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Sanofi develops and markets drugs with a concentration in oncology, immunology, cardiovascular disease, diabetes, over-the-counter treatments and vaccines. 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 just over 20% 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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Descubre los prometedores resultados del estudio de fase 3 IRAKLIA de Sanofi sobre Sarclisa SC en mieloma múltiple.

Sanofi publica resultados prometedores del estudio de fase 3 IRAKLIA con Sarclisa

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On Thursday, Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) released results from the IRAKLIA phase 3 study evaluating the non-inferiority of Sarclisa (isatuximab) subcutaneous formulation via an on-body delivery system (OBDS) versus weight-based dosed Sarclisa IV in combination with pomalidomide and dexamethasone (Pd) in adult patients with relapsed or <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39169252/sanofi-highlights-data-from-blood-cancer-drug-sarclisa-in-new-diagnosed-multiple-myeloma-patients" rel="noreferrer noopener">refractory multiple myeloma</a>.&nbsp;
The <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-01-09-06-00-00-3006798" rel="noreferrer noopener">trial</a> demonstrated that Sarclisa SC, in combination with pomalidomide and dexamethasone (Pd), met its co-primary endpoints of non-inferior objective response rate and observed concentration before dosing (C trough) at steady state.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/12/42530062/sanofis-340b-credit-proposal-draws-federal-warning-for-statutory-violation" rel="noreferrer noopener">Sanofi&#8217;s 340B Credit Proposal Draws Federal Warning For Statutory Violation</a>
Key secondary endpoints were also achieved, including very good partial response, the incidence rate of infusion reactions, and C trough at cycle 2.
The study is ongoing, and the full results will be presented at a forthcoming medical meeting.
Additional studies evaluating Sarclisa SC formulations across different combinations and lines of therapy are ongoing.
The safety and efficacy of Sarclisa SC and the enFuse device have not been evaluated by any regulatory authority outside of their approved indications. Regulatory submissions in the US and in the EU are planned during the first half of 2025.
In September, the FDA approved&nbsp;Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40979253/sanofis-sarclisa-secures-fda-approval-for-first-line-multiple-myeloma-marking-its-third-us-approv" rel="noreferrer noopener">stem cell transplant</a>.
In August, Sanofi released new results from the GMMG-HD7 phase 3 study of Sarclisa in combination with lenalidomide, bortezomib, and dexamethasone (RVd) versus RVd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance in transplant-eligible newly diagnosed <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40260365/sanofis-approved-blood-cancer-drug-sarclisa-shows-improved-progression-free-survival-in-patients-" rel="noreferrer noopener">multiple myeloma patients</a>.
The data&nbsp;show&nbsp;that Sarclisa, combined with RVd during induction therapy, significantly prolonged progression-free survival, resulting in a statistically significant and clinically meaningful reduction in disease progression or death compared to RVd induction regardless of the maintenance regimen.
Price Action: SNY stock closed at $49.23 on Wednesday.
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Image by HJBC via Shutterstock

Sanofi's Blood Cancer Drug's New Subcutaneous Formulation Hits Primary Goal In Late-Stage In Multiple Myeloma

New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma
<ul>
<li>Sarclisa SC formulation added to Pd for the treatment of R/R MM met the co-primary endpoints in the IRAKLIA phase 3 study, demonstrating non-inferiority compared to Sarclisa IV</li>
<li>IRAKLIA is the first global phase 3 study to evaluate the SC administration of a cancer treatment via an OBDS</li>
<li>OBDS is an alternative delivery method designed to improve the patient experience and currently available SC administration</li>
</ul>

Sanofi's Sarclisa Subcutaneous Formulation Achieves Co-Primary Endpoints In IRAKLIA Phase 3 Trial For Multiple Myeloma Treatment

The U.S. reported its <a href="https://www.benzinga.com/general/biotech/25/01/42854890/us-records-first-human-bird-flu-death-high-levels-of-respiratory-illnesses-vaccine-stocks-rally">first human death</a> from the H5 bird flu strain this week, causing a spike in vaccine developer stocks Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>), Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>), CureVac (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) and Pfizer (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>).
Vaccine production efforts are ramping up as health officials monitor the outbreak closely. In<a href="https://www.cdc.gov/bird-flu/situation-summary/index.html" target="_blank" rel="noreferrer noopener"> an update </a>on Monday, CDC said there have been 66 confirmed cases in the U.S. in the 2024 outbreak. 
CDC said the public risk remains low. Bird flu has severely impacted poultry farms and cattle herds across 16 states, marking the worst outbreak of its kind.
See Also: <a href="https://www.benzinga.com/news/25/01/42851023/why-novavax-nvax-stock-is-rising">Why Novavax (NVAX) Stock Is Rising</a>
<h3 class="wp-block-heading">Vaccine Providers in the Limelight</h3>
In the U.S., vaccines against H5N1 are already stockpiled. Approved shots include those from Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), CSL Seqirus, and ID Biomedical Corporation of Quebec, a subsidiary of GlaxoSmithKline (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), which collectively secured $72 million in funding from the U.S. health department in October to boost the production of bird flu vaccines. These traditional vaccines, developed years ago, target older H5N1 strains but are expected to offer some protection.
Moderna, backed by $176 million from the U.S. government's BARDA, is working on an updated mRNA H5N1 vaccine. Other players, including Pfizer and GSK (in collaboration with CureVac), are testing similar candidates.
<h3 class="wp-block-heading">ETFs in Focus</h3>
For investors who want to play the trend but are wary of choosing individual biotech stocks, here are three ETFs that offer diversified exposure to the biotech companies leading the vaccine efforts. With a mix of traditional and mRNA vaccine developers in focus, these funds could benefit as the world prepares for a potential bird flu pandemic.
iShares Genomics Immunology and Healthcare ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IDNA#NYSE">IDNA</a>) tracks the NYSE FactSet Global Genomics and Immuno Biopharma Index, and has already gained 2.5% so far this year. The fund has an expense ratio of 0.47%, and $129.97 million in assets under management (AUM). The fund has currently invested 4.48% of its assets in Moderna. Sanofi, GSK and Novavax are also part of its portfolio of 51 equity holdings.
First Trust Nasdaq Pharmaceuticals ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FTXH#NASDAQ">FTXH</a>) derives its investment strategy from the Nasdaq US Benchmark Index, and has an expense ratio of 0.60%. Pfizer is one of its top holdings, with 7.28% of assets allocated to it.
SPDR S&amp;P Biotech ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XBI#NYSE">XBI</a>) mirrors the S&amp;P&nbsp;Biotechnology Select Industry&nbsp;Index, and charges a 0.35% expense ratio. Out of its present AUM of $6.37 billion, Moderna holds 2.58%. Almost 100% of its holdings are exposed to the biotechnology sector, with only about 0.04% invested in the pharmaceutical sector.
<h3 class="wp-block-heading">The Bird Flu Menace </h3>
The bird flu scare in humans ratcheted higher in late 2024 when a 13-year-old girl in Canada fell critically ill with H5N1 and required a ventilator. Around the same time, the U.S. reported its first severe case in an elderly patient in Louisiana.
Health experts warn that vigilance is key to preventing mutations that could trigger a pandemic. While the technology to develop vaccines quickly is available, governments may need to fund large-scale clinical trials in advance to ensure rapid distribution in case of a health emergency.
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Photo: Shutterstock.

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Bird Flu Sparks Vaccine Stock Surge: ETFs To Watch As H5N1 Outbreak Intensifies

<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.

AEMD

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

Sanofi's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NYSE">SNY</a>) short percent of float has fallen 15.0% since its last report. The company recently reported that it has 3.74 million shares sold short, which is 0.17% of all regular shares that are available for trading. Based on its trading volume, it would take traders 1.75 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/">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">List of the most shorted stocks</a>
<h3>Sanofi Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2024/1735589712_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://pro.benzinga.com/">Benzinga Pro</a>, Sanofi's peer group average for short interest as a percentage of float is 4.35%, 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/">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 Is The Market Feeling About Sanofi?

In the current session, Sanofi Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) is trading at $48.30, after a 0.18% decrease. Over the past month, the stock decreased by 0.88%, and in the past year, by 2.21%. With performance like this, long-term shareholders are more likely to start looking into the company's price-to-earnings ratio. 

<img src="https://www.benzinga.com/files/images/story/2024/1735132508_0.png" alt="Past Year Chart" />

<h3>Sanofi P/E Compared to Competitors</h3>
The P/E ratio measures the current share price to the company's EPS. It is used by long-term investors to analyze the company's current performance against it's past earnings, historical data and aggregate market data for the industry or the indices, such as S&amp;P 500. A higher P/E indicates that investors expect the company to perform better in the future, and the stock is probably overvalued, but not necessarily. It also could indicate that investors are willing to pay a higher share price currently, because they expect the company to perform better in the upcoming quarters. This leads investors to also remain optimistic about rising dividends in the future. 
Compared to the aggregate P/E ratio of the 27.1 in the Pharmaceuticals industry, Sanofi Inc. has a lower P/E ratio of 26.01. Shareholders might be inclined to think that the stock might perform worse than it's industry peers. It's also possible that the stock is undervalued. 

<img src="https://www.benzinga.com/files/images/story/2024/1735132508_1.png" alt="Guage" />

In conclusion, the price-to-earnings ratio is a useful metric for analyzing a company's market performance, but it has its limitations. While a lower P/E can indicate that a company is undervalued, it can also suggest that shareholders do not expect future growth. Additionally, the P/E ratio should not be used in isolation, as other factors such as industry trends and business cycles can also impact a company's stock price. Therefore, investors should use the P/E ratio in conjunction with other financial metrics and qualitative analysis to make informed investment decisions.

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A Look Into Sanofi Inc's Price Over Earnings

Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines
<ul>
<li>Pneumococcal disease remains a major global health challenge despite the availability of current vaccines</li>
<li>This 21-valent pneumococcal conjugate vaccine (PCV21) is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants &amp; toddlers</li>
</ul>

Sanofi Launches Phase 3 Trials For PCV21 And Strengthens Partnership With SK Bioscience On Next-Generation Pneumococcal Conjugate Vaccines

These ten large-cap stocks were the best performers in the last week. Are they in your portfolio?
<ol>
<li>Teva Pharmaceutical Industries Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) stock escalated 33.88% after the company and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) announced that primary endpoints were met in the Phase 2b trial of Duvakitug for <a href="https://www.benzinga.com//node/42531132" target="_blank" rel="noreferrer noopener">ulcerative colitis and Crohn&#8217;s disease</a>.</li>
<li>Klaviyo, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KVYO#NYSE">KVYO</a>) shares surged 12.85%.</li>
<li>Olive Garden parent Darden Restaurants, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DRI#NYSE">DRI</a>) stock rose 12.54% after the company reported better-than-expected second-quarter EPS and <a href="https://www.benzinga.com//node/42585797" target="_blank" rel="noreferrer noopener">issued an FY25 revenue outlook</a>. Several analysts raised the <a href="https://www.benzinga.com/quote/dri/analyst-ratings" target="_blank" rel="noreferrer noopener">price forecast on the stock</a>.</li>
<li>Doximity, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DOCS#NYSE">DOCS</a>) shares upped 10.91%. Stephens &amp; Co. initiated coverage with an Equal-Weight rating and <a href="https://www.benzinga.com/quote/docs/analyst-ratings" target="_blank" rel="noreferrer noopener">a price forecast of $55</a>.</li>
<li>Birkenstock Holding plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BIRK#NYSE">BIRK</a>) shares increased 9.70% after the company reported better-than-expected fourth-quarter financial results and issued FY25 guidance. Several analysts raised <a href="https://www.benzinga.com//node/42599431" target="_blank" rel="noreferrer noopener">the price forecast on the stock</a>.</li>
<li>Jabil Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JBL#NYSE">JBL</a>) stock upped 7.30% after the company reported better-than-expected <a href="https://www.benzinga.com//node/42553094" target="_blank" rel="noreferrer noopener">first-quarter EPS and revenues</a>. Several analysts raised <a href="https://www.benzinga.com/quote/jbl/analyst-ratings" target="_blank" rel="noreferrer noopener">the price forecast on the stock</a>.</li>
<li>Neurocrine Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NBIX#NASDAQ">NBIX</a>) stock rose 6.88%. The FDA approved Crenessity (crinecerfont) capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients four years of age and older with <a href="https://www.benzinga.com//node/42508449" target="_blank" rel="noreferrer noopener">classic congenital adrenal hyperplasia (CAH).</a></li>
<li>GameStop Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GME#NYSE">GME</a>) stock was up 6.54% last week, continuing strength from Q3 earnings.</li>
<li>Dr. Reddy&#8217;s Laboratories Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RDY#NYSE">RDY</a>) stock increased 6.29%.</li>
<li>Li Auto Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LI#NASDAQ">LI</a>) shares upped 6.13% last week.</li>
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Photo by Sundry Photography via Shutterstock

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Teva Pharmaceutical, Li Auto, And Darden Restaurants Are Among Top Large Cap Gainers Last Week (December 16-20): Are The Others In Your Portfolio?

In 2020, CORXEL (formerly Ji Xing) acquired the rights to develop and commercialize aficamten in Greater China (including the Chinese mainland, Hong Kong SAR and Macau SAR, and Taiwan) from Cytokinetics in accordance with Cytokinetics' global registration programs. Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from The Center for Drug Evaluation of the China National Medical Products Administration which recently accepted the New Drug Application for aficamten tablets for&nbsp;the treatment of oHCM for Priority Review.
Sanofi will now acquire CORXEL's rights relating to aficamten in Greater China for an undisclosed amount. Cytokinetics&nbsp;remains eligible to receive up to $150 million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of aficamten in Greater China. Cytokinetics is now also eligible to receive additional undisclosed payments in connection with the execution of the agreement between Sanofi and CORXEL.

CYTK

Cytokinetics Announces Sanofi's Acquisition Of Aficamten Rights For HCM Treatment In Greater China

<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

Teva Pharmaceutical Industries Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Phase 2b RELIEVE UCCD study met its primary endpoints in patients with ulcerative colitis (UC) and <a href="https://www.benzinga.com/24/12/42531132/why-are-teva-and-sanofi-stocks-trading-higher-on-tuesday" target="_blank" rel="noreferrer noopener">Crohn&#8217;s disease (CD)</a>.
In the RELIEVE UCCD study, 36.2% (low-dose) and 47.8% (high-dose) of patients with ulcerative colitis treated with duvakitug achieved clinical remission compared to 20.45% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14.
BofA Securities raised the price target for Teva to $25 from $23 <a target="_blank" href="https://www.benzinga.com/quote/TEVA/analyst-ratings" rel="noreferrer noopener">with a Buy rating</a>, reflecting a strong Phase 2 data update for duvakitug in inflammatory bowel disorders (IBD).
Based on the strength of the data and the emerging product prole, the analyst forecasts nominal peak sales of ~$2 billion (booked by partner), with Teva booking half the profits.
Given the anticipated impact on profits by 2030, BofA factors in the long-term strength of Teva&#8217;s innovative portfolio by applying a valuation multiple of 9.25x to 2025 estimated EV/EBITDA.
Partnership milestone payments provide reliable cash flow, and the analyst sees potential for the stock to gain value as the company shifts toward growth-focused execution.
The TL1a drug class has emerged over the last two years, led by Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Prometheus&#8217; strong Phase 2 data, which was followed by similar data from Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) competitor asset.
BofA writes that TL1a was a class of drug that could offer a very good safety profile, on par with market-leading Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) Entyvio, plus a high rate of efficacy across all major patient subgroups.
Data update from Teva in around 240 patients in Phase 2 showed 16%-27% placebo-adjusted MAYO remission scores in the UC population, with the high dose compared favorably to competitors.
TEVA Price Action: Teva Pharmaceutical stock is up 3.23% at $21.56 at publication Wednesday.
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Photo: Courtey Teva Pharmaceutical Industries

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RHHBY

Teva Pharmaceutical Releases Impressive Phase 2 Candidate Data For Gastro-Related Diseases

<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

U.S. stocks were mostly higher, with the Nasdaq Composite gaining around 1% on Monday.
Shares of RCI Hospitality Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RICK#NASDAQ">RICK</a>) rose sharply during Tuesday's session after the company reported better-than-expected <a href="https://www.benzinga.com/quote/RICK/earnings">quarterly financial results</a>.
RCI Hospitality reported quarterly earnings of $1.63 per share which beat the analyst consensus estimate of 37 cents per share. The company reported quarterly sales of $73.23 million which beat the analyst consensus estimate of $72.98 million.
RCI Hospitality shares surged 15.4% to $60.16 on Tuesday.
Here are some other big stocks recording gains in today's session.
<ul>
<li>Quantum Computing Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QUBT#NASDAQ">QUBT</a>) shares jumped 31.7% to $14.60 after the company announced it was awarded a prime contract by NASA to apply Dirac-3 for imaging and data processing support.</li>
<li>Akso Health Group (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AHG#NASDAQ">AHG</a>) shares surged 25.6% to $1.47.</li>
<li>Arqit Quantum Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARQQ#NASDAQ">ARQQ</a>) shares gained 21.7% to $32.20.</li>
<li>Teva Pharmaceutical Industries Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) climbed 20% to $19.82 after the company and Sanofi announced that primary endpoints were met in the Phase 2b trial of Duvakitug for ulcerative colitis and Crohn&#8217;s disease.</li>
<li>Hesai Group (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSAI#NASDAQ">HSAI</a>) gained 20% to $12.16.</li>
<li>Jupiter Neurosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JUNS#NASDAQ">JUNS</a>) gained 17.8% to $12.10.</li>
<li>SelectQuote, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SLQT#NYSE">SLQT</a>) shares rose 17.3% to $3.2388.</li>
<li>Rezolve AI Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RZLV#NASDAQ">RZLV</a>) gained 15% to $2.4494.</li>
<li>Arqit Quantum Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARQQ#NASDAQ">ARQQ</a>) rose 15% to $30.39.</li>
<li>SkyWater Technology, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SKYT#NASDAQ">SKYT</a>) gained 14.2% to $11.60.</li>
<li>Rigetti Computing, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGTI#NASDAQ">RGTI</a>) gained 11.3% to $9.38.</li>
<li>GameStop Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GME#NYSE">GME</a>) gained 5.3% to $31.01.</li>
<li>Bilibili Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BILI#NASDAQ">BILI</a>) rose 5% to $20.17.</li>
<li>Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) gained 4.8% to $48.08 after the company and Teva announced that primary endpoints were met in the Phase 2b trial of Duvakitug for ulcerative colitis and Crohn&#8217;s disease.</li>
<li>Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) shares rose 3% to $477.19 after Mizuho upgraded the stock from Neutral to Outperform and raised its price target from $230 to $515.</li>
</ul>
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RCI Hospitality, Quantum Computing, Teva Pharmaceutical, Tesla And Other Big Stocks Moving Higher On Monday

On Tuesday, Teva Pharmaceutical Industries Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Phase 2b RELIEVE UCCD study met its primary endpoints in patients with ulcerative colitis (UC) and <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/g42527140/teva-and-sanofi-announce-duvakitug-anti-tl1a-positive-phase-2b-results-demonstrating-best-in-class" rel="noreferrer noopener">Crohn&#8217;s disease (CD)</a>.
RELIEVE UCCD investigated duvakitug (TEV&#8217;574/SAR447189), a human IgG1-λ2 monoclonal antibody targeting TL1A, for moderate-to-severe inflammatory bowel disease (IBD).
In the RELIEVE UCCD study, 36.2% (low-dose) and 47.8% (high-dose) of patients with ulcerative colitis treated with duvakitug achieved clinical remission compared to 20.45% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41384005/amicus-therapeutics-settles-patent-lawsuit-teva-pharmaceuticals-over-generic-version-of-its-rare-" rel="noreferrer noopener">Amicus Therapeutics Settles Patent Lawsuit Teva Pharmaceuticals Over Generic Version Of Its Rare Genetic Disorder Drug</a>
In patients with Crohn&#8217;s disease, 26.1% (low-dose) and 47.8% (high-dose) treated with duvakitug achieved endoscopic response compared to 13.0% on placebo, placebo-adjusted rates were 13.0% (low dose) and 34.8% (high dose).
Overall, the treatment effect was consistent across subgroups.
Detailed results are expected to be presented at a scientific forum in 2025.
Duvakitug was generally well tolerated in ulcerative colitis and Crohn&#8217;s disease, with no safety signal identified.
Overall treatment-emergent adverse events (AE) rates were similar between duvakitug and placebo.
Ulcerative colitis and Crohn&#8217;s disease, the two main types of IBD, are chronic inflammatory conditions of the GI tract resulting in symptoms such as abdominal pain, diarrhea, rectal bleeding, fatigue, and weight loss.
Price Action: At last check Tuesday, TEVA stock was up 20.40% at $19.88, and SNY stock was up 4.07% at $47.76 during the premarket session.
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</ul>

Why Are Teva And Sanofi Stocks Trading Higher On Tuesday?

The Health Resources and Services Administration (HRSA) has warned Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) about its proposed credit model for certain outpatient drugs under the 340B program.
HRSA asserts that the credit system, beginning on January 6, 2025, violates Sanofi's legal obligations under the 340B statute.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/24/11/42097386/cvs-healthcignaunitedhealths-pharmacy-benefit-managers-accuse-ftc-of-overreach-in-effort-to-reshape-drug-rebate-system" rel="noreferrer noopener">Big Pharma's Pharmacy-Benefit Managers Accuse FTC of Overreach In Effort to Reshape Drug Rebate System</a>
Sanofi <a target="_blank" href="https://www.hrsa.gov/sites/default/files/hrsa/opa/dec-13-2024-hrsa-letter-sanofi.pdf" rel="noreferrer noopener">announced</a> in a November 22, 2024, notice that it would introduce a credit model for covered outpatient drugs for specific covered entities, including disproportionate share hospitals, critical access hospitals, rural referral centers, and sole community hospitals.
Under this plan, these entities would pay the Wholesale Acquisition Cost (WAC) upfront and later submit purchase and claim data to receive a credit representing the 340B price difference. Starting March 1, 2025, this model would include consolidated health centers.
Additionally, Sanofi's notice requires hospitals to submit healthcare encounter data to verify claims based on HRSA's 1996 patient guidelines, effective March 1, 2025.
The criteria include ensuring the individual receiving the drug is under the covered entity's care and that prescriptions are tied to services provided by the entity.
HRSA emphasized that the 340B statute establishes a ceiling price as the maximum amount covered entities can be charged for outpatient drugs. Any manufacturer must offer drugs at or below this ceiling price without imposing additional conditions. Sanofi's proposed credit model, which mandates payment above this price without prior approval, directly contradicts the statute.
The agency also warned that proceeding with the credit proposal could lead to severe consequences for Sanofi. These include potential termination of its Pharmaceutical Pricing Agreement (PPA) and civil monetary penalties.
The 340B statute allows sanctions for manufacturers that knowingly overcharge covered entities.
HRSA has instructed Sanofi to halt the implementation of this credit model immediately and provide confirmation by December 20, 2024.
Bristol-Myers Squibb Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) filed a lawsuit against HRSA and the U.S. Department of Health and Human Services, alleging that HRSA's rejection of its proposed rebate model for the 340B Drug Pricing Program <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/42248288/bristol-myers-squibb-files-lawsuit-against-us-agency-for-overreach-in-340b-drug-pricing-program" rel="noreferrer noopener">violates federal law</a>.
Price Action: At last check Tuesday, SNY stock was up 4.14% at $47.79 during the premarket session.
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Image by HJBC via Shutterstock

Government

Sanofi's 340B Credit Proposal Draws Federal Warning For Statutory Violation

WIIM

Sanofi shares are trading higher after the company and Teva announced that primary endpoints were met in the Phase 2b trial of Duvakitug for ulcerative colitis and Crohn's disease.

Teva And Sanofi Announce Primary Endpoints Met In Phase 2b Trial Of Duvakitug  In Ulcerative Colitis And Crohn's

The lawyer assisting <a href="https://www.benzinga.com/topic/robert-f-kennedy-jr">Robert F. Kennedy Jr.</a> in selecting federal health officials for the incoming administration of President-elect Donald Trump has filed a petition urging the government to revoke its approval of the polio vaccine.
The vaccine has safeguarded millions of people for decades against a virus that can cause paralysis or death.
This effort represents just one facet of the broader campaign led by the lawyer, Aaron Siri, who has petitioned for the suspension of 13 other vaccines including COVID as he challenges vaccines across the board and across the country, <a href="https://www.nytimes.com/2024/12/13/health/aaron-siri-rfk-jr-vaccines.html">reported </a>the New York Times on Friday.
<h2 class="wp-block-heading">RFK Jr.&#8217;s Anti-Vaccine Campaign Precedes Him</h2>
Long before COVID-19, Kennedy, <a href="https://www.benzinga.com/government/regulations/24/11/41993115/trump-taps-rfk-jr-for-health-secretary-role-sends-5-vaccine-stocks-lower">Trump's pick</a> to lead the Department of Health and Human Services, gained influence through his anti-vaccine nonprofit Children's Health Defense, spreading fear and distrust about vaccines globally. Kennedy has long promoted the debunked link between vaccines and autism.
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One of Siri&#8217;s criticisms of vaccines is that they&#8217;ve not not undergone randomized, double-blind clinical trials; he says they should be removed from the market until such trials are conducted. This approach would involve denying millions of American children access to polio shots, which public health experts consider unethical due to the known risks of polio. 
"You're substituting a theoretical risk for a real risk," <a href="https://www.nytimes.com/2024/12/13/health/aaron-siri-rfk-jr-vaccines.html">said</a> Dr. Paul A. Offit, a vaccine expert at the Children's Hospital of Philadelphia, according to the Times. 
Polio vaccination has been part of the routine childhood immunization schedule in the United States for decades.
Though Kennedy has stated that he does not intend to restrict access to any vaccines, his ongoing collaboration with Siri raises concerns that vaccine policy could face intensified scrutiny. 
<h2 class="wp-block-heading">What Say You, Donald Trump?</h2>
In an <a href="https://time.com/7200212/person-of-the-year-2024-donald-trump/">interview</a> published Thursday by Time magazine, Trump said he's going to direct Kennedy to study the rising rates of autism diagnoses and that he'd consider getting rid of some vaccines for children, falsely suggesting autism may be caused by vaccines.
"We're going to have a big discussion. The autism rate is at a level that nobody ever believed possible. If you look at things that are happening, there's something causing it," Trump said.
<h2 class="wp-block-heading">Bad News For Pharma Companies</h2>
Pharmaceutical companies that produce either standalone polio vaccines or in combination with other immunizations &#8211; GlaxoSmithKline (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), Sanofi (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) and the privately owned Bilthoven Biologicals &#8211; are not likely to view Kennedy and Siri's anti-vaccine push in a positive light.
Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) no longer produces the so-called <a href="https://www.cdc.gov/polio/vaccines/index.html#:~:text=Polio%20vaccination%20has%20been%20part,the%20United%20States%20since%202000.">inactivated polio vaccine</a>, which is the only polio vaccine given in the U.S. since 2000, though the company played a key role in the eradication of polio and smallpox.
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Image via Shutterstock.

Regulations

Kennedy's Lawyer Urges FDA To Revoke Polio Vaccine Approval, Endangering Millions Of Children

<ul>
<li>Novavax continues to progress Sanofi agreement by achieving first milestone, with additional milestones and ongoing tiered royalties to come, solidifying a strong model for future partnerships</li>
<li>Novavax's COVID-19 vaccine included in Sanofi's two combination vaccine candidates for prevention of influenza and COVID-19, for which Phase 1/2 trials were initiated and Fast Track designation recently granted in the U.S.</li>
</ul>
GAITHERSBURG, Md., Dec. 13, 2024 /PRNewswire/ -- Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>), a global company advancing protein-based vaccines with its Matrix-M&#x2122; adjuvant,&nbsp;today announced progress in Q4 2024 advancing its corporate growth strategy through its partnership with Sanofi. The Company has achieved a milestone associated with its Phase 2/3 clinical trial for&nbsp;its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi.

Novavax Advances Corporate Growth Strategy Through Sanofi Partnership, Including Achievement Of First $50M Milestone

Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis
<ul>
<li>Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS)</li>
<li>Tolebrutinib is the first and only brain-penetrant BTK inhibitor in MS to be designated Breakthrough Therapy by the FDA&nbsp;</li>
</ul>

Sanofi's Tolebrutinib Achieves FDA Breakthrough Therapy Designation For Non-Relapsing Secondary Progressive Multiple Sclerosis (nrSPMS)

Bird flu claims first U.S. life in Louisiana

Berenberg Bank analyst Luisa Hector maintained a Buy rating on Sanofi (SNYNF – Research Report) today and set a price target of €115.00. The compan...

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Financing

Press Releases

Vigil Neuroscience Announces $40 Million Strategic Investment from Sanofi

Sanofi ships U.S. influenza vaccines for the 2024/25 season

Ontario Ministry of Health Announces a Universal Public Program with Beyfortus® this RSV Season

Fluzone® High-Dose Quadrivalent vaccine remains preferentially recommended to protect adults 65 years of age and older against influenza

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Sanofi shipping BEYFORTUS® in US to help protect babies against RSV disease; new manufacturing line approved by FDA

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Global Cancer Rates Surge as Biotech Innovators Work on New Therapies

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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