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Novartis AG (NVS)
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The only company conducting a late stage clinical trial for the treatment of Refractory Ascites due to Liver Cirrhosis $NVS $NVO $ABBV $ICPT $TBIO
Arkk picked up more shares tonight.
Hi. Does anyone have an idea for why ARK Invest is investing in Novartis? I'm assuming it's for the gene therapy division, but I'm not certain.
Why did they keep the Tilray name? Because of Novartis $NVS partnership that Tilray has. Big European pharma with 700 milion population 😉😉
VBI Vaccines Announces European Medicines Agency Acceptance of Marketing
Authorization Application (MAA) for 3-Antigen Prophylactic Hepatitis B Vaccine
CAMBRIDGE, Mass. (December 23, 2020) – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults. The acceptance of the MAA filing begins the EMA’s review process.
“The EMA acceptance of our MAA marks an important milestone for VBI in our effort to enable broad access to our 3-antigen prophylactic hepatitis B vaccine, which we believe has the potential to be an important intervention in the fight to eliminate hepatitis B infections,” said Jeff Baxter, President & CEO. “We are committed to working collaboratively with the EMA during the regulatory process and we look forward to communicating developments related to the MAA throughout 2021.”
The MAA is supported by data from the two pivotal, randomized, double-blind, controlled Phase 3 studies – PROTECT and CONSTANT – as well as other relevant data.
About Hepatitis B
Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma.
About VBI’s 3-Antigen Hepatitis B Vaccine
This vaccine is the only 3-antigen hepatitis B vaccine, comprised of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus, and is approved for use and commercially-available in Israel. In December 2017, VBI initiated patient dosing in a global Phase 3 clinical program that consisted of two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study, which were announced in June 2019 and January 2020, respectively, comprise the basis for the regulatory submissions in the U.S., Europe, and Canada. This vaccine is sold under the name Sci-B-Vac® in Israel.
To learn more about VBI’s 3-Antigen Hepatitis B vaccine visit:
About VBI Vaccines Inc.
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with: (1) the only 3-antigen hepatitis B vaccine, which is approved for use and commercially available in Israel under the name Sci-B-Vac® and recently completed its Phase 3 program in the U.S., Europe, and Canada; and (2) an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s enveloped virus-like particle (eVLP) platform technology enables development of eVLPs that closely mimic the target virus to elicit a potent immune response. VBI’s lead eVLP programs include a vaccine immunotherapeutic candidate targeting glioblastoma (GBM), a prophylactic cytomegalovirus (CMV) vaccine candidate, and a prophylactic coronavirus vaccine program. VBI is headquartered in Cambridge, MA, with research operations in Ottawa, Canada, and research and manufacturing facilities in Rehovot, Israel.
Sci-B-Vac® – VBI Vaccines Inc.
I believe they will buy MeSo, they had terrific results for people dealing with heart faliure . Death rate reduced 60 percent. The end point was a joke. Wait till the results from Covid and back pain come out later thi month .
$NVS need our QS-21
Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19
Phase III study did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care)1
I'm not knoweledgable with novartis.. but who could tell me why ark buys novartis every single day???
Outstanding company, but a deeply unloved stock...
One of the best biopharmaceutical companies in the world. This is a great bargain here at forward P/E lower than 20.
Novartis buy out novn!!!!!!!!!!!!!!!!!!! Novartis eyes on tnxp covid19!!!!!!!!!!!!!!!!!!!!!!!!
They just partnered with MESO for worldwide distribution of Remestemcel-L for ARDS and AGVHD two other Cohorts pending.
filing: $AGEN will lease a building containing approximately *** 83,620 square feet *** in Emeryville California for cGMP #manufacturing space for its
commercial antibody manufacturing requirements ... Agenus will immediately take possession of the Building
$GILD $GSK $INCY $NVS
Stock buyback program. Feeling good!
nvs also buy out novn and tnxp set of covid19. glal!!!!!!!!!!!!!!!!!!!
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Novartis is up 4.92% to 85.04
Looks like Novartis will owe 9 figures in royalties to RGNX for a very long time with approval of Zolgensma.At 1.7 billion market cap of RGNX with its 450 million in cash and 0 debt, it would be much cheaper to buy RGNX as it also owns a 100 AAV gene library which has a private market value of $6 billion USD
Biggest winner is the babies. Then biggest winner is RGNX = Regenex bio which gets 9-13 % royalties on Zolgensma which makes it 9 figures on royalties or $6-7 eps in 24 months. AT RGNX $48 it has $450 million in cach and 0 debt and sells at book value. It owns the $6 billion private market value 100 AAV gene platform which is used by every gene therapy drug to make it work as a gene vector. RGNX worth over $155+ a share and is involved in ALS= Lou Gehrigs disease and Rett syndrome and SMA type 1 and Sma type 2 with Novartis.
The stock will climb into the 90's next week. I will add on to my position on Tuesday. Very impressive week for NVS. Deep pipeline makes NVS a stock with a lot price appreciation for years to come.
FDA Accepts AveXis’ BLA for SMA Drug Zolgensma Under Priority Review
MDA STAFF 12/03/2018
Today, Novartis, the parent company of AveXis Inc., announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) under Priority Review for Zolgensma (formerly known as AVXS-101), a gene therapy for the treatment of spinal muscular atrophy (SMA) type 1. Priority Review status requires the FDA to review the application and make a decision on whether to approve Zolgensma within six months (the typical review period is 10 months). An anticipated decision is expected in May 2019.
Zolgensma is a gene therapy that targets the root cause of SMA by delivering a gene to replace the missing or mutated survival of the motor neuron 1 (SMN1) gene. The therapy is a one-time infusion. SMA is a genetic disease affecting the part of the nervous system that controls voluntary muscle movement. Infants with SMA type 1 typically do not survive more than two years.
Treatment with the therapy in a Phase 1 clinical trial was associated with an increased survival rate compared to the normal course of the disease and the achievement and maintenance of motor milestones that infants with SMA type 1 normally would not be expected to achieve. In the START trial, all 15 patients infused with Zolgensma — three with low dose, 12 with high dose — were alive and event-free at 24 months, compared to 8 percent in a natural history study. An “event” was defined as either death, or at least 16 hours per day of required ventilation support for breathing for 14 consecutive days in the absence of acute reversible illness or surgery. At 24 months, 11 of the 12 high-dose patients could keep their head erect for more than three seconds and sit without support for more than five seconds, 10 patients were able to sit without support for more than 10 seconds, 9 patients were able to sit without support for more than 30 seconds and two patients were able to stand and walk alone without assistance.
The trial also showed meaningful respiratory results. Of the 10 patients who were not using non-invasive ventilation (NIV) at the start of the trial, seven of them remained NIV-free after 24 months. More importantly, all patients, whether ventilated or not, survived respiratory hospitalizations without tracheostomy or permanent ventilation.
The most commonly observed side effect of Zolgensma was elevated liver enzymes.
This announcement underscores the importance of newborn screening to diagnose SMA before babies are symptomatic so they can be treated as early as possible. With the news earlier in the year of SMA being added to the national Recommended Uniform Screening Panel (RUSP), this latest announcement makes it even more important for states to add SMA to their respective newborn screening panels to find babies who may benefit from approved therapies or be eligible to participate in clinical trials.
Zolgensma is currently in Phase 3 clinical trials for SMA type 1 and is also being tested in a Phase 1 trial for SMA type 2. Additionally, Zolgensma is being tested in a Phase 3 trial for pre-symptomatic newborns diagnosed with SMA types 1, 2 and 3.
For information regarding eligibility criteria for currently enrolling or planned clinical trials, view the listings on
, or contact email@example.com.
For more information regarding Zolgensma, check back at mda.org.
Click here to read the press release from AveXis.
Home - ClinicalTrials.gov
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