Novartis AG (NVS)

Novartis Secures Positive EU Backing for SMA Gene Therapy ItvismaApril 24, 2026 7:17 AM
IH Market News
Novartis (NYSE:NVS) said the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a favourable opinion recommending approval of Itvisma, an intrathecal gene therapy for spinal muscular atrophy (SMA).The recommendation covers use in children aged two and above, as well as adolescents and adults with 5q SMA carrying a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. The treatment is designed as a one-time fixed-dose therapy aimed at replacing the defective SMN1 gene.



Clinical Data Supports Efficacy



The positive opinion is based on findings from the pivotal STEER trial, alongside supporting data from the Phase IIIb STRENGTH and Phase I/II STRONG studies.In the STEER study, Itvisma delivered a statistically significant improvement of 2.39 points on the Hammersmith Functional Motor Scale, compared with a 0.51-point gain in the control group, achieving a p-value of 0.0074. These benefits were maintained over a 52-week follow-up period.“Itvisma met the primary endpoint showing motor function improvement versus placebo,” said Tim Hagenacker of the University Hospital Essen. “Even a 1-point difference in the HFSME can translate into tangible functional gains for individuals with SMA, such as the ability to grasp a pen.”



Study Details and Next Steps



The STEER trial included 75 patients treated with Itvisma and 51 patients receiving a sham procedure. Results from both STEER and STRENGTH have been published in Nature Medicine.A final decision from the European Commission is expected within around two months following the committee’s recommendation.



Existing SMA Portfolio



Novartis already markets Zolgensma, a gene therapy approved for infants and young children with SMA, positioning Itvisma as a potential expansion of its treatment offering across a broader patient population.Novartis stock price

Original: Novartis Secures Positive EU Backing for SMA Gene Therapy Itvisma

Novartis to broaden global health initiatives targeting underserved populationsApril 9, 2026 7:12 AM
IH Market News
Novartis AG (NYSE:NVS) said it plans to significantly expand its community health initiatives focused on heart disease and cancer, increasing their reach from 11 countries to more than 30 by 2030. The pharmaceutical company stated that the move is aimed at addressing the slowing progress in combating chronic illnesses across many parts of the world.The expansion will involve three key programs. The first, Inclusive Health Accelerators, will begin this week in five U.S. cities—New York, Los Angeles, Detroit, Houston, and Baltimore—and will focus on improving breast and prostate cancer care through awareness campaigns, expanded screening access, and patient referral services. Another effort, Community Health Initiatives, currently operating in Vietnam, Rwanda, and Bolivia, is set to broaden its presence to at least 10 low- and middle-income countries with the goal of improving the diagnosis and treatment of heart disease and cancer.The third initiative, CARDIO4Cities, developed by the Novartis Foundation, uses real-time health data to help urban areas strengthen cardiovascular care. The program is already active in eight countries—Brazil, the United States, Belgium, Portugal, Finland, Brunei, Singapore, and Australia—and aims to expand to 23 countries by 2030.“We are going further to bring heart disease and cancer care to communities falling through the gaps in health systems,” said Michelle Weese, Chief Corporate Affairs Officer at Novartis. “With progress slowing against chronic disease in many countries, and millions missing out on potential treatment, there is an urgent need for new, sustainable solutions to improve access to care.”Each initiative relies on collaboration with local organizations, health authorities, and private sector partners to improve access to preventive services and early diagnosis. Novartis highlighted a partnership in rural Vietnam that helped double rates of blood pressure control. The CARDIO4Cities program has also shown significant results, delivering three- to six-fold improvements in hypertension control and reducing stroke and heart attack rates within one to two years of implementation.

Original: Novartis to broaden global health initiatives targeting underserved populations

Novartis agrees to acquire U.S. biotech company Excellergy in deal worth up to $2 billionMarch 27, 2026 7:01 AM
IH Market News
Swiss pharmaceutical group Novartis (NYSE:NVS) announced on Friday that it has reached an agreement to acquire California-based biotechnology company Excellergy in a transaction valued at up to $2 billion.Under the terms of the deal, Novartis will make payments totaling as much as $2 billion, including upfront consideration and additional milestone-based payments. The acquisition is expected to be finalized in the second half of 2026, pending customary closing requirements such as regulatory approvals.The company said the transaction is intended to expand its footprint in the immunology space, particularly in therapies targeting food allergies.The announcement follows another recent acquisition move by Novartis. Last week, the company revealed it would acquire a breast cancer drug candidate from U.S. biotech firm Synnovation Therapeutics in a deal valued at up to $3 billion.Novartis stock price

Original: Novartis agrees to acquire U.S. biotech company Excellergy in deal worth up to $2 billion

NVS Just felt like running since 2009. I am still loving this ride like so many others.

🌿 Multiple Sclerosis: Plant Relief vs. Engineered Immunotherapy
Medical cannabis: Oils, sprays, and edibles are used to ease muscle spasms and nerve pain, marketed as natural symptom management.

Biotech/Pharma: Pharma giants invest in immunotherapies and biologics — highly engineered drugs that target immune cells at the molecular level.

The clash: Cannabis offers accessible, plant-based comfort, while biotech emphasizes cutting-edge science and expensive treatments. $NVS $MSOS $MJ $TOKE

Myocarditis is inflammation of the heart.

Before Covid, Dr. McCullough saw two patients with this problem. Now there are over 1000 peer reviewed studies on Covid vaccine myocarditis. pic.twitter.com/jF2NTSgelG— Anna Matson (@AnnaRMatson) May 22, 2025 $NVS

Animal vaccine recalled voluntarily by manufacturer after 8 adverse events and 1 death in pet dogs.

If only they took this level of precaution with humans. pic.twitter.com/CgwdBG7tsv— Rebekah Barnett (@dystopian_DU) November 23, 2023 $NVS

NVS 10Q due Tuesday 4/29

NVS new 52=high

NVS new 52=week high

NVS new 52 week high

https://www.sciencetimes.com/articles/50071/20240508/anavex-life-sciences-alzheimers-treatment-brings-hope-to-millions.htm

Radiopharma stocks higher as sector welcomes the latest M&A deal https://seekingalpha.com/news/4099035-novartis-mariana-oncology-deal-drives-radiopharma ..Shares of radiopharma companies spiked as investors welcomed the latest M&A deal to hit the sector. $NVS $CATX $CLRB $CASI $LNTH and ATNM. for more info click here https://shorturl.at/hoU47

NVS 10Q due 4/23

NVS new 52 week high

NVS new 52 week high

NVS new 52 week high

have you seen yesterday that enzolytics pharm announced that they now have a CURE for hiv/aids called clone3.?

its a home run ---or is it just the runs

https://apis.mail.yahoo.com/ws/v3/mailboxes/@.id==VjN-cV7LhC8rx0EcG5-z9RhWgRsQvGZwTs2qwUxoYR9UStj84lOVi7ZIeMO8HFiplsA65ZbE_cF9gB9A2TSm5APqCg/messages/@.id==AA43g3BH-2gCZMlFEQgiCNhLPmU/content/parts/@.id==2/thumbnail?appid=YMailNorrin&downloadWhenThumbnailFails=true&pid=2

https://www.prnewswire.com/news-releases/dtx-pharma-announces-acquisition-by-novartis-301877974.html. I have cmt. Getting closer to 1st fda approved treatment, hopeful!!!

Former Head of Novartis Respiratory and Allergy Medicine to Advise Clinical Stage Stem Cell Company on COVID-19 and COPD Programs
https://www.otcmarkets.com/stock/TSOI/news/story?e&id=2224788

https://www.novartis.com/news/media-releases/new-novartis-data-demonstrate-only-kisqali-offers-more-life-first-line-setting-postmenopausal-hrher2-advanced-breast-cancer-patients

https://www.novartis.com/news/media-releases/novartis-kymriah-receives-ec-approval-first-car-t-cell-therapy-adults-relapsed-or-refractory-follicular-lymphoma

Novartis also has a collaboration agreement with TScan Therapeutics for development of TCR-T cancer technology, one of the latest and promising therapeutics that could accompany CAR-T.

https://ir.tscan.com/news-releases/news-release-details/tscan-announces-collaboration-novartis-discovery-and-development

TScan entering clinical Phase 1 in 1H 2022.

FDA approves NVS’ Pluvicto*, a radioligand for CRPC:

https://www.globenewswire.com/news-release/2022/03/23/2408996/0/en/Novartis-PluvictoTM-approved-by-FDA-as-first-targeted-radioligand-therapy-for-treatment-of-progressive-PSMA-positive-metastatic-castration-resistant-prostate-cancer.html

NVS obtained this agent from the ECYT buyout in 2018 (#msg-144295734).

*f/k/a 177Lu-PSMA-617.

FDA approves NVS’ Leqvio—(inclisiran)—for lowering LDL-C:

https://www.prnewswire.com/news-releases/fda-approves-novartis-leqvio-inclisiran-first-in-class-sirna-to-lower-cholesterol-and-keep-it-low-with-two-doses-a-year-301450125.html

NVS initially received a CRL from the FDA in late 2020 due to the FDA’s inability to conduct an inspection of the Leqvio’s manufacturing site in Italy (#msg-160327185).

Leqvio is a siRNA dosed semiannually (except for the 3-month interval between the first two doses). NVS picked up this drug when it acquired MDCO in Nov 2019 (#msg-152458295).

ALNY, which will get a 10-20% royalty on global sales, discovered Inclisiran and out-licensed it to MDCO in 2013 (#msg-84151150); with the benefit of hindsight we can say that MDCO clearly got the better of ALNY in this deal.

Leqvio was approved in the EI in late 2020 (https://www.novartis.com/news/media-releases/novartis-receives-eu-approval-leqvio-inclisiran-first-class-sirna-lower-cholesterol-two-doses-year ).

NVS plans $15B share buybacks through 2023—exhausting ~70% of the proceeds from the recent sale of Roche shares:

https://finance.yahoo.com/news/novartis-initiates-usd-15-billion-060000184.html

This might be one reason XBI was down today.

Novartis should invest in mRNA medicine and pair up with companies like Regen Biopharma to speed up this process. Perhaps an outright purchase of this start up company. This will ensure competing with likes of Pfizer and Moderna.

FDA_advisory_panel_endorses Entresto for_heart_failure_in_12-1_vote:

https://www.prnewswire.com/news-releases/novartis-announces-positive-fda-advisory-committee-recommendation-for-use-of-entresto-to-treat-patients-with-hfpef-301193607.html

good news today - Novartis Says Asciminib Showed Superior MMR Rate to Bosulif in Leukemia Trial
December 08 2020 - 11:00AM
Dow Jones News

By Michael Dabaie


Novartis AG said asciminib showed superior major molecular response rate to Bosulif in a chronic myeloid leukemia trial.

The company said results from a Phase III study demonstrate that at 24 weeks, asciminib nearly doubled the major molecular response rate compared with Bosulif in patients resistant to, or intolerant of, at least two prior tyrosine kinase inhibitor therapies.

The data were presented at a late-breaking abstracts session during the 62nd American Society of Hematology Annual Meeting & Exposition, Novartis said.

In the trial, 233 patients were randomized to receive asciminib 40 mg twice daily or Bosulif 500 mg once a day.

Novartis said the U.S. Food and Drug Administration granted Fast Track designation for asciminib. The company said it plans submission to U.S. and EU health authorities in the first half of 2021.

good news today

CHMP approves NVS’ Leqvio (inclisiran) for hypercholesterolemia or mixed dyslipidemia:

https://www.globenewswire.com/news-release/2020/10/16/2109800/0/en/Novartis-receives-positive-CHMP-opinion-for-Leqvio-inclisiran-a-potential-first-in-class-siRNA-for-the-treatment-of-high-cholesterol.html

Rubber-stamping by the European Commission will follow in 2-3 months.

NVS/GMAB—FDA approves Kesimpta—(subcutaneous ofatumumab)—for MS:

https://finance.yahoo.com/news/u-fda-approves-kesimpta-ofatumumab-173300452.html
https://t.co/9AOLIf7Qln?amp=1

NVS acquired the commercial rights to ofatumumab from GSK, and NVS will pay GSK a tiered royalty up to 12% on worldwide sales of Kesimpta (#msg-116391951).

Ofatumumab, administered via IV, was FDA-approved for CLL under the brand name, Arzerra in 2009 (#msg-42935958).

Ofatumumab PFUFA delayed 3mo—>Sep 2020 for MS indication:

https://www.globenewswire.com/news-release/2020/06/02/2042559/0/en/Novartis-provides-update-on-FDA-review-of-ofatumumab-a-self-administered-targeted-B-cell-therapy-for-patients-with-relapsing-multiple-sclerosis.html

The PR does not cite a reason for the delay.

NVS acquired Ofatumumab’s commercial rights in MS from GSK in a 2015 transaction involving a $500M up-front payment by NVS (#msg-116391951).

What am I missing here? Why is no one talking about Novartis for their hydroxychloroquine?

NVS concedes Beovu has new safety issue:

https://www.brolucizumab.info/ Novartis has now completed its review of these post-marketing safety case reports… Based on internal and SRC assessment, it was concluded that there is a confirmed safety signal of rare adverse events of “retinal vasculitis and/or retinal vascular occlusion with or without presence of intraocular inflammation that may result in severe vision loss.”

Based on this review, Novartis has initiated a safety information update to Beovu prescribing information worldwide. Currently approved prescribing information includes intraocular inflammations, visual acuity decrease (including blindness) and retinal artery occlusion as separate terms. We will work with regulatory authorities to finalize the prescribing information update.

In addition, we are working with our data monitoring committees and informing investigators of ongoing clinical trials. Novartis-sponsored studies will be amended so that protocols, Informed Consent Forms and Investigator Brochures reflect this new safety information. Investigators are also being informed to re-consent patients.

Ok thank you

It won't have any effect at all on the share price. It's a goodwill gesture and it's the right thing to do morally.

How much will this affect the stock price 160 mil pills at 4$ is a lot of money

Yes—that was announced on Friday: #msg-154462215.

Is it true NVS to supply 160 mil chloroquine pills to America to help fight corona virus

More on the same story (Beovu safety):

https://endpts.com/novartis-plans-to-wrestle-eylea-market-share-take-a-hit-as-beovu-is-linked-to-safety-concerns/

Acceptance of a BLA/NDA application for review doesn’t generally move the needle for a company as large as NVS unless the FDA grants a priority review when investors expected a standard review, which wasn’t the case here.

And so this got ignored.

https://ih.advfn.com/stock-market/NYSE/novartis-NVS/stock-news/81828953/novartis-fda-ema-accept-filings-for-ofatumumab-i?xref=ff_sidebar_quote

The cause is a safety update re Beovu (the recently approved drug for AMD):

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=153989588

https://www.statnews.com/2020/02/24/safety-concerns-regarding-novartiss-new-eye-drug-boost-regeneron-stock/

5.5% drop on a biotech drug firm like NVS 8 days before the dividend date looks way over done to me with Biotechs in favor and nothing but Good news today and recently on NVS.

Panic selling seems way over done. But then again panics are like that.

You see any bad news at all on NVS I missed?

NVS 12/5/19 R&D Day slides:

https://www.novartis.com/sites/www.novartis.com/files/2019-12-05-novartis-r-d-day-investor-presentation.pdf

NVS PR in conjunction with R&D Day investor webcast:

https://www.globenewswire.com/news-release/2019/12/05/1956569/0/en/Novartis-expects-to-sustain-long-term-growth-with-a-robust-pipeline-of-25-potential-blockbusters-highlighted-at-R-D-Day.html

These shares are a BUY - Up and Away is how we would describe this company
READ REPORT HERE https://pennystocks.news/biotech-mega-merger-novartis-buys-medicines-co-9-7-billion-deal/

NVS acquires MDCO for $85/sh cash—a 64% premium to MDCO’s closing price on 11/15/19, the day before serious buyout rumors began circulating:

https://www.globenewswire.com/news-release/2019/11/24/1951667/0/en/Novartis-to-acquire-The-Medicines-Company-for-USD-9-7-bn-adding-inclisiran-a-potentially-transformational-investigational-cholesterol-lowering-therapy-to-address-leading-global-cau.html

https://www.novartis.com/sites/www.novartis.com/files/novartis-mdco-acquisition.pdf (CC slides)

The nominal deal value is $9.7B (on a fully-diluted basis). There is no CVR.