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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.
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 $500M up-front payment by NVS (#msg-116391951).
What am I missing here? Why is no one talking about Novartis for their hydroxychloroquine?
It won't have any effect at all on the share price. It's a goodwill gesture and it's the right thing to do morally.
How much will this affect the stock price 160 mil pills at 4$ 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
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.
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 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.
News: $NVS ROSEN, A LEADING GLOBAL LAW FIRM, Continues to Investigate Securities Claims Against Novartis AG - NVS
NEW YORK, Nov. 09, 2019 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Novartis AG (NYSE: NVS) resulting from allegations that Novartis may have issued materially misleading business in...
Read the whole news NVS - ROSEN, A LEADING GLOBAL LAW FIRM, Continues to Investigate Securities Claims Against Novartis AG - NVS
FDA approves NVS’ Beovu—(a/k/a brolucizumab/RTH258) for wet AMD—3mo dosing interval after the loading phase:
https://www.globenewswire.com/news-release/2019/10/08/1926199/0/en/Novartis-receives-FDA-approval-for-Beovu-offering-wet-AMD-patients-vision-gains-and-greater-fluid-reductions-vs-aflibercept.html
US list price will be $1,850 per vial—inline with main competitor Eylea—according to Vantage (https://www.globenewswire.com/news-release/2019/10/08/1926199/0/en/Novartis-receives-FDA-approval-for-Beovu-offering-wet-AMD-patients-vision-gains-and-greater-fluid-reductions-vs-aflibercept.html ).
Any clue what too the air out this one this afternoon?
I see no news yet to justify the swan dive mid day today.
I would love to hear more about that whole story?
News: $NVS AveXis receives FDA approval for Zolgensma®, the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA)
BASEL, Switzerland , May 24, 2019 /PRNewswire/ -- AveXis, a Novartis company, today announced the US Food and Drug Administration (FDA) has approved Zolgensma ® (onasemnogene abeparvovac-xioi) for the treatment of pediatric patients less than 2 years of age with spinal muscul...
Got this from https://marketwirenews.com/news-releases/avexis-receives-fda-approval-for-zolgensma-xae-the-first-and-only-gene-therapy-for-pediatric-patients-with-spinal-muscular-atrophy-sma--8242944.html
NVS’ QVM149* scores in phase-2 asthma trial, showing statig-better FEV1 than Advair:
https://www.globenewswire.com/news-release/2019/05/22/1840512/0/en/Novartis-phase-II-data-for-new-inhaled-combination-treatment-QVM149-demonstrates-significant-improvements-over-current-standard-of-care-inhaled-treatment.html
QVM149 is a triple-action LABA/LAMA/ICS drug administered with NVS’ proprietary Breezhaler device. The ICS component of QVM149 is licensed from MRK.
NVS acquires Xiidra from Takeda for $3.4B up-front and $1.9B in contingent milestones:
https://finance.yahoo.com/news/novartis-buys-takedas-dry-eye-223853867.html
Takeda got Xiidra, which they probably never wanted, via the 2018 acquisition of SHPG (#msg-140610505).
AMGN and NVS are at war over Aimovig, so they issue separate, essentially identical PRs re Aimovig data presented at AAN:
https://www.prnewswire.com/news-releases/amgen-to-highlight-extensive-long-term-safety-and-efficacy-data-of-aimovig-erenumab-aooe-across-the-spectrum-of-migraine-at-aan-annual-meeting-300843004.html
https://www.globenewswire.com/news-release/2019/05/02/1815773/0/en/Novartis-to-highlight-extensive-long-term-safety-and-efficacy-data-of-Aimovig-across-the-spectrum-of-migraine-at-AAN.html
Silly.
NVS shares declined on 4/9/19 by the implied value of the ALC spin-off (0.2 shares of ALC for each share of NVS) because that was the day the ALC spin-off went ex-dividend.
I don't understand what you're referring to by the "150% orbit."
I'm not sure how well Mayzent (the new MS drug) will sell.
Higher PE sounds sweet
But if Alcon was an earnings dog, why did the stock price go into orbit 150% and NVS got hammered by about an extra $15 after it gave up Alcon??
The lower price and no reduction in the dividend, and stock buy back and CEO forward guidance all look like a buy down this low.
Is the MS Drug news a good thing or way down the pike?
I am catching up all the news right now, still reading....
I would think that the NVS balance sheet might have shed some Alcon long term liabilities and debt?
The ALC spin-off did not benefit NVS itself except in the sense that it removed a business segment growing more slowly than the rest of NVS.
NVS hopes that this will result in a higher P/E ratio.
p.s. Thanks for your kind words.
DD, do you know what if anything NVS got out of the Alcon IPO spin off?
Reduced debt?
Did NVS sell any Alcon shares and thus raise cash?
I know NVS shareholders got Alcon shares, and they exploded in price in 24 hours.
I presume NVS gave revenue and some profit in the Alcon spin off, so why did they do they spin off since shareholders of NVS got the shares???
Thought maybe you had run across the answer in your awesome DD
Seem to be a lot of moving parts in this company already this year.
Still long here.
NVS completes separation of Alcon, which is now trading as ALC on the NYSE.
NVS was -12% today because it was the ex-dividend date for the Alcon spin-off.
https://www.novartis.com/news/media-releases/novartis-plans-alcon-spin-april-9-2019
NVS sues AMGN re Aimovig collaboration termination:
https://www.reuters.com/article/us-amgen-novartis-lawsuit/novartis-sues-amgen-over-migraine-treatment-aimovig-idUSKCN1RG21I
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