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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
Moderna (MRNA) earns a Zacks Rank #3 two days from its next quarterly earnings release on May 2, 2024, and its Most Accurate Estimate comes in at -$3.55 a share.
By taking the percentage difference between the -$3.55 Most Accurate Estimate and the -$3.59 Zacks Consensus Estimate, Moderna has an Earnings ESP of 0.99%.
the Company will present data from its respiratory portfolio, including vaccines and vaccine candidates against COVID-19 (mRNA-1273, mRNA-1283), influenza (mRNA-1010, mRNA-1011/1012), and respiratory syncytial virus (RSV) (mRNA-1345), along with data related to its latent virus portfolio regarding cytomegalovirus (CMV), at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Barcelona, Spain, from April 27-30, 2024.
https://investors.modernatx.com/news/news-details/2024/Moderna-To-Present-Respiratory--Cytomegalovirus-Research-at-the-ESCMID-Global-Congress/default.aspx
British patients test world’s first personalised mRNA jab for melanoma
Moderna and MSD are researching how their therapy could treat a wide range of cancers.
https://www.independent.co.uk/news/health/moderna-british-patients-bray-fat-duck-b2535073.html
Should You Buy Moderna Before May 12?
Though GSK and Pfizer both got a head start in this market, Moderna could carve out market share and eventually take a leadership position for two reasons. First, mRNA-1345 is the only one to come in a pre-filled syringe format. This makes it easier and faster for healthcare providers to administer, and results in fewer errors. All of this is a big plus for those giving the vaccine and those receiving it.
Second, in the phase 3 clinical trial of mRNA-1345, Moderna didn't observe cases of Guillain-Barre syndrome, a rare neurological disorder. But GSK and Pfizer both reported cases of this autoimmune condition in their trials. Some doctors, seeing this data, may recommend the Moderna product to their patients over others.
https://www.fool.com/investing/2024/04/26/should-you-buy-moderna-before-may-12/
Moderna CEO says AI will help scientists understand ‘most diseases’ in 3 to 5 years
https://gizmodo.com/moderna-ceo-chatgpt-employees-vaccines-openai-1851435620
Moderna and OpenAI Collaborate To Advance mRNA Medicine
At Moderna, OpenAI’s GPTs Are Changing Almost Everything
https://investors.modernatx.com/news/news-details/2024/Moderna-and-OpenAI-Collaborate-To-Advance-mRNA-Medicine/default.aspx
Anktiva is the next-generation immunotherapy drug, according to ImmunityBio executive chairman Dr. Patrick Soon-Shiong: "This drug is the first drug, as far as I know, that activates the natural killer cell that talks to the T-cell and generates complete remission..." pic.twitter.com/DIVc3A8luy
— Yahoo Finance (@YahooFinance) April 23, 2024
impatient dummies----------
Last Friday, we were honored to have Dr. Linda Liau as our 42nd Annual J. Jay Keegan Lecturer. It was an extraordinary afternoon for our residents with a phenomenal presentation and dinner to follow. We are so indebted to Dr. Liau for her time here in #Omaha. @unmc @UCLANsgy pic.twitter.com/tqb36hpn6w
— UNMC Department of Neurosurgery (@UNMC_NeuroSurg) April 22, 2024
Peter Feinberg, recently bought US$183k worth of stock, paying US$2.44 for each share
To be standing with these two giants tonight was inspiring. If I can have one tenth of the career or impact of these two, my career will be a huge success. Thank you, Dr. Liau, for visiting us here in Omaha and sharing your insight with us. @UNMC_NeuroSurg pic.twitter.com/bWtcU2TE3b
— Susan E Greni, MD, MSc (@Susan_Greni) April 20, 2024
$NWBO #DCVax: sounds like Dr. Linda Liau lecture on Friday, 4/19/2024, at the University of Nebraska Medical Center (UNMC), titled: “Immunotherapy for the treatment of Glioblastoma”, was well received. I look forward to getting more information & for Glioblastoma & other solid… https://t.co/ElCQKs8aYj pic.twitter.com/dQ6YNYDSDQ
— ATLnsider (@ATLnsider) April 20, 2024
"The DcVax-L is one of the promising immunotherapy treatments, but there are others licensed for other cancers that I can't access on the NHS because they've not got the supporting evidence from trials for brain cancer because the Conservative government at a UK level hasn't put the money into finding a cure for a cancer that is the biggest cancer killer of children and young adults.