $
(immer ohne Partner wie Pfizer gerechnet)
Der Grund liegt meiner Meinung nach daran, dass in den USA einfach viel mehr Aktienkultur herrscht als in Deutschland. Gute Unternehmen werden dort auch viel schneller an der Börse belohnt als in Deutschland.
Das würde aber eigentlich bedeuten, dass Biontech noch mehr Kurspotenzial hat als Moderna, ich halte Biontech ohnehin für die bessere Firma mit der begabteren Führungsetage.
Privat habe ich auch Biontech, in meinem Wikifolio
https://www.comdirect.de/inf/zertifikate/DE000LS9H4G6
https://www.wikifolio.com/de/de/w/wfbpzukunf
habe ich aber Moderna. Da werde ich mal über eine Anpassung nachdenken und ein wenig in Biontech umschichten.
https://www.marketwatch.com/story/...1628616860?mod=mw_more_headlines
Moderna’s stock price is ‘ridiculous,’ says BofA analyst
Valuation is no longer just ‘unreasonable,’ as bearish analyst Geoff Meacham’s price target implies a decline of more than 75%
https://www.marketwatch.com/story/...2021-08-11?mod=mw_more_headlines
Moderna Inc. shares MRNA, -15.64% tumbled 16% Wednesday to put them on track for their biggest percentage decline since May of 2020, according to Dow Jones data. The stock has now fallen for four of the past five days and has lost more than 20% in a two-day period. On Tuesday, BofA analyst Geoff Meacham published a bearish note on the company that questioned its valuation after its market cap grew to almost $200 billion, putting it ahead of far more established drug companies like the 40-year-old Amgen AMGN, +0.07%, currently valued at about $129.3 billion, and the 130-year old Merck MRK, +0.03%, valued at about $189.7 billion. According to Meachem's analysis, it should be about 75% below its current price. While Moderna's COVID-19 vaccine has been a major contributor to its market cap, to justify $200 billion in value, one would have to assume two things: Moderna would deliver 1 billion to 1.5 billion doses of its COVID-19 vaccine each year through 2038; and its entire pipeline will be 100% successful. That currently involves four programs in Phase 2 trials, 10 Phase 1 programs and eight preclinical programs not yet in human testing, for total peak sales of $30 billion. Moderna's recent revenue has come to about $7 billion in the past four quarters. Shares have gained 266% in the year to date, while the SPDR S&P Biotech ETF XBI, -0.65% has fallen 11% and the S&P 500 SPX, +0.25% ha
Plant Moderna eine Übernahme im Gen-Editing Bereich?
Es scheint nur eine Frage der Zeit, bis Moderna sich breiter aufstellt und die Corona-Milliarden Gewinne neu investieren wird. Motley Fool ist der Meinung, dass Editas (4 Mrd. $) ein mögliches Ziel sein könnte, da es im Vergleich mit CRISPR Therapeutics (10 Mrd. $) und Intellia Therapeutics (12 Mrd. $) verhältnismäßig günstig erscheint. CRSP würde ich lieber in den Händen von VRTX sehen. Ansonsten wäre NTLA schon ein ziemlich teures Sahnestück, EDIT deutlich günstiger und SGMO mit einer MK von 1,5 Mrd. $ wohl ein Schnäppchen. Aber vlt wird es auch BEAM (MK 7 Mrd. $) oder ein völlig anderes Unternehmen, es bleibt spannend...
https://www.fool.com/investing/2021/08/12/...icine-jump-gene-editing/
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Wertpapier: Moderna Inc |
Für die Versorgung mit dem Corona-Impfstoff von Moderna haben das Biotechnologie-Unternehmen und die kanadische Regierung ihre Liefervereinbarung überarbeitet. Diese sieht nun vor, dass in den nächsten zwei Jahren Millionen Dosen geliefert werden. Zusätzlich besteht eine Option für 2024 sowie die Booster-Impfung.....
https://www.businessinsider.com/...ma-strategy-in-gene-editing-2021-8
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Wertpapier: Moderna Inc |
The United States will begin widely distributing Covid-19 booster shots next month as new data shows that vaccine protection wanes over time, top U.S. health officials announced in a joint statement Wednesday.
It’s now “very clear” that immunity starts to fall after the initial two doses, and with the dominance of the delta variant, “we are starting to see evidence of reduced protection against mild and moderate disease,” according to the statement signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S. health leaders. “Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout.”
As a result, U.S. agencies are preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20, starting 8 months after their second dose of Pfizer or Moderna’s vaccines, officials said. While they said recipients of Johnson & Johnson’s single-shot vaccine will likely need boosters, they are awaiting more data in the next few weeks before making a formal recommendation.
“With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well,” officials said.
https://www.bnnbloomberg.ca/video/...-for-covid-booster-shots~2262030
KRON4
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Moderna set to begin clinical trials for an HIV vaccine
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(KRON) – Moderna is set to begin clinical trials of an HIV vaccine that uses mRNA technology, the same technology that led to the success of the COVID-19...
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vor 52 Minuten
https://www.tagesschau.de/wirtschaft/unternehmen/...mpfdosen-101.html
Falls ich das richtig verstanden habe, ist noch gar nicht klar, ob das Problem bei der Abfüllung in Spanien - oder bei dem Einstich in die Ampulle passiert ist
https://myrepublica.nagariknetwork.com/news/...e-stick/?categoryId=81
Japan health minister says Okinawa vaccine contaminants likely from needle stick
TOKYO, August 31: Japan's health minister said on Tuesday it was highly likely that foreign matter found in Moderna Inc (MRNA.O) COVID-19 vaccines in the southern prefecture of Okinawa were caused when needles were stuck into the vials.
Some Moderna shots were temporarily halted in Okinawa on Sunday after foreign materials were discovered in vials and syringes. The health ministry said later needles may have been incorrectly inserted into vials, breaking off bits of the rubber stopper.
"Whatever the reason (for the foreign matter) we have heard that there is no safety or other issues," health minister Norihisa Tamura told reporters, adding that it was not uncommon for foreign material to enter a vial with other vaccines.
"We will continue to gather information and report back," he added.
Japan is facing its biggest wave of COVID-19 infections so far during the pandemic, driven by the highly transmissable Delta variant.
A race to boost inoculations has been hampered by delays in imported vaccines and the discovery of the contaminants in some Moderna doses that prompted the suspension of three batches last week.
Taro Kono, the minister in charge of the inoculation campaign, said on Tuesday he wanted to speed up shipments of vaccines to municipalities that had been forced to put a halt reservations due to shortages.
The government is considering when and how to give out booster shots that may be needed to maintain immunity against the virus but is focusing for now on completing the first two shots for the public, Kono told reporters.
(This story was refiled to correct "where" to "were" in first paragraph.)
Working with the Ministry of Health, Labour and Welfare (MHLW), Moderna, the vaccine manufacturer, ROVI Pharma Industrial Services, S.A. in Spain, Moderna’s European contract manufacturing organization, and Takeda, the authorized distributor, have conducted a thorough investigation, which includes:
•Identification of the root cause of the particles and the corrective and preventive actions being taken;
•An assessment of the nature of a particle from one vial from Lot 3004667; and
•An associated medical safety assessment, to determine if the identified particle poses a health or safety risk.
Root Cause Investigation, and Corrective and Preventive Actions
Three lots of the Moderna COVID-19 Vaccine (Lots 3004667, 3004734 and 3004956) were suspended following reports from vaccination sites of a potential foreign particulate substance observed in unused vials from Lot 3004667.
According to the root cause analysis report, conducted by ROVI, the most probable cause of the particulates identified in lot 3004667 is related to friction between two pieces of metal installed in the stoppering module of the production line due to an incorrect set-up. The two pieces are the star-wheel and the stoppers feeding device piece which feeds stoppers into the star-wheel. It is believed that this condition occurred during the assembling of the line prior to production of batch 3004667 and was a result of improper alignment during a line changeover before starting this batch.
Based on the analysis conducted by ROVI, the manufacturing issue only impacted the lots that were included in the suspension. The following steps have been taken by ROVI to correct and prevent future defects:
•Full inspection of the manufacturing line;
•Improving standard operating procedure for changeover of manufacturing line; and
•Setting alert inspection limits in the automatic visual inspection, as an internal process control.
Takeda, as the Japan Marketing Authorization Holder, is planning to initiate the recall of the three suspended lots 3004667, 3004734, and 3004956 from the market as of September 2, 2021, in consultation with MHLW and reported to the Osaka Prefecture. Moderna as the Global Marketing Authorization Holder is in full agreement with this decision.
Preliminary Particulate Analysis
According to Moderna’s independent analysis, the particle from lot 3004667 has been thoroughly analyzed and is confirmed to be grade 316 stainless steel. This is consistent with the root cause determination described above. Grade 316 is a high grade of stainless steel commonly used in manufacturing and in food processing.
Moderna reicht Zulassungsantrag auf Booster-Dosis ein.
Daneben steht auch Moderna im Kontakt mit der EMA bezüglich einer Auffrischungsdosis: Der Impfstoffhersteller hatte dies bereits vorige Woche angekündigt, nachdem Moderna den Zulassungsantrag für eine Auffrischimpfung bei der FDA eingereicht hatte – nun war es am 3. September soweit. Seither liegen auch der EMA die Zulassungsunterlagen für die Verabreichung einer Auffrischungsdosis mit der Moderna-Vakzine vor.
Sowohl bei Moderna wie auch Pfizer/Biontech soll bei den Auffrischimpfungen mit dem bereits zugelassenen Impfstoff geimpft werden, eine Anpassung an Virusvarianten hat nicht stattgefunden. Während die dritte Dosis Comirnaty® wieder mit 30 µg wie bei den ersten beiden Impfungen erfolgt, will Moderna bei der dritten Dosis Spikevax® nur die halbe Dosis – 50 µg, statt je 100 µg wie bei den Erstimpfungen – einsetzen. Dies genügte in Studien, um die Antikörper gegen die Delta-Variante um das 40-Fache zu erhöhen.
Quelle:
https://www.deutsche-apotheker-zeitung.de/news/...bald-auch-in-der-eu
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Wertpapier: Moderna Inc |
Moderna Announces Significant Advances Across Industry-Leading mRNA Portfolio at 2021 R&D Day
New development candidate for combination respiratory COVID-19 booster + seasonal flu booster vaccine
New pediatric combination development candidate for RSV + hMPV vaccine
Interim Phase 1 data from RSV vaccine candidate in older adults significantly boosted neutralizing antibody titers above baseline
New infectious disease therapeutic vaccine candidate, to complement Epstein-Barr virus prophylactic vaccine
Phase 2 randomized, placebo-controlled study of personalized cancer vaccine fully enrolled; primary endpoint is recurrence free survival at 12 months
Company continues to scale with 37 programs in development, including 22 in ongoing clinical studies
September 09, 2021 07:12 AM Eastern Daylight Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced significant advances across its portfolio of mRNA pipeline programs being presented at the Company’s fifth annual R&D Day today.
“I am proud of the progress that the Moderna team has made in advancing our best-in-class mRNA pipeline while addressing the global COVID-19 pandemic. We believe our mRNA platform can solve the world’s greatest health challenges, from diseases impacting millions, to ultra-rare diseases impacting dozens, to medicines personalized down to the individual level,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Today we are announcing the first step in our novel respiratory vaccine program with the development of a single dose vaccine that combines a booster against COVID-19 and a booster against flu. We are making progress on enrolling patients in our rare disease programs, and we are fully enrolled in our personalized cancer vaccine trial. We believe this is just the beginning of a new age of information-based medicines.”
Updates and recent progress include:
COVID-19 Vaccine Development
Moderna completed the rolling submission process for a Biologics License Application (BLA) for its COVID-19 vaccine (mRNA-1273) in the U.S.
Robust antibody responses have been observed in a Phase 2 study of a third dose/booster of mRNA-1273
New Development Candidates
Combination vaccine candidate (mRNA-1073) that combines Moderna’s COVID-19 vaccine and flu vaccine candidate
Pediatric combination vaccine candidate (mRNA-1365) that combines Moderna’s RSV vaccine candidate with its hMPV vaccine candidate
EBV therapeutic vaccine candidate (mRNA-1195)
Ultra-rare disease, Crigler-Najjar Syndrome Type 1 (mRNA-3351); Moderna to provide investigational mRNA CN-1 therapy to the nonprofit Institute for Life Changing Medicines (ILCM) free of charge
Infectious Diseases
Phase 1 study of quadrivalent seasonal flu vaccine candidate (mRNA-1010) fully enrolled
Positive interim data from Phase 1 study of RSV vaccine candidate (mRNA-1345) from older adult cohort (ages 65-79 years)
Preparing for a global Phase 2/3 study with approximately 34,000 participants of RSV vaccine candidate (mRNA-1345); expected to begin by the end of 2021
Oncology
Phase 2 randomized, placebo-controlled study of personalized cancer vaccine (PCV) (mRNA-4157) in combination with Merck’s pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is fully enrolled
Cardiovascular
Phase 2a study of AZD8601 VEGF-A, being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting surgery with moderately impaired systolic function, led by AstraZeneca, has completed recruitment after enrollment of the low dose cohort
Rare Diseases
Enrollment of the first cohort in Propionic Acidemia (mRNA-3927) Phase 1/2 Paramount study is complete
Investigational New Drug application (IND) open and Orphan Drug Designation granted by U.S. FDA for GSD1a program (mRNA-3745)
Corporate Update
Moderna Genomics (MGX) will leverage Moderna’s current mRNA and lipid nanoparticle (LNP) platform and will pursue novel technology within nucleic acids
Moderna continues to scale, now with 37 programs in development across 34 development candidates1, including 22 in ongoing clinical studies. The Company’s updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 80 peer-reviewed manuscripts.
Select Program Highlights
Core Modalities
Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including vaccines against acute respiratory infections, vaccines against persistent infections, as well as vaccines against threats to global public health.
Vaccines against acute respiratory infections
COVID-19 vaccine development
Moderna COVID-19 Vaccine (mRNA-1273): The World Health Organization (WHO) and health agencies in more than 50 countries have granted emergency use authorization or emergency use listing for the use of the Moderna COVID-19 vaccine in adults. In addition, Moderna has received authorization for use of its COVID-19 vaccine in adolescents ages 12 and up in the European Union and other jurisdictions. On August 25, 2021, Moderna completed the rolling submission process for a Biologics License Application (BLA) for the vaccine in the U.S. Moderna is working with additional health agencies on the authorization and/or approval of its vaccine in additional jurisdictions2. Moderna retains worldwide rights to develop and commercialize the Moderna COVID-19 Vaccine.
Final Analysis of Phase 3 COVE Study: In the final analysis of the Phase 3 COVE study, the Moderna COVID-19 Vaccine showed 93% efficacy (95% CI), with the efficacy remaining durable through six months after administration of the second dose. In this analysis, the Moderna COVID-19 vaccine showed 98.2% efficacy against severe COVID-19 disease and 100% efficacy against death caused by COVID-19. Sub-group analyses were consistent across different populations and the safety profile based on extended safety follow-up was consistent with the Phase 3 COVE study primary results.
Addressing Variants of Concern: Moderna has four development candidates against SARS-CoV-2 variants of concern, including three which have been administered in a Phase 2/3 clinical trial. Initiation of a clinical cohort with the fourth candidate is planned in the coming weeks. The Company’s strategy is to develop booster vaccines against current variants of concern and against potential future variants of concern.
mRNA-1273.351: Variant-specific candidate against the Beta variant
mRNA-1273.617: Variant-specific candidate against the Delta variant
mRNA-1273.211: Multivalent candidate combining the Beta-specific variant and mRNA-1273
mRNA-1273.213: Multivalent candidate combining the Beta-specific and Delta-specific candidates
Booster (Third) Dose: Moderna has submitted for a booster (third) dose of mRNA-1273 at the 50 µg dose level for the following: Emergency Use Authorization (EUA) with the U.S. FDA, Conditional Marketing Approval (CMA) with the European Medicines Agency (EMA) and to additional regulatory agencies. In the amended Phase 2 study, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. After a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults (ages 65 and above). The safety profile following dose 3 was similar to that observed previously for dose 2 of mRNA-1273. An additional analysis showed that a booster dose of mRNA-1273 at the 50 µg dose level induced robust antibody responses and significantly increased geometric mean titers (GMT) for all variants of concern including importantly, Delta (B.1.617.2) by 42.3-fold.
Additional Clinical Studies of mRNA-1273
Phase 2/3 “TeenCOVE” study of mRNA-1273 in adolescents: The Phase 2/3 study of mRNA-1273 in adolescents ages 12-17 years showed that no cases of COVID-19 were observed after two doses of vaccine using the primary case definition, consistent with a vaccine efficacy of 100%. Generally well tolerated, the majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills. The Conditional Marketing Authorization (CMA) for Spikevax3 in the European Union (EU) has been expanded to include adolescents 12 years of age and older. In addition, the Japanese Ministry of Health, Labor and Welfare, Health Canada, as well as other regulatory agencies around the world have also authorized Moderna's COVID-19 vaccine for ages 12 to 17. Moderna has filed for an EUA for adolescents with the U.S. FDA.
Phase 2 “KidCOVE” study of mRNA-1273 in young children: The Phase 2 study of mRNA-1273 in pediatric population ages 6 months to 11 years is ongoing. The Company selected the 50 µg dose for expanded enrollment in the 6 to <12 years old cohort which is now fully enrolled (N=4,000). Dose selection studies are still underway for 2 years to <6 years old and 6 months to <2 years old age groups.
Phase 3 “COVE Transplant” study of mRNA-1273: The Phase 3 study of mRNA-1273 in adults with a kidney or liver transplant is ongoing, including the evaluation of the safety and immunogenicity of a third vaccine dose to these immunocompromised participants.
Next-generation vaccine against COVID-19 (mRNA-1283): The Phase 1 study of mRNA-1283 is fully enrolled. mRNA-1283 is a next-generation vaccine candidate against COVID-19 that encodes for the portions of the SARS-CoV-2 spike protein critical for neutralization, specifically the Receptor Binding Domain (RBD) and N-terminal Domain (NTD). It is being developed as a potential refrigerator stable mRNA vaccine that will facilitate easier distribution and administration by healthcare providers.
Additional vaccines against acute respiratory infections
Seasonal influenza vaccine (mRNA-1010): The Phase 1/2 study evaluating safety and reactogenicity of three different dose levels of mRNA-1010 in adults ages 18-49 years and above 50 years is fully enrolled (N=180). mRNA-1010 encodes for hemagglutinin (HA) glycoproteins of 4 flu strains and targets lineages recommended by the World Health Organization (WHO) for the prevention of influenza, including seasonal influenza A H1N1, H3N2 and influenza B Yamagata and Victoria.
COVID-19 and flu combination vaccine (mRNA-1073): mRNA-1073 encodes for the COVID-19 spike protein and the Flu HA glycoproteins. Moderna owns worldwide commercial rights to mRNA-1073.
Respiratory syncytial virus (RSV) vaccine (mRNA-1345): mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion conformation. RSV is the leading cause of severe respiratory illness in young children and older adults (65+). The Phase 1 study of mRNA-1345 to evaluate the tolerability and reactogenicity of mRNA-1345 in younger adults, women of child-bearing age, older adults and seropositive toddlers is ongoing. All four cohorts of younger adults (ages 18-49 years) and all four cohorts of older adults (ages 65-79 years) are fully enrolled. Today, the Company is sharing Phase 1 interim data from the older adult cohort. Neutralizing antibodies were confirmed to be present at baseline in all participants, as expected. The data showed that a single mRNA-1345 vaccination of 50 µg, 100 µg or 200 µg boosted neutralizing antibody titers against RSV-A by approximately 14-fold and against RSV-B by approximately 10-fold. Data were pooled across dose levels because there was not a significant difference between doses. A single vaccination of 50 µg, 100 µg or 200 µg was well-tolerated in older adults through month 1. Moderna is preparing for a Phase 2/3 study of RSV in older adults (ages older than 60 years) and expects to begin this study by the end of 2021. The Company expects this Phase 2/3 study will be a global study conducted in locations influenced by the epidemiology of RSV and expects to enroll approximately 34,000 participants, subject to agreement with regulatory authorities. The FDA has granted Fast Track designation for mRNA-1345 in adults older than 60 years of age. There is no approved vaccine to prevent RSV. Moderna owns worldwide commercial rights to mRNA-1345.
Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): Moderna is enrolling seropositive pediatric participants (12-36 months of age) in the Phase 1 study of hMPV/PIV3 study (mRNA-1653). The first cohort in this study is fully enrolled. Moderna owns worldwide commercial rights to mRNA-1653.
Pediatric RSV and hMPV combination vaccine (mRNA-1365): mRNA-1365 encodes for the RSV prefusion F glycoprotein and the hMPV F protein. Moderna owns worldwide commercial rights to mRNA-1365.
Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.
Relaxin (mRNA-0184): mRNA-0184 encodes for the relaxin fusion protein. The mRNA sequence of mRNA-0184 is engineered to increase protein expression and prolong half-life. Moderna is planning for a Phase 1 study in participants with chronic heart failure. The Company expects that mRNA-0184 will be administered after heart failure decompensation to bridge patients through the vulnerable period. Moderna owns worldwide commercial rights to mRNA-0184.
Exploratory Modalities
Cancer Vaccines: These programs focus on stimulating a patient’s immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.
Personalized cancer vaccine (PCV) (mRNA-4157): The randomized, placebo-controlled Phase 2 study investigating a 1 mg dose of mRNA-4157 in combination with Merck’s pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is fully enrolled (n=150). The primary endpoint of the Phase 2 study is recurrence-free survival at 12 months. The Phase 1 in multiple cohorts is ongoing and the expanded head and neck cohort is recruiting additional patients. Moderna shares worldwide commercial rights to mRNA-4157 with Merck.
Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.
VEGF-A (AZD8601): The Phase 2a study of AZD8601 VEGF-A, which is being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting surgery with moderately impaired systolic function, led by AstraZeneca, has completed recruitment after enrollment of the low dose cohort (n=11). Moderna has licensed worldwide commercial rights to AZD8601 to AstraZeneca.
Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.
Propionic acidemia (PA) (mRNA-3927): The Phase 1/2 Paramount study of mRNA-3927 is ongoing and enrollment of the first cohort is complete. Moderna owns worldwide commercial rights to mRNA-3927.
Methylmalonic acidemia (MMA) (mRNA-3705): The Phase 1/2 Landmark study to evaluate the safety and pharmacology of mRNA-3705 in patients 1 year of age and older with methylmalonic acidemia (MMA) is ongoing and the first participant has been dosed. Moderna received rare pediatric designation for mRNA-3705. Moderna owns worldwide commercial rights to mRNA-3705.
Glycogen storage disease type 1a (GSD1a) (mRNA-3745): The U.S. FDA has granted mRNA-3745 Orphan Drug Designation and completed its review of the IND application allowing it to proceed to clinic. Individuals with GSD1a have a deficiency in glucose-6-phosphatase resulting in pathological blood glucose imbalance. mRNA-3745 is an IV-administered mRNA encoding human G6Pase enzyme, designed to restore the deficient or defective intracellular enzyme activity in patients with GSD1a. Moderna owns worldwide commercial rights to mRNA-3745.
Crigler-Najjar Syndrome Type 1 (CN-1) (mRNA-3351): mRNA-3351 encodes for the human UGT1A1 and is designed to restore the missing or dysfunctional proteins that causes Crigler-Najjar Syndrome Type 1. mRNA-3351 has been granted Rare Pediatric Disease designation by the U.S. FDA. Moderna will provide investigational mRNA-3351 to the nonprofit Institute for Life Changing Medicines (ILCM) free of charge. ILCM will be responsible for the clinical development of mRNA-3351 and plans to initiate clinical studies of mRNA-3351 in 2022.
Corporate Update
Moderna Genomics (MGX) will leverage Moderna’s current mRNA and lipid nanoparticle (LNP) platform but will also pursue novel technology within nucleic acids. The MGX vision is to be a leader in large, complex genomic editing. Eric Huang, Ph.D. will serve as the Chief Scientific Officer of Moderna Genomics.
Moderna announces a cash position as of August 31, 2021 of approximately $15 billion.
Information about each development candidate in Moderna’s pipeline can be found at investors.modernatx.com. The R&D Day program can be accessed here beginning today at 8:00 am ET.
About Moderna
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past six 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 the Moderna COVID-19 Vaccine (mRNA-1273); its efforts to continue developing vaccines against variant strains of SARS-CoV-2 and for booster doses; the ability of the Moderna COVID-19 Vaccine and booster doses to provide protection against COVID-19 over time and to trigger an antibody response against variants of concern; the safety profile associated with COVID-19 booster candidates; the Company’s plans to submit for a Biologics License Application for mRNA-1273 and other approvals; the enrollment, conduct and timing of clinical trials for programs in the Company’s pipeline, including its vaccine candidates against COVID-19, seasonal flu, CMV, and RSV; plans to develop combination respiratory vaccines; the ability to expand the Company’s portfolio of development programs; the potential to combine different vaccines into a single dose; the ability to use mRNA to enable combination therapeutics personalized for individual tumors and patients; the potential for mRNA medicines to address various diseases with unmet medical need; and the scalability of the Company and its ability to bring potential medicines to market. 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 those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K 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.
1 Includes separate COVID-19 Vaccine (mRNA-1273) programs in development for adults, pediatrics & adolescents and separate RSV vaccine (mRNA-1345) programs in development for adults and pediatrics
2 BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of the Moderna COVID-19 Vaccine with federal funding under Contract no. 75A50120C00034.
3Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.
https://www.manager-magazin.de/unternehmen/pharma/...d94-0e43486aafe4
Moderna entwickelt Impfstoff gegen Corona und Grippe.
https://www.morgenpost.de/vermischtes/...news-deutschland-ticker.html
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Wertpapier: Moderna Inc |
US-Präsident Biden will mit Impfpflicht durchgreifen!
"Als Ihr Präsident kündige ich einen neuen Plan an, mit dem mehr Amerikaner geimpft werden sollen", sagte Biden laut einer von der New York Times veröffentlichten Mitschrift. Er kündigte den Plan am Donnerstag vom Weissen Haus aus an. Das Schlüsselwort hier ist "verlangen".
Nun muss sich eine ganz neue Gruppe von Menschen für die Impfung entscheiden, wenn sie arbeiten wollen. Der Plan sieht vor, dass Unternehmen mit 100 oder mehr Mitarbeitern die Impfung vorschreiben - oder ungeimpfte Mitarbeiter einmal pro Woche testen. Biden verlangt die Impfung aller Regierungsangestellten - ohne die Möglichkeit, sich stattdessen wöchentlich testen zu lassen. Und schliesslich sagt Biden,
dass die 17 Millionen Beschäftigten im Gesundheitswesen des Landes alle geimpft werden müssen.
Insgesamt betreffen die neuen Anforderungen etwa 100 Millionen Amerikaner, d. h. zwei Drittel der Arbeitskräfte, so der Präsident.
Es ist sehr wahrscheinlich, dass auch Arbeitsplätze, die nicht unter Bidens Mandat fallen, auf den Zug aufspringen werden. Eine im letzten Monat von der Versicherungsgesellschaft Willis Towers Watson durchgeführte Umfrage liefert den Beweis dafür. Etwa 52 % der befragten Arbeitgeber gaben an, dass sie bis zum Jahresende eine Art von Impfvorschrift einführen werden, wie ABC News berichtete."
Das kann ja noch heiter werden, wie die US-Amerikaner darauf reagieren, denn wohl nicht alle werden dies einfach schlucken, resp. sich "spritzen" lassen, weil sie der Auffassung sind das "Impfzwang" gegen das Grundrecht der freien Selbstbestimmung verstösst.
Quelle:
https://www.fool.com/investing/2021/09/12/...amp;utm_campaign=article
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auch mein arzt hat mir das alles bestätigt was bei mir im buche steht.
jeder mensch hat unzählige viren,bakterien,keime seit vielen tausend jahren in sich und das alles mutiert jedes jahr aufs neue,der mensch ist immun gegen solche sachen.
big pharma = big business
