Moderna Option Alert: Oct 17 $35 Calls Sweep (8) near the Ask: 927 vs 11501 OI

Moderna Option Alert: Oct 17 $35 Calls Sweep (8) near the Ask: 927 @ $7.55 vs 11501 OI; Ref=$33.23

Moderna Option Alert: Oct 17 $35 Calls Sweep (5) near the Ask: 1053 vs 11501 OI

Moderna Option Alert: Oct 17 $35 Calls Sweep (5) near the Ask: 1053 @ $7.55 vs 11501 OI; Ref=$33.22

Moderna Option Alert: Oct 17 $35 Calls Sweep (12) near the Ask: 784 vs 11501 OI

Moderna Option Alert: Oct 17 $35 Calls Sweep (12) near the Ask: 784 @ $7.55 vs 11501 OI; Ref=$33.25

Moderna Option Alert: Oct 17 $35 Calls Sweep (18) near the Ask: 1328 vs 11501 OI

Moderna Option Alert: Oct 17 $35 Calls Sweep (18) near the Ask: 1328 @ $7.55 vs 11501 OI; Ref=$33.23

Moderna Option Alert: Sep 19 $35 Puts Sweep (27) near the midpoint: 1099 vs 6556 OI

Moderna Option Alert: Sep 19 $35 Puts Sweep (27) near the midpoint: 1099 @ $7.25 vs 6556 OI; Ref=$35.67

Moderna Option Alert: Sep 19 $30 Calls Sweep (3) near the Bid: 665 vs 337 OI

Moderna Option Alert: Sep 19 $30 Calls Sweep (3) near the Bid: 665 @ $11.301 vs 337 OI; Ref=$35.75

Moderna Option Alert: Oct 17 $35 Calls at the Bid: 2000 vs 521 OI

Moderna Option Alert: Oct 17 $35 Calls at the Bid: 2000 @ $9.99 vs 521 OI; Ref=$36.43

Moderna Option Alert: May 16 $30 Puts at the Bid: 3200 vs 112 OI; Earnings 2/14 Before Open 

Moderna Option Alert: May 16 $30 Puts at the Bid: 3200 @ $3.4 vs 112 OI; Earnings 2/14 Before Open Ref=$32.44

Moderna Option Alert: Jan, 2026 $30 Puts at the Ask: 2000 vs 12599 OI; Earnings 2/14 Before Open 

Moderna Option Alert: Jan, 2026 $30 Puts at the Ask: 2000 @ $6.74 vs 12599 OI; Earnings 2/14 Before Open Ref=$32.45

Moderna (NASDAQ:MRNA) Azioni

MODERNA INC

Moderna

Moderna is a commercial-stage biotech that was founded in 2010 and had its initial public offering in December 2018. The firm's mRNA technology was rapidly validated with its covid vaccine, which was authorized in the United States in December 2020. Moderna had 40 mRNA development candidates in clinical development as of September 2024. Programs span a wide range of therapeutic areas, including infectious disease, oncology, cardiovascular disease, and rare genetic diseases.

Jim Cramer Photo by s_bukley on Shutterstock

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Media

GRAL

MRNA

Le oscillazioni di Wall Street non accennano a diminuire. Il noto analista punta il dito contro la Casa Bianca e le sue politiche commerciali.

Jim Cramer accusa Trump: &#34;Il mercato è volatile? Solo se il presidente vuole&#34;

Earnings

News

Pre-Market Outlook

Trading Ideas

DKNG

PANW

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Venerdì in borsa: Palo Alto, Moderna e altre 3 azioni da monitorare

Large Cap

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CVAC

NVAX

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Allarme influenza aviaria: nuovo caso in USA. Ecco 4 azioni da tenere d&#39;occhio

Moderna Inc

FDA Commissioner Marty Makary on Tuesday named Vinay Prasad the next director of the U.S. Food and Drug Administration&#8217;s (FDA) Center of Biologics Evaluation and Research (CBER).
Dr. Prasad has openly criticized the biopharma industry and the FDA for using accelerated approvals broadly based on surrogate endpoints.
&#8220;We are surprised by the announcement because it seems to be in stark contrast to themes and initiatives that have been laid out by Dr. Makary, and it comes on the heels of large personnel departures across the FDA, raising questions on the ability to meet review timelines,&#8221; writes <a href="https://www.benzinga.com/topic/william-blair">William Blair </a>of Blue Matrix.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/05/45234032/fda-expands-surprise-inspections-at-foreign-drug-and-food-facilities-targets-double-standards-in-overseas-manufac" rel="noreferrer noopener">FDA Expands Surprise Inspections At Foreign Drug And Food Facilities, Targets Double Standards In Overseas Manufacturing Oversight</a>
Analyst Matt Phipps adds that there are many questions about how Prasad will shape regulatory decisions as the new head of CBER. Investors also seem confused about what CBER regulates compared to the Center of Drug Evaluation and Research (CDER).
Generally, drugs like antibodies, bispecifics and antibody-drug conjugates (ADCs) are reviewed by CDER, even though they use biologics license applications (BLAs).
CBER, on the other hand, oversees gene and cell therapies, vaccines and some other biological products. CDER typically handles therapeutic antibodies, proteins, cytokines and enzymes.
Blair wrote on Tuesday that for cell and gene therapies stocks that have reacted negatively, there are outstanding questions and increased uncertainty now as the analyst waits to see whether Makary or Prasad will have more impact on the guidelines and regulatory development requirements for these novel therapies, particularly in rare diseases.
Since being confirmed as commissioner, Makary has advocated for more accelerated approval opportunities for ultrarare diseases or therapies with overwhelming efficacy.
The vaccine space continues to face negative sentiment from HHS Secretary Robert F. Kennedy Jr., who requested placebo-controlled studies for new vaccine approvals.
Prasad&#8217;s appointment at CBER will likely continue to pressure this sector.
&#8220;Under Secretary Kennedy&#8217;s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,&#8221; HHS <a target="_blank" href="https://edition.cnn.com/2025/04/30/health/hhs-vaccine-placebo-testing" rel="noreferrer noopener">told</a> CNN in a statement Wednesday.
Blair writes that from the coverage list, Moderna Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) has seen a sharp sell-off and remains in a difficult position with a politically out-of-favor mRNA vaccine technology and a potentially more restrictive CBER head and review process for new vaccine products.
In contrast, Dynavax Technologies Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DVAX#NASDAQ">DVAX</a>) remains largely insulated given that Heplisav is approved and the analyst sees less scrutiny on adult vaccines that are not being pushed as mandatory.
Taysha Gene Therapies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSHA#NASDAQ">TSHA</a>) fell 18%, Solid Biosciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLDB#NASDAQ">SLDB</a>) closed 20.3% lower, Capricor Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CAPR#NASDAQ">CAPR</a>) stock closed 29% lower, Crispr Therapeutics AG (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRSP#NASDAQ">CRSP</a>) stock closed 12% lower, Sarepta Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) stock closed 27% lower, Moderna fell 12%, Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell 4.2%, and Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) closed 3.2% on Tuesday. Virtus LifeSci Biotech Clinical Trials ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BBC#NYSE">BBC</a>) closed 9.74% lower at $17.15 and SPDR Series Trust SPDR S&amp;P Biotech ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XBI#NYSE">XBI</a>) fell 6.63% to $77.17 on Tuesday.
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Photo: Shutterstock

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Biotech

Analyst Ratings

Movers

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CRSP

DVAX

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TSHA

Vinay Prasad's Appointment To FDA's CBER Triggers Questions Over Future Of Cell And Gene Therapy Regulation

<a href="https://news.bloomberglaw.com/health-law-and-business/fda-names-vinay-prasad-as-new-head-of-vaccines-biologics" title="https://news.bloomberglaw.com/health-law-and-business/fda-names-vinay-prasad-as-new-head-of-vaccines-biologics">https://news.bloomberglaw.com/health-law-and-business/fda-names-vinay-prasad-as-new-head-of-vaccines-biologics</a>

BHVN

DSGN

PTCT

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'FDA Names Vinay Prasad as New Head of Vaccines, Biologics'- Bloomberg Law

This whale alert can help traders discover the next big trading opportunities.
Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner.
Traders will search for circumstances when the market estimation of an option diverges heavily from its normal worth. High amounts of trading activity could push option prices to exaggerated or underestimated levels. 
Below are some instances of options activity happening in the Health Care sector: 
<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>UNH</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>05/09/25</td>
<td>$400.00</td>
<td>$51.3K</td>
<td>1.2K</td>
<td>2.2K</td>
</tr>
<tr>
<td>NVAX</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>01/16/26</td>
<td>$12.50</td>
<td>$50.3K</td>
<td>9.5K</td>
<td>1.4K</td>
</tr>
<tr>
<td>MRNA</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>06/20/25</td>
<td>$20.00</td>
<td>$33.2K</td>
<td>3.0K</td>
<td>578</td>
</tr>
<tr>
<td>HIMS</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>01/16/26</td>
<td>$50.00</td>
<td>$137.0K</td>
<td>3.2K</td>
<td>466</td>
</tr>
<tr>
<td>MRK</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>05/30/25</td>
<td>$84.00</td>
<td>$49.2K</td>
<td>684</td>
<td>443</td>
</tr>
<tr>
<td>SRPT</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>05/16/25</td>
<td>$55.00</td>
<td>$30.7K</td>
<td>660</td>
<td>405</td>
</tr>
<tr>
<td>VERA</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>06/20/25</td>
<td>$25.00</td>
<td>$165.0K</td>
<td>1.9K</td>
<td>306</td>
</tr>
<tr>
<td>CAPR</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>09/19/25</td>
<td>$15.00</td>
<td>$48.0K</td>
<td>2.8K</td>
<td>274</td>
</tr>
<tr>
<td>BIO</td>
<td>PUT</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>05/16/25</td>
<td>$210.00</td>
<td>$60.0K</td>
<td>401</td>
<td>250</td>
</tr>
<tr>
<td>PFE</td>
<td>PUT</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>05/16/25</td>
<td>$30.00</td>
<td>$36.2K</td>
<td>1.0K</td>
<td>150</td>
</tr>
</tbody>
</table>

<h2>Explanation</h2>
These bullet-by-bullet explanations have been constructed using the accompanying table. 
• For UNH (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>), we notice a call option trade that happens to be bearish, expiring in 3 day(s) on May 9, 2025. This event was a transfer of 137 contract(s) at a $400.00 strike. The total cost received by the writing party (or parties) was $51.3K, with a price of $375.0 per contract. There were 1204 open contracts at this strike prior to today, and today 2200 contract(s) were bought and sold. 
• Regarding NVAX (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>), we observe a put option trade with bearish sentiment. It expires in 255 day(s) on January 16, 2026. Parties traded 74 contract(s) at a $12.50 strike. The total cost received by the writing party (or parties) was $50.3K, with a price of $680.0 per contract. There were 9573 open contracts at this strike prior to today, and today 1429 contract(s) were bought and sold. 
• Regarding MRNA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>), we observe a put option sweep with bullish sentiment. It expires in 45 day(s) on June 20, 2025. Parties traded 537 contract(s) at a $20.00 strike. This particular put needed to be split into 24 different trades to become filled. The total cost received by the writing party (or parties) was $33.2K, with a price of $62.0 per contract. There were 3002 open contracts at this strike prior to today, and today 578 contract(s) were bought and sold. 
• For HIMS (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HIMS#NYSE">HIMS</a>), we notice a call option sweep that happens to be bullish, expiring in 255 day(s) on January 16, 2026. This event was a transfer of 100 contract(s) at a $50.00 strike. This particular call needed to be split into 10 different trades to become filled. The total cost received by the writing party (or parties) was $137.0K, with a price of $1370.0 per contract. There were 3252 open contracts at this strike prior to today, and today 466 contract(s) were bought and sold. 
• Regarding MRK (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), we observe a put option sweep with bullish sentiment. It expires in 24 day(s) on May 30, 2025. Parties traded 88 contract(s) at a $84.00 strike. This particular put needed to be split into 7 different trades to become filled. The total cost received by the writing party (or parties) was $49.2K, with a price of $560.0 per contract. There were 684 open contracts at this strike prior to today, and today 443 contract(s) were bought and sold. 
• For SRPT (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>), we notice a put option trade that happens to be bearish, expiring in 10 day(s) on May 16, 2025. This event was a transfer of 83 contract(s) at a $55.00 strike. The total cost received by the writing party (or parties) was $30.7K, with a price of $370.0 per contract. There were 660 open contracts at this strike prior to today, and today 405 contract(s) were bought and sold. 
• For VERA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERA#NASDAQ">VERA</a>), we notice a call option sweep that happens to be bullish, expiring in 45 day(s) on June 20, 2025. This event was a transfer of 300 contract(s) at a $25.00 strike. This particular call needed to be split into 6 different trades to become filled. The total cost received by the writing party (or parties) was $165.0K, with a price of $550.0 per contract. There were 1903 open contracts at this strike prior to today, and today 306 contract(s) were bought and sold. 
• For CAPR (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CAPR#NASDAQ">CAPR</a>), we notice a call option sweep that happens to be bullish, expiring in 136 day(s) on September 19, 2025. This event was a transfer of 200 contract(s) at a $15.00 strike. This particular call needed to be split into 14 different trades to become filled. The total cost received by the writing party (or parties) was $48.0K, with a price of $240.0 per contract. There were 2857 open contracts at this strike prior to today, and today 274 contract(s) were bought and sold. 
• For BIO (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BIO#NYSE">BIO</a>), we notice a put option trade that happens to be neutral, expiring in 10 day(s) on May 16, 2025. This event was a transfer of 250 contract(s) at a $210.00 strike. The total cost received by the writing party (or parties) was $60.0K, with a price of $240.0 per contract. There were 401 open contracts at this strike prior to today, and today 250 contract(s) were bought and sold. 
• Regarding PFE (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), we observe a put option trade with neutral sentiment. It expires in 10 day(s) on May 16, 2025. Parties traded 50 contract(s) at a $30.00 strike. The total cost received by the writing party (or parties) was $36.2K, with a price of $725.0 per contract. There were 1013 open contracts at this strike prior to today, and today 150 contract(s) were bought and sold. 
Options Alert Terminology 
 - Call Contracts: The right to buy shares as indicated in the contract. 
 - Put Contracts: The right to sell shares as indicated in the contract. 
 - Expiration Date: When the contract expires. One must act on the contract by this date if one wants to use it. 
 - Premium/Option Price: The price of the contract. 
For more information, visit our <a href="https://pro.benzinga.com/blog/how-to-understand-option-alerts/">Guide to Understanding Options Alerts</a> or read <a href="https://www.benzinga.com/markets/options">more about unusual options activity</a>. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Options

Hims & Hers Health, Inc. Class A Common Stock

HIMS

VERA

10 Health Care Stocks With Whale Alerts In Today's Session

<a href="https://www.washingtonpost.com/politics/2025/05/05/trump-presidency-news/#link-ACU42F27X5AMNOGEOOY7YDJOFE">https://www.washingtonpost.com/politics/2025/05/05/trump-presidency-news/#link-ACU42F27X5AMNOGEOOY7YDJOFE</a>
President Donald Trump will sign an executive order Monday to streamline regulations surrounding pharmaceutical manufacturing in the United States, according to two White House officials who spoke on the condition of anonymity to describe plans that have not been made public.
The order to incentivize domestic drug manufacturing comes ahead of possible <a href="https://www.washingtonpost.com/business/2025/04/10/tariffs-pharmaceuticals-us-drugs-cost/">tariffs on pharmaceuticals</a> — a policy that's on hold, for now, pending an investigation by the Commerce Department to determine whether importing pharmaceuticals is a threat to national security. That Section 232 investigation could be completed this summer, one of the officials said Monday.
But regardless of whether the Trump administration puts tariffs on prescription drugs, Monday's executive order seeks to incentivize more domestic manufacturing of medications.

BNTX

'Trump To Sign Order To Encourage Domestic Drug Manufacturing' - Washington Post

UBS analyst Eliana Merle maintains Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) with a Buy and lowers the price target from $78 to $70.

Price Target

UBS Maintains Buy on Moderna, Lowers Price Target to $70

Barclays analyst Gena Wang maintains Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) with a Equal-Weight and lowers the price target from $45 to $40.

Barclays Maintains Equal-Weight on Moderna, Lowers Price Target to $40

RBC Capital analyst Luca Issi maintains Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) with a Sector Perform and lowers the price target from $32 to $28.

RBC Capital Maintains Sector Perform on Moderna, Lowers Price Target to $28

Evercore ISI Group analyst Cory Kasimov maintains Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) with a In-Line and lowers the price target from $50 to $32.

Evercore ISI Group Maintains In-Line on Moderna, Lowers Price Target to $32

Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) reported on Thursday a first-quarter EPS loss of $(2.52), missing <a href="https://www.benzinga.com/calendars/earnings" target="_blank" rel="noreferrer noopener">the consensus of $(3.12)</a>, down from an EPS loss of $(3.07) a year ago.
The COVID-19 vaccine maker reported quarterly sales of $108 million, down from $167 billion a year ago, beating the&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/ac45128954/moderna-reports-first-quarter-2025-financial-results-and-provides-business-updates" rel="noreferrer noopener">consensus of $106.20 million</a>.
The decline was primarily driven by lower net product sales, which totaled $86 million in the quarter.
The reduction in product sales reflects lower vaccination rates compared to the same period last year and the continued normalization of COVID-19 into a seasonal commercial market, with demand expected to be concentrated in the second half of the year.
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 company reported $84 million in Spikevax sales in the first quarter of 2025, including $29 million in the U.S. and $55 million in international sales.
The company reported $2 million in mRESVIA sales in the first quarter of 2025. Moderna&#8217;s RSV vaccine for adults 60 and older was recently approved in Australia, <a href="https://www.benzinga.com/general/biotech/25/04/44876132/us-advisory-panel-votes-to-expand-recommendation-for-pfizer-gsks-rsv-vaccines-for-older-adults-below-60-years" target="_blank" rel="noreferrer noopener">Switzerland, Taiwan and the U.K</a>.
The cost of sales for the fourth quarter of 2024 was $739 million, which included third-party royalties of $45 million, inventory write-downs of $193 million, and wind-down costs of $259 million, including a non-cash charge of $238 million related to the termination of a contract manufacturing agreement.
Guidance:&nbsp;Moderna has reiterated its <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43727537/moderna-struggles-with-declining-q4-covid-vaccine-sales-stock-slides" rel="noreferrer noopener">2025 revenue outlook</a> of $1.5 billion to $2.5 billion, compared to a consensus of $2.14 billion. Moderna expects revenue of approximately $0.2 billion in the first half of the year, reflecting the seasonality of its respiratory business.
Moderna expanded its cost efficiency and prioritization programs and expects estimated GAAP operating costs of $5.4 to $5.7 billion in 2026, a reduction from the company&#8217;s previous estimate of $5.9 billion.
The company is announcing a new 2027 GAAP operating cost estimate of $4.7 to $5 billion, reducing estimated operating costs by $1.4 to $1.7 billion by 2027 compared to its 2025 estimate.
Moderna shared Phase 3 immunogenicity data for its flu/COVID combination vaccine (mRNA-1083) for adults aged 50 and older at its 2024 R&amp;D Day event.&nbsp;
The company submitted mRNA-1083 for regulatory approval in older adults in 2024. Based on FDA feedback confirming the need for Phase 3 flu efficacy data, Moderna expects an extended review timeline and is now targeting approval in 2026.
Moderna has deprioritized its flu/COVID combination vaccine (mRNA-1083) for adults aged 18-49.
MRNA Price Action: Moderna stock was down 4.52% at $27.25 at publication on Thursday.
Read Next:
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<li><a href="https://www.benzinga.com/25/05/45141818/hf-sinclair-overcomes-tariff-headwinds-sees-q1-strength-in-midstream-and-lubricants" target="_blank" rel="noreferrer noopener">HF Sinclair Overcomes Tariff Headwinds, Sees Q1 Strength In Midstream And Lubricants</a></li>
</ul>
Photo: Shutterstock

Government

Guidance

Moderna Expands Cost-Cutting Program By Up To $1.7 Billion, FDA Approval For Flu/COVID-19 Combo Shot Delayed Into 2026

Watching Moderna; Executive In Conference Call Reportedly Says Company Expects To Make Its May 31 PDUFA Date

WIIM

Moderna shares are trading lower. The company reported Q1 financial results.

Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) affirms FY2025 sales outlook from $1.50 billion-$2.50 billion to $1.50 billion-$2.50 billion vs $2.14 billion estimate.

Moderna Affirms FY2025 Sales Guidance of $1.50B-$2.50B vs $2.14B Est

Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) reported quarterly losses of $(2.52) per share which beat the analyst consensus estimate of $(3.12) by 19.23 percent. This is a 17.92 percent increase over losses of $(3.07) per share from the same period last year. The company reported quarterly sales of $108.00 million which beat the analyst consensus estimate of $106.20 million by 1.70 percent. This is a 35.33 percent decrease over sales of $167.00 million the same period last year.

Earnings Beats

Moderna Q1 EPS $(2.52) Beats $(3.12) Estimate, Sales $108.00M Beat $106.20M Estimate

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COMM

COOK

CRAI

CTRE

CUBE

CWST

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DXCM

ECVT

ELME

Earnings Scheduled For May 1, 2025

Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) will release its quarterly earnings report on Thursday, 2025-05-01. Here's a brief overview for investors ahead of the announcement.
Analysts anticipate Moderna to report an earnings per share (EPS) of $-3.18.
Anticipation surrounds Moderna's announcement, with investors hoping to hear about both surpassing estimates and receiving positive guidance for the next quarter.
New investors should understand that while earnings performance is important, market reactions are often driven by guidance.
<h3>Overview of Past Earnings</h3>
Last quarter the company missed EPS by $0.23, which was followed by a 0.0% drop in the share price the next day.
Here's a look at Moderna's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q4 2024</th>
<th>Q3 2024</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-2.68</td>
<td>-1.90</td>
<td>-3.39</td>
<td>-3.35</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-2.91</td>
<td>0.03</td>
<td>-3.33</td>
<td>-3.07</td>
</tr>
<tr>
<td>Price Change %</td>
<td>3.0%</td>
<td>-7.000000000000001%</td>
<td>-8.0%</td>
<td>-0.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2025/1746036056_0.png" alt="eps graph" />
<h3>Stock Performance</h3>
Shares of Moderna were trading at $27.82 as of April 29. Over the last 52-week period, shares are down 77.69%. Given that these returns are generally negative, long-term shareholders are likely bearish going into this earnings release. 
<h3>Analyst Views on Moderna</h3>
For investors, staying informed about market sentiments and expectations in the industry is paramount. This analysis provides an exploration of the latest insights on Moderna.
Analysts have given Moderna a total of 7 ratings, with the consensus rating being Neutral. The average one-year price target is $43.14, indicating a potential 55.07% upside.
<h3>Peer Ratings Comparison</h3>
The following analysis focuses on the analyst ratings and average 1-year price targets of Neurocrine Biosciences and Exelixis, three prominent industry players, providing insights into their relative performance expectations and market positioning.
<ul>
<li>Analysts currently favor an Buy trajectory for Neurocrine Biosciences, with an average 1-year price target of $166.21, suggesting a potential 497.45% upside.</li>
<li>Analysts currently favor an Buy trajectory for Exelixis, with an average 1-year price target of $37.82, suggesting a potential 35.95% upside.</li>
</ul>
<h3>Peers Comparative Analysis Summary</h3>
The peer analysis summary offers a detailed examination of key metrics for Neurocrine Biosciences and Exelixis, providing valuable insights into their respective standings within the industry and their market positions and comparative performance.

<table>
<thead>
<tr>
<th>Company</th>
<th>Consensus</th>
<th>Revenue Growth</th>
<th>Gross Profit</th>
<th>Return on Equity</th>
</tr>
</thead>
<tbody>
<tr>
<td>Moderna</td>
<td>Neutral</td>
<td>-66.01%</td>
<td>$217M</td>
<td>-9.81%</td>
</tr>
<tr>
<td>Neurocrine Biosciences</td>
<td>Buy</td>
<td>21.84%</td>
<td>$618.40M</td>
<td>3.88%</td>
</tr>
<tr>
<td>Exelixis</td>
<td>Buy</td>
<td>18.16%</td>
<td>$546.79M</td>
<td>6.19%</td>
</tr>
</tbody>
</table>

Key Takeaway:
In terms of consensus rating, Moderna is rated lower than its peers. Moderna has the lowest revenue growth among the group. Moderna also has the lowest gross profit margin. Additionally, Moderna has the lowest return on equity compared to its peers. Overall, Moderna ranks at the bottom across all metrics when compared to its peers.
<h3>Discovering Moderna: A Closer Look</h3>
Moderna is a commercial-stage biotech that was founded in 2010 and had its initial public offering in December 2018. The firm's mRNA technology was rapidly validated with its covid vaccine, which was authorized in the United States in December 2020. Moderna had 40 mRNA development candidates in clinical development as of September 2024. Programs span a wide range of therapeutic areas, including infectious disease, oncology, cardiovascular disease, and rare genetic diseases.
<h3>Financial Milestones: Moderna's Journey</h3>
Market Capitalization Analysis: Falling below industry benchmarks, the company's market capitalization reflects a reduced size compared to peers. This positioning may be influenced by factors such as growth expectations or operational capacity.
Decline in Revenue: Over the 3 months period, Moderna faced challenges, resulting in a decline of approximately -66.01% in revenue growth as of 31 December, 2024. This signifies a reduction in the company's top-line earnings. As compared to its peers, the revenue growth lags behind its industry peers. The company achieved a growth rate lower than the average among peers in Health Care sector.
Net Margin: The company's net margin is below industry benchmarks, signaling potential difficulties in achieving strong profitability. With a net margin of -117.15%, the company may need to address challenges in effective cost control.
Return on Equity (ROE): The company's ROE is below industry benchmarks, signaling potential difficulties in efficiently using equity capital. With an ROE of -9.81%, the company may need to address challenges in generating satisfactory returns for shareholders.
Return on Assets (ROA): Moderna's ROA is below industry standards, pointing towards difficulties in efficiently utilizing assets. With an ROA of -7.48%, the company may encounter challenges in delivering satisfactory returns from its assets.
Debt Management: Moderna's debt-to-equity ratio is below the industry average. With a ratio of 0.07, the company relies less on debt financing, maintaining a healthier balance between debt and equity, which can be viewed positively by investors.
<a href="https://www.benzinga.com/quote/MRNA/earnings">To track all earnings releases for Moderna visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Preview: Moderna's Earnings

The President Donald Trump administration&#8217;s request for Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) to conduct new clinical trials for its COVID-19 vaccine.
What Happened: Novavax announced Monday that the Food and Drug Administration requested a new clinical trial before granting full approval for its protein-based COVID-19 shot, despite the company believing its vaccine remains &#8220;approvable.&#8221; 
The requirement came shortly after FDA Commissioner Marty Makary characterized the annually updated vaccine as &#8220;a new product&#8221; requiring new studies.
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
<div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">To be clear, this is a new product that Novavax is trying to introduce to the market with a study of a different product from 2021. New products require new clinical studies. Under this administration, we are prioritizing the Gold Standard of Science&#8211;not what saves pharma… <a href="https://t.co/1f7NvJ9qEJ">pic.twitter.com/1f7NvJ9qEJ</a>
&mdash; Dr. Martin Makary (@DrMakaryFDA) <a href="https://twitter.com/DrMakaryFDA/status/1916253910039429309?ref_src=twsrc%5Etfw">April 26, 2025</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
The situation developed following leadership changes at the FDA, including the departure of the agency&#8217;s longtime Vaccine Chief over disagreements with Health Secretary Robert F. Kennedy Jr. 
Industry experts note the FDA had been on track to approve Novavax&#8217;s application by April 1, but Trump appointees directed a pause, the Associated Press <a href="https://apnews.com/article/vaccine-novavax-fda-trump-covid-study-4b4465ad77cfb0554b27b7d59c40ae32">reported</a>, citing anonymous sources.
See Also: <a href="https://www.benzinga.com/general/entertainment/25/04/45059675/mrbeast-sparks-outrage-with-100-men-vs-gorilla-post-on-elon-musks-x-peta-claps-back-try-100-reasons-to-leave-animals">MrBeast Sparks Outrage With &#8216;100 Men Vs Gorilla&#8217; Post On Elon Musk&#8217;s X — PETA Claps Back: &#8216;Try 100 Reasons To Leave Animals&#8230;&#8217;</a>
Why It Matters: A United States Department of Health and Human Services spokesman suggested all COVID-19 vaccines could face stricter requirements, stating: &#8220;The urgency to rush approval of boosters without normal oversight no longer exists.&#8221;
Preliminary results from <a href="https://www.benzinga.com/general/biotech/25/04/44824383/novavax-covid-vaccine-shows-milder-side-effects-than-pfizer-biontechs-shot-study">the SHIELD-Utah study</a> showed Novavax&#8217;s 2024-2025 formula targeting the JN.1 strain produced fewer and less severe side effects compared to Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and BioNTech SE&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) mRNA shots.
Former Health Secretary Xavier Becerra defended the safety record of COVID-19 vaccines, noting: &#8220;We had put some 700 million COVID vaccines into the arms of Americans. That&#8217;s a pretty good size clinical trial.&#8221;
Read Next: 
<ul>
<li><a href="https://www.benzinga.com/news/insider-trades/25/04/45059696/airbnb-billionaire-joe-gebbia-buys-over-1-million-worth-of-tsla-stock-ahead-of-elon-musks-robotaxi-launch-in-june">Airbnb Billionaire Joe Gebbia Buys Over $1 Million Worth Of TSLA Stock Ahead Of Elon Musk&#8217;s Robotaxi Launch In June</a></li>
</ul>
Image Via Shutterstock
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Equities

Trump-Era FDA Appointees Request New Trials For Novavax COVID Vaccine, Reportedly Delaying Approval Timeline

Whales with a lot of money to spend have taken a noticeably bullish stance on Moderna.
Looking at options history for Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) we detected 13 trades.
If we consider the specifics of each trade, it is accurate to state that 53% of the investors opened trades with bullish expectations and 23% with bearish.
From the overall spotted trades, 6 are puts, for a total amount of $1,183,210 and 7, calls, for a total amount of $341,156.
<h3>Projected Price Targets</h3>
Based on the trading activity, it appears that the significant investors are aiming for a price territory stretching from $22.5 to $40.0 for Moderna over the recent three months. 
<h3>Analyzing Volume &amp; Open Interest</h3>
Looking at the volume and open interest is an insightful way to conduct due diligence on a stock.
This data can help you track the liquidity and interest for Moderna's options for a given strike price.
Below, we can observe the evolution of the volume and open interest of calls and puts, respectively, for all of Moderna's whale activity within a strike price range from $22.5 to $40.0 in the last 30 days. 
<h3>Moderna Option Activity Analysis: Last 30 Days</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1745607651_0.png" alt="Options Call Chart" />
<h3>Significant Options Trades Detected:</h3>

<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Ask</th>
<th>Bid</th>
<th>Price</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>MRNA</td>
<td>PUT</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>09/19/25</td>
<td>$3.8</td>
<td>$3.6</td>
<td>$3.7</td>
<td>$25.00</td>
<td>$832.5K</td>
<td>10.8K</td>
<td>20</td>
</tr>
<tr>
<td>MRNA</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>09/19/25</td>
<td>$3.65</td>
<td>$3.55</td>
<td>$3.55</td>
<td>$25.00</td>
<td>$127.0K</td>
<td>10.8K</td>
<td>2.6K</td>
</tr>
<tr>
<td>MRNA</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>06/20/25</td>
<td>$6.55</td>
<td>$6.25</td>
<td>$6.33</td>
<td>$22.50</td>
<td>$63.3K</td>
<td>1.7K</td>
<td>350</td>
</tr>
<tr>
<td>MRNA</td>
<td>CALL</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>06/20/25</td>
<td>$6.35</td>
<td>$6.3</td>
<td>$6.35</td>
<td>$22.50</td>
<td>$62.8K</td>
<td>1.7K</td>
<td>450</td>
</tr>
<tr>
<td>MRNA</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>09/19/25</td>
<td>$3.65</td>
<td>$3.5</td>
<td>$3.55</td>
<td>$25.00</td>
<td>$62.1K</td>
<td>10.8K</td>
<td>2.9K</td>
</tr>
</tbody>
</table>

<h3>About Moderna</h3>
Moderna is a commercial-stage biotech that was founded in 2010 and had its initial public offering in December 2018. The firm's mRNA technology was rapidly validated with its covid vaccine, which was authorized in the United States in December 2020. Moderna had 40 mRNA development candidates in clinical development as of September 2024. Programs span a wide range of therapeutic areas, including infectious disease, oncology, cardiovascular disease, and rare genetic diseases.
Having examined the options trading patterns of Moderna, our attention now turns directly to the company. This shift allows us to delve into its present market position and performance
<h3>Where Is Moderna Standing Right Now?</h3>
<ul>
<li>With a volume of 4,280,961, the price of MRNA is up 0.49% at $27.52. </li>
<li>RSI indicators hint that the underlying stock is currently neutral between overbought and oversold.</li>
<li>Next earnings are expected to be released in 6 days.</li>
</ul>
<h3>What Analysts Are Saying About Moderna</h3>
A total of 1 professional analysts have given their take on this stock in the last 30 days, setting an average price target of $32.0.
Unusual Options Activity Detected: Smart Money on the Move
Benzinga Edge's Unusual Options board spots potential market movers before they happen. See what positions big money is taking on your favorite stocks. <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-checkout/?t=Be8be9arja3be22bz20&amp;adType=benzinga-insights&amp;ad=options-activity&amp;campaign=wallstreetadvantage">Click here for access</a>. 
&#x2A; An analyst from Morgan Stanley persists with their Equal-Weight rating on Moderna, maintaining a target price of $32. 
Options are a riskier asset compared to just trading the stock, but they have higher profit potential. Serious options traders manage this risk by educating themselves daily, scaling in and out of trades, following more than one indicator, and following the markets closely.
If you want to stay updated on the latest options trades for Moderna, <a href="https://www.benzinga.com/pro/">Benzinga Pro</a> gives you real-time options trades alerts.

Behind the Scenes of Moderna's Latest Options Trends

Stocks in the U.S. were trading sharply lower by midday Monday, while gold and Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) surged in tandem, as a renewed political storm surrounding Federal Reserve independence shook confidence in the U.S. dollar and triggered a broad-based risk-off <a href="https://www.benzinga.com/government/regulations/25/04/44899280/are-investors-selling-us-treasuries-as-trump-attacks-powell-heres-what-latest-etf-flows-tell-you">mood on U.S. assets.</a>
The market opened the post-Easter trading week with deep losses, after President Donald Trump took to Truth Social demanding immediate rate cuts and blasting Fed Chair Jerome Powell as "Mr. Too Late," accusing him of past political bias and inflation misjudgment. 
Trump wrote that there's "virtually no inflation" and warned of an economic slowdown unless Powell acts "NOW."
The latest barrage reignited fears that central bank independence may be under direct threat, just days after reports emerged that the Trump administration is weighing Powell's removal ahead of his scheduled 2026 term expiration.
The U.S. Dollar Index (DXY) fell as much as 1%, marking its lowest level since early 2022, as the greenback weakened against a basket of major currencies including the Japanese yen, euro and Swiss franc. 
The selloff has intensified speculation that foreign investors may accelerate the repatriation of capital from U.S. assets amid mounting political and monetary instability.
The S&amp;P 500 dropped 2.8% by midday, with the Nasdaq 100 falling 3%, led lower by steep losses in megacap tech and financials. Every major sector was in the red, with 490 of the 500 S&amp;P 500 stocks trading lower.
In another break from historical norms, U.S. Treasury yields climbed even as equities tanked and volatility spiked. The 30-year yield rose 7 basis points to 4.87%, signaling investor selling of government debt. The CBOE Volatility Index (VIX) jumped 15%. 
Gold-linked equities were the few bright spots in an otherwise brutal session. Gold prices – as tracked by the SPDR Gold Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GLD#NYSE">GLD</a>) – surged 2.6% to $3,410 per ounce, pushing the year-to-date gain to nearly 30%—on track for the metal's best annual performance since 2007. 
The move extends gold's stunning 2-month rally, now nearing 20%, amid persistent demand for safe-haven assets.
Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) gained 3.5% to trade at $88,274, echoing gold's momentum as investors seek alternatives to fiat currencies.
Monday&#8217;s Performance In Major US Indices, ETFs
<figure class="wp-block-table is-style-stripes"> 
<table>
<tbody>
<tr>
<td>Major Indices</td>
<td>Price</td>
<td>Chg (%)</td>
</tr>
<tr>
<td>Russell 2000</td>
<td>1,837.81</td>
<td>-2.3%</td>
</tr>
<tr>
<td>Dow Jones</td>
<td>38,097.81</td>
<td>-2.7%</td>
</tr>
<tr>
<td>S&amp;P 500</td>
<td>5,135.83</td>
<td>-2.8%</td>
</tr>
<tr>
<td>Nasdaq 100</td>
<td>17,727.70</td>
<td colspan="2">-3.0%</td>
</tr>
</tbody>
</table>
<figcaption class="wp-element-caption">Updated at 12:20 p.m. ET</figcaption></figure>
According to&nbsp;<a href="https://www.benzinga.com/pro/?utm_source=BZprocontent&amp;t=be2bearmibe3na1">Benzinga Pro</a>&nbsp;data:
<ul>
<li>The&nbsp;SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) fell 2.8% up to $511.49.</li>
<li>The&nbsp;SPDR Dow Jones Industrial Average&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DIA#NYSE">DIA</a>) fell 2.7% to $380.65.</li>
<li>The tech-heavy&nbsp;Invesco QQQ Trust Series&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>)&nbsp;tumbled 3% to $430.76.</li>
<li>The&nbsp;iShares Russell 2000 ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IWM#NYSE">IWM</a>) fell 2.3% to $182.28.</li>
<li>The&nbsp;Consumer Staples&nbsp;Select Sector SPDR Fund (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XLP#NYSE">XLP</a>) outperformed, yet falling 1.4%; the&nbsp;Consumer Discretionary&nbsp;Select Sector SPDR Fund&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XLY#NYSE">XLY</a>) lagged, down 3.5%.</li>
</ul>
<h3 class="wp-block-heading">S&amp;P 500&#8217;s Top Performers On Monday</h3>
<figure class="wp-block-table is-style-stripes"> 
<table>
<thead>
<tr>
<th>Company Name</th>
<th>% Change</th>
</tr>
</thead>
<tbody>
<tr>
<td>Fidelity National Information Services, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FIS#NYSE">FIS</a>)</td>
<td>3.81%</td>
</tr>
<tr>
<td>Discover Financial Services (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DFS#NYSE">DFS</a>)</td>
<td>2.89%</td>
</tr>
<tr>
<td>Netflix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NFLX#NASDAQ">NFLX</a>)</td>
<td>1.75%</td>
</tr>
<tr>
<td>Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>)</td>
<td>1.02%</td>
</tr>
<tr>
<td>Ulta Beauty, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ULTA#NASDAQ">ULTA</a>)</td>
<td>0.86%</td>
</tr>
</tbody>
</table>
</figure>
<h3 class="wp-block-heading">S&amp;P 500&#8217;s Worst Performers On Monday</h3>
<figure class="wp-block-table is-style-stripes"> 
<table>
<thead>
<tr>
<th>Company Name</th>
<th>% Change</th>
</tr>
</thead>
<tbody>
<tr>
<td>Universal Health Services, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UHS#NYSE">UHS</a>)</td>
<td>-10.31%</td>
</tr>
<tr>
<td>Vistra Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VST#NYSE">VST</a>)</td>
<td>-8.34%</td>
</tr>
<tr>
<td>Constellation Energy Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CEG#NASDAQ">CEG</a>)</td>
<td>-8.23%</td>
</tr>
<tr>
<td>Humana Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HUM#NYSE">HUM</a>)</td>
<td>-7.48%</td>
</tr>
<tr>
<td>Blackstone Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BX#NYSE">BX</a>)</td>
<td>-7.42%</td>
</tr>
</tbody>
</table>
</figure>
Read now: 
<ul>
<li><a href="https://www.benzinga.com/news/25/04/44886209/if-you-had-bet-on-gold-after-the-1971-nixon-shock-youd-have-beaten-the-sp-500-unless-you-did-this-one-thing">If You Had Bet On Gold After The 1971 Nixon Shock, You&#8217;d Have Beaten The S&amp;P 500 — Unless You Did This One Thing</a></li>
</ul>
Photo: FOTOGRIN/Shutterstock

Regulations

Broad U.S. Equity ETFs

Econ #s

Federal Reserve

ETFs

$BTC

SPDR Dow Jones Industrial Average ETF Trust

NFLX

ULTA

Select Sector SPDR-Consumer Discretionary

Wall Street Sinks, Dollar Slides As Trump Ramps Up Fed Attacks: What's Driving Markets Monday?

On Wednesday, the Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">respiratory tract disease (LRTD)</a>.
In June 2024, ACIP postponed a vote on a recommendation for adults aged 50-59 at increased risk for RSV-LRTD until additional <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39522040/cdc-advisor-panel-recommends-rsv-shots-in-us-for-people-above-75-years-analyst-says-decision-nega" rel="noreferrer noopener">data becomes available</a>.
The update includes Pfizer Inc.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Abrysvo (Respiratory Syncytial Virus Vaccine), which the U.S. Food and Drug Administration approved in October 2024 for the prevention of RSV-associated LRTD in adults aged 18 to 59 at increased <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41493556/fda-approves-pfizers-respiratory-syncytial-virus-vaccine-abrysvo-for-adults-below-60-years" rel="noreferrer noopener">risk of severe disease</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/government/regulations/25/04/44851905/trumps-new-order-targets-drug-pricing-transparency-and-medicare-cost-reduction" rel="noreferrer noopener">Trump&#8217;s New Order Targets Drug Pricing Transparency And Medicare Cost Reduction</a>
The recommendation also includes GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Arexvy in adults aged 50-59 who are at increased risk <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/b44853850/arexvy-recommended-for-adults-aged-50-59-at-increased-risk-for-severe-respiratory-syncytial-virus-" rel="noreferrer noopener">for severe RSV disease</a>.
This expands on ACIP&#8217;s previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older.
Arexvy is indicated for the prevention of LRTD caused by RSV in individuals 60 years of age and older and individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.
According to the CDC, between 15,000 &#8211; 20,000 RSV-associated hospitalizations occur annually in U.S. adults <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/b44852139/acip-votes-to-expand-recommendation-for-pfizers-rsv-vaccine-abrysvo-to-include-adults-aged-50-to-5" rel="noreferrer noopener">aged 50 &#8211; 59 years</a>.
A systematic review of studies in the U.S. shows that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old.
GSK said the ACIP considered results from a phase 3 trial evaluating the immune response and safety of GSK&#8217;s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions compared to older adults aged 60 years and older where efficacy has been demonstrated after a single dose of GSK&#8217;s RSV vaccine.
The updated recommendation does not benefit Moderna Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) mRNA-based RSV vaccine mRESVIA (mRNA-1345), which is currently approved for adults over 60 years.
William Blair notes Moderna shared Phase 3 data for mRNA-1345 in high-risk adults aged 18-59 at its 2024 R&amp;D Day event and has since submitted an application to the FDA for regulatory approval using a priority review voucher.&nbsp;The FDA <a target="_blank" href="https://investors.modernatx.com/news/news-details/2025/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2024-Financial-Results-and-Provides-Business-Updates/default.aspx" rel="noreferrer noopener">has</a> accepted Moderna&#8217;s application and has assigned a PDUFA goal date of June 12, 2025.
Analyst Myles R. Minter highlights the Phase 3 trial of mRNA-1345 in over 1,000 high-risk individuals between ages 18 and 59. mRNA-1345 demonstrated non-inferior immunogenicity compared to adults age 60 or older for neutralizing antibodies against both RSV-A and RSV-B and a tolerable safety profile.
&#8220;If approved on time, we believe mRESVIA could be added to the updated age group recommendation during the scheduled June 25-26, 2025, ACIP meeting,&#8221; Minter said.
Price Action: PFE stock is up 1.07% 22.28, MRNA stock is down 2.30% at $24.62, and GSK stock is up 1.74% at $35.98 at the last check on Thursday.
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