Tag: Novartis (NVS)

Novartis Gene Therapy Zolgensma Will Be Approved. The FDA Approves a Merck Combination for First-Line Renal cell Carcinoma. Regenxbio and Exelixis Are in Great Shape.

Novartis Gene Therapy Zolgensma Will Be Approved. The FDA Approves a Merck Combination for First-Line Renal cell Carcinoma. Regenxbio and Exelixis Are in Great Shape.

Novartis Gene Therapy Zolgensma Will Be Approved. The FDA Approves a Merck Combination for First-Line Renal Cell Carcinoma. RegenxBio and Exelixis Are in Great Shape.   Novartis' Gene Therpay Product Zolgensma The FDA submission of the gene therapy product Zolgensma was based on positive findings from a trial of 15 babies treated with it. Recently; however, at the Orlando meeting of the Muscular Dystrophy Association …
Novartis: More promising data from a Phase 3 trial with AveXis’ gene therapy Zolgensma® for Spinal Muscular Atrophy Type 1

Novartis: More promising data from a Phase 3 trial with AveXis’ gene therapy Zolgensma® for Spinal Muscular Atrophy Type 1

Novartis Has More Promising Data from Their Phase 3 Gene Therapy Trial with AveXis AveXis, a Novartis (NVS) company, announced positive interim data from its Phase 3 STR1VE trial of Zolgensma® (onasemnogene abeparvovec-xio (AVXS-101) gene therapy in spinal muscular atrophy (SMA) Type 1. About Spinal Muscular Atrophy (SMA) SMA is a severe neuromuscular disease characterized by the loss of motor neurons. The symptoms include progressive muscle weakness …
The Amgen/Novartis story. A Little Curiosity About Alder Biopharmaceuticals.

The Amgen/Novartis story. A Little Curiosity About Alder Biopharmaceuticals.

The Amgen/Novartis Story In May 2018 Amgen (AMGN)  & Novartis (NVS) announced that their novel migraine drug Aimovig™ was granted FDA approval for adults. Aimovig is the first and only FDA-approved migraine treatment designed to specifically block calcitonin-gene-related peptide receptor (CGRP-R) believed to play a critical role in causing migraines.  Amgen and Novartis both expressed their excitement for the . . . This content is …
Prohost Letter #430

Prohost Letter #430

Rheumatoid Arthritis and Gilead The FINCH 1 trial: Has it reached its primary endpoints? How did the drugs respond as compared to placebo; what is the disability index, clinical remission, disease activity rate and safety results? What’s happening with Gilead’s HIV product? Read about Gilead’s collaboration with Galapagos. See how Prohost answers these questions in this issue #430 of the Prohost Letter. Novartis, Novartis, Novartis …
Novartis’ Revolution: A new dimension and  Prohost expectations

Novartis’ Revolution: A new dimension and Prohost expectations

The market is outperforming today. There is important news today about Novartis; part of which we are posting now. There is still more news related to this same company as well as other biotech and biopharmaceutical companies, which will be in the upcoming Prohost Letter #430. We believe that the news we are posting will have a positive impact on the firms that announced them. …
During the Departed Week

During the Departed Week

The Week in Review #39 During the Departed Week Three Prohost Portfolio Picks Hit Their 52-Week Highs The three picks referred to in the above title are, Novartis (NVS), Array (AARY) and Ionis (IONS). Previous Prohost Letters discussed Novartis and Array and continued to remind that they are Prohost favorites. The time has come to take a deeper look at Ionis; starting with the reasons …
Why CRISPR Therapeutics’ stock gained around $8 today

Why CRISPR Therapeutics’ stock gained around $8 today

CRISPR Therapeutics' (CRSP) stock added around $8 today while reporting financial results for the fourth quarter and full year ended December 31, 2018. Here is what Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics, has stated,“This past year was truly transformational for CRISPR Therapeutics as we achieved milestones across our key programs in β-thalassemia, sickle cell disease and immuno-oncology. We’re pleased with the progress we’ve made in …
Successful results were announced by uniQure for its gene therapy, AMT-061, on hemophilia B patients

Successful results were announced by uniQure for its gene therapy, AMT-061, on hemophilia B patients

The United States FDA granted AMT-061 Breakthrough Therapy Designation and The European Medicines Agency gave it access to the Priority Medicine (PRIME) regulatory initiative. Gene therapy firm, uniQure (QURE), announced updated clinical data in patients treated in the ongoing Phase 2b study of AMT-061; an investigational AAV5-based gene therapy containing a patent-protected  FIX9-Padua (Factor 9) for the treatment of patients with severe and moderately severe hemophilia B. The announced data, which …
Now You See It, Now You Don’t

Now You See It, Now You Don’t

Now You See it, Now You Don’t Deliberate Omissions of Real Facts Real facts might be displayed or concealed depending on the news announcers’ or bloggers’ self-interests. The following contains cases of deliberate or unintentional omission of facts that led to the decline of fundamentally sound biotech and biopharmaceutical firms in bullish market during the departed trading week . . . This content is for paid subscribers. Please …
When common sense fails to explain market performance

When common sense fails to explain market performance

Prohost Letter #425 When Common Sense Fails to Explain the Market Performance It is not unusual for the stock market to be in a selloff mood for a few days. However, in the last couple of months, the market unexpectedly plunged deep into the ocean of the unknown. The exaggerated volatility was nerve-wracking for professional analysts. This is especially true for candid analysts who base …
Improving on immunotherapy and preventing one of its serious side effects

Improving on immunotherapy and preventing one of its serious side effects

The Week in Review #34 Improving on Immunotherapy and preventing one of its serious side effects. Removal of glutamine leads to a substantial reduction in cell growth or induces cell death in certain types of cancer cells, indicating that these cells are dependent on, or "addiected" to, glutamine. Normal cells do not depend much on glutamine . . . This content is for paid subscribers. …
Immunotherapy and some other results from ESMO 2018

Immunotherapy and some other results from ESMO 2018

IMMUNOTHERAPY  The Checkpoint Inhibitors The most revered news was the discovery of the checkpoint proteins on the surface of the immune system cells. The checkpoint proteins’ natural job is to put a break on the immune system cells to prevent them from attacking people’s own body cells. An immune attack on host cells can lead to disabling and life-threatening autoimmune diseases. Long before the scientists …
Following the Stars. Less Science and More Logic

Following the Stars. Less Science and More Logic

Prohost Letter #424 Following the Stars Less Science and More Logic We reiterate that while a human star is born every once in a while on Earth, several stars born daily in research labs may be designated every other day by the FDA and other health regulatory agencies around the world. These agencies call these potential stars’ breakthrough drugs, but not all the molecules designated …
Outperformance, underperformance and volatility

Outperformance, underperformance and volatility

The Week in Review #31 IN THE DEPARTED WEEK NOVEL MIGRAINE DRUGS ARE APPROVED ELI LILLY AFTER AMGEN AND TEVA In less than five months, the FDA approved three products belonging to four drug developers – all targeting calcitonin gene-related peptide (CGRP) for the prevention of migraine headache. The latest for Eli Lilly (LLY) last week . . . This content is for paid subscribers. …
Novartis Pleased the Market with Its Q2 Financial Results and Pleased Us with Its Great Scientific Achievements. See Also: The Role AveXis and RegenxBio are Playing Towards the Future Success of Novartis

Novartis Pleased the Market with Its Q2 Financial Results and Pleased Us with Its Great Scientific Achievements. See Also: The Role AveXis and RegenxBio are Playing Towards the Future Success of Novartis

Novartis’ (NVS) financials results exceeded analysts’ expectations. The firm’s research institutions’ strategy, well-designed structure, plans for innovation and accurate execution led to a wealthy and competitive pipeline with more than 200 projects in clinical development. Novartis is flying into the future finding its way to more effective treatments and possible cures. As a matter of fact, Novartis is at the end of the road towards …
Incyte’s promising trial results and its plans to accelerate its future growth

Incyte’s promising trial results and its plans to accelerate its future growth

Incyte (INCY) announced positive topline results from its pivotal Phase 2 REACH1 trial evaluating ruxolitinib (Jakafi®) in combination with corticosteroids for patients with steroid-refractory acute graft-versus-host disease (GVHD). The study met its primary endpoint, with a 55% overall response rate (ORR) at Day 28. In addition, the best overall response rate (BORR), the number of patients achieving a response at any time point during the …
Good news, bad news & comebacks. Some ASCO results too

Good news, bad news & comebacks. Some ASCO results too

The Week in Review #23  ASCO  2018 - Small  publicly-­traded  oncology  biotech  firms,  large  oncology  biotech  firms,  and  giant  biopharmaceutical  firms,  in  addition  to  some  private  biotech  companies,  all  presented  results  and  observations  about  their  cancer  drugs  at  the  2018  American  Society  of  Clinical  Oncology  (ASCO)   meeting.  Most  presentations  were  useful,...
Amgen: The FDA approves Aimovig™. The first specific migraine drug

Amgen: The FDA approves Aimovig™. The first specific migraine drug

The U.S. Food and Drug Administration (FDA) approved Amgen’s (AMGN) new once a month drug Aimovig™ (erenumab-aooe) for the prevention and treatment of migraine in adults. Aimovig is the first and only FDA-approved treatment specifically developed to prevent migraine. The drug blocks calcitonin gene-related peptide receptor (CGRP-R) believed to play a critical role in the occurrence of migraine. The drug will be marketed by Amgen and Novartis (NVS).  Aimovig 70 mg is …
The Biotech Revolution is Alive and Speeding

The Biotech Revolution is Alive and Speeding

The Week in Review #21 Part 1 THE MARKET - Like symphonic orchestras that bring to the listeners’ ears, minds and souls melodies composed by legendary authors, the stock market reflects what’s going on in the world, which would positively or negatively impact the lives and well being of the earth’s residents . . . This content is for paid subscribers. Please click here to subscribe or here to …
Novartis to acquire AveXis. Would the Approval of AVXS-101, If Any, Impact the Sales of Ionis’ Spinraza?

Novartis to acquire AveXis. Would the Approval of AVXS-101, If Any, Impact the Sales of Ionis’ Spinraza?

NOVARTIS TO ACQUIRE AVEXIS A few months ago, Novartis (NVS) CEO agreed to cash out of the company’s consumer health joint venture with GlaxoSmithKline (GSK), which brought in cash intended to further improve and expand Novartis’ pipeline. Here we are. Yesterday, Novartis announced its intention to acquire the gene therapy firm AveXis (AVXS) at $8.7 billion, paying $218 for each share of this firm. In a conference call on Monday, …