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Roy Buchanan – a Citizens JMP analyst expects the news to be significant for $MRNA particularly if the H5N1 strain turns into a worldwide concern.
That’s because the biotech giant has a vaccine currently in a Phase 2 trial that “targets the same evolutionary group as the avian influenza virus” – and it’s convinced that vaccine can be easily adapted to new mutations as well.
Moderna and Pfizer In Talks With U.S. To Make a Bird Flu Vaccine.
O'Connell added that active discussions are under way across federal agencies about what the key triggers would be for deploying H5N1 vaccine doses. She also said discussions are still under way with mRNA vaccine makers Pfizer and Moderna, with an announcement expected soon on how the companies might be involved in vaccine development.
https://www.cidrap.umn.edu/avian-influenza-bird-flu/hhs-advances-plan-produce-48-million-h5n1-vaccine-doses
" news coming soon" today announced that three abstracts on mRNA-4157 (V940), an investigational mRNA individualized neoantigen therapy, have been accepted for presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held May 31 - June 4 in Chicago, IL. mRNA-4157 (V940) is being jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.
https://investors.modernatx.com/news/news-details/2024/Moderna-Announces-Data-to-be-Presented-at-2024-ASCO-Annual-Meeting/default.aspx
We're almost there now---- mRNA-1345 Agency has indicated it expects to complete the review by end of May.
Moderna wins Covid jab patent dispute over Pfizer and BioNTech
https://www.ft.com/content/50c5078c-c9f0-4b35-b916-3475b641c773
MHRA performance data for assessment of clinical trials and established medicines
Updated 15 May 2024
https://www.gov.uk/government/publications/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines/mhra-performance-data-for-assessment-of-clinical-trials-and-established-medicines
$MRNA money machine.....
$1.46 bouncer
a planned interim analysis of ORR will be conducted when the first 225 randomized patients reach one year of treatment in June 2024. The outcome of this analysis is expected in the third quarter of 2024 and, if supportive, we believe could allow for submission of a BLA for accelerated approval in the US.
Cash and cash equivalents as of March 31, 2024 were $118.0 million, compared to $143.2 million at December 31, 2023. During the three months ended March 31, 2024, the company used cash, cash equivalents and restricted cash of $24.9 million. The increase in cash use was primarily driven by milestone payments and payment of other accrued expenses associated with clinical trials, as well as the payment of year-end bonuses. The company continues to expect that it will have sufficient cash to run the company into the fourth quarter of 2025.
Revolutionary Genetics Research Shows RNA May Rule Our Genome
https://www.scientificamerican.com/article/revolutionary-genetics-research-shows-rna-may-rule-our-genome/
A potential approval will also show that Moderna isn't just a one-product company and instead can build a billion-dollar respiratory vaccine portfolio, including several game-changing products!
$MRNA This is an easy buy if I ever saw one.
next catalyst coming$$$$$$$$
The FDA has not informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent the approval of mRNA-1345
William Blair analyst Myles Minter cited "administration constraints" at the FDA for the delay.
"Although regulatory delays are disappointing and usually create noise around the probability of approval, given the 'administrative constraints' information currently available and known FDA backlogs, today's news does not alter our expectation that (Moderna's RSV vaccine) will receive approval under the current (biologics license agreement) review cycle," he said in a report.
Breakthrough in Immunotherapy for Brain Cancer- https://neurosciencenews.com/immunotherapy-glioma-brain-cancer-26075/
Food and Drug Administration will consider approving Moderna's RSV shot.
-is due to make its decision by May 16-
dendritic cell (DC)
As such, the addition of a TLR agonist to ATL-DC vaccination in malignant glioma patients was found to be safe and tolerable.
Overall, the addition of a TLR agonist-induced only Grade 1-2 treatment-related adverse events (TRAEs), and all adverse events reported resolved without further treatment or hospitalization (Table 2). The most common TRAEs were rash (39%), fever (35%), and fatigue (26%; see Table 2), and were more common in patients treated with resiquimod and poly-ICLC. 88.9% of patients who received resiquimod reported a temporary localized, cutaneous rash that resolved without further treatment. Other observed adverse events were not uncommon in the setting of postoperative central nervous system (CNS) tumor treatment. However, no serious adverse events (Grade 3-4) attributable to the treatment were observed
https://www.nature.com/articles/s41467-024-48073-y
Strong balance sheet with approximately $2.1 billion in cash, cash equivalents, and marketable securities as of March 31, 2024
https://finance.yahoo.com/news/crispr-therapeutics-provides-business-reports-200000059.html
Vaccines Have Saved a Staggering 154 Million Lives in The Last 50 Years
https://www.sciencealert.com/vaccines-have-saved-a-staggering-154-million-lives-in-the-last-50-years
Vaccines Have Saved a Staggering 154 Million Lives in The Last 50 Years
https://www.sciencealert.com/vaccines-have-saved-a-staggering-154-million-lives-in-the-last-50-years
How mRNA vaccines could be personalized cancer cures
https://www.axios.com/2024/05/07/how-mrna-vaccines-could-be-personalized-cancer-cures
if the drug works.....can be a runner!
First Patient Begins Newly Approved Sickle Cell Gene Therapy
https://www.nytimes.com/2024/05/06/health/sickle-cell-cure-first.html
game over: announced topline results from the Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS). ENLIGHTEN 1 did not meet its primary endpoint
Moderna plants new solid tumor trials for cancer vaccine, weeds PD-1 work after review
https://www.fiercebiotech.com/biotech/moderna-plants-new-solid-tumor-trials-culls-checkpoint-inhibitor
announced its intention to seek formal confirmation from Nasdaq regarding its compliance with the equity requirements outlined in Rule 5550(b)(1) of the exchange’s regulations. Currently its stockholders’ equity is significantly above the $2.5 million minimum required by Nasdaq Listing Rule 5550(b)(1).
Largest U.S. Pension Sold Verizon, Disney, and Peloton Stock. It Bought Moderna.
The pension bought 538,900 Moderna shares to lift its stake to 1.1 million shares at the end of the first quarter
https://www.msn.com/en-us/money/companies/largest-u-s-pension-sold-verizon-disney-and-peloton-stock-it-bought-moderna/ar-BB1lQqVp
Completed enrollment of pivotal Phase 3 trial of lead investigational therapeutic cancer vaccine, IO102-IO103, in combination with KEYTRUDA® (pembrolizumab), in patients with advanced melanoma; planned interim analysis for overall response rate (ORR) expected in third quarter of 2024 by independent data monitoring committee
Progressed clinical development of IO102-IO103 with first patient dosed in Phase 2 basket trial of IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment of patients with resectable solid tumors
Ended 2023 with cash and cash equivalents of approximately $143.2 million; expected operational runway into the fourth quarter of 2025
https://www.biopharmcatalyst.com/company/IOBT/news/190095
UCLA Neurosurgery at the 2024 AANS Annual Meeting
Monday, May 6:
11:06 AM – 11:26 AM CT - Dr. Linda Liau, Immunotherapy
https://www.uclahealth.org/departments/neurosurgery/ucla-neurosurgery-aans-2024-annual-meeting
-Work continues- The funds will be used for the Company’s ongoing business operations, including beginning initial construction works for the first grade C lab in the Company’s Sawston, UK facility, ordering certain initial long lead-time equipment for the first grade C lab, and facility preparations for delivery of the initial GMP units of the Flaskworks system.
https://www.otcmarkets.com/filing/html?id=17505671&guid=hdQ-k6p3kt77B3h
Moderna (MRNA) Q1 2024 Earnings Call Transcript " Money Machine "
https://www.fool.com/earnings/call-transcripts/2024/05/02/moderna-mrna-q1-2024-earnings-call-transcript/
An initial launch in concert with our strategic partners in the 4th quarter of 2024 with a Neural
A definitive Merger Agreement was executed by and between Bell Buckle Holdings, Inc. RG Barron Funds Ltd. (its former control shareholder), Green Mantis LLC, Roger Hood & Reginald Kelley (new control shareholders). The agreement provides for Bell Buckle Holdings to acquire 100% of Green Mantis LLC and for the control shares of Bell Buckle Holdings to be transferred to Mr. Hood and Mr. Kelley.
https://www.greenmantisllc.com/
I would like to acknowledge the UCLA Brain Tumor Center, especially my neurosurgeon, Dr. Linda Liau for literally saving my life: https://shoutoutla.com/meet-wendy-santana-brain-tumor-awareness-advocate/
Today, we reported financial results and provided business updates for the first quarter of 2024.
Reports first quarter revenues of $167 million, GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
Prepares for launches of RSV vaccine and Spikevax® 2024-2025 formula; reaffirms 2024 expected product sales of approximately $4 billion
Initiated three new clinical studies evaluating Moderna's investigational individualized neoantigen therapy in combination with Merck's Keytruda® for treatment of patients with bladder cancer, kidney cancer and cutaneous squamous cell carcinoma
Advanced three new vaccine programs (Epstein-Barr virus, Varicella-Zoster virus, norovirus) toward Phase 3 clinical trials as announced at Vaccines Day investor event
RSV: The Company anticipates initial regulatory approvals of its RSV vaccine (mRNA-1345) beginning in the first half of 2024.
Moderna is targeting fall 2024 for its U.S. RSV vaccine launch, which will build upon the success of its commercial efforts in the fall COVID-19 market. The Company is encouraged by early indications of widespread consumer awareness and established demand in the RSV market, which Moderna will enter with a strong competitive profile with robust clinical efficacy data, a well-established safety and tolerability profile for its mRNA technology, and as the only pre-filled syringe (PFS) product available.
The PFS ready-to-use formulation will save pharmacists and clinicians time, potentially alleviating wait times and reducing the burden on pharmacy staff. In a study funded by Moderna, the PFS presentation was three to four times more efficient than vaccines requiring reconstitution, measured in doses per hour and based on mean time of preparation.
Cash and Investments: Year-end cash and investments for 2024 are projected to be approximately $9 billion.
Moderna Puts Up Big Quarterly Beat; Could Shares Notch A Breakout
https://www.investors.com/news/technology/moderna-stock-moderna-earnings-q1-2024/?src=A00220
https://news.modernatx.com/news/news-details/2024/Moderna-Reports-First-Quarter-2024-Financial-Results-and-Provides-Business-Updates/default.aspx