its a home run ---or is it just the runs
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!!!
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.
TScan entering clinical Phase 1 in 1H 2022.
FDA approves NVS’ Pluvicto*, a radioligand for CRPC:
NVS obtained this agent from the ECYT buyout in 2018 (#msg-144295734).
FDA approves NVS’ Leqvio—(inclisiran)—for lowering LDL-C:
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:
This might be one reason XBI was down today.
FDA_advisory_panel_endorses Entresto for_heart_failure_in_12-1_vote:
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:
Rubber-stamping by the European Commission will follow in 2-3 months.
NVS/GMAB—FDA approves Kesimpta—(subcutaneous ofatumumab)—for MS:
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:
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 $500M up-front payment by NVS (#msg-116391951).
It won't have any effect at all on the share price. It's a goodwill gesture and it's the right thing to do morally.
How much will this affect the stock price 160 mil pills at 4$ is a lot of money
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):
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:
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.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:
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:
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:
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: