에 대한 최신 뉴스 Sanofi (NASDAQ:SNY) 주식

Sanofi

Sanofi American Depositary Shares (Each repstg one-half of one ordinary share)

NYSE

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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바이킹 펀드 매니지먼트(Viking Fund Management)의 최근 13F 공시를 보면, 2024년 대선을 앞두고 일부 석유 기업 주식을 매도하는 등 3분기에 어떤 회사를 사고 팔았는지 확인할 수 있다. 13F 공시를 통해 보고한 포지션은 다음과 같다.

바이킹 펀드: 3분기에 대형 석유주 매각, 테슬라 포지션 절반으로 축소, 브로드컴 추가 매입

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NOVO

미국 주식 시장이 노동절 연휴로 인해 문을 닫으면서 거래량이 적어 9월에는 글로벌 시장이 조심스럽게 시작되었다.
트레이더들이 유럽중앙은행(ECB)의 임박한 금리 인하를 예상함에 따라 유럽 시장은 소폭 상승 마감했다. 범유럽 유로 스톡스 50 지수는 이날 0.3% 상승해 7월 중순 이후 최고 수준으로 마감했다. 독일에서는 DAX 지수가 0.1% 상승하며 종가 기준으로 새로운 기록을 세웠다.

美 노동절에 유럽 주식은 보합, 독일 DAX는 기록적인 마감, 천연가스 선물은 상승

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목요일 아침 (현지 시간 기준) 미국 주식 선물이 더 높게 거래되면서 오늘 투자자의 관심을 끌 수 있는 일부 주식은 다음과 같다: 월스트리트는 허니웰 인터내셔널(NASDAQ:HON)가 개장 전에 94억 1천만 달러의 매출과 94억 1천만 달러의 분기 이익을 주당 2.42달러로 보고할 것으로 예상하고 있다. Benzinga Pro의 데이터에 따르면 허니웰의 주식은 시간외 거래에서 0.5% 상승한 214.80달러를 기록했다.

목요일 주목해야 할 주식: 아메리칸 항공, 아스트라제네카 그리고 3종목

Sanofi SA

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<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>

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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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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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<li><a href="https://www.benzinga.com/media/24/12/42529245/trump-and-netflix-boss-sarandos-set-for-high-stakes-mar-a-lago-meeting" target="_blank" rel="noreferrer noopener">Trump and Netflix Boss Sarandos Set for High-Stakes Mar-a-Lago Meeting</a></li>
</ul>

Large Cap

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.
Read Also: <a href="https://www.benzinga.com/markets/equities/24/11/42254495/trumps-hhs-pick-rfk-jr-has-a-long-history-of-challenging-global-health-policies">Trump&#8217;s HHS Pick RFK Jr. Has a Long History of Challenging Global Health Policies</a>
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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</ul>
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)

Two combination vaccine candidates for prevention of influenza and COVID-19 granted Fast Track designation in the US
<ul>
<li>First non-mRNA combination vaccine candidates that include two already licensed vaccines to prevent influenza and COVID-19 infections</li>
<li>Two phase 1/2 clinical studies are ongoing to evaluate the safety profile and immune response induced by the combination vaccine candidates&nbsp;</li>
</ul>

Sanofi's Dual Influenza-COVID-19 Vaccines Receive FDA Fast Track Designation For Individuals 50 Years Of Age And Older

Positive results from the pivotal LUNA 3 phase 3 study of rilzabrutinib in adults with persistent or chronic immune thrombocytopenia (ITP), a rare immune-mediated disease, reinforce the efficacy and safety of rilzabrutinib, an oral, reversible, covalent Bruton's tyrosine kinase (BTK) inhibitor, and further support its potential as a first-in-class treatment for ITP. Platelet response was achieved in 65% (n=86) of patients receiving rilzabrutinib compared to 33% (n=23) of patients on placebo. The primary endpoint was met, with rilzabrutinib demonstrating durable platelet response in 23% of ITP adult patients compared to 0% on the placebo arm (p&lt;0.0001), as well as key secondary endpoints including reduced bleeding, number of weeks with platelet response, the need for rescue therapy use, and improved physical fatigue and quality of life measures.

Sanofi Announced Rilzabrutinib Demonstrated Significant Patient Benefit In First Positive Phase 3 Study Of BTK Inhibitor In ITP At ASH; Said  Phase 3 Data Show Rapid And Durable Platelet Response, Reduced Bleeding And Need For Rescue Response

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

AEMD

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

On CNBC's &#8220;Mad Money Lightning Round,&#8221; Jim Cramer said Navitas Semiconductor Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVTS#NASDAQ">NVTS</a>) is &#8220;<a href="https://www.benzinga.com/quote/NVTS/analyst-ratings">losing a lot of money.&#8221;</a>
On Tuesday, Navitas Semiconductor announced that Dr. Ranbir Singh, formerly executive vice president at Navitas and the founder and CEO of GeneSiC Semiconductor, has been appointed to the company's board of directors.
Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) is a &#8220;quandary. I've got to tell you, I expected sales to be better,&#8221; Cramer said. &#8220;I do prefer Eli Lilly (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>)."
On Nov. 15, the FDA accepted for review the resubmission of the supplemental biologics license application (sBLA) for Regeneron Pharmaceuticals and Sanofi SA's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Dupixent (dupilumab) for patients ages 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. Wolfe Research analyst Alexandria Hammond initiated coverage on Regeneron Pharmaceuticals with an Outperform rating and announced a price <a href="https://www.benzinga.com/general/biotech/24/11/42008174/fda-to-revisit-regeneron-sanofis-dupixent-for-rare-skin-disease">target of $1150</a>.
Cramer said LandBridge Company LLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LB#NYSE">LB</a>) is a &#8220;winner.&#8221; He recommended holding on to the stock.
On Nov. 7, LandBridge reported quarterly sales of $28.487 million, which missed the analyst consensus estimate of $33.323 million. On Dec. 4, Piper Sandler analyst Mark Lear maintained LandBridge with a Neutral rating and raised the price target from $39 to $79.
Price Action:
<ul>
<li>Navitas Semiconductor shares gained 4% to settle at $3.14 on Tuesday.</li>
<li>Regeneron Pharmaceuticals shares fell 1.7% to close at $749.57.</li>
<li>LandBridge shares gained 2.8% to close at $74.84 on Tuesday.</li>
</ul>
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Photo: Shutterstock

Long Ideas

Media

NVTS

REGN

Jim Cramer: This Energy Stock Is A 'Winner,' But Navitas Semiconductor Is 'Losing A Lot Of Money'

Bird flu has been detected in a batch of raw milk sold in California and a voluntary recall of the milk has been issued at the request of the state's <a href="https://www.benzinga.com/general/health-care/24/11/42087908/mutated-bird-flu-case-in-california-puts-humans-at-increased-risk-so-which-companies-are-developing-vaccines">department of public health.&nbsp;</a>
The Details: The virus was found during testing of a batch of whole raw milk from Raw Farm in Fresno county. The company has issued a voluntary recall of the batch, which has a &#8220;best by date&#8221; of Nov. 27. 
"Out of an abundance of caution, and due to the ongoing spread of bird flu in dairy cows, poultry, and sporadic human cases, consumers should not consume any of the affected raw milk," the California Department of Public Health said in <a href="https://www.cdph.ca.gov/Programs/OPA/Pages/NR24-039.aspx">a Sunday statement.&nbsp;</a>
Read More: <a href="https://www.benzinga.com/24/11/42194570/starbucks-employee-systems-down-after-software-provider-suffers-ransomware-attack">Starbucks&#8217; Employee Systems Down After Software Provider Suffers Ransomware Attack</a>
California reported 29 confirmed human cases of bird flu since early October, with 28 of the cases resulting from direct contact with infected dairy cows. No person-to-person spread of bird flu has been detected in California or the U.S., according to the state's public health department.&nbsp;
Vaccine Efforts: As concern about the possible spread of bird flu grows, the U.S. government is increasing its efforts to develop a stockpile of vaccines for the disease.&nbsp;
Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) received a $176 million government contract in July to advance development of its bird flu vaccine, leveraging the same mRNA technology used in the company's COVID-19 vaccine.&nbsp;&nbsp;
In October, the Department of Health and Human Services granted GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) and Australian firm CSL Limited $72 million to <a href="https://www.benzinga.com/general/biotech/24/10/41188886/gsk-sanofi-and-csl-secure-us-government-fund-to-boost-bird-flu-vaccine-production-report">more than double</a> the U.S. supply of bird flu vaccines.&nbsp;
According to the CDC, 55 total cases have been reported in the 2024 bird flu outbreak in the U.S. The CDC said that it is monitoring <a href="https://www.cdc.gov/bird-flu/situation-summary/index.html">the bird flu situation </a>carefully and working with states to monitor people with animal exposures, though the current public health risk is low.
Read Next:&nbsp;
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</ul>
Photo: Pexels

MRNA

Bird Flu Found In Raw Milk Leads To Recall In California

<a href="https://www.wsj.com/health/healthcare/sanofi-plans-to-change-hospital-drug-discount-program-18557f6d">https://www.wsj.com/health/healthcare/sanofi-plans-to-change-hospital-drug-discount-program-18557f6d</a>
&nbsp;
An industry fight against <a href="https://www.wsj.com/articles/340b-drug-discounts-hospitals-low-income-federal-program-11671553899?mod=article_inline&amp;mod=article_inline">lucrative drug discounts</a> for hospitals is intensifying as another drugmaker joins the battle: <a href="https://www.wsj.com/market-data/quotes/FR/XPAR/SAN">Sanofi</a>.
The pharmaceutical company plans to change its policy on how it gives discounts to certain hospitals. Sanofi will require institutions to provide pharmacy and medical claims information before receiving federally mandated discounts. The company plans to send a letter, which was reviewed by The Wall Street Journal, to hospitals outlining its new model on Friday, according to people familiar with the matter.&nbsp;

'Sanofi Plans To Change Hospital Drug-Discount Program; French Company Looks To Rein In How It Gives Discounts In Federal Program Designed To Help Hospitals That Serve Low-income And Uninsured Patients' - WSJ

The Federal Trade Commission (FTC) is facing legal challenges from three competing pharmacy-benefit managers (PBMs) over its attempt to restrict their ability to negotiate drug prices for <a target="_blank" href="https://www.benzinga.com/news/large-cap/24/10/41256923/cvs-unitedhealth-request-ftc-chair-recusal-amid-ongoing-pharmacy-benefit-managers-lawsuit" rel="noreferrer noopener">health plan sponsors</a>.
In September, the FTC filed a formal complaint against three major pharmacy benefit managers (PBMs)—CVS Health Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>) Caremark,&nbsp;Cigna Corp&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CI#NYSE">CI</a>), Express Scripts, and&nbsp;UnitedHealth Group Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>) Optum—for allegedly engaging in unfair and anti-competitive practices that have inflated the list&nbsp;<a target="_blank" href="https://www.benzinga.com/government/24/07/39695378/ftc-investigation-uncovers-anti-competitive-practices-by-handful-of-pharmacy-benefit-managers-includ" rel="noreferrer noopener">price of insulin medications</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/government/regulations/24/11/41866438/donald-trumps-second-term-could-reshape-us-healthcare-system-with-major-impacts-on-affordable-care-act-and-medicare" rel="noreferrer noopener">Donald Trump&#8217;s Second Term Could Reshape US Healthcare System, With Major Impacts on Affordable Care Act And Medicare</a>
The&nbsp;complaint&nbsp;accuses the PBMs of creating a system that benefits them financially by prioritizing drug rebates, forcing patients to pay higher costs for life-saving insulin. These PBMs, referred to as the Big Three, administer around 80% of <a target="_blank" href="https://www.benzinga.com/news/large-cap/24/09/40964870/us-federal-trade-commission-sues-cvs-health-cigna-unitedhealths-pharmacy-benefit-managers-for-infl" rel="noreferrer noopener">prescriptions in the U.S</a>.
The PBMs argue that this action seeks to upend current drug rebate contracts and disrupt long-standing practices, all while expanding the FTC&#8217;s authority beyond traditional limits.
The companies also <a target="_blank" href="https://www.bloomberglaw.com/public/desktop/document/ExpressScriptsIncetalvFederalTradeCommissionetalDocketNo424cv0154?doc_id=X11H3MUIQJ4995RQ9NSUPGSE2AP" rel="noreferrer noopener">contend</a> that the administrative proceeding violates constitutional principles by lacking independent judicial oversight and claim that the FTC&#8217;s approach could result in significant and irreparable injury.
The lawsuit stems from the FTC&#8217;s attempt to regulate the drug rebate system, allowing PBMs to secure manufacturers&#8217; discounts.
However, the FTC&#8217;s complaint accuses the PBMs of using their power to create an unfair market, alleging that the system allows drug manufacturers to inflate prices.
In challenging the FTC&#8217;s action, the PBMs argue that this is not just a market dispute but a constitutional issue.
They assert that the FTC&#8217;s administrative proceeding, taking place in an in-house forum where the agency decides the facts, the law, and the outcome, is unconstitutional.
Furthermore, the PBMs argue that the FTC&#8217;s decision to handle the case through this in-house process, with a partisan panel of Democratic commissioners, deprives them of a fair trial.
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<li><a href="https://www.benzinga.com/24/11/42094248/trumps-return-boosts-palantir-national-security-bets-drive-140-billion-market-cap" target="_blank" rel="noreferrer noopener">Palantir Tech&#8217;s $140 Billion Market Cap Gain Is Driven By Trump&#8217;s Victory And Higher Defense Spending Hope &#8211; Is The Stock Overvalued?</a></li>
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Photo by towfiqu barbhuiya via unsplash

Legal

Big Pharma's Pharmacy-Benefit Managers Accuse FTC of Overreach In Effort to Reshape Drug Rebate System

A child in Alameda County, California is the latest case of <a href="https://www.benzinga.com/general/health-care/24/11/41949697/bird-flu-puts-teen-in-critical-condition-as-canada-reports-first-human-case-what-you-need-to-know">bird flu in the U.S.</a> 
According to the <a href="https://www.latimes.com/environment/story/2024-11-19/alameda-county-child-believed-to-be-latest-case-of-bird-flu-source-unknown">Los Angeles Times</a>, the total case count in the U.S. stands at 54. Thirty-one cases are attributed to the dairy industry and 21 to the poultry industry. Two of the case&#8217;s causes are unknown.
Companies are <a href="https://www.benzinga.com/general/biotech/23/03/31416800/large-vaccine-players-including-gsk-moderna-prepare-for-bird-flu-vaccine-just-in-case">racing to develop vaccines</a>, but observers worry that the incoming Trump administration&#8217;s selection of vaccine-skeptic Robert F. Kennedy Jr. to lead the Department of Health and Human Services could put a potential treatment in the crosshairs.
Health researchers are exploring the idea that the virus was spread via wild birds. The California child&#8217;s genetic sequencing has not been released; it is therefore unclear if it is of wild bird or dairy origins.
Meanwhile, a teenager in Canada who was hospitalized with the bird flu possibly showed signs of mutation, the Guardian <a href="https://www.theguardian.com/world/2024/nov/19/bird-flu-cases-mutation-canada">reports</a>.
Experts are reportedly concerned that a mutation in the virus would make it easier to spread, making the odds of a widespread outbreak more likely.
Vaccine Efforts: Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Moderna Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) are currently developing an <a href="https://www.benzinga.com/general/health-care/24/11/41949697/bird-flu-puts-teen-in-critical-condition-as-canada-reports-first-human-case-what-you-need-to-know">mRNA bird flu vaccine</a> using similar technology to the companies' COVID-19 vaccines.
The U.S. government has <a href="https://www.benzinga.com/general/biotech/24/10/41188886/gsk-sanofi-and-csl-secure-us-government-fund-to-boost-bird-flu-vaccine-production-report">also awarded grants</a> to European pharmaceutical giants GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
Regulatory Question Marks: Kennedy, Donald Trump&#8217;s pick to lead the HHS, is widely known as <a href="https://www.benzinga.com/general/biotech/24/11/41822473/trumps-potential-health-czar-robert-f-kennedy-jr-rattles-vaccine-stocks-shoot-first-reaction">a vaccine-skeptic</a>. While the Kennedy family heir says he will not &#8220;take away anybody's vaccines,&#8221; his ultimate regulatory intentions are unclear. A bird flu vaccine could face additional hurdles in a Trump administration.
In the past, Kennedy has falsely associated <a href="https://www.benzinga.com/government/regulations/24/11/41993115/trump-taps-rfk-jr-for-health-secretary-role-sends-5-vaccine-stocks-lower">vaccinations with autism</a> in children, a claim that has been thoroughly disproven in the scientific field. A May Lancet <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00850-X/fulltext">study</a> found that vaccines have saved 154 million lives throughout human history. They have effectively treated polio, measles, pertussis, and other diseases.
Kennedy may face a tough confirmation vote in the Republican-controlled Senate given his pro-choice abortion stances. He has, however, found a unique <a href="https://x.com/jaredpolis/status/1857173250586911189">ally</a> in Colorado Governor Jared Polis, a Democrat.
Pfizer, Moderna and other vaccine manufacturers&#8217; stock fell on the news of Kennedy&#8217;s selection.
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Image: Shutterstock

Equities

Mutated Bird Flu Case In California Puts Humans At Increased Risk, So Which Companies Are Developing Vaccines?

<a href="https://www.cdc.gov/bird-flu/spotlights/h5n1-response-11152024.html" title="https://www.cdc.gov/bird-flu/spotlights/h5n1-response-11152024.html">https://www.cdc.gov/bird-flu/spotlights/h5n1-response-11152024.html</a>

U.S. CDC Says Since April Confirmed Avian Influenza A(H5) Virus Infections In 52 People In US; Aware Of Human Case Of H5N1 Bird Flu Reported In Canada & Is In Communication With Public Health Agency Of Canada

Teva, Sanofi gain after mid-stage trial win for IBD therapy

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Sanofi (SNYNF) Gets a Buy from Jefferies

In a report released today, Richard Vosser from J.P. Morgan maintained a Hold rating on Sanofi (SNYNF – Research Report), with a price target of €1...

Sanofi (SNYNF) Gets a Hold from J.P. Morgan

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Biodexa Takes Aim At Type 1 Diabetes With Innovative Drug Candidate Tolimidone

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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

Alzheimer's Disease Diagnostics & Therapeutics Market Driven by Use of Biomarkers and Advancing R&D Activities

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

Opinion

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

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