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Novartis

Novartis develops and manufactures innovative drugs. The firm's key areas of drug development include oncology, rare diseases, neuroscience, immunology, respiratory, cardio-metabolic, and established medicines. The company sells its products globally, with the United States representing close to one third of total revenue.

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Following an investigation announced in November last year, the FDA said on Thursday that it would now require boxed warnings—the highest safety-rel

FDA Mandates &#34;Boxed Warning&#34; For Bristol Myers, Johnson &amp; Johnson CAR-T-Based Blood Cancer Therapies

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Sustained efficacy with Novartis&#39; Kesimpta for up to 6 years in recently diagnosed relapsing multiple sclerosis. Significant reductions in relapses, MRI lesions, and disability worsening observed.

Novartis Multiple Sclerosis Drug Kesimpta Shows Substantial Benefit Of Up To 6 Years

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Unlock the potential of Avalo Therapeutics with AVTX-009, a promising drug for hidradenitis suppurativa. Oppenheimer upgrades to Outperform, foreseeing Phase 2 progress and market distinction.

Avalo Therapeutics&#39; Newly Acquired Ex-Eli Lilly Drug Could Stand Out In Competitive Hidradenitis Suppurativa Market, Analyst Upgrades

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Following an&nbsp;investigation&nbsp;announced in November last year, the FDA said on Thursday that it would now&nbsp;<a target="_blank" href="https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-boxed-warning-t-cell-malignancies-following-treatment-bcma-directed-or-cd19-directed" rel="noreferrer noopener">require</a>&nbsp;boxed warnings—the highest safety-related caution for medications—for all chimeric antigen receptor (CAR) T-cell therapies.&nbsp;
According to the agency, these blood cancer treatments may pose a&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/01/36736043/focus-on-bristol-myers-gilead-sciences-johnson-johnson-novartis-fda-to-issue-classwide-black-box-" rel="noreferrer noopener">risk of secondary cancers</a>.
The health regulator has required related updates to other&nbsp;label sections, such as warnings and precautions, postmarketing experience, patient counseling information, and medication guides.
The agency said patients and clinical trial participants receiving treatment with these products should be monitored lifelong for secondary malignancies and notify the manufacturer in the event of a new malignancy.
In November, the FDA said it received reports of patients developing T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/11/35996543/eyes-on-novartis-gilead-bristol-myers-as-fda-weighs-risks-vs-benefits-of-approved-car-t-cell-ther" rel="noreferrer noopener">autologous CAR T cell immunotherapies</a>.
The agency said it&#8217;s weighing &#8220;the need for regulatory action&#8221; in response to clinical testing and safety monitoring reports tied to commercial use.&nbsp;
In&nbsp;January, the FDA asked drugmakers to add a boxed warning to their&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/01/36736043/focus-on-bristol-myers-gilead-sciences-johnson-johnson-novartis-fda-to-issue-classwide-black-box-" rel="noreferrer noopener">CAR-T cancer therapies</a>.
In its January 19 notification letters, the agency stressed that the potential risk applies to all&nbsp;currently&nbsp;approved CAR-T products.&nbsp;
The regulatory body has mandated label updates for all six commercial CAR-T therapies, including&nbsp;Bristol Myers Squibb &amp; Co&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>)&nbsp;<a target="_blank" href="https://www.fda.gov/media/175623/download?attachment" rel="noreferrer noopener">Abecma</a>&nbsp;(partnered with partner&nbsp;2seventy bio&nbsp;Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tsvt#NASDAQ">TSVT</a>))and&nbsp;<a target="_blank" href="https://www.fda.gov/media/175622/download?attachment" rel="noreferrer noopener">Breyanzi</a>,&nbsp;Johnson &amp; Johnson&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>)&nbsp;<a target="_blank" href="https://www.fda.gov/media/175624/download?attachment" rel="noreferrer noopener">Carvykti</a>&nbsp;(developed in partnership with&nbsp;Legend Biotech Corporation&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/legn#NASDAQ">LEGN</a>)),&nbsp;Novartis AG&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>)&nbsp;<a target="_blank" href="https://www.fda.gov/media/175625/download?attachment" rel="noreferrer noopener">Kymriah</a>, and&nbsp;Gilead Sciences Inc&#8217;s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>)&nbsp;<a target="_blank" href="https://www.fda.gov/media/175627/download?attachment" rel="noreferrer noopener">Yescarta</a>.
Gilead&#8217;s Tecartus was also part of the list, but later, it was removed from <a href="https://www.benzinga.com/general/biotech/24/01/36760938/gileads-tecartus-dropped-from-fda-list-of-car-t-therapy-with-updated-label-warning-of-risks-of-se" target="_blank" rel="noreferrer noopener">boxed warning requirements</a>.
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FDA Mandates "Boxed Warning" For Bristol Myers, Johnson & Johnson CAR-T-Based Blood Cancer Therapies

Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) <a href="https://www.novartis.com/news/media-releases/novartis-kesimpta-six-year-efficacy-data-show-substantial-benefits-recently-diagnosed-treatment-naive-people-relapsing-multiple-sclerosis" target="_blank" rel="noreferrer noopener">released</a> data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta (ofatumumab) treatment for up to six years in <a href="https://www.benzinga.com/topic/multiple-sclerosis">recently diagnosed relapsing multiple sclerosis</a>.
Recently diagnosed is defined as untreated patients starting treatment within three years of initial diagnosis.
These efficacy outcomes included 44% fewer relapses; 96.4% and 82.7% reductions in MRI lesions (Gd+ T1 and neT2), respectively; and 24.5% and 21.6% fewer 3- and 6-month confirmed disability worsening (CDW) events, respectively, versus those who switched from Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Aubagio (teriflunomide) to Kesimpta.
In the first analysis, the low annualized relapse rate (ARR) experienced by recently diagnosed treatment-naïve RMS patients was further reduced in the ALITHIOS open-label extension study, from 0.104 to 0.050 (52.0% reduction), corresponding to an adjusted ARR of one relapse per 20 years.
<ul>
<li>Rates of 3- and 6-month progression independent of relapse activity (PIRA) with first-line Kesimpta were also lower versus switch.</li>
<li>The observed rapid increase in the proportion of participants with no evidence of disease activity (NEDA-3) with continuous first-line Kesimpta treatment was maintained up to six years.</li>
<li>Patients initially randomized to teriflunomide, improvements across several efficacy outcomes were seen after switching to Kesimpta, including significant reductions in ARR (71.3%) and in MRI lesion activity (Gd+ T1: 98.5% reduction; neT2: 93% reduction), and rapid increase in rates of NEDA-3.1.</li>
<li>Rates of 3- and 6-month CDW events remained higher compared to patients receiving continuous Kesimpta, indicating that the efficacy benefit of first-line Kesimpta on delaying disability worsening was not fully achieved in the switch group.</li>
</ul>
The second analysis looked at the overall ALITHIOS population:
<ul>
<li>Data showed sustained efficacy of continuous Kesimpta up to six years, including low ARR (49.9% reduction between core Phase III trials and extension phase), suppression of MRI lesion activity (Gd+ T1: 56.7% reduction; neT2: 89.3% reduction), sustained reduction of 6-month CDW events (14.1%, relative to the switch group), lower rates of 6-month PIRA, and sustained high rates of NEDA-3.2.</li>
<li>People switching from teriflunomide to Kesimpta experienced reductions in ARR (73.8%) and MRI lesion activity (Gd+ T1: 97.7% reduction; neT2: 91.8% reduction) and a rapid increase in NEDA-3 rates during the extension period.</li>
</ul>
Treatment with Kesimpta for up to six years was well-tolerated with no unexpected safety signals identified.
In fiscal year 2023, Kesimpta&#8217;s sales almost&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/01/36865238/why-is-european-pharma-giant-novartis-stock-trading-lower-today" rel="noreferrer noopener">doubled to $2.2 billion</a>.
Price Action: NVS shares are up 0.15% at $93.34 on the last check Wednesday.
Now Read: <a href="https://www.benzinga.com/general/biotech/24/04/38296093/sanofis-multiple-sclerosis-antibody-shows-reduction-of-disease-activity">Sanofi&#8217;s Multiple Sclerosis Antibody Shows Reduction Of Disease Activity</a>

<ul>
<li>Continuous Kesimpta&reg;&nbsp;treatment for up to six years showed sustained efficacy in recently diagnosed (&le;3 years) treatment-na&iuml;ve people living with relapsing multiple sclerosis (RMS) in an analysis of the ALITHIOS open-label extension study1 
	&nbsp;</li>
<li>Similar efficacy outcomes were demonstrated in a separate analysis of continuous Kesimpta treatment for up to six years in the overall ALITHIOS study population2 
	&nbsp;</li>
<li>Switch from teriflunomide to Kesimpta resulted in significant improvements across several efficacy outcomes such as annualized relapse rate and MRI lesion activity in both analyses1,2 
	&nbsp;</li>
<li>Treatment with Kesimpta for up to six years continues to be well tolerated with consistent safety outcomes, supporting the favorable benefit-risk profile of Kesimpta in RMS2</li>
</ul>

Novartis Announced Earlier, Continuous Kesimpta Treatment For Up To Six Years Showed Sustained Efficacy In Recently Diagnosed (≤3 Years) Treatment-naïve People Living With Relapsing Multiple Sclerosis  In Analysis Of Alithios Open-label Extension Study

Tuesday,&nbsp;Oppenheimer&nbsp;upgraded&nbsp;Avalo Therapeutics Inc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVTX#NASDAQ">AVTX</a>), noting that its AVTX-009 is a promising drug candidate and looks forward to a Phase 2 topline data in 2026 in hidradenitis suppurativa (HS) and additional updates.
In March, Avalo Therapeutics announced the acquisition of a Phase 2-ready anti-IL-1β mAb, which it refers to as AVTX-009, originally developed by&nbsp;Eli Lilly And Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>).
Avalo announced a private placement of $185 million in gross proceeds, including an initial gross upfront&nbsp;<a target="_blank" href="https://www.benzinga.com/trading-ideas/movers/24/03/37984130/micro-cap-avalo-therapeutics-stock-rallies-as-it-snaps-almatabio-for-ex-eli-lilly-drug-for-s" rel="noreferrer noopener">investment of $115.6 million</a>.
Oppenheimer says that the company is preparing to advance &#8216;009 for Phase 2 development in hidradenitis suppurativa (HS), showing confidence in its potential. While topline data won&#8217;t be available until 2026, there&#8217;s consideration to also evaluate &#8216;009 for ulcerative colitis (UC), which could provide interim updates.&nbsp;
The analyst has upgraded to Outperform from Perform,&nbsp;<a target="_blank" href="https://www.benzinga.com/quote/AVTX/analyst-ratings" rel="noreferrer noopener">setting a $35 price target</a>&nbsp;based on the belief that AVTX-009 could stand out in the competitive HS market.
AVTX-009 attaches to IL-1β, a significant target for HS. Despite IL-1α and IL-18 not being recognized as key factors in the disease, lutikizumab from&nbsp;AbbVie Inc&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>), which targets both IL-1α and IL-1β, showed substantial benefits in Phase 2 trials for a severe HS group.&nbsp;
Additionally, MAS825 from&nbsp;Novartis AG&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), which targets both IL-1β and IL-18, succeeded in a placebo-controlled trial for HS.&nbsp;
These findings, along with physiological research on HS inflammatory lesions, strongly suggest the involvement of IL-1β in HS.
The analyst writes that Phase 2 will likely lead to advancing the development process for registration and integrating a pen autoinjector for commercial use.&nbsp;
Anticipating a peak market penetration of 15% and a launch price of $75,000 in 2029, aligning with other approved biologics. Oppenheimer anticipates an increase in patient identification rates for HS, a condition often overlooked.
Price Action: AVTX shares are up 13.9% at $17.36 on the last check Tuesday.
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Avalo Therapeutics' Newly Acquired Ex-Eli Lilly Drug Could Stand Out In Competitive Hidradenitis Suppurativa Market, Analyst Upgrades

On 11 April 2024, Novartis BidCo, Basel, Switzerland, ("Bidder") has published the offer document regarding its takeover offer (cash offer) to the shareholders of MorphoSys AG, Planegg, Germany ("MorphoSys") for the acquisition of all no-par value bearer shares (ISIN DE0006632003) ("MorphoSys&nbsp;Shares") including all no-par value bearer shares represented by American Depositary Shares (ISIN&nbsp;US6177602025) ("MorphoSys&nbsp;ADS") in MorphoSys against payment of a cash consideration in the amount of EUR 68.00 per MorphoSys Share. The acceptance period of the offer will expire on 13&nbsp;May 2024, 24:00 hours (local time Frankfurt am Main, Germany) and 18:00 hours (local time New York, United States of America), unless it is extended pursuant to the applicable rules under the WpÜG.
&nbsp;
As of 12 April 2024 ("Reference Date"), i.e. after the publication of the offer document and prior to the publication pursuant to section 23 para. 1 sentence 1 no. 2 WpÜG, the Bidder acquired 2,023,370 MorphoSys Shares on the stock exchange. The highest price paid was EUR&nbsp;67.95 per MorphoSys Share. The transfer of the 2,023,370&nbsp;MorphoSys&nbsp;Shares to the Bidder is expected to take place within the next few days.
&nbsp;
The aggregate number of MorphoSys Shares for which purchase agreements were entered into on the Reference Date represents approx. 5.36&nbsp;% of all MorphoSys Shares in existence on the Reference Date and approx. 5.37&nbsp;% of all MorphoSys Shares in existence, other than treasury shares held by MorphoSys, on the Reference Date.

Morgan Stanley Capital Protected Notes for S&P 500 Index

MorphoSys AG Form SC TO-T/Amended Shows Novartis BidCo AG Bought 2,023,370 Shares Of Common Stock Or About A 5.36% Stake; Highest Price Paid Was €67.95 Per Share

<ul>
<li>APPLAUSE-IgAN is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with IgAN1 &nbsp;</li>
<li>IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide2; complement activation is a key driver of glomerular inflammation in IgAN3,4 &nbsp;</li>
<li>There is a need for effective, targeted therapies for IgAN2,5; up to 30% of patients with persistent proteinuria (≥1 g/day) may progress to kidney failure within 10 years, requiring maintenance dialysis and/or kidney transplantation6 &nbsp;</li>
<li>Novartis continues to advance broad renal portfolio in late-stage development, exploring the potential to slow disease progression and extend dialysis-free life</li>
</ul>
EAST HANOVER, N.J., April 15, 2024 /PRNewswire/ -- Novartis today presented results from a pre-specified interim analysis of the Phase III APPLAUSE-IgAN study of Fabhalta&#xAE; (iptacopan), an investigational Factor B inhibitor of the alternative complement pathway, in patients with IgA nephropathy (IgAN)1.&nbsp;In the analysis, patients treated with Fabhalta achieved a 38.3% (p&lt;0.0001) proteinuria reduction (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at 9 months when compared to placebo on top of supportive care1.
Proteinuria reduction is an increasingly recognized surrogate marker correlating with progression to kidney failure&nbsp;and has been used as an endpoint in IgAN clinical trials to support accelerated approvals7. The study also showed that Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data1,8. Results were presented today during a late-breaking clinical trials session at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina1.
"In IgAN, part of the immune system called the alternative complement pathway can become overly activated in the kidneys, which causes an inflammatory response, leading to progressive kidney damage and gradual loss of kidney function. The loss of kidney function, together with potential side effects of IgAN treatments available until recently, significantly impact patients' lives," said Professor Dana Rizk, Investigator and APPLAUSE-IgAN Steering Committee Member and professor in the UAB Division of Nephrology. "Fabhalta is the first potential treatment for IgAN that specifically targets the alternative complement pathway."
This pre-specified interim analysis included 250 patients for the efficacy analysis and 443 for the safety analysis1. The APPLAUSE-IgAN study continues in a double-blind fashion, and therefore only limited interim analysis results can be presented9,10. Submission for possible accelerated approval to the FDA was accepted and has received priority review. The primary endpoint evaluating Fabhalta's&nbsp;ability to slow IgAN progression by measuring the annualized total estimated glomerular filtration rate (eGFR) slope over 24 months is expected at study completion in 20259,10.
"IgAN progresses over many years, and patients' needs may evolve such that different therapies may be best used at different times," said David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. "Our renal pipeline includes medicines with a variety of mechanisms which may allow them to be targeted to patients based on their clinical characteristics."
Other data presented at WCN include IgAN and C3 glomerulopathy&nbsp;(C3G) real-world studies. Novartis will be presenting further&nbsp;data from the renal portfolio at future medical meetings.
About APPLAUSE-IgAN APPLAUSE-IgAN (NCT04578834) is a Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of twice-daily oral Fabhalta (200 mg) in 518 adult primary IgAN patients9,10.
The two primary endpoints of the study for the interim and final analysis, respectively, are proteinuria reduction at 9 months as measured by UPCR, and the annualized total eGFR slope over 24 months9,10. At the time of final analysis, the following secondary endpoints will also be assessed: proportion of participants reaching UPCR &lt;1 g/g without receiving corticosteroids/immunosuppressants or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating kidney replacement therapy (KRT), time from randomization to first occurrence of composite kidney failure endpoint event (reaching either sustained ≥30% decline in eGFR relative to baseline or sustained eGFR &lt;15 mL/min/1.73 m2 or maintenance dialysis or receipt of kidney transplant or death from kidney failure), change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire9,10.
The main study population enrolled patients with an eGFR ≥30 mL/min/1.73 m2 and UPCR ≥1 g/g at baseline9,10. In addition, a smaller cohort of patients with severe renal impairment (eGFR 20–30 mL/min/1.73 m2 at baseline) was also enrolled to provide additional information but will not contribute to the main efficacy analyses9,10.
About Fabhalta&#xAE; (iptacopan) Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway1. 
Discovered at Novartis, Fabhalta is currently in development for a range of rare diseases including IgAN, C3G, atypical hemolytic uremic syndrome&nbsp;(aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN).
Fabhalta was approved by the FDA in December 2023 for the treatment of adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH) and received a positive opinion from the CHMP of the EMA in March 202411,12.&nbsp;
About IgA nephropathy (IgAN) IgAN is a heterogeneous, progressive, rare kidney disease2. Each year, approximately 25 people per million worldwide are newly diagnosed with IgAN13.
Up to 30% of people who have IgAN with persistent higher levels of proteinuria (≥1 g/day) may progress to kidney failure within 10 years6. There is a need for effective, targeted therapies for IgAN that can help slow or prevent progression to kidney failure2,5,14.
Novartis commitment in renal At Novartis, our journey in nephrology began more than 40 years ago when the development and introduction of cyclosporine helped reimagine the field of transplantation and immunosuppression. We continue today with the same bold ambition to transform the lives of people living with kidney diseases.
Through our renal portfolio, we are exploring potential therapeutic options to address the current unmet needs of people living with rare kidney diseases, including IgAN, C3G, aHUS, IC-MPGN and LN. New and innovative treatment options that target the underlying causes of rare kidney diseases may slow disease progression and help people live longer without the need for infusions, dialysis or transplantation.
IgAN is a heterogeneous disease presenting with a variety of clinical manifestations, phenotypes, and variable speeds of progression2. In addition to Fabhalta, Novartis is advancing the development of two other therapies in IgAN with highly differentiated mechanisms of action: atrasentan, an investigational oral endothelin A (ETA) receptor antagonist, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody, which are both in Phase III development15,16. Through our IgAN pipeline, we are committed to creating a portfolio of innovative medicines that improve and extend the lives of people living with kidney disease.

Novartis Fabhalta Data Show Clinically Meaningful And Statistically Significant Proteinuria Reduction Of 38.3% Versus Placebo For Patients With IgA Nephropathy

On Wednesday,&nbsp;Vertex Pharmaceuticals Incorporated&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRTX#NASDAQ">VRTX</a>) agreed to acquire&nbsp;Alpine Immune Sciences Inc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALPN#NASDAQ">ALPN</a>) for $65 per share or&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38201798/vertex-pharmaceuticals-move-beyond-its-10b-cystic-fibrosis-franchise-pays-around-5b-for-kidney-di" rel="noreferrer noopener">approximately $4.9 billion in cash</a>.&nbsp;
Evercore notes the deal as a surprise move as it is unusual for Vertex, which has often been critiqued for capital allocation, building up piles of cash amounting to $13.7 billion before the acquisition.&nbsp;
The analyst notes it as a solid acquisition and aligned with Vertex&#8217;s emerging footprint in nephrology following the advancement of inaxaplin in APOL1-mediated kidney disease and early-stage candidate VX-407 for autosomal dominant polycystic kidney disease.&nbsp;
Related:&nbsp;<a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/02/36964644/vertexs-next-generation-cystic-fibrosis-program-shows-efficacy-with-reduced-burden-" rel="noreferrer noopener">Vertex&#8217;s Next-Generation Cystic Fibrosis Program Shows Efficacy With Reduced Burden, Provides Growth Opportunity: Goldman Sachs</a>.
Evercore analyst sees Alpine&#8217;s lead molecule, povetacicept (ALPN-303), to be fourth to market in this class behind Otsuka&#8217;s sibeprenlimab,&nbsp;Vera Therapeutics Inc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERA#NASDAQ">VERA</a>) atacicept, and&nbsp;Novartis AG&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) zigakibar.
Evercore analyst writes that Povetacicept alone can add over $5 billion to the top line, and it models conservatively for indications beyond IgAN.&nbsp;
The analyst upgraded the stock from In-line to Outperform,&nbsp;<a target="_blank" href="https://www.benzinga.com/quote/VRTX/analyst-ratings" rel="noreferrer noopener">with a price target of $438</a>.
BofA writes, &#8220;We think Vertex is putting its money to good work, particularly given its strong balance sheet where investors have been waiting for BD to create additional &#8220;encores&#8221; to its Cystic fibrosis (CF) pipeline. And while this is the first acquisition for Vertex of this size in quite some time, management stressed this was the right deal at the right time and to not make any readthroughs for future acquisitions.&#8221;
BofA maintains the Buy rating with a price target of $550 as the Alpine acquisition further bolsters Vertex&#8217;s late- and early-stage clinical pipelines.
William Blair&nbsp;suggests that Povetacicept&#8217;s potential extends beyond IgAN, potentially leading to it becoming a multibillion-dollar product. Additionally, they anticipate Vertex engaging in business development to broaden its pipeline beyond cystic fibrosis.
Price Action: VRTX shares are up 1.29% at $402.71 on the last check Thursday.
Photo via Shutterstock

ALPN

VERA

VRTX

Vertex's Alpine Acquisition: Unpacking Analyst Predictions on Povetacicept's Potential Impact

High-rolling investors have positioned themselves bullish on Novartis (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), and it's important for retail traders to take note. 
\This activity came to our attention today through Benzinga's tracking of publicly available options data. The identities of these investors are uncertain, but such a significant move in NVS often signals that someone has privileged information.
Today, Benzinga's options scanner spotted 9 options trades for Novartis. This is not a typical pattern.
The sentiment among these major traders is split, with 66% bullish and 33% bearish. Among all the options we identified, there was one put, amounting to $41,080, and 8 calls, totaling $1,464,990.
<h3>Expected Price Movements</h3>
Analyzing the Volume and Open Interest in these contracts, it seems that the big players have been eyeing a price window from $92.5 to $97.5 for Novartis during the past quarter. 
<h3>Insights into Volume &amp; Open Interest</h3>
Looking at the volume and open interest is an insightful way to conduct due diligence on a stock.
This data can help you track the liquidity and interest for Novartis's options for a given strike price.
Below, we can observe the evolution of the volume and open interest of calls and puts, respectively, for all of Novartis's whale activity within a strike price range from $92.5 to $97.5 in the last 30 days. 
<h3>Novartis Call and Put Volume: 30-Day Overview</h3>
<img src="https://www.benzinga.com/files/images/story/2024/1712845015_0.png" alt="Options Call Chart" />
<h3>Biggest Options Spotted:</h3>

<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Ask</th>
<th>Bid</th>
<th>Price</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>NVS</td>
<td>CALL</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>05/17/24</td>
<td>$1.55</td>
<td>$1.15</td>
<td>$1.35</td>
<td>$97.50</td>
<td>$1.0M</td>
<td>1.0K</td>
<td>10.0K</td>
</tr>
<tr>
<td>NVS</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>05/17/24</td>
<td>$1.15</td>
<td>$1.1</td>
<td>$1.15</td>
<td>$97.50</td>
<td>$100.9K</td>
<td>1.0K</td>
<td>766</td>
</tr>
<tr>
<td>NVS</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>05/17/24</td>
<td>$1.5</td>
<td>$1.3</td>
<td>$1.3</td>
<td>$97.50</td>
<td>$63.0K</td>
<td>1.0K</td>
<td>1.8K</td>
</tr>
<tr>
<td>NVS</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>07/19/24</td>
<td>$4.3</td>
<td>$4.2</td>
<td>$4.3</td>
<td>$95.00</td>
<td>$60.6K</td>
<td>145</td>
<td>0</td>
</tr>
<tr>
<td>NVS</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>05/17/24</td>
<td>$1.2</td>
<td>$1.15</td>
<td>$1.2</td>
<td>$97.50</td>
<td>$58.0K</td>
<td>1.0K</td>
<td>885</td>
</tr>
</tbody>
</table>

<h3>About Novartis</h3>
Novartis develops and manufactures innovative drugs. The firm's key areas of drug development include oncology, rare diseases, neuroscience, immunology, respiratory, cardio-metabolic, and established medicines. The company sells its products globally, with the United States representing close to one third of total revenue.
In light of the recent options history for Novartis, it's now appropriate to focus on the company itself. We aim to explore its current performance.
<h3>Novartis's Current Market Status</h3>
<ul>
<li>With a volume of 398,132, the price of NVS is down -0.12% at $94.27. </li>
<li>RSI indicators hint that the underlying stock may be approaching oversold.</li>
<li>Next earnings are expected to be released in 12 days.</li>
</ul>
Options are a riskier asset compared to just trading the stock, but they have higher profit potential. Serious options traders manage this risk by educating themselves daily, scaling in and out of trades, following more than one indicator, and following the markets closely.
If you want to stay updated on the latest options trades for Novartis, <a href="https://benzinga.grsm.io/register174">Benzinga Pro</a> gives you real-time options trades alerts.

Options

Markets

Looking At Novartis's Recent Unusual Options Activity

The deal is for the worldwide development and commercialization of ARV-766, Arvinas&#39; second generation PROTAC&nbsp;androgen receptor (AR) degrader for patients with prostate cancer. The transaction also includes an asset purchase agreement for the sale of Arvinas&#39; preclinical AR-V7 program to Novartis.&nbsp;Arvinas will receive an upfront payment in the aggregate amount of&nbsp;$150.0 million. Under the License Agreement, Arvinas is eligible to receive additional development, regulatory, and commercial milestones of up to&nbsp;$1.01 billion, as well as tiered royalties for ARV-766.

Contracts

ARVN

Arvinas Enters Exclusive Strategic License Agreement With Novartis; Arvinas To Receive $150M Upfront Payment & Up To $1.01B In Milestones

Novartis published today the offer document for the voluntary public takeover offer by its wholly owned subsidiary Novartis BidCo AG for all outstanding shares of MorphoSys AG (&ldquo;MorphoSys&rdquo;), including all shares represented by MorphoSys American Depositary Shares (the &ldquo;Offer&rdquo;), for an offer price of EUR 68.00 per share in cash. The offer price corresponds to a premium of 142% on the volume-weighted average price during the last three months, as of the unaffected January 25, 2024, close.

Novartis Tender Offer For Morphosys  Commences @€68.00/Share

Alpine Immune Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALPN#NASDAQ">ALPN</a>) is reportedly considering strategic options, including a potential sale, following interest from potential buyers. 
The Seattle-based firm is working closely with advisors and evaluating various possibilities, and at least one major pharmaceutical player has expressed interest in an acquisition.
While discussions are ongoing, Bloomberg&nbsp;<a target="_blank" href="https://www.bloomberg.com/news/articles/2024-04-10/alpine-immune-is-said-to-weigh-options-after-takeover-interest?sref=TBDibEcD" rel="noreferrer noopener">cautioned</a>, citing sources familiar with the matter, that no decision has been made, and there&#8217;s no assurance that Alpine Immune will indeed pursue a sale.&nbsp;
Over the past year, Alpine Immune stock has surged from $7.43 to $38.94, more than 400%.
<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="750" height="650" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/04/10141612/newplot-1-3.png" alt="" class="wp-image-286486" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/04/10141612/newplot-1-3.png 750w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/04/10141612/newplot-1-3-300x260.png 300w" sizes="(max-width: 750px) 100vw, 750px" /></figure>
In November 2023, Alpine Immune presented the first clinical data of povetacicept in autoimmune glomerulonephritis during a late-breaking session at the American Society of Nephrology (ASN) Kidney Week, sending shares jump almost 40%.
In IgAN, treatment with low-dose povetacicept, 80 mg SC every four weeks, was associated with clinically meaningful improvements in proteinuria, with a 53.5% reduction from baseline in&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/11/35566208/why-is-alpine-immune-sciences-stock-trading-higher-today" rel="noreferrer noopener">UPCR (n=5) at 24 weeks</a>.&nbsp;
Established in 2015, Alpine Immune specializes in developing therapies for autoimmune and inflammatory conditions.&nbsp;
The company is scheduled to unveil updated data on April 15 regarding the safety and efficacy of its primary product, Povetacicept, for a kidney disease characterized by renal damage&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/04/b38021756/alpine-immune-sciences-to-present-updated-clinical-data-for-povetacicept-in-iga-nephropathy-at-the" rel="noreferrer noopener">impairing filtration functions</a>.
Interest in addressing chronic kidney diseases has surged among major pharmaceutical firms.&nbsp;
Last year,&nbsp;Novartis AG&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NASDAQ">NVS</a>) acquired&nbsp;Chinook Therapeutics Inc.&nbsp;for a potential $3.2 billion deal, primarily to access promising treatments for a&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/06/32812206/why-are-chinook-therapeutics-shares-trading-higher-today" rel="noreferrer noopener">rare kidney ailment</a>.
Price Action:&nbsp;ALPN shares are up 15.50% at $44.98 on the last check Wednesday.

Rumors

Why Is Kidney Disease-Focused Alpine Immune Sciences Stock Trading Higher On Wednesday?

Novartis Says 'In light of recently evolving regulatory guidance on intake limits for nitrosamines in medications, enrollment of new patients in ribociclib early breast cancer (eBC) studies has been paused in alignment with health authorities.'

Mizuho Securities&nbsp;initiated coverage on&nbsp;Enliven Therapeutics Inc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ELVN#NASDAQ">ELVN</a>), a clinical-stage precision oncology company focused on discovering and developing next-generation small molecule kinase inhibitors.
The company&#8217;s lead product, ELVN-001, is under development for Chronic myelogenous leukemia (CML), a slow-progressing blood cancer that begins in the bone marrow.
Thursday, Enliven Therapeutics will host a webcast to discuss initial proof of&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/03/g37994181/enliven-therapeutics-to-share-initial-proof-of-concept-data-from-phase-1-clinical-trial-of-elvn-00" rel="noreferrer noopener">concept data on ELVN-001</a>.
Additional Phase 1 data is expected in 2025, but Mizuho expects late 2024 could also be possible.
Mizuho writes that the CML tyrosine kinase inhibitors (TKI) market is established, ~$13 billion-$14 billion worldwide, and it has been growing since 2001 when&nbsp;Novartis AG&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Gleevec (imatinib) became the first TKI to receive regulatory approval.&nbsp;
Over the last two decades, there have been four generations of TKIs approved for this disease.&nbsp;
However, approved TKIs are still limited in their design and, therefore, still produce various safety/tolerability issues.&nbsp;
The analyst writes that Enliven is well-positioned to address these shortcomings, and if it succeeds in doing so, this should garner an alpha opportunity for investors.&nbsp;
Mizuho initiates with a Buy rating and a&nbsp;<a target="_blank" href="https://www.benzinga.com/quote/ELVN/analyst-ratings" rel="noreferrer noopener">price target of $34</a>.
Mizuho says that in the past two decades, even the least successful CML TKI has consistently generated at least $500 million in sales at its peak.&nbsp;
Additionally, the prevalence of CML is increasing, with the global market currently valued at around $13-14 billion in branded sales.&nbsp;
Considering this, the current trading value of ELVN, at around 1x its projected minimum peak sales in this market, appears to be quite conservative.&nbsp;
Typically, investors are comfortable with multiples of 2-4x the expected peak sales for biotech companies showing growth potential. Therefore, the trading levels for ELVN-001 seem cautious.
Price Action: ELVN shares are up 3.72% at $18.98 on the last check Tuesday.
Illustration of Phrama lab worker created with MidJourney

Initiation

ELVN

Enliven Therapeutics Well-Positioned, With Conservative Trading Levels-Analyst Says

Novartis AG&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) reportedly plans to slash up to 680 positions in its development organization,&nbsp;<a target="_blank" href="https://www.benzinga.com/news" rel="noreferrer noopener">aiding in drug market launches.</a>
The Basel-based company announced that approximately 440 positions will be cut in Switzerland and up to 240 in the U.S. within the next two to three years, Reuters reported.
The job cuts mentioned are distinct from a restructuring initiative that may result in up to 8,000 positions being eliminated from Novartis&#8217;s global workforce of 78,000, the report read.
Swiss pharmaceutical competitor&nbsp;Roche Holding Ltd&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBF#OTC">RHHBF</a>) previously disclosed its plan to reduce 345 positions in product development earlier this year, Reuters stated.&nbsp;
Novartis currently employs approximately 12,500 individuals in development roles, encompassing drug regulation management, analytics, and ancillary functions such as quality assurance.
The personnel are also engaged in formulating the production procedures for drugs post-research, the report added.&nbsp;
Presently, approximately 3,000 roles are in Switzerland and 2,000 in the U.S., implying that around 14% of positions in those nations will be impacted.
During the same period, Novartis announced plans to create new positions, resulting in a net global reduction of 1%-2%, the report read.&nbsp;
These adjustments aim to enhance its capabilities by tapping into local talent pools, including data scientists and regulatory experts in the U.K. Novartis affirmed its continued commitment to development efforts in Switzerland and the U.S., the report added.
Price Action:&nbsp;NVS shares are trading lower by 0.08% to $95.40 on the last check Tuesday.&nbsp;
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors. 
Photo via Wikimedia Commons

Media

RHHBF

Novartis To Axe 680 Development Jobs Amid Global Reshuffle: Report

Friday, the FDA approved&nbsp;Johnson &amp; Johnson&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy and are&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/04/n38128818/carvykti-is-the-first-and-only-bcma-targeted-treatment-approved-by-the-u-s-fda-for-patients-with-r" rel="noreferrer noopener">refractory to lenalidomide</a>.
FDA&#8217;s Oncologic Drugs Advisory Committee unanimously votes 11 to 0, supporting the favorable risk-benefit assessment of Carvykti based on results from the&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/11/35996543/eyes-on-novartis-gilead-bristol-myers-as-fda-weighs-risks-vs-benefits-of-approved-car-t-cell-ther" rel="noreferrer noopener">Phase 3 CARTITUDE-4 study</a>.
With this approval, Carvykti becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as the first relapse.
FDA approval is based on results from the Phase 3 CARTITUDE-4 study, which demonstrated that the earlier use of Carvykti reduced the risk of disease progression or death by 59% compared to standard therapies.
&#8220;We understand the urgency for patients in need of Carvykti, and we have been making considerable progress in increasing supply and availability in anticipation of this milestone approval,&#8221; said Tyrone Brewer, President, U.S. Hematology, Johnson &amp; Johnson Innovative Medicine. &#8220;We more than doubled manufacturing of Carvykti in 2023, we are striving to double again in 2024, and we will continue to invest in our capacity so we can provide this critical therapy to as many patients as possible.&#8221;&nbsp;
Read Next:&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38114915/fda-approves-bristol-myers2seventy-bios-abecma-for-earlier-use-in-pretreated-blood-cancer-patient" rel="noreferrer noopener">FDA Approves Bristol-Myers/2seventy Bio&#8217;s Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer</a>.
In December 2017, Johnson &amp; Johnson entered into an exclusive worldwide license and collaboration agreement with&nbsp;Legend Biotech Corporation&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LEGN#NASDAQ">LEGN</a>) to develop&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37785358/fda-adcomm-favors-expanded-use-of-johnson-johnson-bristol-myers-car-t-therapies-for-type-of-blood" rel="noreferrer noopener">and commercialize Carvykti</a>.
William Blair notes that Legend (<a href="https://www.benzinga.com/quote/LEGN/analyst-ratings" target="_blank" rel="noreferrer noopener">Market Perform rating</a>) and Johnson &amp; Johnson have extended their agreement with Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) until 2029, focusing on producing commercial batches of Carvykti. 
The collaboration aims to double Carvykti&#8217;s manufacturing efforts by 2024 and achieve a minimum of 10,000 manufacturing slots by 2025.&nbsp;
This expansion is seen as a significant milestone for the CAR-T space, particularly with Carvykti&#8217;s approval in the second-line setting, which broadens the scope of eligible patients and strengthens CAR-T as an effective early-line therapy.
The analyst notes Carvykti currently leads in therapy effectiveness, and the market for multiple myeloma treatments is sizable, accommodating numerous competitors. However, newer BCMA-targeted products with improved consistency in manufacturing or ready-made availability could potentially reduce Carvykti&#8217;s market dominance and affect its revenue over time.
Price Action: JNJ shares are down 0.15% at $152.17, and LEGN shares are down 1.19% at $54.28 on Monday.
Photo via Shutterstock

Reiteration

Johnson & Johnson's Carvykti Stands Ahead Of Bristol Myers' Rival Blood Cancer Therapy With FDA Approval For Wider Population

V-INITIATE trial demonstrates that early initiation with Leqvio, prior to guideline-recommended ezetimibe, for ASCVD patients unable to achieve LDL-C goal on statin therapy alone led to significant LDL-C reduction vs. clinician-determined usual care (60% vs. 7% respectively)1 
A significantly greater proportion of the ASCVD patients receiving Leqvio achieved guideline-recommended LDL-C goal vs. the usual care arm while maintaining adherence to statin treatment1 
Results from usual care arm reinforce the urgent need for more aggressive LDL-C lowering in ASCVD patients, 92% of whom did not reach their LDL-C goal with statins alone1 
The Leqvio safety profile was consistent with the Phase III clinical studies and long-term open-label extension trials for up to 6 years of treatment1-4

Novartis Announced Saturday, Data Show Early Addition Of Twice-yearly Leqvio Following Maximally Tolerated Statin Therapy Significantly Reduces LDL-C In ASCVD Patients In Real-world Setting

Thursday,&nbsp;Novartis AG&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) shares are trading higher after the company confirmed&nbsp;<a target="_blank" href="https://www.novartis.com/news/novartis-confirms-plans-file-pluvicto-pre-taxane-label-expansion-h2-2024-based-latest-data-from-phase-iii-psmafore-study" rel="noreferrer noopener">plans</a>&nbsp;to file for Pluvicto pre-taxane label expansion in the second half of 2024 based on data from its Phase 3 PSMAfore study.
Updated overall survival (OS) results from a pre-planned analysis at approximately 75% information fraction demonstrate an OS hazard ratio less than 1.0 (HR&lt;1.0) in the intent-to-treat (ITT) population unadjusted for cross-over.
Radiographic progression-free survival (rPFS) and other secondary efficacy endpoints are consistent with previous interim analysis results presented in 2023.
With an additional eight months of follow-up, Pluvicto&#8217;s safety profile remains consistent with previous interim analyses presented in 2023.
Also Read:&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/02/36954650/novartis-agrees-to-acquire-german-blood-cancer-drug-developer-morphosys-for-2-7b" rel="noreferrer noopener">Novartis Agrees To Acquire German Blood Cancer-Drug Developer MorphoSys For €2.7B</a>.
The Swiss pharmaceutical giant confirmed its plans to file in the second half of 2024 for a label expansion of Pluvicto for advanced prostate cancer for patients before receiving taxane-based chemotherapy.
In October 2023, Novartis&nbsp;<a target="_blank" href="https://www.novartis.com/news/media-releases/novartis-delivers-12-sales-and-21-core-operating-income-growth-from-continuing-operations-cc1-executes-sandoz-spin-achieves-important-innovation-milestones-and-raises-fy-2023-guidance" rel="noreferrer noopener">delayed</a>&nbsp;the regulatory submission for the label expansion from 2023 to&nbsp;<a target="_blank" href="https://www.novartis.com/sites/novartis_com/files/q4-2022-media-release-en.pdf" rel="noreferrer noopener">2024</a>.
Pluvicto is approved in the U.S., the E.U., and other countries to treat adults with a type of advanced cancer called PSMA-positive mCRPC and who have already been treated with other anticancer treatments (ARPI and taxane-based chemotherapy).&nbsp;
In 2023, Novartis recorded $980 million&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/01/36865238/why-is-european-pharma-giant-novartis-stock-trading-lower-today" rel="noreferrer noopener">from Pluvicto sales</a>.
Price Action: NVS shares are up 2.98% at $97.18 on the last check Thursday.
Photo via Wikimedia Commons

Why Is Novartis Stock Trading Higher On Thursday?

WIIM

Novartis shares are trading higher after the company confirmed plans to file for Pluvicto pre-taxane label expansion in the second half 2024 based on data from its Phase III PSMAfore study.

<a href="https://www.novartis.com/news/novartis-confirms-plans-file-pluvicto-pre-taxane-label-expansion-h2-2024-based-latest-data-from-phase-iii-psmafore-study" title="https://www.novartis.com/news/novartis-confirms-plans-file-pluvicto-pre-taxane-label-expansion-h2-2024-based-latest-data-from-phase-iii-psmafore-study">https://www.novartis.com/news/novartis-confirms-plans-file-pluvicto-pre-taxane-label-expansion-h2-2024-based-latest-data-from-phase-iii-psmafore-study</a>

Novartis Earlier Said It Plans To File For Pluvicto Pre-Taxane Label Expansion In H2 2024 Based On Data From Phase III PSMAfore Study

Genscript Biotech Entered Into Master Manufacturing And Supply Services Agreement With Novartis

VGK Vs. QQQ: How Europe's 'GRANOLAS' Could Outperform The US 'Magnificent 7'

CVS favors Humira copycats hurting AbbVie's market share: Evercore

TG Therapeutics: The Cloud Over Briumvi

Johnson & Johnson: Buy This Bargain Before It's Gone

TG Therapeutics wins VA contract for Briumvi

Caribou Biosciences: 2 Clinical Data Updates In 2024 Could Bring Value

FDA requires labeling changes to CAR-T cell therapies to reflect cancer risk

Unveiling Pfizer's Potent Cocktail: Key Drivers Of Free Cash Flow Growth

Novartis Looks To Get Back On Track With Q1 Earnings

Tech advances are catalyzing the Health Care sector with improved investor sentiment - SSGA

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AMGN

ASML

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CRBU

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Press Releases

Medullary Thyroid Cancer Pipeline, Clinical Trials Studies, Emerging Drugs, Mergers and Acquisition, Licensing, Agreements & Collaborations, and Latest News 2023 (Updated)

Small Cap

Opinion

Global Oncology Drugs Market Size Projected to Reach $484 Billion by 2030

Novartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH

Novartis presents new 48-week results from Phase III APPLY-PNH trial showing sustained efficacy and long-term safety of Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH)

Voyager Therapeutics Enters Capsid License Agreement and Strategic Collaboration with Novartis to Advance Novel Gene Therapies

Erasca Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials

Biotech's Role in Addressing the Pancreatic Cancer Emergency

New Novartis data show early addition of twice-yearly* Leqvio® (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting

Arvinas Enters into a Transaction with Novartis, including a Global License Agreement for the Development and Commercialization of PROTAC® Androgen Receptor (AR) Protein Degrader ARV-766 for the Treatment of Prostate Cancer

New Novartis Fabhalta® (iptacopan) data show clinically meaningful and statistically significant proteinuria reduction of 38.3% versus placebo for patients with IgA nephropathy (IgAN)

ACRS

CSE:DTC

ERAS

IBRX

NUVB

ONCY

TPTX

TSX:ONC

VYGR

Axsome Therapeutics

AstraZeneca PLC - American Depositary Shares

AstraZeneca

Bristol-Myers Squibb Company Common Stock

Bristol-Myers Squibb

Corcept Therapeutics Incorporated - Common Stock

Corcept Therapeutics

Catalent

Elanco Animal Health Incorporated Common Stock

Elanco Animal Health

GSK plc American Depositary Shares (Each representing two Ordinary Shares)

HUTCHMED (China) Limited - American Depositary Shares

HUTCHMED (China)

Indivior

Intra-Cellular Therapies Inc. - Common Stock

Intra-Cellular Therapies

Jazz Pharmaceuticals plc - Ordinary Shares

Jazz Pharmaceuticals

Johnson & Johnson

Eli Lilly and Co

Merck & Co

Novo Nordisk

Organon

Prestige Consumer Healthcare Inc. Common Stock

Prestige Consumer

Pfizer

Dr. Reddy's Laboratories Ltd Common Stock

Dr Reddy's Laboratories

Royalty Pharma plc - Class A Ordinary Shares

Royalty Pharma

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Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of Common Stock)