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Novartis AG (NVSEF)
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Misleading Title Reuters!
"Novartis suspends two cancer therapies over quality concerns"
If you read the article, you learn that NVS temporarily suspended manufacturing at a plant in Italy but were continuing to supply the therapy out of a plant in Spain.
Getting Pluvicto approved is so happy to see! I worked for Endocyte where that drug was initially developed before Novartis bought out the company. And that imaging agent Locametz was my baby that I spent most of my time on there. I'm glad to see something come from all that research.
Do not buy at 1 month peak!!! Pump is here!!!
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NVS is down 5.05% to 79.32
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 firstname.lastname@example.org.
For more information regarding Zolgensma, check back at mda.org.
Click here to read the press release from AveXis.
Home - ClinicalTrials.gov
Calling all Novartis insiders/employees .... any truth to the statement... "Gerons banking info has been added to the NOVARTIS financial system?" thanks for your input.
RGNX and NVS reporting on Bloomberg very positive news on Zolgensma Novartis logo: a global healthcare company
AveXis presented robust data at AAN demonstrating efficacy of Zolgensma® in broad spectrum of spinal muscular atrophy (SMA) patients
May 05, 2019
Interim data reported for the first time from STRONG in SMA Type 2 showed rapid motor function gains and milestone achievements with intrathecal Zolgensma (onasemnogene abeparvovec-xioi; AVXS-101)
New interim data from STR1VE in SMA Type 1 continued to show prolonged event-free survival, increases in motor function and significant milestone achievement consistent with Phase 1 START trial
Interim data reported for the first time from SPR1NT in pre-symptomatic SMA showed age-appropriate motor milestone achievement
Basel, May 5, 2019 - AveXis, a Novartis company, today announced interim data from ongoing trials of the investigational product Zolgensma® (onasemnogene abeparvovec-xioi; AVXS-101)1 that showed positive results across a broad spectrum of patients with spinal muscular atrophy (SMA). These included the first presentation of data from the Phase 1 STRONG trial, which showed motor function gains and milestone achievements in patients with SMA Type 2 via intrathecal (IT) delivery; new data from the Phase 3 STR1VE trial, which continued to show prolonged event-free survival, increases in motor function and significant milestone achievement consistent with the Phase 1 START trial; and the first presentation of data from the Phase 3 SPR1NT trial, which showed motor milestone achievement consistent with normal development in SMA patients treated pre-symptomatically. These data were presented during the 2019 American Academy of Neurology (AAN) Annual Meeting.
"With just a single, one-time dose, we are seeing Zolgensma provide prolonged survival, rapid motor function improvement and milestone achievements that patients never experience if their disease is left untreated," said David Lennon, President of AveXis. "These robust data presented at AAN represent a growing body of evidence that support the use of Zolgensma as a potential foundational therapy for the treatment of SMA across a variety of populations."
Phase 1 STRONG Data as of March 8, 2019
STRONG is a Phase 1, open-label, dose-comparison, multi-center trial designed to evaluate the safety and tolerability of one-time IT administration of Zolgensma in patients with SMA Type 2 who have three copies of the SMN2 gene, and who are able to sit but cannot stand or walk at the time of study entry. Patients were stratified into two groups based on age at time of dosing: patients who are >=6 months but <24 months, and patients who are >=24 months but <60 months. The primary efficacy outcome for patients who were >=6 to <24 months is the ability to stand without support >=3 seconds; the primary efficacy outcome for patients who were >=24 to >60 months is change in Hammersmith Functional Motor Scale-Expanded (HFMSE) score from baseline. Three dosing strengths are being evaluated. Only 3/34 (8.8 percent) patients were excluded due to elevated AAV9 antibodies.
Patients in the STRONG study showed improvement in motor function, with 19 patients (12/12 dosed at >=24 to <60 months and 7 who were dosed at >=6 to <24 months who then became old enough to be evaluated on the HSMSE) having a mean 4.2-point increase from baseline in HFMSE as of their most recent study visit (5-12 months post-treatment). Half of the patients (6/12) who were >=24 months at dosing experienced a >=3-point improvement from baseline in HFMSE by one-month post dosing.
Since dosing, 22 motor milestones in 10 patients have been achieved according to the Bayley-III Gross Motor Milestone Scale across the Dose A and Dose B treatment groups, including two patients who gained the ability to stand independently, one of whom went on to walk alone in the younger group, and one additional patient who gained the ability to walk with assistance in the older group. The median duration of follow-up was 6.5 months. Efficacy data from Dose C are not presented because enrollment is not complete.
All patients (n=30) were alive. There were two serious treatment-related adverse events. Both were of transaminase elevation. The frequency of patients with adverse events of transaminase elevation appeared to be lower than that seen with intravenous (IV) administration of Zolgensma.
"With an average of just over six months of data available for these Type 2 patients following treatment with Zolgensma, we are pleased to see they are achieving motor milestones, including the ability to stand and walk," said Olga Santiago, M.D., Chief Medical Officer of AveXis. "Based on these early promising data, we plan to approach regulators to define the path to registration for intrathecal administration of Zolgensma."
Phase 3 STR1VE Data as of March 8, 2019
STR1VE is an ongoing, open-label, single-arm, single-dose, multi-c
This is why the selloff today: NEW YORK, Aug 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that some data from early testing of Novartis’ more than $2 million gene therapy Zolgensma was manipulated, but the agency believes the treatment should remain on the market.
The FDA said it is carefully assessing the situation. It said the manipulation involves the accuracy of certain data from product testing performed in animals, which was used by the manufacturer to support the development of its production process.
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.
I'm not knoweledgable with novartis.. but who could tell me why ark buys novartis every single day???
Novartis rumored to be in talks to acquire Zolgensma partner RGNX for $160 a share. RGNX at $50
For what its worth, March 4th, 2021 we go ex dividend $3.37 per share. Novartis (NVS) pays annually vs. quarterly.
Not so sure why this has been sliding, daily.
Beats earnings...drops 2 dollars. Makes sense
NVS is donating 30 million doses. How is that going to translate into revenue? It can claim a charitable contribution, I suppose, but that's the extent of it.
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 .
Since 2014 the SP has been hovering around $82.00! Almost a decade and no change in SP...give or take a few $'s! Should I sell the next time it rallies? Any catalysts?
Terrific safety profile . Zolgensma has been used 150 times x w/o incident. Event this month found to be due to bad RSV pneumonia and neurological complications. NOT the drug.
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