最新ニュース Sanofi (NASDAQ:SNY) 株価情報

Sanofi

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Sanofi develops and markets drugs with a concentration in vaccines, immunology, oncology, cardiovascular disease, diabetes, and over-the-counter treatments. However, the company's decision in late 2019 to pull back from the cardio-metabolic area will likely reduce the firm's footprint in this large therapeutic area. The company offers a diverse array of drugs with its highest revenue generator, Dupixent, representing about 30% of total sales, but profits are shared with Regeneron. Just over 40% of total revenue comes from the United States and 25% from Europe. Emerging markets represent the majority of the remainder of revenue.

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On Thursday, Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) reported first-quarter 2025 sales of $667 million, compared to&nbsp;$94 million&nbsp;a year ago, beating the&nbsp;<a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $343.85 million</a>.
Higher product sales for the first quarter of 2025 were primarily due to&nbsp;$603 million&nbsp;of revenue recognized with the termination of two Advance Purchase Agreements (APA) and related to cash received in prior years.&nbsp;
$45 million&nbsp;of Licensing, Royalties, &amp; Other Revenue in the first quarter of 2025 was higher than the prior year due to&nbsp;$40 million&nbsp;of Sanofi revenue associated with upfront payment, milestone amortization, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45282885/novavax-reports-first-quarter-2025-financial-results-and-operational-highlights" rel="noreferrer noopener">and cost reimbursement</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/04/45059756/trump-era-fda-appointees-request-new-trials-for-novavax-covid-vaccine-reportedly-delaying-approval-timeline" rel="noreferrer noopener">Trump-Era FDA Appointees Request New Trials For Novavax COVID Vaccine, Reportedly Delaying Approval Timeline</a>
The COVID-19 vaccine maker reported an earnings per share of $2.93, a turnaround from a loss of $1.05, beating the Wall Street Estimate of 71 cents.
"I am pleased with the progress we have made in the first quarter on our corporate growth strategy," said&nbsp;John Jacobs, President and Chief Executive Officer, Novavax. "We remain focused on creating shareholder value as we advance our three priorities for the year – optimizing our partnership with Sanofi, advancing new and existing partnership opportunities and continuing the development of our early-stage organic pipeline."&nbsp;
Nuvaxovid sales reached $608 million, up from $82 million a year ago.
Cost of sales&nbsp;for the first quarter of 2025 was&nbsp;$14 million, compared to&nbsp;$59 million&nbsp;in the same period in 2024.
R&amp;D expenses&nbsp;were&nbsp;$89 million, compared to&nbsp;$93 million a year ago, primarily due to reductions in overall expenditures related to COVID-19 vaccine development.
SG&amp;A expenses&nbsp;reached $48 million, compared to&nbsp;$87 million&nbsp;a year ago, due to the completion of commercial activities and ongoing cost reduction efforts.
Cash and equivalents were $747 million as of March 31, 2025, compared to $938 million as of December 31, 2024.
Guidance: Beginning with the 2025-2026 vaccination season, Novavax transitioned lead commercial responsibility of Nuvaxovid to Sanofi for select markets.
Since Novavax relies on Sanofi SA's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) sales forecasts for certain revenue components, these are not included in the Full-Year 2025 Revenue Framework.
For 2025, Novavax expects to achieve adjusted total revenue between&nbsp;$975 million&nbsp;and&nbsp;$1.025 billion versus the consensus of $724.16 million and the prior <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/44013531/novavax-reports-smaller-q4-loss-shifts-focus-from-commercializing-covid-19-vaccine-to-maximize-value" rel="noreferrer noopener">range of $300 million-$350 million</a>.
Nuvaxovid product sales for 2025 are expected to be $610 million, and adjusted supply sales of $20-$35 million.
According to a media report in early April, the regulators missed the deadline for deciding to grant full&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44613147/fda-delays-full-approval-decision-on-novavaxs-covid-19-vaccine" rel="noreferrer noopener">approval to Novavax's shot</a>.
In an SEC filing, Novavax&nbsp;<a target="_blank" href="https://www.benzinga.com/secfilings/25/04/44946464/novavax-inc-general-corporate-statement-form8" rel="noreferrer noopener">said</a>, "We believe that our Biologics License Application (BLA) is approvable based on conversations with U.S. Food and Drug Administration (FDA), as of our Prescription Drug User Fee Act date on&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44966369/novavaxs-covid-19-vaccine-nears-fda-full-approval-stock-jumps" rel="noreferrer noopener">April 1 and through today</a>."
The company said that it received formal communication from the FDA in the form of an information request for a post-marketing commitment to generate additional clinical data.
Price Action: NVAX stock is up 16.10% at $6.91 at the last check on Thursday.
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NVAX

COVID Vaccine Maker Novavax Stock Soars 16% - Here's Why

On Friday, AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) reported topline data from Phase 3 KALOS and LOGOS trials in patients <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">with uncontrolled asthma</a>.
KALOS and LOGOS trials assessed the efficacy and safety of Breztri Aerosphere&nbsp;(budesonide/glycopyrronium/formoterol fumarate or BGF) compared with two fixed-dose, dual-combination therapies of budesonid (an ICS) and formoterol fumarate (LABA) and&nbsp;Symbicort&nbsp;pressurized metered-dose inhaler (pMDI).
KALOS and LOGOS included approximately 4,400 randomized patients.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44083934/amgen-astrazeneca-partnered-asthma-drug-shows-rapid-and-sustained-effect-in-chronic-rhinosinusitis" rel="noreferrer noopener">Amgen-AstraZeneca Partnered Asthma Drug Shows Rapid And Sustained Effect In Chronic Rhinosinusitis</a>
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/breztri-met-primary-endpoints-in-ph3-asthma-trials.html" rel="noreferrer noopener">trials</a> met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) medicines.
No new safety or tolerability signals were identified for&nbsp;Breztri&nbsp;in KALOS or LOGOS.
Full results from the two Phase 3 trials will be shared with regulatory authorities and presented at an upcoming medical meeting.
Breztri&nbsp;is an inhaled triple-combination therapy approved for chronic obstructive pulmonary disease (COPD) in adults in more than 80 countries worldwide, including the US, EU, China, and Japan.
In addition to the two registrational trials (KALOS and LOGOS),&nbsp;two qualifying trials, LITHOS and VATHOS, also met their primary endpoints. LITHOS and VATHOS included approximately 1,000 randomized patients.
In April, Sanofi SA&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) reported&nbsp;preliminary results from the TIDE-Asthma phase 2 study of amlitelimab and its efficacy in <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44822758/sanofi-asthma-drug-misses-primary-goal-plans-for-pivotal-study" rel="noreferrer noopener">heterogeneous inflammatory asthma</a>.
<ul>
<li>The primary endpoint of the annualized exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium and low doses.</li>
<li>Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a numerically greater reduction in exacerbations at the high dose at week 60.</li>
<li>A nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control was evident.</li>
<li>In a patient subgroup, amlitelimab showed nominally significant and clinically meaningful improvements in exacerbations (with a reduction of more than 70%), lung function, and asthma control at week 60.</li>
</ul>
AstraZeneca announced in its&nbsp;first-quarter presentation&nbsp;(PDF) on Tuesday that it had <a target="_blank" href="https://www.astrazeneca.com/content/dam/az/PDF/2025/q1/Q1-2025-results-clinical-trials-appendix.pdf" rel="noreferrer noopener">stopped</a> working on a phase 1 Alzheimer's disease drug and two phase 2 programs for migraine and osteoarthritis pain and painful diabetic neuropathy.
On Tuesday, the European pharma giant reported first-quarter 2025 sales of $13.59 billion, up 7% year over year (+10% at constant currency), slightly missing the&nbsp;consensus of $13.71 billion, driven by double-digit growth in <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/45069668/astrazeneca-q1-sales-and-earnings-rise-warns-china-import-tax-could-be-up-to-8-million-ceo-says-tariff-related-exposure-limited" rel="noreferrer noopener">oncology and biopharmaceuticals</a>.
Price Action: AZN stock is up 1.52% at $71.58&nbsp;at the last check Friday.
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Large Cap

AstraZeneca's Triple-Combination Therapy Breztri Hits Primary Goals In Two Pivotal Studies For Asthma

Opella today becomes an independent global leader in consumer healthcare, marking a pivotal step in Sanofi's strategy. Sanofi announces today the closing of the sale to CD&amp;R of a 50.0% controlling stake of its consumer healthcare business Opella. Sanofi retains a significant shareholding of Opella with a 48.2% stake. Bpifrance will own a 1.8% stake in Opella and will join the Board. The transaction was completed on the terms previously disclosed. Sanofi has received total net cash proceeds of around €10 billion

Asset Sales

Sanofi Closed Sale Of 50% Stake In Opella To CD&R For €10B

Sanofi SA&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) reported Thursday a first-quarter 2025 business operating income of 2.9 billion euros ($3.06 billion), up 20.1% year over year and <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">18.7%&nbsp;in constant currency</a>.
The company&nbsp;<a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-24-05-30-00-3067075" rel="noreferrer noopener">reported</a> first-quarter sales of 9.89 billion euros ($10.42 billion), beating the <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $9.77 billion</a>. This was driven by launches, Dupixent, and favorable Beyfortus phasing.
Sales increased 10.8% year over year and 9.7% on constant currency. U.S. sales were 4.66 billion and increased by 15.4%.
The performance was driven by pharma launches, Dupixent, and Lantus, while legacy medicines were lower. Vaccine sales were broadly stable, including lower sales of Beyfortus.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44822758/sanofi-asthma-drug-misses-primary-goal-plans-for-pivotal-study" rel="noreferrer noopener">Sanofi Asthma Drug Misses Primary Goal, Plans For Pivotal Study</a>
The French drugmaker reported adjusted EPS of 1.79 euros or 94 cents per ADS, missing the consensus of 95 cents, up 17% (+15.7% on constant currency).
Sales of Dupixent, Sanofi&#8217;s blockbuster eczema drug, rose 20.3% to 3.5 billion euros due to strong volume growth across all indications and regions. The first COPD launches are underway.
Pharma launches increased 43.8% to 847 million euros, led by Altuviiio (hemophilia&nbsp;drug), Nexviazyme (Pompe disease), Sarclisa (multiple myeloma), and Rezurock (chronic graft-versus-host disease).
Vaccine sales were up 11.4% to 1.3 billion euros, driven by favorable Beyfortus (RSV) phasing and geographical roll-out.
Beyfortus sales were 284 million euros, driven by additional sales in the Northern Hemisphere, particularly Germany and Japan.
Polio/Pertussis/Hib (PPH) primary and booster vaccine sales were 668 million euros and increased by 3.8%, primarily due to demand for boosters to re-vaccinate adolescents and adults.
&#8220;We had a strong start in 2025 with sales growth of 9.7%, benefiting from investments in innovation and a favorable base of comparison. Our focus on pipeline value delivered further growth for Sanofi with sales from launches of new medicines and vaccines growing by 46.5%,&#8221; said Paul Hudson, Chief Executive Officer.
Guidance: Sanofi <a target="_blank" href="https://www.sanofi.com/assets/dotcom/content-app/events/quaterly-results/2025/2025-q1-2025-results/2025_04_24_Sanofi_Q1_2025_Results.pdf" rel="noreferrer noopener">confirmed</a> its 2025 guidance. In 2025, sales are anticipated to grow by a mid-to-high single-digit percentage at CER.
Sanofi confirms the expectation of a strong rebound in business EPS with growth at a low double-digit level.
On Wednesday, Innate Pharma SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IPHA#NASDAQ">IPHA</a>) <a target="_blank" href="https://www.businesswire.com/news/home/20250422582040/en/Innate-Pharma-Regains-Its-Rights-on-CD123-Targeting-ANKET-and-Announces-Sanofis-Intention-to-Make-a-Strategic-Investment-in-the-Company" rel="noreferrer noopener">reviewed</a> their January 2016 Research Collaboration and License Agreement with Sanofi:
<ul>
<li>As previously disclosed and in alignment with its current strategic priorities, Sanofi will opt to pursue the development of SAR&#8217;514/IPH6401 (BCMA ANKET) in autoimmune indications under the agreement.</li>
<li>Additionally, Sanofi and Innate agreed to terminate the 2016 Agreement regarding SAR&#8217;579/IPH6101 (CD123 ANKET); Innate will regain its rights on SAR&#8217;579/IPH6101.</li>
</ul>
As part of these discussions, Sanofi and Innate have agreed to Sanofi&#8217;s potential investment of up to 15 million euros in new shares of Innate. If the ongoing market conditions are satisfactory, the size and price of this equity investment will be determined.
Price Action: SNY stock is down 0.83% to $52.58 at the last check on Thursday.
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IPHA

French Drugmaker Sanofi Clocks 20% Q1 Profit Growth, Forecasts Strong Rebound In Annual Profit

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Earnings Scheduled For April 24, 2025

<ul>
<li>Investment is in addition to the ongoing partnership as shared previously, including continuing the development of BCMA targeting ANKET&#xAE; program in autoimmune indications, and more</li>
</ul>

Innate Pharma Confirms €15M Capital Increase Backed By Sanofi To Advance ANKET® Autoimmune Pipeline

Guidance confirmed&nbsp;
<ul>
<li>In 2025, sales are anticipated to grow by a mid-to-high single-digit percentage at CER5 . Sanofi confirms the expectation of a strong rebound in business EPS with growth at a low double-digit percentage at CER (before share buyback)6&nbsp;</li>
<li>Sanofi intends to complete a share buyback program in 2025 of €5 billion of which 72% was already repurchased</li>
</ul>

Sanofi Reaffirms 2025 Guidance: Sales To Grow Mid-To-High Single Digits (CER), Business EPS To Rise Low Double Digits (CER)

Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) reported quarterly earnings of $0.94 per share which missed the analyst consensus estimate of $0.95 by 0.95 percent. This is a 2.99 percent decrease over earnings of $0.97 per share from the same period last year. The company reported quarterly sales of $10.41 billion which beat the analyst consensus estimate of $9.77 billion by 6.51 percent. This is a 8.43 percent decrease over sales of $11.36 billion the same period last year.

Earnings Beats

Earnings Misses

Sanofi Q1 Adj. EPS $0.94 Misses $0.95 Estimate, Sales $10.41B Beat $9.77B Estimate

<ul>
<li>Innate to regain its rights on CD123 targeting ANKET&#xAE; SAR443579 (SAR'579) /IPH6101 currently in development for AML</li>
<li>Potential investment of up to €15M by Sanofi in Innate Pharma through a capital increase, subject to market conditions</li>
<li>Sanofi to continue development of BCMA targeting ANKET&#xAE; program in autoimmune indications</li>
<li>Innate still eligible for more than €1 billion R&amp;D and commercial milestones</li>
</ul>

Innate Pharma Regains SAR'579 Rights For AML As Sanofi Proposes €15M Strategic Equity Investment

Regeneron Pharmaceuticals, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) on Tuesday announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotechnologies to manufacture and supply bulk drug products of Regeneron&#8217;s commercial biologic medicines at their Holly Springs, <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">North Carolina, campus</a>.
Regeneron, already one of the world&#8217;s largest biologics manufacturers, will nearly double its U.S. large-scale manufacturing capacity by accessing Fujifilm&#8217;s <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44916999/regeneron-announces-new-investment-in-manufacturing-of-its-industry-leading-biologic-medicines" rel="noreferrer noopener">new biopharmaceutical facility</a>.
With technology transfer beginning immediately and a 10-year term, the total investment is estimated to exceed $3 billion.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44870253/fda-accepts-priority-review-of-regenerons-flagship-drug-eylea-hd-for-expanded-use" rel="noreferrer noopener">FDA Sets The Countdown: Regeneron&#8217;s Eylea HD Could Be Headed For Major Expansion</a>
&#8220;Regeneron is an American success story, with over 80 percent of our workforce and assets in the U.S. and all of our FDA-approved medicines invented in our New York laboratories&#8230;&#8221; said Leonard Schleifer, Board co-Chair, president and CEO of Regeneron.
&#8220;FUJIFILM Diosynth Biotechnologies will be bringing additional capacity online in 2025, 2026 and beyond as it completes the current $7 billion of expansion projects underway in both Europe and United States,&#8221; &nbsp;said Toshihisa Iida, director, corporate vice president, general manager of Life Sciences Strategy Headquarters and Bio-CDMO Division,<a href="https://www.benzinga.com/pressreleases/25/04/b44917015/fujifilm-diosynth-biotechnologies-and-regeneron-sign-a-10-year-u-s-manufacturing-agreement-valued-" target="_blank" rel="noreferrer noopener"> FUJIFILM Corporation, Japan</a>.
Regeneron continues to invest heavily in its New York State operations. An approximately $3.6 billion expansion of its Tarrytown campus is underway, creating 1,000 full-time, high-skill jobs and expanding research, preclinical manufacturing, and support facilities.
In addition, the company is constructing a brand new fill/finish manufacturing facility in Rensselaer, New York. It has acquired an over 1 million-square-foot property in Saratoga Springs, New York, for production support activities and, potentially, additional manufacturing capacity.
Regeneron has added more than 7,000 jobs in the past five years, most of which are high-paying R&amp;D and manufacturing jobs based in the U.S.
Regeneron&#8217;s ongoing and planned investments in New York and North Carolina infrastructure and manufacturing are expected to total more than $7 billion.
On Friday, the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for Regeneron&#8217;s Eylea (aflibercept) Injection 8 mg <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44886470/regeneron-provides-update-on-eylea-hd-aflibercept-injection-8-mg-supplemental-biologics-license-ap" rel="noreferrer noopener">across all approved indications</a>.
The CRL did not identify any issues with the safety or efficacy of Eylea HD in its approved indications and dosing regimens. The FDA did not agree with Regeneron&#8217;s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label). Regeneron is evaluating the FDA&#8217;s decision.
On Friday, the FDA approved Regeneron and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) partnered Dupixent&nbsp;(dupilumab) for adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44884755/dupixent-dupilumab-approved-in-the-u-s-as-the-first-new-targeted-therapy-in-over-a-decade-for-chro" rel="noreferrer noopener">antihistamine treatment</a>.
Price Action: REGN stock is up 4.2% at $585.25 at last check Tuesday.
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Photo: Shutterstock

REGN

Regeneron Expands US Manufacturing With $3 Billion Fujifilm Deal

Contracts

Earendil Labs And Sanofi Entered Into A License Agreement For Two Bispecific Antibodies In The Field Of Autoimmune And Inflammatory Bowel Diseases, HXN-1002 and HXN-1003, For An Upfront Payment Of $125M And $1.72B In Milestone Payments

<a target="_blank" href="https://www.benzinga.com/quote/SNY" rel="noreferrer noopener">Sanofi SA</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) on Tuesday shared progress from its mid- to <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">late-stage respiratory pipeline</a>.
The French drug maker <a href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-15-05-00-00-3061368" target="_blank" rel="noreferrer noopener">reported</a> preliminary results from the TIDE-Asthma phase 2 study of amlitelimab and its efficacy in heterogeneous inflammatory asthma. Here&#8217;s what we know: 
<ul>
<li>The primary endpoint of the annualized exacerbation rate at week 48 was not met at the highest dose level, leading to nominal significance at the medium and low doses.</li>
<li>Treatment with amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a numerically greater reduction in exacerbations at the high dose at week 60.</li>
<li>A nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control was evident.</li>
<li>In a patient subgroup, amlitelimab showed nominally significant and clinically meaningful improvements in exacerbations (with a reduction of more than 70%), lung function, and asthma control at week 60.</li>
<li>The phase 3 program is currently being planned.</li>
<li>In the TIDE-Asthma study, patients were treated every four weeks for the first 24 weeks and every 12 weeks for the remaining 36 weeks. Amlitelimab&#8217;s durable efficacy through 60 weeks of treatment supports a quarterly maintenance dosing schedule.</li>
<li>The safety profile was consistent with previous studies across indications, with no new safety signals identified throughout the 60-week treatment period.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44724763/pharma-industry-faces-jitters-as-trump-hints-at-historic-tariffs-bofa-outlines-probable-timeline" rel="noreferrer noopener">Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline</a>
Separately, Sanofi said lunsekimig is being explored in a broad population of asthma patients, regardless of their inflammation and severity status.
<ul>
<li>The readout of the AIRCULES phase 2 study in moderate to severe asthma is anticipated in 2026 </li>
<li>The AIRLYMPUS phase 2 study in high-risk asthma was initiated in Q4 2024.</li>
<li>The readout of the phase 2 study in patients with chronic rhinosinusitis with nasal polyps is anticipated in 2026.</li>
<li>A phase 2/3 study in chronic obstructive pulmonary disease (COPD) will begin in 2025.</li>
</ul>
In partnership with Regeneron Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>), two phase 3 studies were initiated so far this year.
Itepekimab is currently being explored in COPD in two phase 3 studies, AERIFY-1 and AERIFY-2, with the readout anticipated in H2 2025, and in one phase 2 study, AERIFY-3, with the readout anticipated in H2 2025.
Finally, itepekimab is being explored in a phase 2 study in bronchiectasis, with the readout anticipated in 2026.
In May 2024, Sanofi <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2024/2024-05-22-17-15-00-2886776?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" rel="noreferrer noopener">reported</a> results from the Phase 2 study of oral&nbsp;rilzabrutinib&nbsp;in adult patients with uncontrolled moderate-to-severe asthma.
Two doses of&nbsp;rilzabrutinib, 800 mg daily and 1200 mg <a target="_blank" href="https://www.benzinga.com/news/24/05/38970663/first-advanced-oral-treatment-for-asthma-sanofis-investigational-drug-shows-potential" rel="noreferrer noopener">daily, were studied</a>.
The data showed that treatment with oral&nbsp;rilzabrutinib&nbsp;at both high and low doses led to a numerical reduction in loss of asthma control (LOAC) events (the primary endpoint) and improvements in symptoms in adult patients with uncontrolled moderate-to-severe asthma.&nbsp;
Price Action: SNY stock is down 1.33% at $51.15 at the last check Tuesday.
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Image: Shutterstock

Sanofi Asthma Drug Misses Primary Goal, Plans For Pivotal Study

Sanofi's respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD
<ul>
<li>New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma</li>
<li>Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma</li>
<li>Itepekimab expanding into chronic rhinosinusitis along with COPD and bronchiectasis; phase 3 readouts in COPD in H2 2025 and bronchiectasis in 2026</li>
</ul>

Sanofi's Amlitelimab Shows Clinically Meaningful Efficacy In Phase 2 Asthma Study, Phase 3 Program In Planning

Sanofi's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NYSE">SNY</a>) short percent of float has fallen 30.77% since its last report. The company recently reported that it has 4.00 million shares sold short, which is 0.18% of all regular shares that are available for trading. Based on its trading volume, it would take traders 1.6 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>Sanofi Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1744315224_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for Sanofi 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 Sanofi'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>, Sanofi's peer group average for short interest as a percentage of float is 4.11%, 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.

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How Do Investors Really Feel About Sanofi?

U.S.&nbsp;President Donald Trump, on Tuesday, disclosed plans for a "major tariff" on <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">foreign pharmaceuticals</a>.
"We're&nbsp;going to be announcing very&nbsp;shortly a major tariff on&nbsp;pharmaceuticals… when they hear that&nbsp;they will leave China, they&nbsp;will leave other places because… most of their product&nbsp;is sold here," Trump expressed at&nbsp;a National Republican <a target="_blank" href="https://www.benzinga.com/25/04/44708204/trump-hints-at-major-tariff-on-imported-pharmaceuticals-us-pharma-stocks-tumble-in-wednesday-pre-market" rel="noreferrer noopener">Congressional Committee&nbsp;dinner</a>.
He also told reporters on board his Air Force One plane that "pharma" tariffs would arrive "at a level that you haven't really seen before," saying these would be announced "in the near future," BBC <a target="_blank" href="https://www.bbc.com/news/articles/cedyylj1v32o" rel="noreferrer noopener">report</a> added.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">Trump Tariff Strategy Creates ‘Self-Inflicted Market Debacle': Analyst</a>
When President Trump announced tariffs last week, he excluded pharmaceuticals from the new tariffs, likely a relief for the industry under pressure following his prior comments suggesting a 25% tariff&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44652075/us-tariffs-spare-drugmakers-but-threaten-diabetes-device-industry" rel="noreferrer noopener">on pharmaceutical imports</a>.&nbsp;
On Wednesday, in a surprise announcement from President Donald Trump, a 90-day pause on tariffs for countries that have not retaliated <a target="_blank" href="https://www.benzinga.com/topic/tariffs" rel="noreferrer noopener">against U.S. trade measures.</a>
The news ignited a broad risk-on rally, catapulting major indices to multi-month highs and sending volatility plunging.
Trump's latest Truth Social post slammed China for showing "a lack of respect" and declared an immediate 125% tariff hike on Chinese goods.
"At some point, hopefully in the near future, China will realize that the days of ripping off the U.S.A. and other Countries is no longer sustainable or acceptable," he said.
He praised the over 75 countries that, in his words, "have not, at my strong suggestion, retaliated in any way, shape, or form."
As a reward, those countries would benefit from a temporary 10% reciprocal tariff and a 90-day pause on additional duties.
The biopharma industry has historically been shielded from tariffs, including during Trump's first term.
Although Trump didn't provide many details, his remarks have unsettled buyers, especially those who depend on medicines from India. India provides nearly half of all generic drugs used in the U.S., helping cut billions from healthcare costs.
The U.S. is a major market, buying about a third of India's $13 billion in yearly drug exports.
Indian drug companies warn that if tariffs are added, they'd have to raise prices—which could increase healthcare costs in the U.S.
Even though some companies like Cipla and Dr. Reddy's Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) have factories in the U.S., most say it's too expensive to move production for low-profit generic drugs.
BofA Securities analyst says if the Trump administration plans to impose tariffs on the pharmaceutical industry, it would likely do so through a "Section 232 investigation" under the Trade Expansion Act of 1962 to determine whether importing certain goods threatens national security.
The typical timeline for a Section 232 investigation is about a year. If the same timeline applied here, tariffs on drug imports likely wouldn't take effect until late in the year—at the earliest.
It's unclear whether the Section 232 investigation into the drug industry is about to start, but based on recent comments from the administration, it seems possible. However, launching an investigation doesn't guarantee that tariffs will follow.
As the first quarter 2025 earnings season starts soon, analyst Tim Anderson says it will be worth watching whether companies discuss potential tariffs during earnings calls.
That said, any actual earnings impact likely wouldn't show up until sometime after 2025, which could leave investors with more questions than answers.
Wedbush analyst Daniel Ives <a target="_blank" href="https://www.benzinga.com/25/04/44698325/trump-tariff-strategy-self-inflicted-market-debacle-says-wedbush-analyst" rel="noreferrer noopener">on Tuesday wrote</a> that "saying we can just make this in the USA" understates how complex the supply chain in Asia really is—and how electronics, chips, semiconductors, hardware, and smartphones have been built for U.S. consumers over the past 30 years."
Shares of major drugmakers such as Gilead Sciences&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Eli Lilly&nbsp;And Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), AstraZeneca&nbsp;Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Roche&nbsp;Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi&nbsp;SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Novartis&nbsp;AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Argenx&nbsp;SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARGX#NASDAQ">ARGX</a>), UCB&nbsp;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>), Novo Nordisk&nbsp;A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>), Regeneron Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell on Wednesday, only reverse course later after the 90-day tariff pause.
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</ul>
Photo by MargJohnsonVA via Shutterstock

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Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline

Bank of America Securities <a href="https://www.benzinga.com/general/biotech">writes that SMid-cap biotech</a>, companies with small to mid-sized market capitalizations, had a rocky start to the year.
Many companies in the coverage are down 20-40% year-to-date (NBI: -2.35%).
Tariff concerns and the U.S. Food and Drug Administration (FDA) shakeup added further near-term uncertainty to an already challenging <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">already challenging outlook</a>.
Earlier this week, Peter Marks resigned from his role at the FDA&#8217;s Center for Biologics Evaluation and Research.
Marks was a top regulator at the FDA and played a key role in ensuring the quick approval of vaccines <a href="https://www.benzinga.com/25/03/44562368/moderna-novavax-shares-are-tumbling-monday-whats-going-on" target="_blank" rel="noreferrer noopener">during the COVID-19 pandemic</a>.
In March, the U.S. Department of Health and Human Services unveiled a sweeping restructuring plan on Thursday to cut costs, streamline operations and refocus priorities.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/04/44627279/ftc-pauses-lawsuit-against-cvs-cigna-unitedhealths-pbms-amid-commissioner-shortage" rel="noreferrer noopener">FTC Pauses Lawsuit Against CVS, Cigna, UnitedHealth&#8217;s PBMs Amid Commissioner Shortage</a>
The changes, aligned with President&nbsp;Donald Trump's&nbsp;executive order on government efficiency, will reduce the agency&#8217;s workforce, consolidate divisions, and emphasize efforts to <a target="_blank" href="https://www.benzinga.com/government/regulations/25/03/44519638/us-department-of-health-and-human-services-aligns-with-trumps-executive-order-to-cut-10k-jobs-save-18-billion" rel="noreferrer noopener">combat chronic illness</a>.
The analyst points out that public biotech companies raised only $4.7 billion, compared to $13.6 billion last year, highlighting ongoing challenges in the capital market.
&#8220;And while we see these macro headwinds as likely to continue over the course of 2025, <a href="https://www.benzinga.com/markets/25/04/44627820/trumps-reciprocal-tariffs-on-india-exempt-pharma-easing-mark-cubans-price-hike-concerns">drugs being exempt from reciprocal tariffs</a> should offer some much-needed near-term reprieve for the sector, in our view,&#8221; BofA analyst writes.
Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) is just one example of FDA. On Wednesday, the regulators missed the deadline for deciding to grant full approval to Novavax&#8217;s Covid-19 shot.
BofA expects more details on the delay in the coming weeks. The expected $125 million milestone payment from Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) will likely be pushed to the second half of 2025.
Despite small and mid-cap biotech stocks being among the worst performers this year, the sector may still present a strong opportunity. Most of these companies (80%) are pre-commercial and have minimal exposure to tariffs or FDA decisions, with only 2 out of 29 under BofA coverage awaiting FDA approval.
The bigger challenges are high interest rates and limited access to capital, but these risks are already factored into valuations. While negative headlines may continue to impact sentiment and investment flows, the recent broad sell-off could be an appealing entry point.
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Image: Shutterstock

Despite Headwinds, Biotech Sell-Off Could Offer Buying Opportunity: Analyst

The <a href="https://www.benzinga.com/topic/u-s-food-and-drug-administration">U.S. Food and Drug Administration</a> (FDA) on Thursday granted orphan drug designation to Sanofi SA&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) rilzabrutinib.
The treatment is an investigational, novel, advanced, oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, for two rare diseases, warm autoimmune hemolytic anemia (wAIHA) and <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">IgG4-related disease (IgG4-RD)</a>.
The FDA grants orphan drug designation to investigational therapies that address rare medical diseases or conditions that affect fewer than 200,000 people in the US.
Rilzabrutinib is <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-03-05-00-00-3054815" rel="noreferrer noopener">currently</a> under regulatory review in the US, the EU, and China for its potential use in immune thrombocytopenia (ITP).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44440233/pharmaceutical-firms-say-uk-investment-is-unlikely-unless-payment-levy-is-adressed" rel="noreferrer noopener">Pharmaceutical Firms Say UK Investment Is &#8216;Unlikely&#8217; Unless Payment Levy Is Addressed</a>
The target action date for the FDA regulatory decision on ITP, which was granted fast-track designation, is Aug. 29.
Rilzabrutinib also received orphan drug designation for ITP in the US, EU, and Japan.
Results from a phase 2b study on wAIHA&nbsp;presented at ASH 2024 demonstrated that treatment with rilzabrutinib showed clinically meaningful outcomes on response rate and disease markers.
In IgG4-RD patients, results from a phase 2a study showed treatment with rilzabrutinib for 52 weeks led to reduction in disease flare, other disease markers, and glucocorticoid sparing.
The safety profile of rilzabrutinib in both studies was consistent with previous studies.
Last week, the FDA approved&nbsp;Sanofi&#8217;s Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without&nbsp;<a target="_blank" href="https://www.benzinga.com/25/03/44560065/fda-approves-sanofis-hemophilia-drug" rel="noreferrer noopener">factor VIII or IX inhibitors</a>.
The&nbsp;<a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-03-28-20-07-38-3051637" rel="noreferrer noopener">approval</a>&nbsp;is based on data from the ATLAS phase 3 studies that demonstrated clinically meaningful bleed protection as measured by annualized bleeding rates.
Price Action: Sanofi&#8217;s stock is up 3.54% at $55.86 during the premarket session at the last check Thursday.
Read Next:
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</ul>
Image: Shutterstock

Why Is French Pharma Giant Sanofi Stock Trading Higher On Thursday?

U.S. stocks were lower, with the Dow Jones index falling over 1,200 points on Thursday.
Shares of Lamb Weston Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LW#NYSE">LW</a>) rose sharply during Thursday's session after the company reported better-than-expected third-quarter financial results and issued FY25 sales guidance <a href="https://www.benzinga.com/quote/LW/earnings">above estimates</a>.
Lamb Weston reported quarterly earnings of $1.10 per share which beat the analyst consensus estimate of 87 cents per share. The company reported quarterly sales of $1.52 billion which beat the analyst consensus estimate of $1.49 billion.
Lamb Weston shares jumped 10% to $59.52 on Thursday.
Here are some other big stocks recording gains in today's session.
<ul>
<li>The Goodyear Tire &amp; Rubber Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GT#NASDAQ">GT</a>) shares jumped 12.5% to $10.25.</li>
<li>Northern Dynasty Minerals Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NAK#NYSE">NAK</a>) gained 12% to $1.0250.</li>
<li>Skyline Builders Group Holding Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SKBL#NASDAQ">SKBL</a>) shares rose 7.1% to $11.10.</li>
<li>National Grid plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NGG#NYSE">NGG</a>) shares rose 6.5% to $70.08.</li>
<li>SBA Communications Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SBAC#NASDAQ">SBAC</a>) shares gained 6.1% to $232.69.</li>
<li>Anbio Biotechnology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NNNN#NASDAQ">NNNN</a>) rose 5.6% to $7.39.</li>
<li>The Kroger Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KR#NYSE">KR</a>) climbed 4.7% to $70.44.</li>
<li>American Tower Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AMT#NYSE">AMT</a>) shares rose 4.4% to $227.53.</li>
<li>Valneva SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VALN#NASDAQ">VALN</a>) gained 4.2% to $7.29.</li>
<li>Fresenius Medical Care AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FMS#NYSE">FMS</a>) rose 4.2% to $25.76.</li>
<li>McKesson Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MCK#NYSE">MCK</a>) gained 4% to $721.00. McKesson, on Wednesday, completed acquisition of PRISM Vision Holdings, LLC.</li>
<li>Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) rose 3% to $55.59 as the FDA granted Orphan Drug Status to the company's Rilzabrutinib for two rare autoimmune diseases with high unmet needs.</li>
</ul>
Now Read This: 
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<li><a href="https://www.benzinga.com/analyst-ratings/price-target/25/04/44625270/top-3-tech-and-telecom-stocks-youll-regret-missing-this-month">Top 3 Tech And Telecom Stocks You&#8217;ll Regret Missing This Month</a> </li>
</ul>
Photo via Shutterstock

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Lamb Weston Posts Better-Than-Expected Results, Joins Sanofi And Other Big Stocks Moving Higher On Thursday

Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines
<ul>
<li>Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease</li>
<li>Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia&nbsp;</li>
</ul>

FDA Grants Orphan Drug Status To Sanofi's Rilzabrutinib For Two Rare Autoimmune Diseases With High Unmet Needs

Nurix received a $15 million license extension fee from Sanofi under its 2019 collaboration agreement, bringing the total amount received by Nurix to date to $105 million.
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NRIX

Nurix Licenses Drug Discovery Program To Sanofi Targeting Novel Transcription Factor For Autoimmune Diseases; Is Eligible For Additional $465M In Milestones Plus Royalties

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Sanofi commits $18 million to Howard University College of Medicine, Meharry Medical College, and Morehouse School of Medicine to increase diversity in clinical studies

FLUBLOK® (Influenza Vaccine) US label updated with one of Sanofi's largest flu vaccine safety studies in pregnant individuals

Beyfortus® immunization to protect infants from RSV has begun

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