Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Moderna exercises option to license proprietary targeting technology from Autolus
LONDON, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programed T cell therapies, today announces that Moderna (MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, has exercised its option to license Autolus’ proprietary binders against an undisclosed immuno-oncology target for the development and commercialization of mRNA therapeutics.
This follows an original agreement with Moderna announced on August 2, 2021, granting Moderna an exclusive option to license Autolus’ proprietary binders for up to four immuno-oncology targets for incorporation in certain mRNA therapeutics. On exercise of the option, Autolus has received an option exercise payment and is eligible to receive development and commercial milestone payments for each product successfully commercialized. In addition, Autolus would be entitled to receive royalties on net sales of all products commercialized under the agreement.
“The collaboration with Moderna has been a productive partnership, and it’s great to see this work progressing to the next stage,” said Dr. Martin Pule, CSO of Autolus. “The use of our technology in Moderna’s mRNA platform continues to underscore Autolus’ leadership in the development of innovative differentiated binder and cell programming technologies.”
https://finance.yahoo.com/news/moderna-exercises-option-license-proprietary-110000823.html
huge news cancer$$$$$$ The Phase 2 trial is fully enrolled and primary data are expected in the fourth quarter of 2022.
The investigational vaccine is currently being tested in a Phase 2 clinical trial as a treatment for patients with high-risk melanoma in combination with Merck’s Keytrduda, an anti-PD-1 therapy that has been approved to treat several types of cancer. It is Merck’s best-selling drug, with $5.2 billion in revenue in 2021.
mrna multibagger$$$$$
A capsule that tunnels through mucus in the GI tract could be used to orally administer large protein drugs such as insulin.
https://news.mit.edu/2022/protein-drugs-gi-tract-0928
There's a spike in respiratory illness among children — and it's not just COVID
Moderna's pivotal Phase 3 placebo-controlled clinical trial of mRNA-1345 RSV
The study has been designed to provide an efficacy readout in the 2022-2023 winter season.
https://www.npr.org/2022/10/11/1127873967/respiratory-illness-covid-children-hospitalizations-health
Roll-out of Moderna Spikevax bivalent Covid-19 vaccine brought forward to Oct 14
https://www.straitstimes.com/singapore/health/roll-out-of-moderna-spikevax-bivalent-covid-19-vaccine-brought-forward-to-oct-14
For decades, fear and failure in the hunt for an RSV vaccine. Now, success.
https://www.washingtonpost.com/health/2022/10/10/rsv-vaccine/
Respiratory Syncytial Virus Vaccine Program: Respiratory syncytial virus (RSV) causes a substantial disease burden in older adults aged 65 years and older. There are approximately 177,000 RSV-related hospitalizations in adults 65 and older in the U.S. each year and approximately 14,000 RSV-related deaths. Globally, there are more than 1.5 million episodes of acute respiratory tract infection related to RSV each year.
Moderna's pivotal Phase 3 placebo-controlled clinical trial of mRNA-1345, an RSV vaccine, will evaluate its effectiveness in older adults (adults 60 years of age and older); so far, the trial has enrolled more than 24,000 of the anticipated 34,000 participants. The study has been designed to provide an efficacy readout in the 2022-2023 winter season.
Since RSV also causes a significant disease burden in children, mRNA-1345 is being tested in an ongoing Phase 1 trial in pediatric populations.
Monkeypox: A dangerous variant circulating in the DRC could go global
https://www.newscientist.com/article/2341569-monkeypox-a-dangerous-variant-circulating-in-the-drc-could-go-global/
$SIGA
.... no doubt the result of early read outs on flu, cardiac therapies & skin cancer & solid tumors all in the time context of 3 to 12 months. the boom will start soon$$$$$$$$$$
https://www.skynews.com.au/australia-news/coronavirus/moderna-to-release-updated-booster-shot/video/903c0e8b5e383c12570476334c66488d
Q3 ended last week. At least $80m in sales compared to $9m reported Q2. Nov 4'ish should have the Q3 pr$$$$$$$$
The monkeypox virus is mutating. Are scientists worried
If health officials detect an uptick in the number of virus samples carrying these mutations, that could be a possible signal that they are helping the virus to spread.
The good news is that, although the monkeypox virus continues to evolve, no mutations have affected the part of its genome that encodes a protein targeted by tecovirimat, an antiviral drug being tested for use against monkeypox in humans.
https://www.nature.com/articles/d41586-022-03171-z
Scientists design and validate promising HIV vaccine strategy:
https://www.scripps.edu/news-and-events/press-room/2022/20220930-schief-hiv.html
Moderna Inc has refused to hand over to China the core intellectual property behind the development of its COVID-19 vaccine, leading to a collapse in negotiations on its sale there, the Financial Times reported on Saturday, citing people familiar with the matter.
go moderna!
https://finance.yahoo.com/news/moderna-refused-china-request-reveal-235759755.html
Moderna says several product launches coming!
MODERNA CREATES NEW EXECUTIVE COMMITTEE ROLE AHEAD OF NEW PRODUCT LAUNCHES
Moderna announced that it has appointed a new chief technical operations and quality officer -- Jerh Collins, who is to take up the position next Monday, Oct. 3.
Collins replaces Juan Andres, who is remaining at the company in the new role of president of strategic partnerships and enterprise expansion. His mandate will be, in Moderna's words, to "focus on building out the organization to support the growing pipeline." The company said that this is in preparation for several upcoming product launches, although it provided no details about them.
Prior to joining Moderna, Collins had worked for 30 years at pharmaceutical giant Novartis where he filled a variety of managerial roles, including head of global chemical operations.
https://investors.modernatx.com/news/news-details/2022/Moderna-Creates-New-Executive-Committee-Role-Ahead-of-New-Product-Launches/default.aspx
NEWS OUT: SIGA Technologies Announces New Contract Awarded by U.S. Department of Defense for the Procurement of up to $10.7 Million of Oral TPOXX®
https://investor.siga.com/news-releases/news-release-details/siga-technologies-announces-new-contract-awarded-us-department
EUROPEAN MEDICINES AGENCY ACCEPTS MODERNA'S CONDITIONAL MARKETING AUTHORIZATION FILING FOR ITS OMICRON BA.4/BA.5 TARGETING BIVALENT COVID-19 VACCINE
https://investors.modernatx.com/news/news-details/2022/European-Medicines-Agency-Accepts-Modernas-Conditional-Marketing-Authorization-Filing-for-its-Omicron-BA.4BA.5-Targeting-Bivalent-COVID-19-Vaccine/default.aspx
An oral insulin option has long evaded researchers, but ORMD-0801 could be close to changing that. One of the world’s premier diabetes experts, Dr. Anne Peters, a professor of medicine at the Keck School of Medicine of USC and director of the USC Clinical Diabetes Programs, recently joined Oramed’s Scientific Advisory Board. Seeing someone with her credibility in the diabetes community advising Oramed to bring this insulin option to people with diabetes is encouraging.
conclusion is that Oramed Pharmaceuticals is a great speculative biotech play to look into. I think it has a great shot at success in developing its oral insulin drug, ORMD-0801, for Type 2 Diabetes. If one or both of the ongoing late-stage studies with this drug for this indication are successful, then it would drastically change the diabetes treatment market landscape.
38.83
(Mil)
Shares Outstanding
-
2.2%
0.85 (Mil)
Institutional Ownership
-
47.06%
18.15 (Mil)
Insider Ownership
Institutional Trading of Oramed Pharmaceuticals:
https://www.tickerreport.com/banking-finance/9422809/cantor-fitzgerald-equities-analysts-reduce-earnings-estimates-for-oramed-pharmaceuticals-inc-nasdaqormp.html
According to a new research study that analyzed electronic health records of more than 1 million patients ages 18 and younger, children who were infected with COVID-19 show a substantially higher risk of developing type 1 diabetes (T1D).
https://scitechdaily.com/covid-19-linked-with-substantial-increase-in-type-1-diabetes-in-children-as-much-as-72/
$MRNA
SIGA expects to complete delivery of these most recent orders in 2022. To date this year, including the recent orders, SIGA has received approximately $76 million of international orders for oral TPOXX (tecovirimat) from twelve international customers. It is currently expected that at least $65 million of these orders will be delivered in 2022.
news: SIGA Announces Approximately $16 Million of International Procurement Orders Received in August and Early September for Oral TPOXX® (Tecovirimat)
September 26, 2022 at 10:07 AM EDT
https://investor.siga.com/news-releases/news-release-details/siga-announces-approximately-16-million-international
Today, the Commission has secured over 10,000 treatment courses of tecovirimat to treat Monkeypox.
https://ec.europa.eu/commission/presscorner/detail/en/ip_22_5482
"Basically zero safety concerns"
positive mid-stage trial data showed its investigational drug ORMD-0801 reduced liver fat content in Type 2 Diabetes patients with non-alcoholic steatohepatitis (NASH).
The company did not identify the amount by which liver fat content was reduced in these patients over the treatment period.
a disease that impacts more than 30 million people in the United States!
ORA-D-013-1, the larger of the two trials, completed enrollment with top line data expected January 2023, Crazy potential here!
That is where the real potential is, stock could have insane growth if Oral insulin is a success$$$$$$$
Robust Balance Sheet: $169 Million in Cash and Investments
Our financial position is strong with a robust balance sheet, no debt and approximately $169 million in cash . This position gives us sufficient runway to complete our pivotal oral insulin (ORMD-0801) Phase 3 trials and advance us towards potential FDA approval. In addition, we will continue investing in our PODTM oral delivery pipeline, as well as pursuing opportunities to capitalize on strategic prospects.
nice$
Moderna exec: 'eager' to collaborate with China on supplying COVID vaccines
https://financialpost.com/pmn/business-pmn/moderna-exec-eager-to-collaborate-with-china-on-supplying-covid-vaccines
1- Phase 3 immunogenicity and safety study of flu vaccine, mRNA-1010, is fully enrolled; Company to pursue accelerated approval pathway in 2023
2-Phase 3 clinical trial of RSV vaccine, mRNA-1345, has enrolled more than 24,000 of the 34,000-participant target
3-Moderna's CMV vaccine candidate, mRNA-1647, comprises six mRNAs encoding two antigens in one vaccine and is designed to protect against CMV infection. mRNA-1647 is being evaluated in the Phase 3 CMVictory trial to prevent congenital CMV. To date, more than 40% of anticipated participants are enrolled. The study will determine the efficacy, safety, and immunogenicity of mRNA-1647 against CMV infection in women ages 16-40 years. Enrollment is ongoing in the U.S. and internationally.
In addition to congenital infection, CMV has a major impact on morbidity and mortality in transplant patients. CMV is a frequent complication after transplantation since the ability to fight infection after transplant is decreased. Moderna is planning to test mRNA-1647 in a randomized, placebo-controlled, study to evaluate the efficacy, safety, and immunogenicity of mRNA-1647 in patients who have undergone a high-risk stem cell transplant.
Company is on track to report data from its Phase 2 personalized cancer vaccine (PCV) study in 4Q 2022
As Moderna's pipeline advances, preparations are underway for multiple vaccine launches globally between 2023-2026
the kids work hard$$$$$$$$
Big buy!!!!!!!
personalized treatments for cancer: https://www.wsj.com/articles/modernas-ceo-on-its-new-covid-19-booster-prospects-for-cancer-vaccines-11663339811?siteid=yhoof2
ANNOUNCEMENT: The first participants were dosed yesterday in our second Phase 3 trial of our seasonal influenza vaccine candidate, mRNA-1010. This trial is designed to test efficacy compared to a currently licensed seasonal influenza vaccine!!!!!!!!!
Moderna CEO on Covid-19 Boosters, Personalized Cancer Vaccines:
https://www.wsj.com/video/events/moderna-ceo-on-covid-19-boosters-personalized-cancer-vaccines/396CE717-4CA0-4A1F-A18B-A3DB8B970071.html
SIGA Technologies has now secured the rights to sell TPOXX to commercial customers and is working to make this life-saving medication more widely available
https://stock.vi.app/market-price/siga-technologies-to-sell-tpoxx-to-commercial-customers/
winners$$$$$$$$$$$
Vanderbilt researchers are developing an artificial intelligence algorithm that can precisely track and count monkeypox lesions. They are also spearheading the effort to develop lesion classification guidelines, which will be used when evaluating the potential use of tecovirimat, an antiviral that is FDA-approved against smallpox, as a therapy for monkeypox.
https://news.vanderbilt.edu/2022/09/15/vanderbilt-nih-and-the-institut-national-de-recherche-biomedicale-team-up-to-tackle-monkeypox%e2%80%af/
Go to 38:06......listen to his answer about eligibility and indication for TPOXX and you tell me- do you hear anything that indicates they were worried about drug resistance? NO
https://www.ama-assn.org/about/events/what-physicians-need-know-about-tecovirimat-tpoxx-treatment-monkeypox
Interview is a Stark contrast to the CDC website guidance they posted today.
WHY would they literally massively promote this drug at a webinar one day and then, literally OUT of nowhere, the next day, LIE and say a mutation may be one amino acid away from rendering this drug totally useless