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Novartis

Novartis develops and manufactures innovative drugs. 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.

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The U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval for Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">rapid disease progression</a>.
Vanrafia is a once-daily, non-steroidal, oral treatment that can be added to supportive care, including a renin-angiotensin system inhibitor with or without a sodium-glucose co-<a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/n44619827/novartis-receives-fda-accelerated-approval-for-vanrafia-atrasentan-the-first-and-only-selective-en" rel="noreferrer noopener">transporter-2 inhibitor</a>.
Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase 3 ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44592342/apellis-pharmaceuticals-rare-kidney-disease-drug-under-fda-review-seeks-to-compete-novartis-recently-approved-drug" rel="noreferrer noopener">FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals</a>
It has not been established whether Vanrafia slows kidney function decline in patients with IgAN.
The continued approval of Vanrafia may be contingent upon verifying clinical benefit from the ongoing Phase 3 ALIGN study evaluating whether Vanrafia slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline at week 136.
The eGFR data are expected in 2026 and are intended to support traditional FDA approval.
In the ongoing Phase 3 ALIGN study, patients receiving Vanrafia in combination with a RAS inhibitor achieved clinically meaningful and statistically significant proteinuria reduction of 36.1% compared to placebo, with results seen as early as week 6 and sustained through week 36.
A similar treatment effect of Vanrafia was seen in an additional group of patients treated with both an RAS inhibitor and an SGLT2 inhibitor (37.4% reduction in UPCR vs. placebo).
The ALIGN study showed that Vanrafia has a favorable safety profile consistent with previously reported data.
This is Novartis&#8217;s third U.S. approval for its kidney disease portfolio in the last year. Fabhalta&nbsp;was granted FDA approval in <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44544720/fda-oks-novartis-prostate-cancer-treatment-triples-eligible-patient-pool" rel="noreferrer noopener">C3 glomerulopathy in&nbsp;March 2025</a> and accelerated approval in <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40254535/fda-approves-expanded-use-of-novartis-rare-disease-drug-fabhalta-for-kidney-disease" rel="noreferrer noopener">IgAN in&nbsp;August 2024</a>.
Fabhalta is also being studied in rare kidney diseases, including atypical hemolytic uremic syndrome, immune complex membranoproliferative glomerulonephritis, and lupus nephritis.
An investigational subcutaneously administered anti-APRIL monoclonal antibody, zigakibart, is currently in Phase 3 development in IgAN, with results expected in 2026.
Price Action: NVS stock is up 2.16% at $113.17 at the last check Thursday.
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Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year

<ul>
<li>Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program1</li>
<li>Phase III data showed Vanrafia achieved proteinuria reduction of 36.1% (P&lt;0.0001) vs. placebo with improvements seen at Week 6 and sustained through Week 36 and favorable safety1,2</li>
<li>IgAN is a progressive, rare kidney disease; up to 50% of patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis3-9</li>
<li>With third FDA approval in under 1 year across its renal portfolio, Novartis is uniquely positioned to lead a transformation in kidney care</li>
</ul>

Reported Earlier, Novartis Gains FDA Accelerated Approval For Vanrafia, The First Selective ETA Receptor Antagonist For Proteinuria Reduction In IgA Nephropathy

The U.S. Food and Drug Administration (FDA) on Tuesday accepted and granted Priority Review designation to Apellis Pharmaceuticals, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APLS#NASDAQ">APLS</a>) supplemental New Drug Application (sNDA) for Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative <a href="https://www.benzinga.com/general/health-care">glomerulonephritis (IC-MPGN)</a>.
C3G and primary IC-MPGN are rare kidney diseases. Excessive C3c deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe.
Also Read: <a href="https://www.benzinga.com/general/biotech/25/03/44383078/jp-morgan-cut-apellis-price-forecasts-cites-longer-peak-sales-timing-for-syfovre" target="_blank" rel="noreferrer noopener">JPMorgan Cut Apellis&#8217; Price Forecasts, Cites Longer Peak Sales Timing For Syfovre</a>
The Prescription Drug User Fee Act (PDUFA) target action <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44581423/apellis-announces-fda-acceptance-and-priority-review-of-the-supplemental-new-drug-application-for-" rel="noreferrer noopener">date is July 28, 2025</a>.
The supplemental application submission supported by Phase 3 VALIANT results at Week 26:
<ul>
<li>Proteinuria reduction:&nbsp;The study met its primary endpoint, demonstrating a statistically significant 68% (p&lt;0.0001) proteinuria reduction in Empaveli-treated patients compared to placebo.</li>
<li>Stabilization of kidney function:&nbsp;Empaveli-treated patients achieved stabilization of kidney function (nominal p=0.03) as measured by eGFR.</li>
<li>Reduction of C3c staining:&nbsp;A substantial proportion of Empaveli-treated patients achieved a reduction in C3c staining intensity (nominal p&lt;0.0001).&nbsp;71% of Empaveli-treated patients showed complete clearance of C3c staining compared to placebo.</li>
</ul>
Empaveli showed favorable safety and tolerability, which is consistent with its established profile.
William Blair writes, &#8220;We believe the recent approval of Fabhalta (iptacopan) for the treatment of adults with C3G bodes well for an approval of Empaveli given it demonstrated what we believe is best-in-class data and did so in a broader population that included adolescents, patients with IC-MPGN, and post-transplant patients, which should support a broader label and larger addressable market.&#8221;
In March, the FDA approved Novartis AG&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) oral Fabhalta&nbsp;(iptacopan) for adults with C3 glomerulopathy (C3G) to reduce proteinuria (protein in the urine), making it the first and only treatment&nbsp;<a target="_blank" href="https://www.benzinga.com/25/03/44439352/fda-approves-expanded-use-of-novartis-rare-disease-drug-as-only-treatment-for-rare-type-of-kidney-disease" rel="noreferrer noopener">approved for this condition</a>.
Price Action: APLS stock is up 8.05% at $23.63&nbsp;at the last check Tuesday.
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FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals

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Trump Administration Health Agency Firings Include Staff Overseeing Bird Flu Response

The U.S. Food and Drug Administration (FDA) on Friday approved Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Pluvicto for <a href="https://www.benzinga.com/topic/fda-0">prostate cancer patients</a>.
The <a href="https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer" target="_blank" rel="noreferrer noopener">expanded</a> indication, which approximately triples the number of patients eligible to receive Pluvicto, is based on the Phase 3 PSMAfore trial results.
The patients have prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) and have been treated with an androgen receptor pathway inhibitor (ARPI) therapy.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44439352/fda-approves-expanded-use-of-novartis-rare-disease-drug-as-only-treatment-for-rare-type-of-kidney-disease" rel="noreferrer noopener">FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease</a>
In the study, Pluvicto (lutetium Lu 177 vipivotide tetraxetan) reduced the risk of radiographic progression or death by 59% compared to a change in ARPI in patients with PSMA-positive mCRPC after treatment with ARPI therapy.
At an updated exploratory analysis, Pluvicto more than doubled median radiographic progression-free survival (11.6 months vs. 5.6 months).
In PSMAfore, the final overall survival (OS) analysis numerically favored Pluvicto, with a hazard ratio of 0.91, but was not statistically significant.
The OS analysis was confounded by the high rate of patients who crossed over from the control arm to Pluvicto (60.3%). When adjusted for crossover, the OS hazard ratio was 0.59.
Additional findings from the PSMAfore study showed Pluvicto demonstrated a consistent and favorable safety profile.
In March 2022, the FDA approved Pluvicto for adult patients with advanced PSMA-positive mCRPC that has spread to <a target="_blank" href="https://www.benzinga.com/general/biotech/22/03/26274467/fda-approves-novartis-pluvicto-as-first-targeted-radioligand-therapy-for-prostate-cancer" rel="noreferrer noopener">other body parts (metastatic)</a>.
These patients have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).
Novartis is investigating Pluvicto in earlier stages of the disease, including metastatic hormone-sensitive prostate cancer (PSMAddition) and oligometastatic prostate cancer (PSMA-DC).
Price Action: NVS stock is up 0.81% at $112.30 at the last check Friday.
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FDA OKs Novartis Prostate Cancer Treatment, Triples Eligible Patient Pool

The Association of the British Pharmaceutical Industry (ABPI) is urging ministers to address excessive levies on manufacturers to ensure the sector remains competitive globally.
The life sciences industry, a key pillar of the UK&#8217;s economic strategy, could struggle to attract investment unless payment rates are adjusted.
Last week, the government <a href="https://www.abpi.org.uk/media/news/2025/march/uk-set-to-demand-a-third-of-pharmaceutical-company-revenue-in-second-half-of-2025/" target="_blank" rel="noreferrer noopener">proposed</a> raising the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies&#8217; National Health Service (NHS) sales in the second half of 2025.
The payment rate is the revenue companies must hand back to the government on their sales of branded medicines to the NHS. It is an additional charge to the taxes paid by companies.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44362710/uk-pharma-industry-trade-association-restores-wegovyozempic-maker-novo-nordisks-membership-after-two-years-of-suspension" rel="noreferrer noopener">UK Pharma Industry Trade Association Restores Wegovy/Ozempic Maker Novo Nordisk&#8217;s Membership After 2 Years Of Suspension</a>
UK pharmaceutical leaders from Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), Boehringer Ingelheim, Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), Daiichi Sankyo Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>), Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</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>), Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) and UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) point to the challenges to investing in the U.K.
The pharmaceutical sector <a target="_blank" href="https://www.abpi.org.uk/media/news/2025/march/medicine-levy-makes-the-uk-un-investable-say-pharma-leaders/" rel="noreferrer noopener">contributes</a> over 17.6 billion pounds ($22.76 billion) directly to the U.K. economy, with an additional 45 billion generated through research and development spillovers.
However, companies argue that growth is being stifled due to escalating mandatory payments. Under the current system, firms must pay between 23.5% and 35.6% of their branded medicine sales revenue to the NHS. This is significantly higher than other European nations, where comparable rates range from 5.7% to 9%, ABPI writes.
The ABPI report highlights that while the UK once led in medicine availability, it has slipped to ninth place in Europe over the past decade. One year after launch, medicine usage in England is only 52% of the average of comparable nations, rising to 62% after five years.
Additionally, the UK has dropped from fourth to tenth in global rankings for phase 3 clinical trials, lagging behind Spain, Germany and Italy.
Investment in UK pharmaceutical research has also declined, with the country&#8217;s share of global R&amp;D investment falling from 7.3% to 5.7% in just three years.
This marks the fastest decline of any European G7 nation. Meanwhile, NHS funding has grown by 33% in real terms over the past decade, but spending on branded medicines has been capped at annual growth rates between 1.1% and 2%, declining by 11% when adjusted for inflation.
The industry and government have long collaborated on agreements to ensure NHS access to medicines.
The latest, the Voluntary Scheme for Branded Medicines, Pricing, Access, and Growth (VPAG), was intended to realign UK payment rates with international standards. While rates for newer medicines briefly dropped to 15.1% in 2024, they surged again in 2025 to 23.5% for newer medicines, with companies still paying 10.6%-35.6% for older products.
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Pharmaceutical Firms Say UK Investment Is 'Unlikely' Unless Payment Levy Is Adressed

On Thursday, the U.S. Food and Drug Administration (FDA) approved Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) oral Fabhalta&nbsp;(iptacopan) for adults with C3 glomerulopathy (C3G) to reduce proteinuria (protein in the urine), making it the first and only treatment <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">approved for this condition</a>.
C3G is&nbsp;a rare kidney disease characterized by damage to the glomeruli (kidney filters) due to dysregulation of the complement system, specifically the alternative pathway, leading to C3 protein accumulation.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44402261/novartis-new-data-from-single-dose-gene-therapy-shows-meaningful-efficacy-safety-in-patients-with-spinal-muscular-atrophy" rel="noreferrer noopener">Novartis New Data From Single-Dose Gene Therapy Shows Meaningful Efficacy, Safety In Patients With Spinal Muscular Atrophy</a>
The pivotal Phase 3 APPEAR-C3G study <a target="_blank" href="https://www.novartis.com/us-en/news/media-releases/novartis-receives-third-fda-approval-oral-fabhalta-iptacopan-first-and-only-treatment-approved-c3-glomerulopathy-c3g" rel="noreferrer noopener">evaluated</a> the efficacy and safety of twice-daily oral Fabhalta in adult patients with C3G.
Treatment with Fabhalta resulted in a clinically meaningful reduction in proteinuria, which was seen as early as 14 days and sustained at 12 months.
Similarly, in the open-label period, proteinuria reduction was seen in participants who switched to Fabhalta.
Last month, Fabhalta received a positive CHMP Opinion in C3G by the European Medicines Agency (EMA). Regulatory reviews for this indication are ongoing in&nbsp;China&nbsp;and Japan.&nbsp;
This is the third US approval for Fabhalta and its second within the Novartis kidney disease portfolio since&nbsp;August 2024, when Fabhalta was granted accelerated approval by the FDA for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
Continued approval for this indication is contingent upon confirmatory evidence.
Fabhalta received its first FDA approval in&nbsp;December 2023&nbsp;for adults with paroxysmal nocturnal hemoglobinuria (PNH).
In the fourth quarter of 2024, Fabhalta generated <a target="_blank" href="https://www.benzinga.com/general/health-care/25/01/43380284/novartis-q4-earnings-beat-estimates-ceo-dismisses-entresto-patent-expiration-worries" rel="noreferrer noopener">sales of $57 million</a>.
In addition to Fabhalta, Novartis is advancing the late-stage development of two additional IgAN therapies with highly differentiated mechanisms of action: atrasentan, an investigational oral endothelin A receptor antagonist that received FDA filing acceptance in Q2 2024 with a decision anticipated in H1 2025, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody currently in Phase 3 development.&nbsp;
Price Action: NVS stock is down 0.45% at $112.70 at the last check Friday.
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FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease

<ul>
<li>Phase III study showed sustained proteinuria reduction at one year with favorable safety1</li>
<li>Fabhalta is the only oral alternative complement pathway inhibitor thought to target the underlying cause of C3G1-3</li>
<li>C3G is an ultra-rare kidney disease typically diagnosed in young adults and often progresses to kidney failure2-4</li>
<li>Novartis continues to advance multiple kidney disease treatments with high unmet need, compounding capabilities and strengthening unique leadership presence</li>
</ul>

Reported Earlier, Novartis Secures Third FDA Approval For Oral Fabhalta In Rare Kidney Disease C3G

Monte Rosa Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GLUE#NASDAQ">GLUE</a>) on Thursday revealed clinical results from its MRT-6160 Phase 1 single ascending dose/multiple ascending <a href="https://www.benzinga.com/general/biotech" target="_blank" rel="noreferrer noopener">dose (SAD/MAD) study</a>.
The study objectives were to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics, including VAV1 degradation and its impact on T and B cell function <a href="https://www.benzinga.com/pressreleases/25/03/g44413112/monte-rosa-therapeutics-announces-fourth-quarter-2024-financial-results-and-provides-corporate-upd" target="_blank" rel="noreferrer noopener">following ex vivo stimulation</a>.
Results demonstrated sustained, dose-dependent VAV1 degradation of greater than 90% in peripheral blood T cells after single and multiple dose administration. Similar results were observed in peripheral blood B cells.
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Sustained suppression of TCR-mediated T and B cell activation measured by CD69 was observed following single and multiple dose administration and&nbsp;ex vivo&nbsp;activation of whole blood.
<ul>
<li>MRT-6160 also inhibited the secretion of inflammatory cytokines by up to 99% from whole blood-derived T cells following&nbsp;ex vivo&nbsp;activation of TCR. It demonstrated significant and sustained attenuation of IL-6 production across dose levels following B cell stimulation.</li>
<li>The administration of MRT-6160 was generally well-tolerated, and no serious adverse effects were observed.</li>
<li>The current Phase 1 data and chronic toxicology package support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases.</li>
</ul>
Further development of MRT-6160 toward Phase 2 studies is ongoing in collaboration with Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>).
In October 2024, Monte Rosa Therapeutics announced a global exclusive development and commercialization license agreement with&nbsp;Novartis&nbsp;to advance VAV1 MGDs,&nbsp;<a target="_blank" href="https://www.benzinga.com/markets/equities/24/10/41573834/why-is-monte-rosa-therapeutics-stock-surging-on-monday" rel="noreferrer noopener">including MRT-6160</a>.
Novartis has agreed to pay Monte Rosa $150 million upfront. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory and sales milestones, beginning upon initiation of Phase 2 studies and tiered royalties on ex-U.S. net sales.
The company says cash, cash equivalents, restricted cash and marketable securities as of Dec. 31, 2024, of $377 million is expected to provide a cash runway into 2028.
GLUE Price Action: Monte Rosa Therapeutics stock is up 5.11% at $7.04 at publication Thursday.
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Novartis Partner Monte Rosa Therapeutics Touts Positive Data From Early-Stage Study Of Investigational Drug Candidate For Immune-Mediated Disorders

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Ird Nvs pus Genetics Inc Filed Complaint For Patent Infringement Of Certain Ryzumvi Patents Against Sandoz In District Of New Jersey; Complaint Seeks, Among Other Relief, Equitable Relief Enjoining Sandoz From Infringing Ryzumvi Patents

On Wednesday, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) announced safety and efficacy results from the Phase 3 program for investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad population of patients aged two to &lt;18 years with <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">spinal muscular atrophy (SMA)</a>.
In the Phase 3 STEER study, <a target="_blank" href="https://www.novartis.com/news/media-releases/new-novartis-phase-iii-data-demonstrate-meaningful-efficacy-and-safety-results-intrathecal-onasemnogene-abeparvovec-broad-patient-population-sma" rel="noreferrer noopener">treatment</a> with OAV101 IT led to a statistically significant 2.39-point improvement on the Hammersmith Functional Motor Scale Expanded (HFMSE), an assessment of motor ability and disease progression, vs. 0.51 points in the sham control arm.
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Novartis <a target="_blank" href="https://www.novartis.com/news/media-releases/novartis-intrathecal-onasemnogene-abeparvovec-phase-iii-study-meets-primary-endpoint-children-and-young-adults-sma" rel="noreferrer noopener">released</a> topline data from the Phase 3 STEER study in December 2024.
In the Phase 3b STRENGTH study, treatment with OAV101 IT in patients who have discontinued treatment with Biogen Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) Spinraza (nusinersen) or Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Evrysdi (risdiplam) demonstrated stabilization of motor function over 52 weeks of follow-up.
The results add to the growing body of evidence within the OAV101 IT development program, which has evaluated a broad population of over 170 patients with SMA, spanning a total of over 6.4 years across the STEER, STRENGTH, and Phase 1/2 STRONG studies.
OAV101 IT is an investigational gene replacement therapy designed to directly address the genetic root cause of the disease by replacing the nonworking&nbsp;SMN1 gene with a single dose.
In the registrational STEER study, efficacy and safety were studied in treatment naïve patients with SMA Type 2, aged two to less than 18 years, who could sit but had never walked independently. Key findings:
<ul>
<li>The trial met its primary endpoint of change from baseline to 52 weeks in HFMSE score, with OAV101 IT demonstrating a statistically significant 2.39-point improvement on the HFMSE vs 0.51 points in the sham group.</li>
<li>All secondary endpoints consistently favor OAV101 IT, despite not achieving statistical significance due to the pre-planned multiple testing procedure.</li>
</ul>
The open-label Phase 3b STRENGTH study evaluated the safety, tolerability and efficacy of OAV101 IT in patients with SMA aged two to less than 18 years who had discontinued treatment with nusinersen or risdiplam.&nbsp;Key findings:
<ul>
<li>OAV101 IT demonstrated a favorable safety profile that was consistent with the STEER study.</li>
<li>The motor endpoint of efficacy, HFMSE, demonstrated stabilization for the overall study population over 52 weeks. The increase from baseline to 52 weeks in HFMSE least squares (LS) total score was 1.05.</li>
</ul>
Price Action: NVS stock is down 0.75% at $111.38 at the last check Wednesday.
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Novartis New Data From Single-Dose Gene Therapy Shows Meaningful Efficacy, Safety In Patients With Spinal Muscular Atrophy

<a href="https://asia.nikkei.com/Business/Pharmaceuticals/Novartis-sees-radioactive-cancer-drugs-becoming-10bn-business-CEO" title="https://asia.nikkei.com/Business/Pharmaceuticals/Novartis-sees-radioactive-cancer-drugs-becoming-10bn-business-CEO">https://asia.nikkei.com/Business/Pharmaceuticals/Novartis-sees-radioactive-cancer-drugs-becoming-10bn-business-CEO</a>

'Novartis Sees Radioactive Cancer Drugs Becoming $10B Business: CEO' - Nikkei Asia

Telemedicine operator Teladoc Health Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TDOC#NYSE">TDOC</a>) has entered a pharmacy integration agreement with Eli Lilly And Co's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) LillyDirect, a direct-to-consumer pharmacy partner, to streamline access to Zepbound (tirzepatide) for members of Teladoc's Comprehensive <a target="_blank" href="https://www.benzinga.com/topic/weight-loss" rel="noreferrer noopener">Weight Care Program</a>.
Last year, Eli Lilly&nbsp;announced a&nbsp;new&nbsp;website allowing patients to get a prescription for weight loss through a telehealth provider,&nbsp;<a target="_blank" href="https://www.benzinga.com/top-stories/24/05/38798101/pfizer-follows-eli-lillys-footsteps-to-sell-medicines-directly-to-patients" rel="noreferrer noopener">marking an industry first</a>.
The collaboration aims to provide affordable and safe options for individuals without insurance coverage for GLP-1 medications <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44164208/teladoc-health-adds-glp-1-self-pay-option-to-comprehensive-weight-care" rel="noreferrer noopener">used for obesity treatment</a>.
Under the agreement, eligible Teladoc Health members prescribed Zepbound by their provider will have the medication delivered directly to their homes via LillyDirect's digital healthcare platform.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/01/42970274/teladoc-shares-surge-as-amazon-partnership-fuels-push-for-consumer-centric-healthcare" rel="noreferrer noopener">Teladoc Stock Gains As Amazon Partnership Fuels Push for Consumer-Centric Healthcare</a>
Teladoc's Comprehensive Weight Care and Primary360 teams will have full visibility into each stage of the fulfillment process, including dispensing, shipping, delivery, and refills.
Beyond medication access, Teladoc's Comprehensive Weight Care Program offers a multi-disciplinary approach to obesity management. Members receive support from licensed clinicians with specialized training in obesity medicine, registered dietitians, and health coaches.
Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>)&nbsp;recently introduced&nbsp;NovoCare Pharmacy, a direct-to-patient delivery service to improve access to Wegovy (semaglutide) for&nbsp;<a target="_blank" href="https://www.benzinga.com/25/03/44143391/novo-nordisk-boosts-wegovy-access-with-lower-pricing-and-home-delivery" rel="noreferrer noopener">cash-paying patients</a>.
In February, Teladoc reported fourth-quarter revenue&nbsp;of $640.5 million, down 3% year over year, almost in line with the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/02/g43989576/teladoc-health-reports-full-year-and-fourth-quarter-2024-results" rel="noreferrer noopener">consensus estimates</a>.
Price Action: TDOC stock is up 8.02% at $9.75 at the last check Thursday.
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Photo by Ciara Kimsey via Shutterstock

Contracts

TDOC

Teladoc Health Partners With Eli Liily's LillyDirect to Expand Access to Zepbound For Weight Loss

<a href="https://asia.nikkei.com/Business/Pharmaceuticals/Novartis-to-mass-produce-next-generation-cancer-drugs-in-Japan" title="https://asia.nikkei.com/Business/Pharmaceuticals/Novartis-to-mass-produce-next-generation-cancer-drugs-in-Japan">https://asia.nikkei.com/Business/Pharmaceuticals/Novartis-to-mass-produce-next-generation-cancer-drugs-in-Japan</a>

Global

'Novartis To Mass Produce Next-Generation Cancer Drugs In Japan' - Nikkei Asia

Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) released data Sunday on its Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored phase 3 OUtMATCH study for Xolair (omalizumab) for one or more food allergies.
Stage 2 of the OUtMATCH study showed Xolair was more effective with fewer side effects than multi-allergen oral immunotherapy (OIT) in the first-ever head-to-head trial comparing the two treatment approaches.
<ul>
<li>In the first head-to-head trial comparing Xolair to OIT, the <a href="https://www.roche.com/media/releases/med-cor-2025-03-02" target="_blank" rel="noreferrer noopener">study</a> met its primary endpoint, showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein and two other food allergens without experiencing an allergic reaction, compared to 19% in the OIT group.</li>
<li>These findings were largely driven by the high rates of adverse events (AEs) in the OIT group.</li>
<li>Serious AEs (30.5% for OIT vs. 0% for Xolair), AEs leading to treatment discontinuation (22% vs. 0%), and AEs treated with epinephrine (37.3% vs. 6.9%) were all more common in the OIT group.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42597251/roche-prothena-partnered-mid-stage-parkinsons-trial-misses-primary-endpoint-but-cling-on-signs-of-clinical-benefits" rel="noreferrer noopener">Roche-Prothena Partnered Mid-Stage Parkinson&#8217;s Trial Misses Primary Endpoint, But Cling On Signs Of Clinical Benefits</a>
Additionally, preliminary results from Stage 3 of the OUtMATCH study provide early data on introducing allergenic foods into a patient&#8217;s diet after stopping Xolair.
Stage 3 is ongoing, and study investigators continue to analyze data from additional patients who completed Stage 2 and then entered Stage 3.
In the US, Genentech, a member of the Roche Group, and Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) are co-developing and co-promoting Xolair.
Last February, the FDA approved Xolair for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older <a target="_blank" href="https://www.benzinga.com/pressreleases/24/02/b37182116/fda-approves-xolair-as-first-and-only-medicine-for-children-and-adults-with-one-or-more-food-aller" rel="noreferrer noopener">with IgE-mediated food allergy</a>.
Price Action: RHHBY stock closed at $41.74 on Friday.
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Image: Shutterstock

Roche Touts Food Allergy Drug As Superior Than Oral Immunotherapy

Novartis Announces Presentation Of 17 Abstracts At 2025 AAAAI/WAO And AAD Meetings, Featuring Phase III REMIX-1/2 Data On Remibrutinib For Chronic Urticaria, Long-Term Cosentyx Data In Hidradenitis Suppurativa, And Phase II Patient Outcomes For Remibrutinib In HS

A federal court rejected Novartis Pharmaceuticals&#8217;, a unit of Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) legal challenge to the Medicare Drug Price Negotiation Program, ruling that the program does not violate constitutional protections against excessive fines, unlawful takings, or compelled speech.
The court determined that pharmaceutical manufacturers are not legally required to participate in the program, and those that do must adhere to its terms.
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For over 30 years, Congress has imposed price ceilings on prescription drugs purchased by federal agencies, including the Departments of Defense and Veterans Affairs.
These agencies also have the authority to negotiate prices below these limits. The Inflation Reduction Act of 2022 expanded this model by granting the Department of Health and Human Services (HHS) similar authority to negotiate prices for Medicare-covered drugs that lack generic competition and constitute a significant portion of Medicare spending.
Under the law, the Centers for Medicare &amp; Medicaid Services (CMS) can negotiate prices for high-expenditure drugs. Manufacturers who disagree with the program&#8217;s terms or the proposed pricing are not legally obligated to participate.
Novartis, however, <a target="_blank" href="https://storage.courtlistener.com/recap/gov.uscourts.ca3.123657/gov.uscourts.ca3.123657.25.0_1.pdf" rel="noreferrer noopener">argued</a> that the program imposed unconstitutional burdens, challenging it on three grounds: that it violated the Eighth Amendment&#8217;s prohibition on excessive fines, the Fifth Amendment&#8217;s protection against takings without just compensation, and the First Amendment&#8217;s ban on compelled speech.
The court dismissed Novartis&#8217; Eighth Amendment claim, citing the Anti-Injunction Act, which prevents lawsuits challenging the constitutionality of a tax before it is enforced.
Additionally, the court ruled that the program does not amount to a government taking under the Fifth Amendment, as it does not forcibly seize or mandate the sale of the company&#8217;s drugs.
Instead, the government offers to purchase medications under specific terms, which Novartis can choose to accept or decline. If a company finds the negotiated price unfavorable but still opts to sell, it does not constitute an unlawful taking.
Price Action: NVS stock is down 1.64% at $107.83 at the last check on Wednesday.
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Photo: Courtesy of Satur via Shutterstock

Court Dismisses Novartis Challenge To Medicare Drug Price Negotiation Program

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&nbsp;
<h2>Situation Update</h2>
February 26, 2025 &ndash; CDC continues to respond to the public health challenge posed by a multistate outbreak of avian influenza A(H5N1) virus, or &quot;H5N1 bird flu,&quot; in dairy cows, poultry, and other animals in the United States. CDC is working in collaboration with the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), Administration for Strategic Preparedness and Response (ASPR), state public health and animal health officials, and other partners using a <a href="https://www.cdc.gov/one-health/about/index.html">One Health approach</a>.

CDC A(H5N1) Bird Flu Response Update February 26, 2025; Confirmed 3 Human Cases Of H5 Bird Flu In People Who Became Ill In 2025 - Website

Macro Economic Events

Econ #s

Economics

U.S. Agriculture Secretary Brooke Rollins Says USDA Will Invest Up To $1B In Strategy To Curb Avian Flu; USDA Is Not Yet Authorizing Use Of Bird Flu Vaccines For Chickens

Novartis's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) short percent of float has fallen 4.55% since its last report. The company recently reported that it has 4.08 million shares sold short, which is 0.21% of all regular shares that are available for trading. Based on its trading volume, it would take traders 1.82 days to cover their short positions on average.
<h3>Why Short Interest Matters</h3>
Short interest is the number of shares that have been sold short but have not yet been covered or closed out. <a href="https://www.benzinga.com/money/how-to-short-a-stock?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">Short selling</a> is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises.
Short interest is important to track because it can act as an indicator of market sentiment towards a particular stock. An increase in short interest can signal that investors have become more bearish, while a decrease in short interest can signal they have become more bullish.
See Also: <a href="https://www.benzinga.com/short-interest?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">List of the most shorted stocks</a>
<h3>Novartis Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1740574814_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for Novartis has declined since its last report. This does not mean that the stock is going to rise in the near-term but traders should be aware that less shares are being shorted.
<h3>Comparing Novartis's Short Interest Against Its Peers</h3>
Peer comparison is a popular technique amongst analysts and investors for gauging how well a company is performing. A company's peer is another company that has similar characteristics to it, such as industry, size, age, and financial structure. You can find a company's peer group by reading its 10-K, proxy filing, or by doing your own similarity analysis.
According to <a href="https://www.benzinga.com/pro/">Benzinga Pro</a>, Novartis's peer group average for short interest as a percentage of float is 4.09%, which means the company has less short interest than most of its peers.
Did you know that increasing short interest can actually be bullish for a stock? <a href="https://www.benzinga.com/money/how-to-make-money-on-a-short-squeeze?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">This post by Benzinga Money explains how you can profit from it.</a>
This article was generated by Benzinga's automated content engine and was reviewed by an editor.

Short Sellers

Short Ideas

Is the Market Bullish or Bearish on Novartis?

Press Releases

PureTech Founded Entity Seaport Therapeutics Names Lauren White as Chief Financial Officer

Ratio Enters License and Collaboration Agreement with Novartis for SSTR2-targeting Radiotherapeutic Candidate

PTC Therapeutics Enters into a Global License and Collaboration Agreement with Novartis for PTC518 Huntington's Disease Program

Promising Data for Treating Gastrointestinal Cancer Leading to Hopeful Advancements for Pancreatic & Anal Cancers

GeminiBio Appoints Mike Stella to Board

Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU)

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G)

The Radoff-JEC Group Nominates Three Highly Qualified Candidates for Election to the Atea Pharmaceuticals Board of Directors

Global Radiotherapy Market Expected to Reach $9.62 Billion By 2030 Realizing Growth Due to Technological Advancements

Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN)

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