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Moderna, Novavax, Inovio, BioNtech, 'RNA vaccin-producenten'

1. voda 9 mei 2024 16:23

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   ’Moderna en Pfizer zijn gewoon beter’
   Coronavaccin AstraZeneca van de markt, is dat zorgelijk voor wie deze prik kreeg?
   
   www.telegraaf.nl/nieuws/1782127150/co...
2. voda 10 mei 2024 13:14

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   Novavax noteerde voorbeurs meer dan 50,0 procent hoger, na ondertekening van een co-exclusieve licentieovereenkomst met de Franse geneesmiddelenfabrikant Sanofi voor zijn Covid-vaccin vanaf 2025.
   
   Door: ABM Financial News.
3. Succes 10 mei 2024 19:25

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   Novavax Soars on $1.2 Billion Sanofi Vaccine Licensing Deal
   
   (Bloomberg) -- Novavax Inc. shares surged after the company signed a $1.2 billion licensing agreement with Sanofi that includes commercializing a combined Covid-19 and flu shot.
   
   Novavax will receive $500 million in upfront payments as well as a further $700 million if all development, regulatory and launch milestones are met, according to a statement Friday. Novavax, which will receive tiered royalties on any vaccine sales, said Sanofi is also taking a minority equity stake of about 5% in the US company.
   
   ...
   
   finance.yahoo.com/news/sanofi-inks-1-...
4. Riding the Tiger 14 mei 2024 08:29

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   Vogelgriep in US
   
   We zijn met teveel mensen op deze planeet. En ook met teveel beesten. Het is niet de vraag of er een nieuwe pandemie komt, maar wanneer. Vogelgriep verspreidt zich over de US ; kan dit virus overgaan naar mensen ? Ik hoop van niet, maar Novavax gaat dan nog maar eens door the roof gaan...
   
   theconversation.com/bird-flu-detected...
5. Riding the Tiger 14 mei 2024 08:35

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   eenvandaag.avrotros.nl/item/experts-b...
6. Riding the Tiger 23 mei 2024 10:50

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   Novavax - klaar voor een short squeeze
   
   Novavax is geïmplodeerd na Covid. Eind 2019 kon je ze kopen aan 4 $, ze stegen naar 300 $, en daalden terug naar 4 $. Ik heb de run in 2019 gemist, omdat ING ze niet aanbood ; dat was zeer frustrerend...
   
   Ik heb ze dan maar gekocht aan +/- 4$ een eindje geleden. Als je de grafiek van Novavax bekijkt, heeft die de laatste 20 jaar ongeveer 8 X de 100 $ grens doorbroken.
   
   Daar zijn verschillende redenen voor. De belangrijkste is, de kans op een nieuwe pandemie. Ik dacht dat het een paar jaar zou duren, maar niet dus. Er is in Australië, India en US een uitbraak van Bovine Flu. Dat is vogelgriep, die zich op runderen zet. Er zijn ook enkele gevallen van menselijke besmettingen. Vogelgriep muteert snel, dus is een uitbraak niet onmogelijk...
   
   Daarnaast is Novavax één van de meest geshorte aandelen van Nasdaq, en heeft het onlangs een mega deal gesloten met Sanofi voor 1,6 Mia $. Deze cocktail kan ontploffen ; een short sqeeze is mogelijk...
   
   PS. Ik hoop niet op een nieuwe pandemie. Maar de constatering dat we met teveel mensen leven op deze te kleine mooie bol, is een teken aan de wand....
7. DeZwarteRidder 23 mei 2024 10:59

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   De koersen van Biontech en Moderna zijn aan het exploderen.
8. MisterBlues 23 mei 2024 11:43

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   Moderna stond sowieso absurd laag gezien pijplijn en vaccin op de markt. Nu is er het gerucht dat Moderna (en wellicht BioNtech) vogelvaccin gaan maken.
   
   Novavax stond 1,5 maand terug nog < 4 dollar, inmiddels > 15 dollar. Tel uit je winst. Novavax heeft Sanofi gestrikt (of omgekeerd) voor lucratieve deal. Novavax is bovendien als een van de weinige producenten betrouwbaar als alternatief voor mRNA vaccins.
9. MisterBlues 24 mei 2024 06:46

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   Vaccine Stocks Rise on Growing Threat of Bird Flu Infections
   
   Shares of several vaccine makers soared after reports suggest that the Biden administration is in discussions with Moderna MRNA and Pfizer PFE to set up a possible vaccine program aimed at preventing the spread of the H5N1 virus, also known as bird flu, in humans.
   
   These reports came to light after the discovery of two cases of H5N1 virus in dairy farm workers in Texas and Michigan this year. Both these workers experienced symptoms in the eye after coming into contact with dairy cows infected with the H5N1 virus.
   
   Though the Centers for Disease Control and Prevention (CDC) stated that the risk to the general public remains low, due to lack of evidence of human-to-human transmission. However, the regulatory body remains vigilant and is even using its flu surveillance systems to monitor for H5N1 activity.
   
   Per the latest CDC data, nine states have confirmed bird flu cases in cows, with 52 dairy herds affected.
   
   In response to the reports, shares of Moderna, Pfizer, Novavax NVAX, CureVac CVAC and BioNTech rose 13.7%, 3.6%, 5.3%, 18.8% and 11.1%, respectively, on Wednesday.
   
   Some vaccine makers mentioned above are already developing a vaccine for bird flu. An article from Barron’s reported that Moderna is evaluating its bird flu vaccine in a mid-stage study.
   
   Earlier this month, Novavax mentioned that it is conducting pre-clinical studies on a vaccine for H5N1 bird flu. NVAX claimed that this vaccine uses a new approach for immunizing against the virus.
   
   Last month, CureVac announced that it has started a phase I/II study on its bird flu vaccine. CureVac is developing this investigational mRNA-based vaccine in collaboration with GSK.
   
   The signs of a potential bird flu transmission have provided some respite to these vaccine-focused stocks, especially for those involved in the COVID-19 vaccine roll-out. Vaccine makers, especially Moderna and Pfizer, have been suffering a heavy beatdown in product sales and market value as COVID-19 cases have significantly dropped compared with the last couple of years. Investors are counting on these companies to lead the fight against the next pandemic if one does arise.
10. MisterBlues 24 mei 2024 06:59

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    quote:

    Riding the Tiger schreef op 23 mei 2024 10:50:

    Daar zijn verschillende redenen voor. De belangrijkste is, de kans op een nieuwe pandemie. Ik dacht dat het een paar jaar zou duren, maar niet dus. Er is in Australië, India en US een uitbraak van Bovine Flu. Dat is vogelgriep, die zich op runderen zet. Er zijn ook enkele gevallen van menselijke besmettingen. Vogelgriep muteert snel, dus is een uitbraak niet onmogelijk...
    

    De mRNA techniek - samen met AI - van Moderna kan een versnelde route afleggen richting markt. Ook Sanofi en Novavax zijn al begonnen. Zouden deze vaccinmakers ook denken aan vaccins voor dieren? - wel even iets anders.
    
    Ik vraag me af of het zin heeft en rendabel is om uit voorzorg de runderen te vaccineren. In NL is het nu gewenst je schapen en geiten tegen Q-koorts te vaccineren. Ook vaccinatie voor blauwtong is in het nieuws geweest. Zouden de commerciële vaccinmakers - met vaccins voor mensen - hierin willen stappen - dus niet wachten tot het overspringt maar kijken of het rendabel is de megastallen te bedienen...
12. MisterBlues 24 mei 2024 07:18

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    Moderna and Pfizer In Talks With U.S. To Make a Bird Flu Vaccine
    By Josh Nathan-Kazis
    
    Updated May 22, 2024, 6:18 pm EDT / Original May 22, 2024, 3:40 pm EDT
    
    Moderna and Pfizer are in talks with the federal government over a potential avian flu vaccine program, the head of the U.S. government’s pandemic response administration said late Wednesday.
    
    The disclosure came amid a run-up in shares of vaccine makers. Moderna stock spiked in Wednesday trading, climbing 13.7% over the course of the day amid swelling concerns over the avian influenza outbreak in U.S. cattle.
    
    After the market closed, the Assistant Secretary of Preparedness and Response at the Department of Health and Human Services, Dawn O’Connell, said on a press call that the agency is in conversation with both Moderna and Pfizer about making avian influenza vaccines using messenger RNA-based technology.
    
    “We continue to have active conversations with both manufacturers, and the negotiations are ongoing,” O’Connell said. “We are looking to wrap this up and have something to say very soon.”
    
    www.barrons.com/articles/moderna-stoc...
13. MisterBlues 24 mei 2024 07:30

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    Wat Moderna betreft: RSV goedkeuring - of afkeuring - is nabij
    
    Aardige post van het Yahoo forum:
    
    What I really can't understand right now is why are some here excessively worrying about bird flu being just a hype when the REAL right at the corner risk is for RSV not getting accepted next week? Say bird flu was a hype (not saying it is but lets assume), then when and how would some skeptics picture the timeline for the revelation of Bird flu as a hype? Will the revelation be tomorrow, next week, next month, or next year? Would we see an announcement from the CDC? How will it be revealed? Will there be an announcement for the end of the non-pandemic? Or would it just fade quietly into the background as Moderna provides actual progress on its other products to justify the valuation already gained? I'd say the later. For the bearish thesis to effectively play out, skeptics need to pay attention to RSV not bird flu news fading. Fingers nervously crossed for tomorrow morning's or next week's RSV update.
14. MisterBlues 29 mei 2024 08:55

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    Moderna Stock Had a Very Bad Day. Here’s Why.
    www.barrons.com/articles/moderna-stoc...
    ...............Hype vogeltjesgriep even minder, maar wat ook speelt:
    
    More extensive delays could imperil the company’s participation in the Centers for Disease Control and Preventions’ mid-June meeting on RSV vaccines, at which it will make recommendations for how the shots will be used. The outcome of that meeting will be key for the coming commercial showdown between GSK, Pfizer, and Moderna, all of which plan to sell RSV vaccines this year.
    
    Also coming are the data Moderna plans to present at a major cancer conference that starts at the end of this week on mRNA-4157, an individualized cancer therapy it is developing with Merck. The drug is the cornerstone of Moderna’s cancer hopes, and its plans to expand beyond the respiratory vaccines that have defined its early history.
    
    Wat mij betreft een bijkoop kans komende dagen als de koers nog wat meer daalt...
15. MisterBlues 1 juni 2024 09:55

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    Moderna Receives U.S. FDA Approval for RSV Vaccine mRESVIA(R)
    
    mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
    
    CAMBRIDGE, MA / ACCESSWIRE / May 31, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna.
    
    "The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform," said Stéphane Bancel, Chief Executive Officer of Moderna. "mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators' time and reducing the risk of administrative errors. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19. With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases."
    
    RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia that causes a particularly large burden of disease in infants and older adults. Each year in the U.S., approximately 60,000-160,000 older adults are hospitalized and 6,000-10,000 die due to RSV infection.[1]
    
    The FDA's approval of mRESVIA is based on positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%). These results were published in The New England Journal of Medicine. A follow-up analysis of the primary endpoint was performed during FDA review, including cases that started before the primary analysis cut-off date but were not confirmed until afterward. The results were consistent with the primary analysis [VE 78.7% (CI 62.9%, 87.8%)] and were included in the U.S. package insert. An additional longer-term analysis showed continued protection against RSV LRTD over 8.6 months median follow-up.
    
    No serious safety concerns were identified in the Phase 3 trial. The most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia.
    
    Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.
    
    Moderna has filed for mRNA-1345 approval with regulators in multiple markets around the world.
    
    About mRESVIA® (RSV Vaccine, mRNA)
    
    mRESVIA®is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines.
    
    About Moderna
    
    Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.
    
    Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
    
    INDICATION
    mRESVIA (RSV Vaccine, mRNA) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.
16. MisterBlues 3 juni 2024 17:31

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    Moderna has added a new press release to its website:
    
    Moderna & Merck Announce 3-Year Data For mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated Sustained Improvement in Recurrence-Free Survival & Distant Metastasis-Free Survival Versus KEYTRUDA in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection
    
    At a median planned follow-up of the Phase 2b study at 34.9 months, mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 62% compared to KEYTRUDA alone in these patients
    
    The 2.5-year recurrence-free survival rate of mRNA-4157 (V940) in combination with KEYTRUDA was 74.8% as compared to 55.6% for KEYTRUDA alone, with the benefit observed across exploratory subgroups
    
    The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer, in addition to Phase 2 studies in patients with renal cell carcinoma and urothelial carcinoma and a Phase 2/3 study for cutaneous squamous cell carcinoma
    
    CAMBRIDGE, MA and RAHWAY, NJ / ACCESSWIRE / June 3, 2024 / Moderna, Inc. (NASDAQ:MRNA) and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from a planned analysis from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection (n=157). With a median follow-up of approximately three years (34.9 months), adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA continued to demonstrate a clinically meaningful and durable improvement in recurrence-free survival (RFS), the primary endpoint of the study, reducing the risk of recurrence or death by 49% (HR [95% CI], 0.510 [0.288-0.906]; two-sided nominal p-value 0.019) compared with KEYTRUDA alone. mRNA-4157 (V940) in combination with KEYTRUDA also continued to demonstrate a meaningful improvement in distant metastasis-free survival (DMFS), a key secondary endpoint of the study, compared with KEYTRUDA alone, reducing the risk of developing distant metastasis or death by 62% (HR [95% CI], 0.384 [0.172-0.858], two-sided nominal p-value 0.015).
    
    These data are being presented today during a rapid oral abstract session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #LBA9512). With an additional year of planned follow-up, these data build on the earlier analysis of the primary and key secondary endpoints of the study, presented in 2023. The 2.5-year recurrence-free survival rate of mRNA-4157 (V940) in combination with KEYTRUDA was 74.8%, as compared to 55.6% for KEYTRUDA alone, with the benefit observed across exploratory subgroups.
    
    "We are encouraged by the latest results from the KEYNOTE-942/mRNA-4157-P201 study. These data highlight the sustained benefit in RFS and DMFS of mRNA-4157 (V940) as adjuvant treatment in combination with KEYTRUDA in people with resected high-risk melanoma. Importantly, this benefit was observed across various patient exploratory subgroups, reflecting the potential of mRNA-4157 (V940) for a broad range of these patients," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology. "These findings reinforce our commitment to advancing this innovative treatment in collaboration with Merck, and we are dedicated to harnessing mRNA technology to potentially transform cancer therapy and improve patient outcomes."
    
    "The sustained improvements in recurrence-free survival and distant metastasis-free survival observed at approximately three years in the KEYNOTE-942/mRNA-4157-P201 study provide further support of the potential of mRNA-4157 (V940) in combination with KEYTRUDA to help patients with resected high-risk melanoma," said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "We look forward to building on our legacy of turning breakthrough science into medicines that may have a meaningful impact on patients' lives as we continue advancing our broad clinical development program evaluating this novel approach with Moderna."
    
    Moderna ook op dit front goed bezig. Zie website van Moderna en clinical trials:
    classic.clinicaltrials.gov/ct2/show/N...
17. MisterBlues 3 juni 2024 17:32

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    Moderna has added a new presentation to its website:
    
    ASCO 2024 Trial in Progress (melanoma)
    s29.q4cdn.com/435878511/files/doc_pre...
    
    Click here for a complete listing of Moderna presentations.
18. MisterBlues 3 juni 2024 17:33

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    Moderna has added a new presentation to its website:
    
    ASCO 2024 Trial in Progress (NSCLC)
    s29.q4cdn.com/435878511/files/doc_pre...
    
    Click here for a complete listing of Moderna presentations.
19. MisterBlues 3 juni 2024 17:34

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    Moderna en Novavax weer sterren van de beurs.
20. MisterBlues 6 juni 2024 17:21

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    Moderna's Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program
    
    Center for Biologics Evaluation and Research has chosen mRNA-3705 as one of four investigational medicines for accelerated development to address unmet medical needs for rare diseases
    
    CAMBRIDGE, MA / ACCESSWIRE / June 6, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. mRNA-3705 is an investigational therapeutic for methylmalonic acidemia (MMA) due to methylmalonic-CoA mutase (MUT) deficiency.
    
    "We are excited about this opportunity and proud that our investigational mRNA therapeutic for MMA was selected by the U.S. FDA for the START pilot program. This selection highlights the promise of Moderna's innovative mRNA platform beyond vaccines and the potential this novel medicine may have in addressing the serious and unmet medical needs of MMA," said Kyle Holen, M.D., Moderna's Senior Vice President and Head of Development, Therapeutics and Oncology. "Selection for this program will enable enhanced communication with the U.S. FDA, resulting in acceleration of our development program as we prepare for pivotal study initiation for mRNA-3705 in 2024."
    
    The START pilot program was initiated by the U.S. FDA in September 2023 to accelerate the development of novel treatments addressing unmet medical needs in rare diseases, with an initial selection of up to seven novel treatments, three by the Center for Drug Evaluation and Research (CDER) and four by the Center for Biologics Evaluation and Research (CBER). The milestone-driven initiative is intended to help the progression to pivotal clinical studies or pre-BLA/NDA meeting stages by enhancing communications between manufacturers and the U.S. FDA. Selected manufacturers will benefit from rapid, ad-hoc U.S. FDA interactions to support clinical development, such as study design, patient population, and statistical methods, beyond standard formal meetings. The program is designed to generate high-quality, reliable data to support marketing approvals, ensuring promising treatments advance efficiently through regulatory milestones.
    
    MMA is a rare, life-threatening, inherited metabolic disorder that is most commonly (approximately 60% of cases) caused by a deficiency in the mitochondrial enzyme MUT. This deficiency can lead to metabolic crises due to a toxic buildup of acids in the body, progressing into multi-organ disease. As a result, MMA is associated with significant mortality and morbidity, and there are no approved therapies. Standard of care includes dietary and palliative measures. Currently, liver or combined liver and kidney transplants are the only effective treatments.
    
    mRNA-3705 is being investigated in a Phase 1/2 study, called the "Landmark study," an adaptive, open-label study designed to evaluate the safety and tolerability of the investigational therapeutic administered via intravenous infusion in patients one year and older with isolated MMA due to methylmalonyl-CoA mutase (hMUT) deficiency.
21. MisterBlues 6 juni 2024 17:22

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    Moderna
    Recently, we published our first annual COVID-19 report, which provides an overview of the landscape in 2023-2024. The report compares the burden of COVID-19 to influenza, evaluates barriers to vaccine uptake, and discusses the continued evolution of the virus, including the potential for more virulent variants. It also addresses lower public acceptance of vaccination, identifying the obstacles contributing to these issues and offering solutions to improve COVID-19 response in future seasons.
    
    www.modernatx.com/en-US/media-center/...