最新ニュース Novartis (NYSE:NVS) 株価情報

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 comprising close to one third of total revenue.

Novartis AG

NEVADA SUNRISE METALS CRP by NEVADA SUNRISE METALS CORP.

Nevada Sunrise Metals Corp

NOVUS HLDGS LTD SHS by NOVUS HLDGS LTD SHS

Novus Holdings Ltd

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Envista Holdings Corp

Biotech

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General

Hims & Hers Health, Inc. Class A Common Stock

HIMS

U.S. FDA Chief Califf Says Current Regulations Not Enough To Protect Americans From Risks Of Compounded GLP-1 Drugs

On Thursday, Outlook Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OTLK#NASDAQ">OTLK</a>) completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT evaluating ONS-5010 in wet age-related macular <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g43023003/outlook-therapeutics-announces-complete-twelve-week-efficacy-and-safety-results-of-norse-eight-cli" rel="noreferrer noopener">degeneration (wet AMD) patients</a>.
ONS-5010 demonstrated non-inferiority to Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) / Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Lucentis (ranibizumab) at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025.
The difference in the mean between ONS-5010 and ranibizumab was -1.009 best corrected visual acuity (BCVA) letters.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37893076/why-is-eye-disease-focused-outlook-therapeutics-stock-trading-higher-on-friday" rel="noreferrer noopener">Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Higher On Friday?</a>
BCVA measures how well a person can see after wearing corrective lenses, such as glasses or contact lenses.
In the intent-to-treat (ITT) population, NORSE EIGHT demonstrated a mean 5.5 letter improvement in BCVA in the ONS-5010 arm and 6.5 letter improvement in BCVA in the ranibizumab arm.
As previously announced, in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment (SPA) with the U.S. <a target="_blank" href="https://www.benzinga.com/24/11/42214804/why-is-eye-disease-focused-outlook-therapeutics-stock-trading-lower-on-wednesday" rel="noreferrer noopener">Food and Drug Administration (FDA)</a>.
However, BCVA data across all study timepoints demonstrated an improvement in vision, increasing over time, and the presence of biologic activity.
Overall, in NORSE EIGHT, ONS-5010 demonstrated mean visual acuity improvements of +3.3 letters at week 4, +4.2 letters at week 8, and +5.5 letters at week 12.
ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab.
ONS-5010/LYTENAVA (bevacizumab gamma) has been approved in the European Union and the United Kingdom. Outlook Therapeutics intends to begin launching in Europe in the first half of calendar 2025.
The company also entered into agreements for warrant inducement transactions expected to result in up to $20.4 million in gross proceeds.
The company will use the proceeds to fund its ONS-5010 clinical development programs, the European commercial launch of LYTENAVA, and working capital and general corporate purposes.
Price Action: OTLK stock is down 9.78% at $2.06 at last check Thursday.
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</ul>

Health Care

Financing

Offerings

Movers

Trading Ideas

OTLK

RHHBY

Outlook Therapeutics Vision Loss Drug At Par With Novartis Drug

<a href="https://www.washingtonpost.com/health/2025/01/16/bird-flu-testing-patients-in-hospital/">https://www.washingtonpost.com/health/2025/01/16/bird-flu-testing-patients-in-hospital/</a>
&nbsp;
The Centers for Disease Control and Prevention says hospitals treating people for the flu should test them for avian influenza within 24 hours.

AEMD

NVAX

'As Bird Flu Affects More People And Animals, CDC Urges Faster Testing' - Washington Post

"We will work to appropriately enforce the combination patent through its pediatric exclusivity period expiring in July 2025. We will also continue to defend and protect all our important intellectual property and regulatory rights relating to Entresto."

Large Cap

Legal

The US Court Of Appeals For The Federal Circuit Affirms The Validity Of The Novartis' Entresto (Sacubitril/Valsartan) Combination Patent

Illumina, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ILMN#NASDAQ">ILMN</a>), a global leader in DNA sequencing and array-based technologies, today announced a pilot proteomics program to analyze 50,000 UK Biobank samples in collaboration with deCODE Genetics, Standard BioTools, Tecan, GSK, Johnson &amp; Johnson, and Novartis. The pilot program is based on Illumina's upcoming proteomics assay, Illumina Protein Prep&#x2122;, powered by SOMAmer&#xAE; technology, a next-generation sequencing (NGS) based solution that will help scale access to proteomic insights.

ILMN

Illumina Launches Proteomics Pilot with 50,000 UK Biobank Samples, Partners with GSK, J&J, and Novartis

The settlement agreement&nbsp;permits&nbsp;Sandoz&nbsp;to begin selling generic versions of CAPLYTA on July 1, 2040, or earlier under certain circumstances.
Similar patent litigation brought by Intra-Cellular Therapies against other parties remains pending in the U.S. District Court for the District of New Jersey.&nbsp;

ITCI

Intra-Cellular Therapies Enters Settlement Agreement With Sandoz Resolving Patent Litigation Related To CAPLYTA Patent; No Terms Disclosed

Editor&#8217;s Note: This article has been corrected to reflect that Truist initiated coverage of Solid Biosciences on Wednesday.
On Wednesday, Truist initiated coverage on Solid Biosciences Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLDB#NASDAQ">SLDB</a>), <a href="https://www.benzinga.com/general/biotech">a clinical-stage biotech</a> developing gene therapies for diseases of the skeletal and cardiac muscles.
Truist initiated with a Buy rating and <a href="https://www.benzinga.com/quote/SLDB/analyst-ratings">a price target of $16</a>.
The new unified platform combines Solid Biosciences&#8217; expertise in designing microdystrophin (uDys) transgenes with AavantiBio&#8217;s advanced AAV manufacturing process. Analyst Joon Lee suggests this could create a top-tier gene therapy for Duchenne muscular dystrophy, SGT-003.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42490072/solid-biosciences-positioned-for-next-gen-duchenne-muscular-dystrophy-treatment-success-analyst" rel="noreferrer noopener">Solid Biosciences Positioned For Next-Gen Duchenne Muscular Dystrophy Treatment Success: Analyst</a>
The analyst highlights that an interim review of SGT-003 human trial data, expected in the first quarter of 2025, could reduce risks for Solid Biosciences' lead Duchenne muscular dystrophy program and its broader musculoskeletal gene therapy platform.
Additionally, the company plans to submit a second investigational new drug application for Catecholaminergic polymorphic ventricular tachycardia in the first half of 2025.
The Truist analyst adds that Solid Biosciences is ahead of Kate Therapeutics and Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) in developing DMD treatments, as their programs are still in preclinical stages. Solid Biosciences' SGT-003 has the potential to stand out thanks to its unique uDys design, which includes a nitric oxide synthase domain that could offer additional benefits.
Analyst Lee highlights that the field of DMD gene therapy is highly competitive, with approved treatments and several others in clinical trials. However, Solid Biosciences stands out with its unique approach, combining an advanced payload (uDys+nNOS) and a specialized delivery method (AAV-SLB101).
During a recent FDA-hosted meeting, parents of DMD patients voiced concerns that existing treatments, like Sarepta Therapeutics Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) Elevidys—the only approved gene therapy for DMD—are not enough.
&#8220;Based on the recent FDA hosted meeting where parents of DMD patients expressed the need for better options, we think there&#8217;s not only room but a need for better gene therapies,&#8221; the analyst said.
On Wednesday, the FDA cleared the company&#8217;s Investigational New Drug application for SGT-212 for Friedreich&#8217;s ataxia, a degenerative disease caused by insufficient frataxin protein levels.
Phase 1b trial initiation is expected in the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g42861492/solid-biosciences-announces-fda-ind-clearance-for-first-in-industry-dual-route-of-administration-g" rel="noreferrer noopener">second half 2025</a>.
Price Action: SLDB stock is up 4.7% at $4.10 at last check Wednesday.
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</ul>
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Analyst Color

Initiation

Analyst Ratings

SLDB

SRPT

Solid Biosciences Outpaces Competitors In Duchenne Gene Therapy Development (CORRECTED)

<a href="https://ldh.la.gov/news/H5N1-death#:~:text=The%20Louisiana%20Department%20of%20Health,to%20have%20underlying%20medical%20conditions.">https://ldh.la.gov/news/H5N1-death#:~:text=The%20Louisiana%20Department%20of%20Health,to%20have%20underlying%20medical%20conditions.</a>
&nbsp;
<h3>Current general public health risk remains low</h3>
January 06, 2025
The Louisiana Department of Health reports the patient who had been hospitalized with the first human case of highly pathogenic avian influenza (HPAI), or H5N1, in Louisiana and the U.S. has died. The patient was over the age of 65 and was reported to have underlying medical conditions. The patient contracted H5N1 after exposure to a combination of a non-commercial backyard flock and wild birds.&nbsp;
LDH&#39;s extensive public health investigation has identified no additional H5N1 cases nor evidence of person-to-person transmission. This patient remains the only human case of H5N1 in Louisiana.&nbsp;
The Department expresses its deepest condolences to the patient&#39;s family and friends as they mourn the loss of their loved one. Due to patient confidentiality and respect for the family, this will be the final update about the patient.&nbsp;
While the current public health risk for the general public remains low, people who work with birds, poultry or cows, or have recreational exposure to them, are at higher risk.&nbsp;
The best way to protect yourself and your family from H5N1 is to avoid sources of exposure. That means avoiding direct contact with wild birds and other animals infected with or suspected to be infected with bird flu viruses.&nbsp;
Protecting yourself and others from H5N1 infection
<ul>
<li>Do not touch sick or dead animals or their droppings and do not bring sick wild animals into your home.</li>
<li>Keep your pets away from sick or dead animals and their feces.</li>
<li>Do not eat uncooked or undercooked food. Cook poultry, eggs and other animal products to the proper temperature and prevent cross-contamination between raw and cooked food.</li>
<li>Avoid uncooked food products such as unpasteurized raw milk or cheeses from animals that have a suspected or confirmed infection.</li>
<li>If you work on poultry or dairy farms, talk to your provider about getting your seasonal flu vaccination. It will not prevent infection with avian influenza viruses, but it can reduce the risk of coinfection with avian and flu viruses.</li>
<li>Report dead or sick birds or animals to the USDA toll-free at 1-866-536-7593 or the Louisiana Department of Agriculture and Forestry Diagnostic Lab at 318-927-3441.</li>
</ul>
If you have been exposed to sick or dead birds or other animals or work on a farm where avian influenza has been detected, watch for respiratory symptoms or conjunctivitis. If you develop symptoms within 10 days after exposure to sick or dead animals, tell your healthcare provider that you have been in contact with sick animals and are concerned about avian influenza. This will help them give you appropriate advice on testing and treatment. Stay home and away from others while you have symptoms.

NNVC

'LDH Reports First U.S. H5N1-Related Human Death' - Louisiana Department Of Health

CVS Health Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>) subsidiary, Aetna Inc., has filed a lawsuit against more than 20 generic drug manufacturers. The lawsuit alleges a coordinated scheme to fix prices, <a href="https://www.benzinga.com/topic/drug-prices">allocate markets, and stifle competition</a>.
The result was a significant overcharge for essential medications.
Defendants include Teva Pharmaceutical Industries Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>), Amneal Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMRX#NASDAQ">AMRX</a>), Dr. Reddy&#8217;s Laboratories Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Viatris, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTRS#NASDAQ">VTRS</a>), among others.
The <a target="_blank" href="https://civilinquiry.jud.ct.gov/DocumentInquiry/DocumentInquiry.aspx?DocumentNo=29056426" rel="noreferrer noopener">lawsuit</a> accuses the defendants of orchestrating one of the largest price-fixing conspiracies in U.S. history, causing inflated drug prices and widespread harm to consumers, insurers, and the healthcare system.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42600472/your-healthcare-costs-are-soaring-us-spending-reached-5-trillion-in-2023-with-major-increase-in-obesity-and-diabetes-drugs-hospital-services" rel="noreferrer noopener">Your Healthcare Costs are Soaring! US Spending Reached $5 Trillion In 2023 with Major Increase in Obesity and Diabetes Drugs, Hospital Services</a>
The lawsuit claims that these pharmaceutical companies colluded to artificially raise generic drug prices by as much as 2,762%.
Examples include clomipramine (2,600% increase), nadolol (+2,762%), and oxybutynin chloride (up to 1,500%).
Aetna alleges this conspiracy exploited market conditions, fostered cronyism, and suppressed competition, while depriving third-party payers like Aetna of expected cost savings.
According to the complaint, the defendants utilized secretive methods to implement their price-fixing strategies. These included in-person meetings, private phone calls, and strategic coordination during trade association events. Evidence of collusion was deliberately minimized, with written communications often destroyed to evade detection.
Central to the allegations is the so-called &#8220;fair share&#8221; system, which allocated market share and dictated price increases among competitors. This strategy, referred to as the &#8220;rules of engagement,&#8221; ensured that generic drugmakers avoided undercutting one another, thereby maintaining inflated prices. In some cases, competitors allegedly submitted cover bids to maintain an artificial equilibrium in the market.
The lawsuit highlights Teva Pharmaceuticals as an example of this practice, alleging the company collaborated with select &#8220;high-quality&#8221; competitors to lead and follow each other&#8217;s price hikes.
This agreement reportedly extended to various drugs, enabling the companies to dominate the market and secure extraordinary profits.
Aetna contends that the defendants&#8217; actions have severely impacted the U.S. healthcare system, driving up costs for insurers, consumers, and government programs like Medicare Part D.
The insurer is seeking treble damages and injunctive relief under state antitrust and unfair competition laws to recover losses and prevent future anticompetitive practices.
Price Action: CVS stock is up 2.31% at $46.85 at last check Monday.
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Image: Shutterstock

AMRX

TEVA

VTRS

CVS Health's Aetna Files Lawsuit Against Drugmakers For Alleged Inflated Generic Drug Prices

This pivotal study assessed the efficacy and safety of investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in treatment-naïve patients with spinal muscular atrophy (SMA) Type 2, aged two to less than 18 years who are able to sit but have never walked independently.
Efficacy and safety results for OAV101 IT were compared against a sham control, a procedure designed to mimic the administration of an investigational drug, without delivering any active treatment.

Reported Earlier, Novartis Reports Topline Results From Phase III STEER Study; Study Met Its Primary Endpoint

According to a report, U.S. healthcare spending grew by 7.5% to $4.9 trillion in 2023. The increase was fueled by higher enrollment in private health plans and expanded use of medical services, driven by legislative changes and post-pandemic rebounds in care utilization.
Healthcare spending accounted for 17.6% of the U.S. economy, outpacing GDP growth of 2.9%. Spending on retail prescription drugs <a target="_blank" href="https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2024.01375" rel="noreferrer noopener">saw</a> the most significant rise, jumping 11.4% to $449.7 billion.
The report attributed this to increased use of medications for obesity and diabetes.
Also Read: <a target="_blank" href="https://www.benzinga.com/government/regulations/24/11/41866438/donald-trumps-second-term-could-reshape-us-healthcare-system-with-major-impacts-on-affordable-care-act-and-medicare" rel="noreferrer noopener">Donald Trump&#8217;s Second Term Could Reshape US Healthcare System, With Major Impacts on Affordable Care Act And Medicare</a>
The rapid growth in spending for drugs used to treat diabetes and obesity contributed to faster overall growth in retail prescription drug expenditures and private health insurance and Medicare spending growth.
Hospital care spending rose 10.4% to $1.5 trillion in 2023, marking the fastest growth since 1990. Hospital discharges increased by 1.6%, with Medicare beneficiaries driving higher outpatient service utilization.
Spending on physician and clinical services also climbed by 7.4% to $978 billion, with private insurance and Medicare patients contributing to this rise.
Enrollment in private health insurance grew by 1.6%, adding 3.3 million Americans.
Private insurance spending surged by 11.5%, reaching $1.5 trillion and accounting for 30% of national healthcare expenditures.
Medicare spending grew 8.1% to $1 trillion, representing 21% of total healthcare spending. Medicaid spending, however, grew more slowly at 7.9%, reflecting the end of the COVID-19 public health emergency.
The report also revealed that 92.5% of Americans had health insurance in 2023, up from 92.0% in 2022, underscoring the broader coverage expansion in recent years.
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Photo by MargJohnsonVA via Shutterstock

Government

streetTRACKS Dow Jones U.S. Large Cap Value Index Fund

iShares Dow Jones US Pharmaceuticals Index Fund

iShares Dow Jones US Health Care Provides Index Fund

iShares Trust Dow Jones US Healthcare Sector Index Fund

Your Healthcare Costs are Soaring! US Spending Reached $5 Trillion In 2023 with Major Increase in Obesity and Diabetes Drugs, Hospital Services

<a href="https://www.gov.ca.gov/2024/12/18/governor-newsom-takes-proactive-action-to-strengthen-robust-state-response-to-bird-flu/#:~:text=What%20you%20need%20to%20know,ongoing%20cross%2Dagency%20response%20efforts" title="https://www.gov.ca.gov/2024/12/18/governor-newsom-takes-proactive-action-to-strengthen-robust-state-response-to-bird-flu/#:~:text=What%20you%20need%20to%20know,ongoing%20cross%2Dagency%20response%20efforts">https://www.gov.ca.gov/2024/12/18/governor-newsom-takes-proactive-action-to-strengthen-robust-state-response-to-bird-flu/#:~:text=What%20you%20need%20to%20know,ongoing%20cross%2Dagency%20response%20efforts</a>

CA Governor Newsom Proclaimed State Of Emergency To Further Enhance State's Preparedness And Accelerate The Bird Flu Cross-Agency Response Efforts

<a href="https://www.cdc.gov/bird-flu/situation-summary/index.html" title="https://www.cdc.gov/bird-flu/situation-summary/index.html">https://www.cdc.gov/bird-flu/situation-summary/index.html</a>

Macro Economic Events

Economics

CDC Confirms First Severe Case Of H5N1 Bird Flu In U.S. On December 13; Patient Hospitalized With Severe Case Of Avian Influenza A Virus Infection In Louisiana

Collaboration will leverage BioAge's differentiated human longevity data and platform and Novartis expertise in the biology of physical exercise to identify drug targets to treat diseases related to aging
Novartis to pay up to $20M comprising upfront payments and research funding; BioAge may receive up to $530M in future long-term research, development, and commercial milestones
RICHMOND, Calif., Dec. 18, 2024 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced a multi-year research collaboration with Novartis. The collaboration aims to identify and validate multiple novel therapeutic drug targets by investigating the biological mechanisms that drive diseases related to aging and mediate the beneficial effects of physical exercise.

Contracts

BIOA

BioAge Labs Announces Multi-Year Collaboration With Novartis To Discover Novel Targets For Therapies That Address Age-Related Diseases And Conditions; Novartis To Pay Up To $20M Comprising Upfront Payments And Research Funding; BioAge May Receive Up To $530M In Future Long-Term Research, Development, And Commercial Milestones

The Institute for Clinical and Economic Review (ICER) has identified five prescription drugs whose price increases in 2023 lacked sufficient clinical evidence to justify the hikes.
Gilead Sciences Inc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>) Biktarvy, Johnson &amp; Johnson's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) Darzalex, Novartis AG's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Entresto, Exelixis Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EXEL#NASDAQ">EXEL</a>) Cabometyx, and Pfizer Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Xeljanz are among the five drugs flagged for unsupported price increases.
These five drugs' unsupported net price increases <a target="_blank" href="https://icer.org/news-insights/press-releases/icer-announces-most-significant-drug-price-hikes-unsupported-by-new-clinical-evidence-in-us/" rel="noreferrer noopener">produced</a> $815 million in incremental added costs to U.S. payers in 2023. These price increases contributed significantly to the overall spending surge.
ICER's analysis <a target="_blank" href="https://icer.org/wp-content/uploads/2024/12/UPI_2024_Report_121224.pdf" rel="noreferrer noopener">revealed</a> that the other five drugs on the list did demonstrate new clinical evidence to justify their increased costs.
Merck &amp; Co Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Keytruda, AstraZeneca Plc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Imfinizi and Tagrisso, Bristol Myers Squibb &amp; Co's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Opdivo, and Amgen Inc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) Prolia
The findings are part of ICER's latest Unsupported Price Increases (UPI) report, which examines the top 10 drugs with significant net price increases in the past year.
ICER's Vice President of Research, Dr. Foluso Agboola, highlighted the impact of these price hikes, noting they exceed inflation rates and strain the healthcare system.
The ICER report highlighted that Gilead's Biktarvy saw its wholesale acquisition cost increase by 5.9%, with its hike costing U.S. payers $359 million in additional drug spending.
According to the ICER report, the Darzalex price before discounts increased by 7.6%, compared to 6.2% for Entresto, 7.5% for Cabometyx, and 6% for Xeljanz.
Those price increases added an additional $190 million, $108 million, $86 million, and $72 million to 2023 U.S. drug spending, respectively.
Methodology Behind ICER's Findings
<ul>
<li>ICER's evaluation followed a detailed protocol introduced in April 2024. The organization assessed drugs meeting criteria such as ranking among the top 250 by U.S. sales revenue and exceeding consumer price index growth plus 2% in their Wholesale Acquisition Cost.</li>
<li>The analysis focused on distinguishing price increases driven by value from those unrelated to new clinical evidence.</li>
<li>Manufacturers provided input, and ICER reviewed published studies for evidence of additional health benefits.</li>
</ul>
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</ul>
Photo by MargJohnsonVA via Shutterstock

Media

AMGN

EXEL

GILD

Drug Price Hikes Unsupported By Evidence Cost US $815 Million: ICER Report

<ul>
<li>Scemblix demonstrated sustained superior major molecular response (MMR) vs. all investigator-selected TKIs (74.1% vs. 52%) and vs. imatinib alone (76.2% vs. 47.1%), meeting both ASC4FIRST 96-week key secondary endpoints.</li>
<li>Scemblix showed a clinically relevant 15.1% higher MMR rate vs. second generation (2G) TKIs (72.0% vs. 56.9%).</li>
<li>96-week data extend favorable safety and tolerability profile for Scemblix vs. imatinib and 2G TKIs, with fewer grade ≥3 AEs and less than half the discontinuation rate due to AEs.</li>
</ul>

On Saturday, Novartis Announced Longer-term Results From Phase 3 ASC4FIRST Trial Of Scemblix (Asciminib) Compared To Standard-Of-Care Tyrosine Kinase Inhibitors And Imatinib Alone In Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia

On Friday, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) revealed topline results from the APPULSE-PNH Phase 3B study of Fabhalta&nbsp;(iptacopan) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who were switched from anti-C5 therapies (Hb ≥10g/dL following treatment with eculizumab or ravulizumab).
Ultomiris (ravulizumab) and Soliris&nbsp;(eculizumab) are commonly used anti-C5 therapies, and they are made by AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>).
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/10/41634528/positive-outlook-for-novartis-as-company-capitalizes-on-growing-treatment-opportuni" rel="noreferrer noopener">Positive Outlook For Novartis As Company Capitalizes On Growing Treatment Opportunities, Analyst Highlights</a>
PNH is a rare complement-mediated blood disorder. People with PNH have an acquired mutation in some of their hematopoietic stem cells, which are located in the bone marrow and can grow and develop into red blood cells, white blood cells, and platelets.
This mutation <a target="_blank" href="https://www.novartis.com/news/media-releases/new-phase-iiib-data-shows-novartis-fabhalta-improved-hemoglobin-levels-adult-patients-paroxysmal-nocturnal-hemoglobinuria-who-switched-from-anti-c5-therapy" rel="noreferrer noopener">causes</a> them to produce RBCs that are susceptible to premature destruction by the complement system.
After 24 weeks of treatment with Fabhalta, the average hemoglobin (Hb) level improved compared to baseline. The study&#8217;s safety profile of Fabhalta monotherapy was consistent with previously reported data.
Data will be presented at an upcoming medical meeting in 2025.
The FDA recently granted accelerated approval for Fabhalta to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, and development is ongoing in multiple complement-mediated diseases.
Last month, Novartis raised its mid-term sales guidance, increasing its compound annual growth rate (CAGR) target to 6% from 5% <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/42115127/novartis-confident-in-growth-as-it-elevates-midterm-sales-forecast-ceo-narasimhan-highlights-robust-pipeline-supporting-long-term-strategy" rel="noreferrer noopener">for 2023-2028</a>.
The upgrade reflects performance from current growth drivers and anticipated launches, many of which are expected to retain U.S. exclusivity into the 2030s.
Earlier this week, PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) signed an exclusive global license and collaboration agreement with&nbsp;Novartis for its PTC518 Huntington&#8217;s disease program, which&nbsp;<a target="_blank" href="https://www.benzinga.com/24/12/42272846/ptc-therapeutics-inks-licensing-pact-with-novartis-worth-3-billion-for-huntingtons-program" rel="noreferrer noopener">includes related molecules</a>.
Under the agreement, PTC will receive an upfront payment of $1.0 billion, up to $1.9 billion in development, regulatory and sales milestones, a profit share in the U.S., and double-digit tiered royalties on ex-U.S. sales.
<h2 class="wp-block-heading">Is Novartis A Good Stock To Buy?</h2>
Wall Street analysts view Novartis on the whole as a Neutral, given the history of coverage over the past three months. Graham Perry from B of A Securities in Novartis is the most bearish, expecting a 3.7% fall in the stock in the coming year.
But looking at how the market as a whole thinks of the stock, you can reference historical price action for views on whether investors feel strongly about the stock one way or another. In the past 3 months, Novartis fell 12.4%, which indicates that opinion soured on the business and how attractive it is to own based on either its stock price, or underlying fundamentals, like revenue, which rose 8.84% over the past year.
A complete overview of how Wall Street views individual stocks is available <a href="https://www.benzinga.com/analyst-stock-ratings">here</a>, while real time updates on the latest analyst actions will be delivered via <a href="https://pro.benzinga.com">Benzinga PRO</a>. Try it for free.
Price Action: At the last check on Friday, NVS stock was up 0.18% to $102.34.
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Photo by Taljat David via Shutterstock

PTCT

Novartis Touts Encouraging Data From Late-Stage Study For Fabhalta In Rare Type Of Blood Disorder

<a href="https://x.com/leahjdouglas/status/1865080809100582944" title="https://x.com/leahjdouglas/status/1865080809100582944">https://x.com/leahjdouglas/status/1865080809100582944</a>

Reuters Agriculture & Energy Policy Reporter Leah Douglas Posts On X "SCOOP: The USDA is issuing a federal order mandating the national milk supply be tested for bird flu. Testing will begin Dec. 16 in six states: CA, CO, MI, MS, PA, OR. Bird flu has infected nearly half of dairy farms in California, the top milk state."

Novartis Announced Topline Results From The APPULSE-PNH Phase 3B Study Of Twice-daily Oral Monotherapy Fabhalta (Iptacopan) In Paroxysmal Nocturnal Hemoglobinuria Patients Who Were Switched From Anti-C5 Therapies, After 24 Weeks Of Treatment With Fabhalta, The Average Hb Level Improved Versus Baseline

On Monday, Janux Therapeutics, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JANX#NASDAQ">JANX</a>) revealed updated interim clinical data for its <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/b42277571/janux-announces-doses-selected-for-phase-1b-expansion-trials-supported-by-encouraging-efficacy-and" rel="noreferrer noopener">JANX007 clinical program</a>.
&#8220;These clinical data show substantial activity with JANX007 in 5L metastatic castration-resistant prostate cancer patients and provide compelling support for the doses we&#8217;ve selected for expansion trials directed at pre-PLUVICTO 2L and 3L patients,&#8221; said David Campbell, president and CEO of Janux Therapeutics.
Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Pluvicto is a radiopharmaceutical used to treat adults with prostate-specific membrane antigen­–­positive metastatic castration-resistant prostate cancer.
The patients enrolled in the trial were heavily pretreated with a median of four prior lines of therapy.
High prostate-specific antigen (PSA) response rates and deep PSA declines were observed across all doses; 100% of patients achieved the best PSA50&nbsp;declines, 63% achieved the best PSA90&nbsp;declines, and 31% achieved the best PSA99&nbsp;declines.
Durability of PSA declines at a target dose ≥ 2 mg was observed; 75% of patients maintained PSA50&nbsp;declines at ≥ 12 weeks, and 50% of patients maintained PSA90&nbsp;declines at ≥ 12 weeks.
Deep and durable PSA responses were observed irrespective of resistance driver aberration status or prior treatments.
Anti-tumor activity was observed with confirmed and unconfirmed partial responses in 50% (4/8) of patients.
JANX007 was well-tolerated with cytokine release syndrome (CRS) and CRS-related adverse events primarily limited to cycle 1 and grades 1 and 2. The maximum tolerable dose for JANX007 has not yet been reached.
Based on these efficacy and safety results, two once-weekly step dose regimens have been identified for Phase 1b expansion trials directed at pre-Pluvicto 2L and 3L patients.
Janux anticipates providing another update on JANX007 in 2025.
William Blair analysts, in a Tuesday research note, wrote, &#8220;We believe the results exceed even lofty investor expectations.&#8221;
The analysts increased the peak sales estimate for JANX007 in the U.S. from $1.7 billion to $3 billion based on the drug&#8217;s improving clinical profile and <a href="https://www.benzinga.com/quote/JANX/analyst-ratings" target="_blank" rel="noreferrer noopener">reiterated its Outperform rating</a>.
Despite the strong year-to-date share appreciation, Janux shares continue to have meaningful upside potential, they said. 
&#8220;The updated results with JANX007 continue to support a best-in-disease profile, with strong safety and efficacy in heavily pretreated mCRPC patients,&#8221; they added. 
Price Action: JANX stock is up 69.2% at $68 during the premarket session at last check Tuesday.
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JANX

Janux Therapeutics' Prostate Cancer Trial Data Exceeds Investor Expectations: Analyst

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