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Axxcess Wealth Management LLC lessened its stake in Johnson & Johnson (NYSE:JNJ – Free Report) by 44.1% during the 3rd quarter, according to the company in its most recent filing with the Securities and Exchange Commission. The institutional investor owned 50,379 shares of the company’s stock after selling 39,667 shares during the period. Axxcess Wealth Management LLC’s holdings in Johnson & Johnson were worth $13,337,000 at the end of the most recent quarter.

Other hedge funds and other institutional investors have also made changes to their positions in the company. Outlook Capital Management LLC acquired a new stake in Johnson & Johnson during the second quarter valued at $28,000. Matrix Trust Co raised its position in shares of Johnson & Johnson by 56.2% in the second quarter. Matrix Trust Co now owns 150 shares of the company’s stock worth $38,000 after acquiring an additional 54 shares during the period. Montgomery Financial Services LLC acquired a new position in shares of Johnson & Johnson in the second quarter worth about $43,000. Polaris Financial Partners purchased a new stake in shares of Johnson & Johnson during the 3rd quarter worth about $56,000. Finally, Bullseye Investment Management LLC purchased a new stake in shares of Johnson & Johnson during the 2nd quarter worth about $63,000. Institutional investors and hedge funds own 69.55% of the company’s stock.

Johnson & Johnson Price Performance Shares of JNJ opened at $264.13 on Friday. The stock has a market cap of $635.85 billion, a PE ratio of 40.02, a price-to-earnings-growth ratio of 2.65 and a beta of 0.21. Johnson & Johnson has a 1-year low of $184.66 and a 1-year high of $281.07. The firm has a fifty day moving average price of $265.64 and a 200 day moving average price of $250.21. The company has a debt-to-equity ratio of 0.44, a current ratio of 1.02 and a quick ratio of 0.81.

Johnson & Johnson (NYSE:JNJ – Get Free Report) last announced its earnings results on Tuesday, October 13th. The company reported $2.59 earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of $2.53 by $0.06. The business had revenue of $25.40 billion for the quarter, compared to analyst estimates of $25.38 billion. Johnson & Johnson had a net margin of 16.20% and a return on equity of 31.64%. The company’s revenue for the quarter was up 5.9% compared to the same quarter last year. During the same period last year, the firm posted $2.80 earnings per share. Johnson & Johnson has set its FY 2026 guidance at 11.050-11.150 EPS. As a group, sell-side analysts anticipate that Johnson & Johnson will post 11.12 EPS for the current year. Johnson & Johnson Announces Dividend The business also recently declared a quarterly dividend, which will be paid on Tuesday, December 8th. Stockholders of record on Tuesday, November 24th will be paid a dividend of $1.34 per share. The ex-dividend date of this dividend is Tuesday, November 24th. This represents a $5.36 dividend on an annualized basis and a dividend yield of 2.0%. Johnson & Johnson’s dividend payout ratio is 81.21%.

Insider Activity In other Johnson & Johnson news, EVP Elizabeth Forminard sold 15,918 shares of the company’s stock in a transaction on Thursday, August 6th. The stock was sold at an average price of $257.00, for a total value of $4,090,926.00. Following the sale, the executive vice president owned 16,994 shares of the company’s stock, valued at approximately $4,367,458. This represents a 48.37% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is accessible through the SEC website. Also, EVP Jennifer L. Taubert sold 15,000 shares of the stock in a transaction dated Monday, August 17th. The shares were sold at an average price of $263.36, for a total transaction of $3,950,400.00. Following the completion of the sale, the executive vice president directly owned 194,451 shares in the company, valued at approximately $51,210,615.36. The trade was a 7.16% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. Insiders sold 64,515 shares of company stock worth $17,271,766 in the last 90 days. 0.16% of the stock is currently owned by corporate insiders.

Key Stories Impacting Johnson & Johnson Here are the key news stories impacting Johnson & Johnson this week:

Positive Sentiment: The United Kingdom approved J&J’s oral psoriasis treatment, expanding the company’s commercial opportunity in a major market and strengthening its immunology pipeline. UK approves J&J’s oral psoriasis pill Positive Sentiment: J&J reported first real-world data for its VARIPULSE Pro platform and 12-month outcomes for the OMNYPULSE platform in atrial-fibrillation treatment. The results could support adoption of its MedTech portfolio and help offset weakness in other device businesses. J&J reports VARIPULSE Pro and OMNYPULSE data Positive Sentiment: J&J has benefited from investor rotation into defensive healthcare and consumer-staples companies amid broader large-cap weakness, reinforcing demand for its relatively stable earnings and dividend profile. Defensive stocks attract buyers Neutral Sentiment: J&J’s implied fair value was raised from $270.59 to $279.41 per share, but analyst views remain divided. Supporters cite earnings resilience and the drug pipeline, while others point to valuation, MedTech execution risk and possible dilution from recent deals. J&J fair value adjustment Negative Sentiment: A proposed combination involving J&J’s orthopedics business and Smith & Nephew reportedly collapsed over a leadership dispute. The development removes potential strategic benefits and may raise questions about execution, although Smith & Nephew declined to comment. Orthopedics merger reportedly collapsed Negative Sentiment: J&J reclaimed its 50-day moving average, but falling earnings estimates, a premium valuation and weakness in MedTech are limiting the bullish technical signal. Erste Group also downgraded the shares to “Hold,” adding to near-term investor caution. J&J stock outlook and valuation concerns Analyst Upgrades and Downgrades JNJ has been the subject of several recent analyst reports. Morgan Stanley cut their price target on Johnson & Johnson from $294.00 to $292.00 and set an “overweight” rating for the company in a research note on Thursday, October 15th. Raymond James Financial set a $280.00 price target on Johnson & Johnson in a research report on Monday, August 3rd. Johnson Rice downgraded Johnson & Johnson from a “buy” rating to a “hold” rating in a research note on Wednesday. Argus set a $300.00 price target on shares of Johnson & Johnson in a report on Wednesday, July 29th. Finally, Freedom Capital upgraded shares of Johnson & Johnson from a “hold” rating to a “strong-buy” rating in a research report on Thursday, July 16th. One research analyst has rated the stock with a Strong Buy rating, seventeen have given a Buy rating and eight have assigned a Hold rating to the company. Based on data from MarketBeat.com, the company has a consensus rating of “Moderate Buy” and an average target price of $275.92.

View Our Latest Research Report on Johnson & Johnson

Johnson & Johnson Company Profile (Free Report)

Johnson & Johnson (NYSE: JNJ) is a global healthcare company headquartered in New Brunswick, New Jersey. Founded in 1886, the company develops and markets products and services for patients, healthcare professionals and institutions worldwide.

Johnson & Johnson operates through two principal segments: Innovative Medicine and MedTech. Innovative Medicine focuses on pharmaceuticals for areas such as immunology, oncology, neuroscience, infectious diseases and cardiovascular conditions.

Further Reading Five stocks we like better than Johnson & Johnson Spotify Soars After Earnings as the Company Touts AI Benefits and Moderating Costs Lockheed Martin’s Record $292 Billion Backlog Comes With a Delivery Test Palantir’s Next Big Test Isn’t a Partnership—It’s the Numbers Kinder Morgan’s $4.7 Billion Pipeline Bet Could Be Bigger Than Its Earnings Beat Want to see what other hedge funds are holding JNJ? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Johnson & Johnson (NYSE:JNJ – Free Report).

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AMG Asset Management Group Inc. increased its holdings in Johnson & Johnson (NYSE:JNJ – Free Report) by 172.0% during the 3rd quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission (SEC). The fund owned 3,852 shares of the company’s stock after purchasing an additional 2,436 shares during the quarter. AMG Asset Management Group Inc.’s holdings in Johnson & Johnson were worth $1,020,000 as of its most recent filing with the Securities and Exchange Commission (SEC).

A number of other hedge funds also recently bought and sold shares of the business. Jupiter Topco LLC bought a new stake in shares of Johnson & Johnson in the 2nd quarter worth approximately $1,967,399,000. Diamant Asset Management Inc. raised its holdings in shares of Johnson & Johnson by 24,436.5% during the first quarter. Diamant Asset Management Inc. now owns 4,473,008 shares of the company’s stock valued at $109,338,000 after acquiring an additional 4,454,778 shares in the last quarter. Corient Private Wealth LP raised its holdings in shares of Johnson & Johnson by 127.3% during the second quarter. Corient Private Wealth LP now owns 6,060,922 shares of the company’s stock valued at $1,539,292,000 after acquiring an additional 3,393,981 shares in the last quarter. Wellington Management Group LLP lifted its stake in Johnson & Johnson by 12.5% in the second quarter. Wellington Management Group LLP now owns 22,588,696 shares of the company’s stock worth $5,736,851,000 after acquiring an additional 2,513,321 shares during the period. Finally, Amundi boosted its holdings in Johnson & Johnson by 17.5% in the first quarter. Amundi now owns 13,406,820 shares of the company’s stock valued at $3,277,163,000 after acquiring an additional 2,001,139 shares in the last quarter. Hedge funds and other institutional investors own 69.55% of the company’s stock.

Key Headlines Impacting Johnson & Johnson Here are the key news stories impacting Johnson & Johnson this week:

Positive Sentiment: The United Kingdom approved J&J’s oral psoriasis treatment, expanding the company’s commercial opportunity in a major market and strengthening its immunology pipeline. UK approves J&J’s oral psoriasis pill Positive Sentiment: J&J reported first real-world data for its VARIPULSE Pro platform and 12-month outcomes for the OMNYPULSE platform in atrial-fibrillation treatment. The results could support adoption of its MedTech portfolio and help offset weakness in other device businesses. J&J reports VARIPULSE Pro and OMNYPULSE data Positive Sentiment: J&J has benefited from investor rotation into defensive healthcare and consumer-staples companies amid broader large-cap weakness, reinforcing demand for its relatively stable earnings and dividend profile. Defensive stocks attract buyers Neutral Sentiment: J&J’s implied fair value was raised from $270.59 to $279.41 per share, but analyst views remain divided. Supporters cite earnings resilience and the drug pipeline, while others point to valuation, MedTech execution risk and possible dilution from recent deals. J&J fair value adjustment Negative Sentiment: A proposed combination involving J&J’s orthopedics business and Smith & Nephew reportedly collapsed over a leadership dispute. The development removes potential strategic benefits and may raise questions about execution, although Smith & Nephew declined to comment. Orthopedics merger reportedly collapsed Negative Sentiment: J&J reclaimed its 50-day moving average, but falling earnings estimates, a premium valuation and weakness in MedTech are limiting the bullish technical signal. Erste Group also downgraded the shares to “Hold,” adding to near-term investor caution. J&J stock outlook and valuation concerns Wall Street Analyst Weigh In Several research analysts have commented on the stock. Guggenheim restated a “buy” rating and issued a $287.00 price objective on shares of Johnson & Johnson in a report on Wednesday, October 7th. Weiss Ratings raised shares of Johnson & Johnson from a “buy (b)” rating to a “buy (b+)” rating in a research note on Thursday, October 8th. UBS Group set a $270.00 price target on shares of Johnson & Johnson in a research report on Wednesday, October 14th. Sanford C. Bernstein set a $270.00 price target on shares of Johnson & Johnson in a research note on Thursday, October 15th. Finally, The Goldman Sachs Group restated a “buy” rating and issued a $282.00 price objective on shares of Johnson & Johnson in a report on Thursday, July 16th. One equities research analyst has rated the stock with a Strong Buy rating, seventeen have assigned a Buy rating and eight have issued a Hold rating to the company’s stock. According to MarketBeat.com, the stock currently has a consensus rating of “Moderate Buy” and a consensus price target of $275.92. Check Out Our Latest Research Report on Johnson & Johnson

Insider Buying and Selling at Johnson & Johnson In other news, EVP Jennifer Taubert sold 15,000 shares of the stock in a transaction on Monday, August 17th. The stock was sold at an average price of $263.36, for a total transaction of $3,950,400.00. Following the transaction, the executive vice president directly owned 194,451 shares of the company’s stock, valued at $51,210,615.36. This represents a 7.16% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available through this link. Also, EVP Elizabeth Forminard sold 15,918 shares of the firm’s stock in a transaction on Thursday, August 6th. The stock was sold at an average price of $257.00, for a total value of $4,090,926.00. Following the completion of the transaction, the executive vice president owned 16,994 shares in the company, valued at approximately $4,367,458. This trade represents a 48.37% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. In the last ninety days, insiders sold 64,515 shares of company stock worth $17,271,766. Insiders own 0.16% of the company’s stock.

Johnson & Johnson Price Performance JNJ opened at $264.13 on Friday. The company has a debt-to-equity ratio of 0.44, a quick ratio of 0.81 and a current ratio of 1.02. The stock has a market capitalization of $635.85 billion, a P/E ratio of 40.02, a P/E/G ratio of 2.65 and a beta of 0.21. The company’s 50-day simple moving average is $265.64 and its two-hundred day simple moving average is $250.21. Johnson & Johnson has a 52-week low of $184.66 and a 52-week high of $281.07.

Johnson & Johnson (NYSE:JNJ – Get Free Report) last announced its quarterly earnings results on Tuesday, October 13th. The company reported $2.59 EPS for the quarter, topping analysts’ consensus estimates of $2.53 by $0.06. Johnson & Johnson had a net margin of 16.20% and a return on equity of 31.64%. The firm had revenue of $25.40 billion during the quarter, compared to analyst estimates of $25.38 billion. During the same period in the previous year, the business posted $2.80 earnings per share. The business’s revenue for the quarter was up 5.9% on a year-over-year basis. Johnson & Johnson has set its FY 2026 guidance at 11.050-11.150 EPS. As a group, analysts predict that Johnson & Johnson will post 11.12 EPS for the current year.

Johnson & Johnson Announces Dividend The business also recently announced a quarterly dividend, which will be paid on Tuesday, December 8th. Shareholders of record on Tuesday, November 24th will be given a $1.34 dividend. This represents a $5.36 dividend on an annualized basis and a yield of 2.0%. The ex-dividend date of this dividend is Tuesday, November 24th. Johnson & Johnson’s payout ratio is 81.21%.

Johnson & Johnson Profile (Free Report)

Johnson & Johnson (NYSE: JNJ) is a global healthcare company headquartered in New Brunswick, New Jersey. Founded in 1886, the company develops and markets products and services for patients, healthcare professionals and institutions worldwide.

Johnson & Johnson operates through two principal segments: Innovative Medicine and MedTech. Innovative Medicine focuses on pharmaceuticals for areas such as immunology, oncology, neuroscience, infectious diseases and cardiovascular conditions.

Featured Stories Five stocks we like better than Johnson & Johnson Spotify Soars After Earnings as the Company Touts AI Benefits and Moderating Costs Lockheed Martin’s Record $292 Billion Backlog Comes With a Delivery Test Palantir’s Next Big Test Isn’t a Partnership—It’s the Numbers Kinder Morgan’s $4.7 Billion Pipeline Bet Could Be Bigger Than Its Earnings Beat Want to see what other hedge funds are holding JNJ? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Johnson & Johnson (NYSE:JNJ – Free Report).

Receive News & Ratings for Johnson & Johnson Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Johnson & Johnson and related companies with MarketBeat.com's FREE daily email newsletter.

Diversify Advisory Services LLC cut its holdings in Johnson & Johnson (NYSE:JNJ – Free Report) by 2.8% during the third quarter, according to its most recent Form 13F filing with the SEC. The fund owned 92,125 shares of the company’s stock after selling 2,609 shares during the period. Diversify Advisory Services LLC’s holdings in Johnson & Johnson were worth $23,333,000 at the end of the most recent reporting period.

Several other hedge funds also recently added to or reduced their stakes in JNJ. Wellington Management Group LLP raised its holdings in Johnson & Johnson by 12.5% in the 2nd quarter. Wellington Management Group LLP now owns 22,588,696 shares of the company’s stock valued at $5,736,851,000 after buying an additional 2,513,321 shares during the period. Deutsche Bank AG lifted its position in Johnson & Johnson by 8.5% in the second quarter. Deutsche Bank AG now owns 15,661,323 shares of the company’s stock valued at $3,977,506,000 after buying an additional 1,225,676 shares during the last quarter. Amundi lifted its position in Johnson & Johnson by 17.5% in the first quarter. Amundi now owns 13,406,820 shares of the company’s stock valued at $3,277,163,000 after buying an additional 2,001,139 shares during the last quarter. Janus Henderson Group PLC boosted its stake in Johnson & Johnson by 1.9% during the first quarter. Janus Henderson Group PLC now owns 7,872,478 shares of the company’s stock worth $1,924,323,000 after buying an additional 148,497 shares during the period. Finally, Jupiter Topco LLC purchased a new position in Johnson & Johnson during the second quarter worth about $1,967,399,000. 69.55% of the stock is currently owned by hedge funds and other institutional investors.

Johnson & Johnson News Roundup
Here are the key news stories impacting Johnson & Johnson this week:

Positive Sentiment: Positive sector rotation: JNJ is benefiting from fresh demand for defensive healthcare stocks, alongside gains in Procter & Gamble and Coca-Cola. Investors appear to be favoring companies with relatively stable demand and cash flows amid broader market pressure. Procter & Gamble Jumps as Defensive Buyers Enter
Positive Sentiment: Medical-device progress: Johnson & Johnson reported real-world data for its VARIPULSE Pro platform and 12-month outcomes for the OMNYPULSE platform in atrial-fibrillation treatment. The results could support adoption of its electrophysiology portfolio and provide another growth avenue beyond pharmaceuticals. Johnson & Johnson Reports VARIPULSE and OMNYPULSE Data
Positive Sentiment: Drug growth and guidance: Recent coverage highlights stronger pharmaceutical performance and Johnson & Johnson’s higher 2026 outlook, with projected sales of approximately $101.2 billion at the midpoint. The company also maintains a 64-year record of annual dividend increases, reinforcing its appeal to income-focused investors. Johnson & Johnson Drugs Lift Guidance
Neutral Sentiment: Mixed business outlook: One business is advancing strongly while another has stalled, leaving investors focused on whether new growth can justify JNJ’s premium valuation relative to competitors such as Merck and AbbVie. JNJ Stock Has a New Growth Story
Negative Sentiment: Analyst caution and valuation risk: Erste Group Bank downgraded JNJ from “buy” to “hold.” Commentary also notes that the stock’s elevated valuation could constrain returns, particularly as Treasury yields near 5% make government bonds more competitive with dividend stocks. Erste Group Bank Ratings

Johnson & Johnson Stock Up 3.8%
Shares of NYSE:JNJ opened at $267.67 on Friday. The company has a debt-to-equity ratio of 0.44, a current ratio of 1.09 and a quick ratio of 0.81. The firm has a market capitalization of $645.05 billion, a PE ratio of 40.56, a price-to-earnings-growth ratio of 2.55 and a beta of 0.21. The firm’s 50-day moving average is $265.57 and its two-hundred day moving average is $250.11. Johnson & Johnson has a 1 year low of $184.66 and a 1 year high of $281.07.
Johnson & Johnson (NYSE:JNJ – Get Free Report) last issued its quarterly earnings results on Tuesday, October 13th. The company reported $2.59 earnings per share (EPS) for the quarter, topping the consensus estimate of $2.53 by $0.06. Johnson & Johnson had a net margin of 16.20% and a return on equity of 31.54%. The business had revenue of $25.40 billion for the quarter, compared to analysts’ expectations of $25.38 billion. During the same quarter in the prior year, the company earned $2.80 earnings per share. The business’s quarterly revenue was up 5.9% on a year-over-year basis. Johnson & Johnson has set its FY 2026 guidance at 11.050-11.150 EPS. Analysts predict that Johnson & Johnson will post 11.12 EPS for the current year.

Johnson & Johnson Dividend Announcement
The firm also recently announced a quarterly dividend, which will be paid on Tuesday, December 8th. Shareholders of record on Tuesday, November 24th will be issued a dividend of $1.34 per share. The ex-dividend date is Tuesday, November 24th. This represents a $5.36 dividend on an annualized basis and a yield of 2.0%. Johnson & Johnson’s dividend payout ratio is 81.21%.

Insiders Place Their Bets
In other Johnson & Johnson news, EVP Timothy Schmid sold 33,597 shares of the stock in a transaction that occurred on Wednesday, September 2nd. The shares were sold at an average price of $274.74, for a total transaction of $9,230,439.78. Following the sale, the executive vice president directly owned 25,447 shares in the company, valued at $6,991,308.78. This represents a 56.90% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is available through this link. Also, EVP Jennifer Taubert sold 15,000 shares of the firm’s stock in a transaction that occurred on Monday, August 17th. The shares were sold at an average price of $263.36, for a total transaction of $3,950,400.00. Following the completion of the transaction, the executive vice president directly owned 194,451 shares of the company’s stock, valued at $51,210,615.36. This represents a 7.16% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. Insiders have sold a total of 64,515 shares of company stock worth $17,271,766 in the last ninety days. 0.16% of the stock is owned by corporate insiders.

Wall Street Analysts Forecast Growth
Several equities analysts have recently commented on the stock. Leerink Partners decreased their price objective on shares of Johnson & Johnson from $276.00 to $272.00 and set an “outperform” rating on the stock in a report on Wednesday, October 14th. HSBC lifted their target price on shares of Johnson & Johnson from $290.00 to $320.00 and gave the company a “buy” rating in a report on Thursday, September 10th. Citigroup boosted their target price on Johnson & Johnson from $298.00 to $303.00 and gave the company a “buy” rating in a research report on Monday, October 5th. Wall Street Zen cut Johnson & Johnson from a “buy” rating to a “hold” rating in a research note on Saturday, August 1st. Finally, Freedom Capital upgraded Johnson & Johnson from a “hold” rating to a “strong-buy” rating in a research report on Thursday, July 16th. One analyst has rated the stock with a Strong Buy rating, seventeen have issued a Buy rating and eight have given a Hold rating to the stock. According to data from MarketBeat, the stock has an average rating of “Moderate Buy” and a consensus price target of $275.92.

Read Our Latest Report on Johnson & Johnson

Johnson & Johnson Company Profile
(Free Report)

Johnson & Johnson (NYSE: JNJ) is a global healthcare company headquartered in New Brunswick, New Jersey. Founded in 1886, the company develops and markets products and services for patients, healthcare professionals and institutions worldwide.

Johnson & Johnson operates through two principal segments: Innovative Medicine and MedTech. Innovative Medicine focuses on pharmaceuticals for areas such as immunology, oncology, neuroscience, infectious diseases and cardiovascular conditions.

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Johnson and Johnson just posted a quarter where one business charged ahead while another quietly stalled, and which side wins out will determine whether the stock earns its premium valuation over rivals like Merck and AbbVie.

Our 24/7 Wall St. price target for Johnson & Johnson (NYSE:JNJ | JNJ Price Prediction) is $288.66 over the next 12 months. From the $258.93 close on October 20, that works out to 11.48% upside, and our rating is buy.

Metric
Value

Current Price
$258.93

24/7 Wall St. Price Target
$288.66

Upside/Downside
11.48%

Recommendation
BUY

Confidence Level
90%

Our confidence in this call is high. Right now the growth comes from pharma. Last quarter Innovative Medicine grew 7.9% and MedTech grew 2.5%. Over the next year, I think the stock depends on whether devices can close that gap. If MedTech steadies, our target is likely too low.

A Talc Charge Hid a Solid Third Quarter
Shares dropped 1.3% to $255.99 at midday. They are up 2.97% for the week, down 5.19% over the past month and up 25.69% year to date. The 52-week range is $180.59 to $281.07.

In the quarter reported October 13, sales came in at $25.4 billion. Adjusted EPS was $2.59, while GAAP EPS fell to $0.09. About $7 billion of charges explain the drop: the proposed talc settlement plus costs tied to the Firefly Bio deal and the Cell BioMedicines partnership.

Management cut adjusted EPS guidance to $11.05 to $11.15. Leave out the $0.64 deal impact and EPS growth would be close to 9%.

Why Bulls See More Than $300
Our bull case reaches $302.93, which is 17% upside. Tremfya grew 68%, and management sees it becoming a $10 billion-plus franchise. New data released October 19 showed durable fistula remission in Crohn’s disease.

The oral psoriasis drug ICOTYDE has more than 20,000 patients on therapy. CAPLYTA reached $1 billion in year-to-date sales. J&J is targeting more than $50 billion in oncology sales by 2030.

Wall Street is supportive too: there are 16 Buy or Strong Buy ratings and a consensus target of $279.41.

MedTech Is the Business That Has to Catch Up
Our bear case is $250.82. MedTech sales outside the U.S. rose just 0.1%. Abiomed fell 1.5% and surgery fell 1%. Timothy Schmid, speaking for MedTech, put it plainly: “Simply put, we can do better, and we absolutely will.”

Two more risks add to the pressure. Firefly Bio and Cell BioMedicines are expected to reduce 2027 EPS by $1.36 per share, and Stelara keeps losing sales to biosimilars.

The other side deserves weight. U.S. MedTech grew 4.8% and Shockwave grew 17.2%. MedTech’s adjusted margin improved to 22.9%, and VARIPULSE Pro is still awaiting U.S. approval. Separating the Orthopaedics business should also sharpen the focus on the device units that remain.

J&J Trades at a Premium to Merck and AbbVie

Company
Forward P/E
Quarterly Revenue Growth

Johnson & Johnson
21
5.9%

Merck
15
5.1%

AbbVie
16
10.2%

Merck (NYSE:MRK) is a direct oncology competitor with similar growth. Its forward P/E is 15, which suggests investors are paying extra for J&J’s broader set of drug launches.

AbbVie (NYSE:ABBV) has also had to replace sales from a major immunology drug facing biosimilars. It is growing faster at 10.2% and trades at a lower multiple. Against these two peers, our target looks reasonable but leaves little room for MedTech to disappoint.

Pharma Momentum Supports Our BUY Rating
Our 24/7 Wall St. price target is $288.66, with a buy rating and 90% confidence. What tips the call is that strong launches are outrunning Stelara’s decline.

I’d be a buyer if the December 8 Enterprise Business Review shows a credible plan to fix MedTech. I’d stay on the sidelines if device sales outside the U.S. keep stalling into 2027. On balance, I think the drug pipeline earns J&J its premium.

Year
24/7 Wall St. Price Target

2026
$261.98

2027
$287.67

2028
$314.27

2029
$338.34

2030
$358.63

These projections assume J&J keeps executing on its double-digit growth plan. The biggest swing factors are a faster MedTech recovery on the upside and new litigation costs on the downside.

Contact [email protected] for any questions or corrections.

Novem Group boosted its stake in shares of Johnson & Johnson (NYSE:JNJ – Free Report) by 187.7% in the third quarter, according to the company in its most recent Form 13F filing with the Securities & Exchange Commission. The firm owned 22,748 shares of the company’s stock after buying an additional 14,842 shares during the period. Novem Group’s holdings in Johnson & Johnson were worth $6,022,000 as of its most recent filing with the Securities & Exchange Commission.

Other hedge funds also recently bought and sold shares of the company. Wellington Management Group LLP raised its position in shares of Johnson & Johnson by 12.5% in the 2nd quarter. Wellington Management Group LLP now owns 22,588,696 shares of the company’s stock worth $5,736,851,000 after acquiring an additional 2,513,321 shares in the last quarter. Deutsche Bank AG boosted its position in Johnson & Johnson by 8.5% during the second quarter. Deutsche Bank AG now owns 15,661,323 shares of the company’s stock valued at $3,977,506,000 after purchasing an additional 1,225,676 shares in the last quarter. Amundi boosted its position in Johnson & Johnson by 17.5% during the first quarter. Amundi now owns 13,406,820 shares of the company’s stock valued at $3,277,163,000 after purchasing an additional 2,001,139 shares in the last quarter. Janus Henderson Group PLC boosted its position in Johnson & Johnson by 1.9% during the first quarter. Janus Henderson Group PLC now owns 7,872,478 shares of the company’s stock valued at $1,924,323,000 after purchasing an additional 148,497 shares in the last quarter. Finally, Jupiter Topco LLC purchased a new position in Johnson & Johnson in the second quarter valued at about $1,967,399,000. Hedge funds and other institutional investors own 69.55% of the company’s stock.

Analysts Set New Price Targets A number of brokerages have commented on JNJ. Johnson Rice reiterated a “buy” rating on shares of Johnson & Johnson in a report on Monday, August 3rd. HSBC raised their price target on shares of Johnson & Johnson from $290.00 to $320.00 and gave the company a “buy” rating in a report on Thursday, September 10th. Evercore set a $300.00 price objective on shares of Johnson & Johnson in a research report on Tuesday. Wall Street Zen cut shares of Johnson & Johnson from a “buy” rating to a “hold” rating in a research report on Saturday, August 1st. Finally, Weiss Ratings upgraded shares of Johnson & Johnson from a “buy (b)” rating to a “buy (b+)” rating in a research note on Thursday, October 8th. One investment analyst has rated the stock with a Strong Buy rating, eighteen have assigned a Buy rating and six have given a Hold rating to the company. According to data from MarketBeat, Johnson & Johnson currently has a consensus rating of “Moderate Buy” and a consensus price target of $275.92.

View Our Latest Stock Report on Johnson & Johnson Johnson & Johnson Price Performance Shares of NYSE JNJ opened at $259.42 on Wednesday. Johnson & Johnson has a fifty-two week low of $184.66 and a fifty-two week high of $281.07. The company has a market cap of $625.17 billion, a PE ratio of 39.31, a P/E/G ratio of 2.51 and a beta of 0.21. The company has a debt-to-equity ratio of 0.44, a quick ratio of 0.81 and a current ratio of 1.09. The business has a 50-day simple moving average of $265.53 and a two-hundred day simple moving average of $249.84.

Johnson & Johnson (NYSE:JNJ – Get Free Report) last posted its quarterly earnings data on Tuesday, October 13th. The company reported $2.59 earnings per share (EPS) for the quarter, beating the consensus estimate of $2.53 by $0.06. The firm had revenue of $25.40 billion for the quarter, compared to the consensus estimate of $25.38 billion. Johnson & Johnson had a net margin of 16.20% and a return on equity of 31.54%. The company’s revenue for the quarter was up 5.9% compared to the same quarter last year. During the same quarter in the prior year, the company posted $2.80 earnings per share. Johnson & Johnson has set its FY 2026 guidance at 11.050-11.150 EPS. As a group, equities analysts expect that Johnson & Johnson will post 11.12 EPS for the current fiscal year.

Johnson & Johnson Dividend Announcement The business also recently announced a quarterly dividend, which will be paid on Tuesday, December 8th. Shareholders of record on Tuesday, November 24th will be given a dividend of $1.34 per share. This represents a $5.36 annualized dividend and a yield of 2.1%. The ex-dividend date of this dividend is Tuesday, November 24th. Johnson & Johnson’s payout ratio is currently 81.21%.

Trending Headlines about Johnson & Johnson Here are the key news stories impacting Johnson & Johnson this week:

Positive Sentiment: MedTech launch supports growth: J&J introduced the next-generation Shockwave C2 Aero Fly coronary intravascular lithotripsy catheter in the U.S. The device delivers pulses at 2 Hz and is designed to reduce treatment time for calcified coronary lesions, potentially improving physician adoption and strengthening J&J’s cardiovascular portfolio. J&J launches Shockwave C2 Aero Fly catheter Positive Sentiment: Pipeline data remains constructive: TREMFYA maintained or improved remission in Crohn’s disease patients with perianal fistulas through 48 weeks, supporting the drug’s potential expansion and helping offset concerns about future competition to older products. J&J TREMFYA Crohn’s disease data Positive Sentiment: Supportive analyst view: TD Cowen reiterated a Buy rating and $300 price target, citing underappreciated pharmaceutical and MedTech growth. J&J’s latest quarterly results also exceeded EPS and revenue expectations, providing a favorable earnings backdrop. Neutral Sentiment: Acquisition strategy under review: Analysts see growing sales from acquired heart technologies and a larger hospital network, but competition, development costs and the need to convert revenue growth into stronger ownership returns remain concerns. J&J medical device deals analysis Negative Sentiment: Competitive and valuation risks: Rapport reported positive Phase II results for a novel oral bipolar drug licensed from J&J, potentially creating a future competitor to J&J’s Caplyta. Separately, JLPascual downgraded J&J to Sell, while commentary highlights that the stock trades at a premium multiple and must sustain earnings growth to justify it. Insider Buying and Selling at Johnson & Johnson In other Johnson & Johnson news, EVP Elizabeth Forminard sold 15,918 shares of the company’s stock in a transaction that occurred on Thursday, August 6th. The shares were sold at an average price of $257.00, for a total transaction of $4,090,926.00. Following the transaction, the executive vice president owned 16,994 shares in the company, valued at approximately $4,367,458. This represents a 48.37% decrease in their position. The sale was disclosed in a document filed with the SEC, which can be accessed through the SEC website. Also, EVP Timothy Schmid sold 33,597 shares of the firm’s stock in a transaction on Wednesday, September 2nd. The stock was sold at an average price of $274.74, for a total transaction of $9,230,439.78. Following the completion of the transaction, the executive vice president directly owned 25,447 shares of the company’s stock, valued at approximately $6,991,308.78. This represents a 56.90% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. In the last quarter, insiders have sold 64,515 shares of company stock worth $17,271,766. 0.16% of the stock is owned by corporate insiders.

Johnson & Johnson Company Profile (Free Report)

Johnson & Johnson (NYSE: JNJ) is a global healthcare company headquartered in New Brunswick, New Jersey. Founded in 1886, the company develops and markets products and services for patients, healthcare professionals and institutions worldwide.

Johnson & Johnson operates through two principal segments: Innovative Medicine and MedTech. Innovative Medicine focuses on pharmaceuticals for areas such as immunology, oncology, neuroscience, infectious diseases and cardiovascular conditions.

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New TREMFYA® (guselkumab) 3-year as-observed data show clinical remission rates of up to 94% (172/183 patients) and endoscopic remission rates of up to 52% (89/172 patients) in adults with moderate to severe Crohn’s disease in the 100 mg q8w dose group1FUZION data show combined fistula remission was maintained through Week 48 across both maintenance dose regimens, including an increase from 28% at Week 24 to 35% at Week 48 in the 100 mg q8w dose group2Together, these findings expand the evidence for guselkumab across long-term disease management and one of the most difficult-to-treat manifestations of Crohn’s disease1,2 BEERSE, BELGIUM (19 October 2026) – Johnson & Johnson today announced new data that further expands the clinical evidence supporting TREMFYA® (guselkumab) in Crohn's disease (CD) at the 2026 United European Gastroenterology Week (UEG Week). Research from the Phase 3 GALAXI studies shows durable efficacy and a consistent safety profile for guselkumab through three years (Week 144) of maintenance treatment in adults with moderately to severely active CD, reinforcing its long-term benefit in this chronic, progressive disease.1 Additionally, late-breaking one-year results from the Phase 3 FUZION study showed that guselkumab maintained or improved fistula remission through Week 48 in adults with CD with perianal fistula.2

"The treatment goals in Crohn's disease continue to evolve beyond short-term symptom management towards achieving durable disease control that can be sustained over years," said Mark Graham, Therapeutic Area Head, Immunology, J&J Innovative Medicine EMEA. "These findings reinforce the potential of guselkumab across different stages and manifestations of Crohn's disease, from sustained remission over three years to encouraging outcomes in patients living with perianal fistula, one of the most challenging complications of the disease."

Crohn’s disease is one of the two main forms of inflammatory bowel disease (IBD), which affects an estimated two million people across Europe.3 Guselkumab is an IL-23p19 subunit inhibitor approved in IBD that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.4,5,6,7 Findings for the unique mechanism of action are limited to in vitro studies, and the clinical significance of this finding is not known.8 IL-23 is a cytokine secreted by activated monocytes/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases, including Crohn’s disease.9

Three-year GALAXI results support the known efficacy and safety profile of guselkumab

Patients in the GALAXI 2 and 3 studies received intravenous induction followed by one of two guselkumab maintenance dosing regimens: 100 mg administered subcutaneously every eight weeks (q8w; n=286) or 200 mg administered subcutaneously every four weeks (q4w; n=296).1 In total, 432/582 patients continued treatment through Week 144.1 These were as-observed analyses and do not represent outcomes in the full randomised population.1 Participants who discontinued, lacked Week 144 data or underwent dose adjustment were not included.1 Across both regimens, clinical and endoscopic remission were maintained through three years of treatment.1 At Week 144 in the long-term extension (LTE), the data show:a

94% (172/183) of patients receiving guselkumab 100 mg q8w and 91% (185/204) receiving guselkumab 200 mg q4w achieved clinical remission.b,189% (162/183) of patients receiving guselkumab 100 mg q8w and 88% (179/204) receiving guselkumab 200 mg q4w achieved 90-day corticosteroid-free clinical remission.152% (89/172) of patients receiving guselkumab 100 mg q8w and 61% (119/195) receiving guselkumab 200 mg q4w achieved endoscopic remission.c,174% (432/582) of guselkumab-treated patients remained on treatment through three years.1 Safety findings through Week 144 were consistent with the known safety profile of guselkumab in Crohn’s disease.1 Common adverse reactions associated with guselkumab include respiratory tract infections, diarrhoea, and injection site reactions.4

The three-year results demonstrate durable clinical, corticosteroid-free and endoscopic remission across both guselkumab maintenance regimens.1

"In a chronic condition such as Crohn's disease, maintaining remission is as important as achieving it," said Prof. Silvio Danese, Gastroenterologist and Professor of Gastroenterology at Vita-Salute San Raffaele University and IRCCS San Raffaele Hospital in Milan, Italy.d "The three-year GALAXI results provide valuable longer-term evidence, showing that high levels of clinical remission were accompanied by sustained endoscopic and corticosteroid-free outcomes across both guselkumab maintenance regimens."

New FUZION 48-week analysis extends evidence in Crohn’s disease with perianal fistula

The 48-week findings showed that combined fistula remission, which incorporates both clinical and radiological assessment, was maintained or improved in both guselkumab maintenance regimens.2 Among patients initially randomised to the guselkumab 100 mg q8w maintenance regime (n=113), combined fistula remissione further increased from 28% at Week 24 to 35% at Week 48.2,10 Results at Week 48 include patients who underwent blinded dose adjustment to guselkumab 200 mg every four weeks at Week 24 (n=55).2 Similar findings were observed for rates of clinically assessed fistula remission.f,2

Results among patients receiving guselkumab 200 mg every 4 weeks (q4w; n=115) remained consistent through Week 48 (27% at Week 24 to 26% at Week 48).2,10 Similar findings were observed for clinically assessed fistula remission.2 Overall, 90% of all randomised patients, which included both bio-naïve and bio-experienced patients, completed treatment through Week 48.2

“Perianal fistula remains one of the most debilitating complications of Crohn's disease, where achieving durable disease control beyond symptom improvement is a challenge,” said Ailsa Hart, Ph.D., Director of St Mark's Hospital Inflammatory Bowel Disease Research, Consultant Gastroenterologist, and study investigator.g “The latest findings from the FUZION study show that patients treated with guselkumab maintained or improved upon the clinical benefits observed at Week 24, providing encouraging evidence for its use in this patient population.”

Safety findings through Week 48 were consistent with the known safety profile of guselkumab in Crohn’s disease.2 Common adverse reactions associated with guselkumab include respiratory tract infections, diarrhoea, and injection site reactions.4

These results reinforce the previously shared Week 24 results from FUZION,2,10 making guselkumab the only IL-23 inhibitor to demonstrate efficacy in a dedicated, randomised, placebo-controlled trial in patients with Crohn’s disease with perianal fistula, one of the most difficult-to-treat manifestations of the disease.2

Together, the GALAXI and FUZION findings presented at UEG Week 2026 underscore the growing breadth of evidence supporting guselkumab across Crohn's disease, from sustained long-term remission in moderately to severely active disease to efficacy in patients living with complex fistulising complications.1,2,11

Editor’s notes:

The Week 144 clinical remission, 90-day corticosteroid-free clinical remission and endoscopic remission results above represent the as observed data for the three-year GALAXI analysis.1 The observed analysis set included participants who entered the LTE, received ≥1 partial or complete study drug dose during the LTE, remained on treatment, and had data available at Week 144; participants who had a dose adjustment were not included.1Clinical remission was defined as a CDAI score <150.1Endoscopic remission was defined as an SES-CD ≤4, with a ≥2-point reduction and no subscore >1 on any subcomponent.1Silvio Danese is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.Combined fistula remission was defined as 100% closure of all external openings without development of new fistulas or abscesses and without any drainage by external openings, occurring spontaneously or after gentle finger compression and absence of collections >2cm of the perianal fistulas in at least two of three dimensions, confirmed by a blinded central review of the MRI results.2Clinically assessed fistula remission was defined as: 100% closure of all treated external openings without development of new fistulas or abscesses and without any drainage by external openings, occurring spontaneously or after gentle finger compression.2Ailsa Hart is a paid consultant for Johnson & Johnson. She has not been compensated for any media work. About the GALAXI programme (EudraCT 2017-002195-13)12

GALAXI is a double-blind, placebo-controlled, active-controlled (ustekinumab), parallel group, global, multicentre Phase 2/3 programme designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (immunomodulators, corticosteroids) and/or biologics (infliximab, adalimumab, certolizumab pegol, vedolizumab).12 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3, n=1021).12 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomised and includes a long-term extension that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years.4,12,13 Clinical outcomes include clinical remission (Crohn's Disease Activity Index [CDAI] <150), while endoscopic outcomes include endoscopic response and endoscopic remission as assessed using the Simple Endoscopic Score for Crohn's Disease (SES-CD).12

About the FUZION study (EudraCT 2021-000491-10)14

FUZION is a randomised, placebo-controlled, double-blind, multicentre, Phase 3 study designed to evaluate the efficacy and safety of guselkumab in adults with Crohn’s disease with perianal fistula.14 Patients enrolled in the study had one or more active draining perianal fistulas confirmed by blinded central MRI review, Crohn’s Disease Activity Index [CDAI] <350, and inadequate response to oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or up to 2 advanced therapy classes.10,14 Patients were randomised 2:2:1 to receive guselkumab 200 mg intravenous (IV) induction at Weeks 0, 4, 8 followed by guselkumab 100 mg subcutaneous (SC) maintenance therapy every 8 weeks (q8w); or guselkumab 200 mg IV infusion at Weeks 0, 4, 8 followed by guselkumab 200 mg SC maintenance therapy every 4 weeks (q4w); or placebo.10

About Crohn’s disease

Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated two million people across Europe.3 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.15 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss, and fever.16 There is currently no cure for Crohn’s disease.17

About guselkumab

Developed by Johnson & Johnson, guselkumab is the first approved fully-human, IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23.4,5,6,7 Findings for the unique mechanism of action are limited to in vitro studies, and the clinical significance of this finding is not known.8

Guselkumab is approved in the EU for the treatment of moderate to severe plaque psoriasis (Pso) in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug therapy.4 It is also approved in the EU and U.S. for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a JAK inhibitor and for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.4,18

Johnson & Johnson maintains exclusive worldwide marketing rights to guselkumab.

Guselkumab important safety information

In controlled periods of clinical studies with guselkumab, adverse drug reactions (ADRs) that consisted of respiratory tract infections were very common (≥10 percent); increased transaminases, headache, diarrhoea, arthralgia, rash and injection site reactions were common (≥1 to <10 percent); and herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, hypersensitivity, anaphylaxis, and urticaria were rare ADRs (≥0.1 percent to <1 percent).4

Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://www.jnj.com/innovativemedicine/emea/

Follow us at https://www.linkedin.com/company/jnj-innovative-medicine-emea.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behaviour and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Media contact:
Sophie Daneau
[email protected]

Investor contact:
Jessica Margevich
[email protected]

CP-606720
October 2026

References

Sands BE, et al. Efficacy and safety of guselkumab maintenance therapy in patients with moderately to severely active Crohn’s disease: results through week 144 from the phase 3 GALAXI 2 & 3 studies. Oral presentation (OP105) at the United European Gastroenterology Week Congress (UEGW). October 2026.Hart A, et al. Efficacy and safety of guselkumab in perianal fistulizing Crohn’s disease: Week 48 results from the Phase 3, randomized, double-blind, placebo-controlled FUZION trial. LB09 at the United European Gastroenterology Week Congress (UEGW). October 2026.Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78.EU SmPC: European Medicines Agency. TREMFYA Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf . Accessed October 2026.EU SmPC: European Medicines Agency. Ilumetri Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/ilumetri-epar-product-information_en.pdf. Accessed October 2026.EU SmPC: European Medicines Agency. Skyrizi Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf. Accessed October 2026.EU SmPC: European Medicines Agency. Omvoh Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/omvoh-epar-product-information_en.pdf. Accessed October 2026.Sachen KL, et al. Guselkumab binding to CD64+ IL-23–producing myeloid cells enhances potency for neutralizing IL-23 signaling. J Crohns Colitis. 2025; 12;16:1532852. Available at: https://doi.org/10.3389/fimmu.2025.1532852.Schinocca C, et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: an overview. Frontiers in Immunology. 2021 Feb 22;12:321. Available at: https://doi.org/10.3389/fimmu.2021.637829.Sands BE, et al. Efficacy of guselkumab in perianal fistulizing Crohn’s disease: Week 24 results from the phase 3, randomized, double-blind, placebo-controlled, multicenter FUZION study. P5691 at ACG Annual Scientific Meeting 2026. October 2026.Schubert S, et al. Early symptomatic response to guselkumab in inflammatory bowel disease: first real-world data from the german GORGEOUS study. ePoster (PP1357) at the United European Gastroenterology Week (UEGW). October 2026.EU Clinical Trials Register. Clinicaltrialsregister.eu. A Phase 2/3, randomised, double-blind, placebo- and active-controlled, parallel-group, multicentre protocol to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease (GALAXI). Identifier: 2017-002195-13. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-002195-13/ES. Accessed October 2026.ClinicalTrials.gov. A Study of the efficacy and safety of guselkumab in participants with moderately to severely active crohn's disease. Identifier: NCT03466411. Available at: https://clinicaltrials.gov/study/NCT03466411#study-plan. Accessed October 2026.ClinicalTrials.gov. A study of guselkumab in participants with fistulizing, perianal Crohn’s disease (FUZION CD). Identifier: NCT05347095. Available at: https://clinicaltrials.gov/study/NCT05347095. Accessed October 2026.Crohn’s & Colitis Foundation. Causes of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed October 2026.Crohn’s & Colitis Foundation. Signs and symptoms of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms. Accessed October 2026.NHS. Crohn’s disease treatment. Available at: https://www.nhs.uk/conditions/crohns-disease/treatment/. Accessed October 2026.U.S. Food and Drug Administration. TREMFYA Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf. Accessed October 2026.

Forum Financial Management LP lowered its stake in shares of Johnson & Johnson (NYSE:JNJ – Free Report) by 20.4% in the third quarter, according to its most recent 13F filing with the SEC. The fund owned 10,052 shares of the company’s stock after selling 2,573 shares during the period. Forum Financial Management LP’s holdings in Johnson & Johnson were worth $2,661,000 as of its most recent SEC filing.

Several other hedge funds also recently modified their holdings of the stock. Wellington Management Group LLP grew its stake in shares of Johnson & Johnson by 12.5% in the 2nd quarter. Wellington Management Group LLP now owns 22,588,696 shares of the company’s stock worth $5,736,851,000 after acquiring an additional 2,513,321 shares in the last quarter. Deutsche Bank AG boosted its position in Johnson & Johnson by 8.5% in the second quarter. Deutsche Bank AG now owns 15,661,323 shares of the company’s stock worth $3,977,506,000 after purchasing an additional 1,225,676 shares during the last quarter. Amundi increased its position in shares of Johnson & Johnson by 17.5% during the 1st quarter. Amundi now owns 13,406,820 shares of the company’s stock valued at $3,277,163,000 after purchasing an additional 2,001,139 shares during the last quarter. Jupiter Topco LLC purchased a new position in shares of Johnson & Johnson in the 2nd quarter worth about $1,967,399,000. Finally, Janus Henderson Group PLC increased its holdings in Johnson & Johnson by 1.9% during the first quarter. Janus Henderson Group PLC now owns 7,872,478 shares of the company’s stock worth $1,924,323,000 after buying an additional 148,497 shares during the last quarter. Hedge funds and other institutional investors own 69.55% of the company’s stock.

Key Johnson & Johnson News Here are the key news stories impacting Johnson & Johnson this week:

Positive Sentiment: Raised 2026 outlook: Third-quarter operational sales grew 6%, reaching $25.4 billion, and management increased full-year operational sales guidance to approximately $100.7 billion at the midpoint. Adjusted EPS also exceeded analysts’ expectations. Johnson & Johnson: 3 Key Takeaways for Long-Term Investors Positive Sentiment: Pharmaceutical momentum and pipeline potential: Strong demand for TREMFYA, early momentum for ICOTYDE and oncology investments helped offset weakness elsewhere. Investors are also watching J&J’s newly approved surgical robot as a potential long-term MedTech growth driver. Does Raised 2026 Outlook Change the Bull Case for Johnson & Johnson? Positive Sentiment: Defensive appeal and income support: Investors rotating away from technology stocks amid inflation and interest-rate concerns are favoring dividend-paying healthcare companies. J&J also affirmed its $1.34-per-share fourth-quarter dividend, payable in December 2026. Morgan Stanley maintained an “overweight” rating with a $292 price target. Neutral Sentiment: Institutional demand: ETFs recorded approximately $107.4 million of net buying in JNJ, suggesting some portfolio managers continue to view the company as a defensive holding. However, this flow is not necessarily evidence of a change in operating fundamentals. Johnson & Johnson Sees $107.4 Million in Net ETF Buying Negative Sentiment: MedTech weakness remains the main overhang: Medical-device sales missed Wall Street forecasts, while international pricing pressure and acquisition-related costs weighed on results. Analysts described the quarter as setting a negative tone for the broader pharmaceutical sector. Johnson & Johnson Stock Falls on MedTech Miss Negative Sentiment: Valuation and analyst caution: JNJ trades at a premium earnings multiple, increasing the risk of further pressure if growth disappoints. Erste Group expressed a negative view on fiscal 2027 earnings, while RBC lowered its price expectations. Insider Activity In other Johnson & Johnson news, EVP Jennifer L. Taubert sold 15,000 shares of the business’s stock in a transaction on Monday, August 17th. The stock was sold at an average price of $263.36, for a total value of $3,950,400.00. Following the sale, the executive vice president directly owned 194,451 shares of the company’s stock, valued at approximately $51,210,615.36. The trade was a 7.16% decrease in their ownership of the stock. The transaction was disclosed in a legal filing with the SEC, which can be accessed through this link. Also, EVP Timothy Schmid sold 33,597 shares of the stock in a transaction dated Wednesday, September 2nd. The shares were sold at an average price of $274.74, for a total transaction of $9,230,439.78. Following the sale, the executive vice president directly owned 25,447 shares in the company, valued at $6,991,308.78. This trade represents a 56.90% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. In the last 90 days, insiders have sold 64,515 shares of company stock worth $17,271,766. Corporate insiders own 0.16% of the company’s stock. Wall Street Analyst Weigh In Several equities analysts have weighed in on the company. Weiss Ratings raised Johnson & Johnson from a “buy (b)” rating to a “buy (b+)” rating in a report on Thursday, October 8th. HSBC upped their price target on shares of Johnson & Johnson from $290.00 to $320.00 and gave the company a “buy” rating in a research note on Thursday, September 10th. Argus set a $300.00 price objective on Johnson & Johnson in a research note on Wednesday, July 29th. Bank of America reiterated a “neutral” rating and issued a $278.00 target price on shares of Johnson & Johnson in a research note on Tuesday, September 29th. Finally, Guggenheim reiterated a “buy” rating and issued a $287.00 price objective on shares of Johnson & Johnson in a research report on Wednesday, October 7th. One investment analyst has rated the stock with a Strong Buy rating, eighteen have given a Buy rating and six have assigned a Hold rating to the company’s stock. According to MarketBeat, Johnson & Johnson currently has a consensus rating of “Moderate Buy” and a consensus price target of $274.87.

Check Out Our Latest Analysis on Johnson & Johnson

Johnson & Johnson Price Performance Shares of Johnson & Johnson stock opened at $255.54 on Monday. The stock has a market capitalization of $615.82 billion, a P/E ratio of 38.72, a price-to-earnings-growth ratio of 2.53 and a beta of 0.21. Johnson & Johnson has a one year low of $184.66 and a one year high of $281.07. The company has a debt-to-equity ratio of 0.44, a current ratio of 1.09 and a quick ratio of 0.81. The business’s 50 day simple moving average is $265.66 and its two-hundred day simple moving average is $249.66.

Johnson & Johnson (NYSE:JNJ – Get Free Report) last announced its quarterly earnings results on Tuesday, October 13th. The company reported $2.59 earnings per share (EPS) for the quarter, topping analysts’ consensus estimates of $2.53 by $0.06. Johnson & Johnson had a net margin of 16.20% and a return on equity of 31.54%. The business had revenue of $25.40 billion for the quarter, compared to analyst estimates of $25.38 billion. During the same quarter last year, the firm earned $2.80 EPS. The company’s revenue was up 5.9% on a year-over-year basis. Johnson & Johnson has set its FY 2026 guidance at 11.050-11.150 EPS. Analysts forecast that Johnson & Johnson will post 11.12 EPS for the current year.

Johnson & Johnson Announces Dividend The company also recently disclosed a quarterly dividend, which will be paid on Tuesday, December 8th. Shareholders of record on Tuesday, November 24th will be issued a $1.34 dividend. The ex-dividend date is Tuesday, November 24th. This represents a $5.36 dividend on an annualized basis and a yield of 2.1%. Johnson & Johnson’s dividend payout ratio is 81.21%.

(Free Report)

Johnson & Johnson (NYSE: JNJ) is a global healthcare company headquartered in New Brunswick, New Jersey. Founded in 1886, the company develops and markets products and services for patients, healthcare professionals and institutions worldwide.

Johnson & Johnson operates through two principal segments: Innovative Medicine and MedTech. Innovative Medicine focuses on pharmaceuticals for areas such as immunology, oncology, neuroscience, infectious diseases and cardiovascular conditions.

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Johnson & Johnson just posted a quarter that sent shares sliding despite a headline beat, yet analysts keep piling into the bull camp with price targets well above current levels. Here is what the numbers actually say about whether this…

Our 24/7 Wall St. price target for Johnson & Johnson (NYSE:JNJ | JNJ Price Prediction) is $291.60 over the next 12 months. That means 15.57% upside from the model’s reference price of $252.32. Our rating is a buy, and our confidence is high.

Metric
Value

Current Price
$252.32

Price Target from 24/7 Wall St.
$291.60

Upside/Downside
15.57%

Recommendation
BUY

Confidence Level
90%

J&J has a beta of 0.206, a dividend yield of 1.99%, and 64 consecutive years of dividend increases (the kind of multi-decade run we screened for in our free Dividend Kings guide, which you can grab here).

Its oncology business is also growing at a double-digit pace. Shares traded at $257.62 noon Thursday, up 1.46% on the session.

MedTech Miss Cools a Strong 2026 Run
The stock is up 26.49% year to date and 38.02% over the past year. It has slipped 3.27% over the past month and now sits between a 52-week low of $180.59 and a 52-week high of $281.07.

J&J reported third-quarter results on October 13. Sales rose 6% to $25.4 billion, and adjusted EPS came in at $2.59. Innovative Medicine grew 7.9%. MedTech grew only 2.5%, and shares fell after the device miss.

Management also reset adjusted EPS guidance to $11.05 to $11.15 to account for the Firefly Bio and SAIL Biomedicines deals. It announced a $5.5 billion resolution of the ovarian talc litigation as well.

Why Bulls See $304 and Beyond
The bull case is $304.22. TREMFYA grew 68.2%, and management believes it can become a “$10 billion plus franchise.” Oncology grew about 17%, and J&J wants to be the top oncology company by 2030 with sales above $50 billion.

Management sees “a clear path to double digit growth by the end of the decade” without any further acquisitions. More catalysts are on the calendar: the OTTAVA robot, a DePuy Synthes spin targeted for mid-2027 and a December 8 Enterprise Business Review.

On the ratings side, 16 analysts rate the stock a Buy or Strong Buy.

What Could Go Wrong for J&J
The bear case sits at $252.88, essentially flat. STELARA sales fell 54%, and Abiomed declined 1.5%. The deal dilution is $1.36 per share next year, which puts our forward EPS input at risk.

As a counterpoint, management said EPS growth would approach 9% without those transactions, and the talc agreement could remove a long-running drag.

How J&J Compares to Merck and AbbVie
Merck (NYSE:MRK) is a direct oncology rival. It trades at 15x forward earnings, but KEYTRUDA’s patent expiration explains part of that discount.

AbbVie (NYSE:ABBV) competes with TREMFYA in immunology. It trades at 16x forward earnings while growing revenue 10.2%.

Company
Forward P/E
Dividend Yield
Revenue Growth (YoY)

J&J
21
1.99%
6.6%

Merck
15
2.34%
5.1%

AbbVie
16
2.43%
10.2%

J&J accounts for a premium multiple, so our target looks somewhat aggressive next to these peers. That premium gets diversification and a lower risk of losing exclusivity on a single key drug.

Why J&J’s Defensive Profile Supports Our Target
A 24/7 Wall St. price target of $291.60 supports a buy with 90% confidence. Durable pharma growth is the deciding factor.

The thesis strengthens if TREMFYA and oncology keep growing faster than STELARA declines. It weakens if MedTech weakness spreads beyond Abiomed and international markets.

Our model projects these values if current trends hold.

Year
Price Target from 24/7 Wall St.

2026
$255.36

2027
$291.60

2028
$323.87

2029
$351.98

2030
$380.13

J&J would need to keep executing on its current strategy for these projections to hold. The DePuy Synthes spin or new pipeline results could move the path significantly in either direction.

Contact [email protected] for any questions or corrections.

TD Waterhouse Canada Inc. increased its holdings in shares of Johnson & Johnson (NYSE:JNJ – Free Report) by 22.6% in the third quarter, according to the company in its most recent filing with the Securities and Exchange Commission. The firm owned 1,232,683 shares of the company’s stock after purchasing an additional 227,243 shares during the period. Johnson & Johnson accounts for about 0.8% of TD Waterhouse Canada Inc.’s holdings, making the stock its 28th biggest holding. TD Waterhouse Canada Inc. owned approximately 0.05% of Johnson & Johnson worth $319,176,000 as of its most recent filing with the Securities and Exchange Commission.

Several other large investors have also recently added to or reduced their stakes in the stock. Wellington Management Group LLP lifted its stake in shares of Johnson & Johnson by 12.5% during the second quarter. Wellington Management Group LLP now owns 22,588,696 shares of the company’s stock worth $5,736,851,000 after purchasing an additional 2,513,321 shares in the last quarter. Deutsche Bank AG boosted its position in shares of Johnson & Johnson by 8.5% in the second quarter. Deutsche Bank AG now owns 15,661,323 shares of the company’s stock worth $3,977,506,000 after buying an additional 1,225,676 shares during the period. Amundi grew its stake in shares of Johnson & Johnson by 17.5% in the first quarter. Amundi now owns 13,406,820 shares of the company’s stock valued at $3,277,163,000 after buying an additional 2,001,139 shares in the last quarter. Jupiter Topco LLC acquired a new stake in shares of Johnson & Johnson in the second quarter valued at about $1,967,399,000. Finally, Janus Henderson Group PLC grew its stake in shares of Johnson & Johnson by 1.9% in the first quarter. Janus Henderson Group PLC now owns 7,872,478 shares of the company’s stock valued at $1,924,323,000 after buying an additional 148,497 shares in the last quarter. 69.55% of the stock is currently owned by institutional investors and hedge funds.

Johnson & Johnson Stock Performance Shares of JNJ stock opened at $255.54 on Monday. The company has a debt-to-equity ratio of 0.44, a current ratio of 1.09 and a quick ratio of 0.81. The company’s fifty day moving average price is $265.66 and its two-hundred day moving average price is $249.66. The firm has a market capitalization of $615.82 billion, a P/E ratio of 38.72, a P/E/G ratio of 2.53 and a beta of 0.21. Johnson & Johnson has a 12 month low of $184.66 and a 12 month high of $281.07.

Johnson & Johnson (NYSE:JNJ – Get Free Report) last announced its earnings results on Tuesday, October 13th. The company reported $2.59 earnings per share for the quarter, beating the consensus estimate of $2.53 by $0.06. Johnson & Johnson had a return on equity of 31.54% and a net margin of 16.20%. The company had revenue of $25.40 billion during the quarter, compared to the consensus estimate of $25.38 billion. During the same period last year, the firm earned $2.80 earnings per share. The company’s revenue was up 5.9% on a year-over-year basis. Johnson & Johnson has set its FY 2026 guidance at 11.050-11.150 EPS. On average, research analysts anticipate that Johnson & Johnson will post 11.12 earnings per share for the current fiscal year. Johnson & Johnson Dividend Announcement The firm also recently declared a quarterly dividend, which will be paid on Tuesday, December 8th. Investors of record on Tuesday, November 24th will be issued a $1.34 dividend. The ex-dividend date of this dividend is Tuesday, November 24th. This represents a $5.36 dividend on an annualized basis and a yield of 2.1%. Johnson & Johnson’s dividend payout ratio is currently 81.21%.

Johnson & Johnson News Roundup Here are the key news stories impacting Johnson & Johnson this week:

Positive Sentiment: Raised 2026 outlook: Third-quarter operational sales grew 6%, reaching $25.4 billion, and management increased full-year operational sales guidance to approximately $100.7 billion at the midpoint. Adjusted EPS also exceeded analysts’ expectations. Johnson & Johnson: 3 Key Takeaways for Long-Term Investors Positive Sentiment: Pharmaceutical momentum and pipeline potential: Strong demand for TREMFYA, early momentum for ICOTYDE and oncology investments helped offset weakness elsewhere. Investors are also watching J&J’s newly approved surgical robot as a potential long-term MedTech growth driver. Does Raised 2026 Outlook Change the Bull Case for Johnson & Johnson? Positive Sentiment: Defensive appeal and income support: Investors rotating away from technology stocks amid inflation and interest-rate concerns are favoring dividend-paying healthcare companies. J&J also affirmed its $1.34-per-share fourth-quarter dividend, payable in December 2026. Morgan Stanley maintained an “overweight” rating with a $292 price target. Neutral Sentiment: Institutional demand: ETFs recorded approximately $107.4 million of net buying in JNJ, suggesting some portfolio managers continue to view the company as a defensive holding. However, this flow is not necessarily evidence of a change in operating fundamentals. Johnson & Johnson Sees $107.4 Million in Net ETF Buying Negative Sentiment: MedTech weakness remains the main overhang: Medical-device sales missed Wall Street forecasts, while international pricing pressure and acquisition-related costs weighed on results. Analysts described the quarter as setting a negative tone for the broader pharmaceutical sector. Johnson & Johnson Stock Falls on MedTech Miss Negative Sentiment: Valuation and analyst caution: JNJ trades at a premium earnings multiple, increasing the risk of further pressure if growth disappoints. Erste Group expressed a negative view on fiscal 2027 earnings, while RBC lowered its price expectations. Analyst Ratings Changes Several equities research analysts recently commented on the company. Bank of America reiterated a “neutral” rating and set a $278.00 target price on shares of Johnson & Johnson in a report on Tuesday, September 29th. Scotiabank restated an “outperform” rating and issued a $305.00 price target on shares of Johnson & Johnson in a report on Thursday, July 16th. Sanford C. Bernstein set a $270.00 price target on Johnson & Johnson in a report on Thursday. Johnson Rice reaffirmed a “buy” rating on shares of Johnson & Johnson in a research report on Monday, August 3rd. Finally, Raymond James Financial set a $280.00 price objective on shares of Johnson & Johnson in a research note on Monday, August 3rd. One research analyst has rated the stock with a Strong Buy rating, eighteen have given a Buy rating and six have given a Hold rating to the company. According to MarketBeat, Johnson & Johnson has a consensus rating of “Moderate Buy” and a consensus target price of $274.87.

Check Out Our Latest Stock Report on Johnson & Johnson

Insider Activity at Johnson & Johnson In other Johnson & Johnson news, EVP Timothy Schmid sold 33,597 shares of the firm’s stock in a transaction that occurred on Wednesday, September 2nd. The stock was sold at an average price of $274.74, for a total transaction of $9,230,439.78. Following the completion of the sale, the executive vice president owned 25,447 shares in the company, valued at $6,991,308.78. This trade represents a 56.90% decrease in their position. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is available through the SEC website. Also, EVP Elizabeth Forminard sold 15,918 shares of the firm’s stock in a transaction that occurred on Thursday, August 6th. The shares were sold at an average price of $257.00, for a total value of $4,090,926.00. Following the sale, the executive vice president owned 16,994 shares of the company’s stock, valued at approximately $4,367,458. This trade represents a 48.37% decrease in their position. The SEC filing for this sale provides additional information. Over the last 90 days, insiders sold 64,515 shares of company stock valued at $17,271,766. Insiders own 0.16% of the company’s stock.

(Free Report)

Johnson & Johnson (NYSE: JNJ) is a global healthcare company headquartered in New Brunswick, New Jersey. Founded in 1886, the company develops and markets products and services for patients, healthcare professionals and institutions worldwide.

Johnson & Johnson operates through two principal segments: Innovative Medicine and MedTech. Innovative Medicine focuses on pharmaceuticals for areas such as immunology, oncology, neuroscience, infectious diseases and cardiovascular conditions.

Recommended Stories Five stocks we like better than Johnson & Johnson These 3 Green Stocks Have a Growth Story That Goes Far Beyond Washington Meta Claims Frontier-Class AI Status With New Muse Wonder Models Berkshire Just Backed This Little-Known Stock—Should You Chase It? Broadcom’s CEO Sees Years of AI Demand But Warns of a Bigger Threat to the Boom Want to see what other hedge funds are holding JNJ? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Johnson & Johnson (NYSE:JNJ – Free Report).

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Cliftonlarsonallen Wealth Advisors LLC boosted its stake in Johnson & Johnson (NYSE:JNJ – Free Report) by 23.5% during the 3rd quarter, according to the company in its most recent disclosure with the SEC. The firm owned 39,674 shares of the company’s stock after acquiring an additional 7,547 shares during the period. Cliftonlarsonallen Wealth Advisors LLC’s holdings in Johnson & Johnson were worth $10,503,000 as of its most recent filing with the SEC.

A number of other hedge funds and other institutional investors have also recently added to or reduced their stakes in the stock. National Pension Service lifted its holdings in Johnson & Johnson by 1.3% during the second quarter. National Pension Service now owns 5,226,968 shares of the company’s stock valued at $1,327,493,000 after purchasing an additional 67,484 shares during the last quarter. IFP Advisors Inc boosted its position in Johnson & Johnson by 8.8% during the second quarter. IFP Advisors Inc now owns 38,760 shares of the company’s stock worth $9,844,000 after purchasing an additional 3,133 shares during the period. Elefante Mark B increased its stake in shares of Johnson & Johnson by 9.8% in the second quarter. Elefante Mark B now owns 28,686 shares of the company’s stock worth $7,285,000 after purchasing an additional 2,563 shares in the last quarter. Signal Advisors Wealth LLC increased its stake in shares of Johnson & Johnson by 76.1% in the first quarter. Signal Advisors Wealth LLC now owns 15,126 shares of the company’s stock worth $3,697,000 after purchasing an additional 6,539 shares in the last quarter. Finally, Gradient Investments LLC increased its stake in shares of Johnson & Johnson by 9.9% in the second quarter. Gradient Investments LLC now owns 152,831 shares of the company’s stock worth $38,815,000 after purchasing an additional 13,737 shares in the last quarter. 69.55% of the stock is currently owned by hedge funds and other institutional investors.

Analyst Upgrades and Downgrades A number of analysts recently commented on the stock. HSBC upped their price target on shares of Johnson & Johnson from $290.00 to $320.00 and gave the company a “buy” rating in a research note on Thursday, September 10th. Citigroup lifted their price objective on shares of Johnson & Johnson from $298.00 to $303.00 and gave the company a “buy” rating in a research note on Monday, October 5th. Argus set a $300.00 price objective on shares of Johnson & Johnson in a research note on Wednesday, July 29th. Scotiabank reissued an “outperform” rating and set a $305.00 target price on shares of Johnson & Johnson in a report on Thursday, July 16th. Finally, Stifel Nicolaus set a $260.00 target price on Johnson & Johnson in a research report on Wednesday, July 15th. One investment analyst has rated the stock with a Strong Buy rating, eighteen have issued a Buy rating and six have assigned a Hold rating to the company’s stock. Based on data from MarketBeat.com, Johnson & Johnson has an average rating of “Moderate Buy” and a consensus price target of $273.61.

Check Out Our Latest Analysis on JNJ Johnson & Johnson Price Performance JNJ stock opened at $253.49 on Thursday. The firm has a 50 day moving average of $265.80 and a 200-day moving average of $249.47. The firm has a market capitalization of $610.89 billion, a P/E ratio of 23.34, a price-to-earnings-growth ratio of 2.54 and a beta of 0.21. Johnson & Johnson has a 12 month low of $184.66 and a 12 month high of $281.07. The company has a current ratio of 1.09, a quick ratio of 0.81 and a debt-to-equity ratio of 0.44.

Johnson & Johnson (NYSE:JNJ – Get Free Report) last posted its earnings results on Tuesday, October 13th. The company reported $2.59 earnings per share for the quarter, topping analysts’ consensus estimates of $2.53 by $0.06. Johnson & Johnson had a net margin of 16.20% and a return on equity of 31.54%. The business had revenue of $25.40 billion for the quarter, compared to analyst estimates of $25.38 billion. During the same quarter in the prior year, the firm posted $2.80 EPS. Johnson & Johnson’s revenue was up 5.9% on a year-over-year basis. Johnson & Johnson has set its FY 2026 guidance at 11.050-11.150 EPS. As a group, sell-side analysts predict that Johnson & Johnson will post 11.10 earnings per share for the current fiscal year.

Johnson & Johnson Announces Dividend The company also recently declared a quarterly dividend, which will be paid on Tuesday, December 8th. Stockholders of record on Tuesday, November 24th will be given a dividend of $1.34 per share. This represents a $5.36 dividend on an annualized basis and a dividend yield of 2.1%. The ex-dividend date is Tuesday, November 24th. Johnson & Johnson’s payout ratio is 62.11%.

Key Johnson & Johnson News Here are the key news stories impacting Johnson & Johnson this week:

Positive Sentiment: JNJ exceeded third-quarter adjusted earnings expectations, reporting EPS of $2.59 versus a $2.53 consensus, while revenue rose 5.9% year over year to $25.4 billion. Innovative Medicine was the primary growth engine, with reported 7.9% growth and strong demand for newer products. Johnson & Johnson reports Q3 2026 results and raises 2026 guidance Positive Sentiment: The company raised its 2026 outlook to $101.0 billion-$101.4 billion in revenue and $11.05-$11.15 in adjusted EPS. The improved forecast provides support for the stock despite the quarter’s mixed details. JNJ Q3 earnings call highlights Positive Sentiment: JNJ declared a quarterly dividend of $1.34 per share, equivalent to $5.36 annually and approximately a 2.2% yield, reinforcing its appeal to income-focused investors. Johnson & Johnson announces quarterly dividend Insider Activity In related news, EVP Elizabeth Forminard sold 15,918 shares of Johnson & Johnson stock in a transaction on Thursday, August 6th. The stock was sold at an average price of $257.00, for a total transaction of $4,090,926.00. Following the completion of the sale, the executive vice president owned 16,994 shares of the company’s stock, valued at approximately $4,367,458. This trade represents a 48.37% decrease in their ownership of the stock. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is accessible through the SEC website. Also, EVP Timothy Schmid sold 33,597 shares of the business’s stock in a transaction dated Wednesday, September 2nd. The stock was sold at an average price of $274.74, for a total value of $9,230,439.78. Following the transaction, the executive vice president owned 25,447 shares of the company’s stock, valued at approximately $6,991,308.78. The trade was a 56.90% decrease in their ownership of the stock. The SEC filing for this sale provides additional information. In the last three months, insiders sold 87,569 shares of company stock worth $23,064,544. Company insiders own 0.16% of the company’s stock.

(Free Report)

Johnson & Johnson (NYSE: JNJ) is a global healthcare company that develops, manufactures and markets products through two primary business segments: Innovative Medicine and MedTech. Its operations serve patients, healthcare professionals and consumers in markets around the world.

The Innovative Medicine segment focuses on prescription medicines in areas including immunology, oncology, neuroscience, cardiovascular and metabolic disease, infectious diseases, and pulmonary hypertension.

See Also Five stocks we like better than Johnson & Johnson Tesla Wants to Make Its Own Chips—What Could Go Wrong? IREN Limited’s AI Pivot Gains Traction—But Can Its Data Centers Deliver? PBF Energy’s Stunning Rally Faces a Critical Test Citi Stock Falls Despite Earnings Beat: What Investors Need to Know Want to see what other hedge funds are holding JNJ? Visit HoldingsChannel.com to get the latest 13F filings and insider trades for Johnson & Johnson (NYSE:JNJ – Free Report).

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13.10.2026 15:03, JNJ

Farmaceutická společnost Johnson & Johnson zveřejnila výsledky hospodaření za 3Q 2026, které jsou tržbami na úrovni analytického konsensu. Společnost zároveň navýšila výhled očištěného zisku na akcii. Poptávku po nových lécích na rakovinu a autoimunitní onemocnění zastiňuje slabší růst segmentu zdravotnických zařízení MedTech.

Výsledky společnosti Johnson & Johnson (JNJ) za 3Q 2026

 
3Q 2026
Konsensus 3Q 2026
3Q 2025

Tržby (mld. USD)
25,40
25,4
24,0

Čistý zisk (mld. USD)
*0,21
--
5,15

Očištěný zisk na akcii (EPS, USD/akcie)
2,59
2,52
2,80

Tržby společnosti ve 3Q vzrostly meziročně o 5,9 % na 25,4 mld. USD.

Tržby v USA vzrostly meziročně o 9,1 % na 15 mld. USD a mezinárodní tržby zaznamenaly 1,5% růst na 10,4 mld. USD. V rámci segmentu inovativní medicíny tržby vzrostly o 7,7 % na 16,76 mld. USD při očekávání trhu ve výši 16,59 mld. USD a tržby v segmentu MedTech vzrostly 2,5% tempem na 8,64 mld. USD při konsensu 8,77 mld. USD.

Výdaje na vývoj a výzkum ve 3Q činily 4,65 mld. USD při očekávání 4,15 mld. USD.

*Vykázaný čistý zisk je dle společnosti ovlivněn jednorázovým mimořádný nákladem souvisejícím s urovnáním sporů, akvizice Firefly Bio a strategickou spoluprácí se Sail Biomedicines.

Tržby vybraných léků Johnson & Johnson ve 3Q

Tržby vybraných léků Johnson & Johnson ve 3Q 2026

 
Tržby
Konsenzus
Meziroční změna

Darzalex (v mld. USD)
4,24
4,31
+15 %

Tremfya (v mld. USD)

2,40
2,21
+68 %

Erleada (v mld. USD)
1,02
1,05
+9,3 %

Invega Sustenna (v mld. USD)
1,00
0,96
+7,4 %

Imbruvica (v mld. USD)
0,56
0,59
-19 %

Výhled na rok 2026
Společnost nově očekává celoroční tržby ve středu výhledového rozpětí na úrovni 101,2 mld. USD, což představuje meziroční růst o 7,4 %. Analytický konsensus byl na 101,24 USD. Na úrovni očištěného zisku na akcii zvyšuje výhled do pásma 11,05 USD až 11,15 USD.

Akcie Johnson & Johnson
V předburzovní fázi akcie J&J odepisují 2,17 % na 258 USD.

Zdroj: Johnson & Johnson, Bloomberg

Marek Chudoba, Fio banka, a.s.

New long-term data showed clinical remission rates of up to 94% and endoscopic remission rates of up to 61% in adults with moderately to severely active Crohn's disease
88% of patients achieved 90-day corticosteroid-free clinical remission

, /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new three-year data from the Phase 3 GALAXI 2 and 3 studies showing durable efficacy and a consistent safety profile for TREMFYA® (guselkumab) in adults with moderately to severely active Crohn's disease.1 The Week 144 long-term extension (LTE) results being presented at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting reveal long-term clinical and endoscopic outcomes across both TREMFYA maintenance regimens in this chronic disease.

Clinical and endoscopic outcomes sustained through three years with TREMFYA

Patients in the GALAXI 2 and 3 studies received intravenous induction followed by one of two TREMFYA maintenance dosing regimens: 100 mg administered subcutaneously every eight weeks (q8w) or 200 mg administered subcutaneously every four weeks (q4w). At Week 144 the LTE data show:1a

94% of patients receiving TREMFYA 100 mg q8w and 91% receiving TREMFYA 200 mg q4w achieved clinical remission.b
88% of patients receiving TREMFYA 100 mg q8w and 88% receiving TREMFYA 200 mg q4w achieved 90-day corticosteroid-free clinical remission, respectively.
52% of patients receiving TREMFYA 100 mg q8w and 61% receiving TREMFYA 200 mg q4w achieved endoscopic remission.c
74% of TREMFYA-treated patients remained on treatment through three years. 

Safety findings through Week 144 were consistent with the well-established safety profile of TREMFYA in Crohn's disease.1

"In a chronic, lifelong disease, the ability to sustain clinical and endoscopic outcomes through three years is particularly meaningful for patients," said David Rubin, MD, Director of the Inflammatory Bowel Disease Center at the University of Chicago.d "These results contribute to the growing body of evidence that TREMFYA can provide patients with deep and sustained remission over time, creating a strong foundation for long-term disease management."

Long-term disease control is an important need in Crohn's disease management

As Crohn's disease is a lifelong disease with no cure, patients and physicians need treatments that can provide sustained control of symptoms and intestinal inflammation over time. These results represent one of the most comprehensive three-year datasets in Crohn's disease reported to date, demonstrating durable clinical, corticosteroid-free and endoscopic remission across both TREMFYA maintenance regimens.

"Johnson & Johnson has built deep expertise in immune-mediated diseases including inflammatory bowel disease, and our research is designed to answer questions that arise over the course of this chronic condition," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "The clinical and endoscopic remission observed with TREMFYA through three years reinforces our commitment to generating long-term evidence that can help physicians make informed treatment decisions for people living with Crohn's disease."

TREMFYA is the only approved dual-acting monoclonal antibody in inflammatory bowel disease (IBD) that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC. Findings are based on in vitro studies.2 3 4 5 6

For a full list of all Johnson & Johnson data being presented at ACG visit: https://www.jnj.com/innovativemedicine/immunology/gastroenterology. 

Editor's notes: 

a. The Week 144 clinical remission, 90-day corticosteroid-free clinical remission and endoscopic remission results above represent the as observed data for the three-year GALAXI analysis. The observed analysis set included participants who entered the LTE, received ≥1 partial or complete study drug dose during the LTE, remained on treatment, and had data available at Week 144; participants who had a dose adjustment were not include
b. Clinical remission was defined as a CDAI score <150.
c. Endoscopic remission was defined as an SES-CD ≤4, with a ≥2-point reduction and no subscore >1 on any subcomponent.
d. Dr. David Rubin is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.

About the GALAXI program (NCT03466411) 

GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of TREMFYA in participants with moderately to severely active Crohn's disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab). GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3). Each GALAXI study employed a treat-through design and includes a long-term extension period that will assess clinical, endoscopic, and safety outcomes with TREMFYA treatment through a total of five years. Patients received TREMFYA 200 mg intravenous induction at Weeks 0, 4 and 8 followed by TREMFYA 200 mg subcutaneous maintenance every 4 weeks; or TREMFYA 200 mg intravenous induction at Weeks 0, 4 and 8, followed by TREMFYA7

About Crohn's disease

Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans and an estimated four million people across Europe.89 Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.10 Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.  Some patients may also develop fistulas, abnormal connections between the intestine and other organs or tissues, which can be associated with pain, drainage, infection, and substantial impairment in quality of life. Currently no cure is available for Crohn's disease.11

About TREMFYA (guselkumab)

Developed by Johnson & Johnson, TREMFYA is the first fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for the dual-acting mechanism are limited to in vitro studies that demonstrate TREMFYA binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.

TREMFYA is a prescription medicine approved in the U.S. to treat:

adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
adults and children 6 years and older who also weigh at least 88 pounds (40 kg) with active psoriatic arthritis.
adults with moderately to severely active ulcerative colitis.
adults with moderately to severely active Crohn's disease. 

TREMFYA is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderate-to-severe Crohn's disease and adults with moderate-to-severe ulcerative colitis.

The manufacturer for TREMFYA is Janssen Biotech, Inc. 

Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA. For more information, visit: www.tremfya.com.

TREMFYA IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TREMFYA?

TREMFYA is a prescription medicine that may cause serious side effects, including:

Serious Allergic Reactions. Stop using TREMFYA and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

          o fainting, dizziness, feeling lightheaded (low blood pressure)

          o swelling of your face, eyelids, lips, mouth, tongue or throat

o trouble breathing or throat tightness

o chest tightness

o skin rash, hives

o itching

Infections. TREMFYA may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA and may treat you for TB before you begin treatment with TREMFYA if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA.

Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

          o fever, sweats, or chills

          o muscle aches

          o weight loss

          o cough

          o warm, red, or painful skin or sores on your body different from your psoriasis

o diarrhea or stomach pain

o shortness of breath

o blood in your phlegm (mucus)

o burning when you urinate or urinating more often than normal

Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA. Your healthcare provider may stop treatment with TREMFYA if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:

          o unexplained rash

          o vomiting

          o tiredness (fatigue)

          o yellowing of the skin or the whites of your eyes

o nausea

o stomach pain (abdominal)

o loss of appetite

o dark urine

Do not use TREMFYA if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA.

Before using TREMFYA, tell your healthcare provider about all of your medical conditions, including if you:

have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA?"
have an infection that does not go away or that keeps coming back.
have TB or have been in close contact with someone with TB.
have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA.
are pregnant or plan to become pregnant. It is not known if TREMFYA can harm your unborn baby.
Pregnancy Registry: If you become pregnant during treatment with TREMFYA, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA during pregnancy.
are breastfeeding or plan to breastfeed. It is not known if TREMFYA passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of TREMFYA?

TREMFYA may cause serious side effects. See "What is the most important information I should know about TREMFYA?"

The most common side effects of TREMFYA include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis.

These are not all the possible side effects of TREMFYA. Call your doctor for medical advice about side effects.

Use TREMFYA exactly as your healthcare provider tells you to use it.

Please read the full Prescribing Information, including Medication Guide, for TREMFYA and discuss any questions that you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Dosage Forms and Strengths: TREMFYA is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.   

Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com 

Follow us at @JNJInnovMed. 

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to TREMFYA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

REFERENCES
____________________________

1 D'Haens GR, Rubin DT, et al. Efficacy and Safety of Guselkumab Through Week 96 After Intravenous or Subcutaneous Induction in Participants With Crohn's Disease: Phase 3 Long-term Extension Data From GALAXI 2 and GALAXI 3 P5693   at ACG Annual Scientific Meeting 2026. October 13 2026.

2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.  

3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.

4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.  

6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.  

7 Panaccione, R et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn's disease: results of the GALAXI 2 & 3 phase 3 studies. Oral presentation (Abstract #1057b) at Digestive Disease Week (DDW) 2024. May 2024.

8 Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview. Accessed August 2026.

9 Ng SC, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. The Lancet. 2017;390:2769-78.

10 Crohn's & Colitis Foundation. What is Crohn's disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes. Accessed August 2026.

11 Crohn's & Colitis Foundation. Signs and symptoms of Crohn's disease. Available at https://www.crohnscolitisfoundation.org/patientsandcaregivers/what-is-crohns-disease/symptoms. Accessed August 2026.

 
Media contact:
Craig Stoltz
[email protected]

Investor contact:
Jess Margevich
[email protected]

SOURCE Johnson & Johnson Innovative Medicine

Treasury bills guarantee your rate until maturity while Johnson and Johnson has raised its dividend for 64 straight years, but depending on your tax state and timeline, one of these income streams quietly keeps far more money in your pocket…

As of October 9, 2026, Treasury bills paid an average yield of 3.98% on the 4-week bill, 4.15% on the 13-week bill, 4.31% on the 26-week bill and 4.44% on the 52-week bill. The longer you lend to the government, the more it pays you. This month’s dividend challenger is Johnson & Johnson (NYSE:JNJ | JNJ Price Prediction), one of the most dependable dividend payers in the market, and on current yield alone it comes in below every one of those bills.

What a Treasury Bill Is and What Happens When It Matures A Treasury bill is a short-term loan to the federal government. The IRS describes bills, notes and bonds as “direct debts (obligations) of the U.S. government”, and says bills generally come in 4-, 8-, 13-, 26-, or 52-week maturities. You can buy them at auction through TreasuryDirect or through a brokerage account, and brokerages also let you buy bills that are already trading. Bidders at each auction set the rate, so it reflects market conditions on that day.

Bills make no regular interest payments. They are “generally issued at a discount in the amount of $100 and multiples of $100”. You pay less than face value up front and take in the full face value at maturity. According to the IRS, “the difference between the discounted price you pay for the bills and the face value you receive at maturity is interest income.”

At maturity, the face value lands in your account and the deal is complete. If you want income to keep coming, you buy a new bill, either by hand or through an automatic reinvestment setting, and you take whatever rate the next auction sets. The 3.98% on the 4-week bill holds for four weeks. The 4.44% on the 52-week bill holds for one year. Neither rate continues past maturity.

Risks That Government Backing Leaves in Place Reinvestment risk: If short-term rates fall, every rollover pays less. A retiree living off a bill ladder takes an income cut each time rates drop. Price risk before maturity: Sell a bill before it matures and the market sets the price. If rates have risen since you bought, you get less than you planned. With bills the swing is small because the maturities are short, but it exists. Inflation risk: The government’s full faith and credit ensures the dollars you are owed. It says nothing about what those dollars will buy. Limits of the support: Treasuries are direct government obligations. They carry no FDIC deposit insurance, and none is needed for timely payment. Still, debt-ceiling standoffs have at times shook bills that mature near a possible default date. Dividend Safety Comes First: How J&J’s Payout Compares With a Bill J&J’s dividend record is long and continuous. In April 2026, the board raised the quarterly dividend 3.1% to $1.34 per share from $1.30, the 64th consecutive year of increases. That run makes it a Dividend King.

The business is earning enough to pay it. Second-quarter 2026 revenue reached $25.31B, up 6.6%, and adjusted EPS of $2.90 beat the $2.85 consensus. Management then raised full-year 2026 guidance to revenue of $100.80B to $101.40B and adjusted EPS of $11.60 to $11.75, well above the $5.36 per share annualized forward dividend. Free cash flow was $19.7B in fiscal 2025, and the CFO said the company is “on track for our full-year free cash flow outlook approaching $21 billion.” He added: “We also remain committed to returning capital directly to shareholders, primarily through our dividend.”

The main pressure: competition from Stelara biosimilars created an near 460-basis-point drag to overall second-quarter sales growth. Litigation charges came to $267M in the quarter. The company also plans to separate its Orthopaedics business within 18 to 24 months and ended the quarter with net debt of about $28 billion. None of this has put the payout at risk so far, but these are the items that would show up first if the dividend came under pressure.

Yield Today, and What Each Payment Can Do Based on the $5.36 annualized forward dividend and the October 9, 2026 closing price of $261.44, J&J’s forward dividend yield is about 2.05%. That is a yield, meaning the cash income relative to today’s price. A total return would also include any change in the share price.

Income source Yield As of Can the payment be cut? Can the payment grow? 4-week T-bill 3.98% Oct. 9, 2026 No, until maturity No, until maturity 13-week T-bill 4.15% Oct. 9, 2026 No, until maturity No, until maturity 26-week T-bill 4.31% Oct. 9, 2026 No, until maturity No, until maturity 52-week T-bill 4.44% Oct. 9, 2026 No, until maturity No, until maturity J&J forward dividend 2.05% Oct. 9, 2026 close Yes, at the board’s discretion Yes, at the board’s discretion The core trade-off: once you buy a bill, its rate cannot be cut. J&J’s dividend is a board decision each quarter, and a board can reduce or suspend it. The bill’s rate also cannot rise during its life, while the dividend can grow. J&J paid $1.06 a quarter in 2021, $1.19 in 2023 and $1.34 in 2026. Back in 1999, the quarterly payment was $0.25. A bill ladder’s income also changes over time, but it follows auction rates rather than a company’s profits, so it can move down as easily as up.

The bigger difference is principal. A bill held to maturity pays back face value. J&J stock never matures and comes with no ensures price. Its 52-week range goes from $180.57 to $281.07. The shares rose 39.9% over the year to October 9 but lost 2.11% over the latest month. A retiree who has to sell shares in a down month locks in that loss.

Taxes Can Decide Which Income Keeps More The IRS states that interest from Treasury bills, notes and bonds “is subject to federal income tax but is exempt from all state and local income taxes.” It is taxed federally at ordinary income rates and reported on Form 1099-INT. Bill interest is generally reported “when the bill is paid at maturity”, so a 26-week or 52-week bill bought now pushes that income into the 2027 tax year.

J&J’s payouts are qualified dividends, taxed at long-term capital-gains rates federally for most retail holders, and generally subject to state income tax. To get the qualified rate, you have to hold the shares for a minimum period around the ex-dividend date.

In a high-tax state such as New York, California or New Jersey, the state exemption makes each dollar of bill interest worth more after tax. In a state with no income tax, such as Florida or Texas, the exemption is worth nothing, and the dividend’s lower federal rate carries more weight. Retirees in lower federal brackets may owe little or no federal tax on qualified dividends.

Account type matters too. In a traditional IRA or 401(k), both tax benefits disappear: withdrawals are taxed as ordinary income federally and in most states, whether the money came from Treasury interest or J&J dividends. In a Roth, qualified withdrawals are tax-free either way. These tax differences only come into play in a taxable brokerage account.

Who Each Income Stream Suits Treasury bills suit retirees who need a known dollar amount on a known date within the next year, live in a high-tax state, hold the money in a taxable account, and accept that each rollover resets the rate. J&J suits retirees with enough time to ride out price swings who want income supported by a 64-year record of increases to help keep up with inflation, and who accept that a board sets the payout rather than a contract. Retirees who need both certainty and growth often hold some of each, with the bills covering near-term spending and the dividend stock meeting longer-term needs.

Contact [email protected] for any questions or corrections.

Johnson & Johnson (JNJ -1.99%) has many qualities. It is one of the largest healthcare companies in the world and boasts an incredibly diversified business and an AAA rating from S&P Global, the highest rating available. However, whatever one might say about Johnson & Johnson, the company is hardly a good pick for growth-oriented investors. Still, the drugmaker may improve sales and earnings growth over the next few years, and by 2030, it may be growing faster than many expect. Here is why.

Image source: The Motley Fool.

Johnson & Johnson has made important changes Johnson & Johnson is a diversified healthcare player, but it used to be even more so. The company had a consumer health business through which it offered various over-the-counter healthcare products. Many of them were fairly well-known brands. However, this was a mature business that typically grew its sales more slowly than Johnson & Johnson's two other segments: biopharma and medtech.

So, Johnson & Johnson decided to get rid of it. The company completed the separation of its consumer health division, which became a stand-alone, publicly traded company, in 2023. It may already have had a positive impact on Johnson & Johnson. Removing the slower-growth business has arguably helped lift top-line growth somewhat. In fact, immediately after the separation, Johnson & Johnson slightly raised its growth outlook for the fiscal year 2023.

However, there is something else to consider. Johnson & Johnson can now focus its investments on its two core, faster-growing business units. That could eventually allow the company to launch more innovative and lucrative products within these two divisions, leading to even faster revenue and earnings growth. This isn't the sort of thing that can happen overnight. But over the next few years, we could see that story unraveling before our very eyes. That's one reason Johnson & Johnson could grow faster than many expect by 2030.

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The medtech business could be key Johnson & Johnson's biopharma business is performing well and has recently won important new approvals, including that of ICOTYDE, a medicine for plaque psoriasis. However, the company's medtech segment could also make significant progress over the next few years, partly due to the recent approval of its Ottava robotic surgery system. The U.S. Food and Drug Administration cleared the Ottava for multiple soft tissue procedures in general surgery.

Johnson & Johnson will be competing with the market leader, Intuitive Surgical (ISRG -0.19%), in the robotic surgery space. However, there is a vast opportunity in this field. As Johnson & Johnson points out, fewer than 8% of relevant eligible procedures are performed robotically. Johnson & Johnson plans to seek clearance for Ottava elsewhere and should also pursue other indications. It will take some time to ramp up sales of this device, but Tim Schmid, the company's executive vice president and chairman of medtech, expects that Ottava will make a meaningful financial impact by the end of the decade.

Perhaps that's too optimistic, but the Ottava could eventually become a meaningful growth driver. Meanwhile, Johnson & Johnson is separating its lower-growth orthopedics division into a stand-alone company, which should help boost sales growth within its medtech business once the separation is complete.

Some risks to consider Johnson & Johnson's medium-term prospects look attractive, but there are some risks to consider, including some that could harm revenue and earnings growth. For instance, the company is dealing with government-led price negotiations in the U.S., and while it is handling the issue well right now, things could worsen on that front over the next few years.

Further, Johnson & Johnson still has to contend with thousands of lawsuits alleging that its talc-based products gave plaintiffs cancer. But the company has made progress on that front. It recently proposed a $5.5 billion settlement (contingent on certain conditions) that could help it put most of these lawsuits to bed.

Turning to government price negotiations, the company's deep pipeline and diversified drug portfolio could help it continue to overcome that obstacle. Finally, Johnson & Johnson is a fantastic dividend stock, boasting a streak of 64 consecutive annual payout increases, making it a Dividend King (a title for companies with at least 50 consecutive annual dividend increases). All good reasons why the stock is a buy

Johnson & Johnson just logged its 64th straight year of dividend growth, but biosimilar threats, a MedTech slowdown, and lingering talc litigation raise a real question about whether that streak justifies buying the stock right now.

This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.

Johnson & Johnson (NYSE:JNJ | JNJ Price Prediction) raised its quarterly dividend 3.1% to $1.34 per share this year, marking its 64th consecutive year of dividend growth. The quarterly rate rose from $1.13 to $1.19 in 2023, then $1.24, $1.30 and $1.34. At $253.88 the stock yields just 2.05%.

Growth Is Outrunning the Stelara Cliff Biosimilar competition cut Stelara sales by 55.7% in the second quarter. Worldwide sales reached $25.3 billion, with J&J growing double digits excluding Stelara. Tremfya, set to replace it, brought in $2 billion, up 71%. Darzalex sales passed $4 billion, up 17.6%.

“We are not dependent on one or two products. We have a broad, durable portfolio that has 28 platforms, each generating more than $1 billion in annual revenue.”

AbbVie (NYSE:ABBV) is replacing Humira similarly. Its Skyrizi grew 24.4% to $5.505 billion, while Humira fell 35.9%. J&J’s replacement franchise is growing faster and includes Icotyde, an oral psoriasis drug that collected more than 18,000 prescriptions in a launch ahead of projections.

Pfizer (NYSE:PFE) shows what happens when the replacement pipeline falls behind. It yields 6.25% but guides 2026 revenue to $59.5 billion to $62.5 billion with roughly $1.5 billion in generic and biosimilar pressures. That high yield pays investors for a flat top line.

MedTech Is Where the Weakness Shows Since the consumer-health split, J&J reports two divisions. Innovative Medicine posted $16.4 billion in sales, and MedTech posted $8.9 billion with only 3.6% operational growth. Abiomed fell 2%, and inventory issues in China cut electrophysiology growth by about 400 basis points. Shockwave grew 14.7%. Management remains confident about Abiomed’s heart pump:

“We remain confident in the long-term potential for Impella.”

The company also plans to spin off DePuy Synthes, its orthopaedics business, by mid-2027. That will leave a smaller device unit weighted more toward faster-growing products.

Litigation Costs Are Now Visible In July, J&J agreed to a talc settlement that could resolve tens of thousands of lawsuits. Litigation charges totaled $854 million in the fourth quarter of 2025 and $330 million in the first quarter of 2026. Second-quarter net other expense reached $331 million. In August, Reuters reported that three scientists defeated J&J’s defamation suit over talc research, with J&J saying it would appeal.

Valuation Has Reset After the Pullback The stock fell 7.76% over the past month after a one-year gain of 37.61%. It trades at a forward P/E of 21, with the analyst target at $279.50. Analysts rate it 5 strong buys and 11 buys against one sell. Management expects full-year free cash flow to approach $21 billion and raised adjusted operational EPS guidance to $11.50 to $11.65. CFO Joe Wolk repeated the payout commitment:

“We also remain committed to returning capital directly to shareholders, primarily through our dividend.”

Verdict: The business fundamentals make J&J worth a closer look at today’s price. Oncology and immunology growth offset the Stelara decline, free cash flow guidance supports the dividend, and litigation risk now has a number attached. MedTech is the weak link. Watch Abiomed’s recovery and the Enterprise Business Review on December 8, 2026.

Contact [email protected] for any questions or corrections.

When considering defensive dividend stocks, the healthcare sector is a great place to look. After all, even during a recession, people need medicine and surgery, and there's always a need for medical breakthroughs.

However, among stocks in the recession-resistant healthcare sector, one in particular stands out as a blue chip dividend to buy and hold for the long run: Johnson & Johnson (JNJ -0.41%).

Image source: Getty Images.

A growth-focused stalwart among Dividend Kings For 64 consecutive years, Johnson & Johnson has raised its quarterly cash dividend. This long track record of dividend growth places it in the Dividend Kings category, or stocks with at least 50 years of consecutive annual dividend growth.

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With this strong dedication to growing the dividend, it's no surprise that Johnson & Johnson is just as diligent on operational growth. By jettisoning slower-growing businesses and pivoting toward faster-growing segments of healthcare, such as hematology, the company can sustain the revenue and earnings growth necessary to both implement dividend increases and maintain the stock's valuation of around 21 times forward earnings.

Well positioned to generate solid total returns When it comes to total returns, or the combination of price appreciation and cash returns from dividends, the ingredients are in place with Johnson & Johnson. Beyond the healthcare industry's recession-resistant dynamics, there are cold, hard numbers that support dividend sustainability.

For one, based on analyst estimates calling for 2026 earnings of $11.08 per shareand forward annual dividends of $5.36 per share, shares trade at a forward payout ratio of under 50%, a level most consider sustainable. Second, J&J's historic dividend growth, plus the size of the dividend itself, has been fairly modest. The stock has a 2.1% forward yield, with annual payout growth in the mid-single-digits .

While perhaps not the most exciting combination, J&J's modest yield, long track record of dividend growth, and focus on overall operational growth all point to solid total returns over a long time frame.

Revolutionary IL-23R targeted oral peptide delivers sustained skin clearance and a favorable safety profile in patients with psoriasis affecting sensitive, highly visible areas of the body 60% of patients with scalp psoriasis and 89% with genital psoriasis achieved site-specific complete skin clearance at Week 112 , /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new two-year data from the Phase 3 ICONIC-TOTALa study demonstrating the positive impact of ICOTYDE® (icotrokinra) on high-impact plaque psoriasis (PsO) sites. ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor1, in adults and pediatric patients 12 years of age and older (adolescents).

The late-breaking results, shared as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2026, evaluated adults and adolescents with at least moderate high-impact site involvement. Through Week 112, ICOTYDE demonstrated sustained skin clearance.2

"People with plaque psoriasis that affect high-impact sites deal with severe functional disability and intense daily pain. Even when these affected areas cover a small percentage of the body, they often do not respond to topical creams, limit activity, and degrade mental health due to unrelenting symptoms," said Richard B. Warren, M.D., Ph.D., Professor of Dermatology, University of Manchester.b "These robust two-year data validate that ICOTYDE provides enduring skin clearance with a favorable safety profile, making it a pivotal advancement in plaque psoriasis treatment."

ICOTYDE clinical data highlights2

Among patients treated with ICOTYDE, rates of clear or almost clear skin (Investigator's Global Assessment [IGA] 0/1)c increased from 57% at Week 16 to 67% at Week 24 and 70% at Week 112. At Week 112, high rates of site-specific complete skin clearance were reported among ICOTYDE-treated patients: 60% of patients with scalp psoriasis achieved a scalp-specific Investigator's Global Assessment (ss-IGA)d score of 0; 89% of patients with genital psoriasis achieved a Physician's Global Assessment of Genitalia (sPGA-G)e score of 0; 63% of patients with psoriasis affecting the hands and/or feet achieved a hand and/or foot Physician's Global Assessment (hf-PGA)f score of 0. Nail psoriasis improved over time, with mean percentage improvement in modified Nail Psoriasis Severity Index (mNAPSI)g increasing from 33% at Week 16 to 62% at Week 52 to 71% at Week 112. Safety findings through Week 112 remained consistent with the established safety profile of ICOTYDE, with no new safety signals identified.2  "Availability of long-term data are vital for informing the treatment of plaque psoriasis including particularly challenging areas of the body where conventional treatments may fall short," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "These two-year ICOTYDE results empower physicians to treat high-impact sites, knowing that data support sustained clinical outcomes for patients."

Editor's notes:

a. ICONIC-TOTAL evaluates the efficacy and safety of ICOTYDE compared with placebo in participants with at least moderate scalp, genital, and/or hand/foot PsO with once daily ICOTYDE or placebo, with placebo-to-ICOTYDE transition at Week 16.

b. Dr. Warren is a paid consultant for Johnson & Johnson. He has not been compensated for any media work.

c. The Investigator's Global Assessment (IGA) is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease.3 

d. The scalp-specific Investigator's Global Assessment (ss-IGA) is a five-point scale where scalp lesions are assessed in terms of clinical signs of redness, thickness, and scaliness on a severity score ranging from 0 to 4, where 0 indicates absence of disease, 1 is very mild, 2 is mild, 3 is moderate and 4 indicates severe disease.

e. The Physician's Global Assessment of Genitalia (sPGA-G) is a six-point scale used to evaluate the severity of genital psoriasis at a given time point ranging from 0 to 5, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, 4 is severe and 5 indicates very severe disease.4

f. The Physician's Global Assessment of Psoriasis on the Hands and/or Feet (hf-PGA) assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet as: clear (0), almost clear (1), mild (2), moderate (3) and severe (4).5

g. The modified Nail Psoriasis Severity Index (mNAPSI) is a composite score used to assess the severity of nail psoriasis based on features of the nail matrix and nail bed, with scores ranging from 0 to 13 per fingernail, where 0 indicates no nail psoriasis and higher scores indicate greater disease severity.

About the ICONIC clinical development program 

The pivotal Phase 3 ICONIC clinical development program includes four studies of ICOTYDE in patients with moderate-to-severe plaque PsO.

ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary.6 ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of ICOTYDE compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.7 ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) are RCTs to evaluate the efficacy and safety of ICOTYDE compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.8,9 Additional studies underway include: ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) in active psoriatic arthritis; ICONIC-ASCEND (NCT06934226) in moderate-to-severe plaque psoriasis; ICONIC-UC (NCT071196748) in moderately to severely active ulcerative colitis; and ICONIC-CD (NCT7196722) in moderately to severely active Crohn's disease.10,11,12,13,14

About plaque psoriasis

Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.15 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.16 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.16 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.17 Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.18 Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.19

About ICOTYDE® (icotrokinra) 

ICOTYDE® (icotrokinra) is the first and only targeted oral peptide designed to precisely block the IL-23 receptor, which underpins the inflammatory response in moderate-to-severe plaque PsO.1,20,21 ICOTYDE binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, precise inhibition of IL-23 signaling in human T cells.22 Clinical significance of these findings is unknown.

ICOTYDE is currently approved in the U.S. for the treatment of moderate-to-severe plaque PsO in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. Patients on ICOTYDE take one pill, once daily upon waking with water on an empty stomach, at least 30 minutes before eating.23

ICOTYDE is also approved in Europe, Japan and China for the treatment of adults and adolescents with psoriasis. 

ICOTYDE was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop ICOTYDE in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.24, 25, 26

ICOTYDE is also being studied in active psoriatic arthritis, moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease.10,11,12,13,14 

ICOTYDE INDICATION AND IMPORTANT SAFETY INFORMATION

WHAT IS ICOTYDE (icotrokinra)?
ICOTYDE 200 mg is a prescription medicine used to treat moderate to severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ICOTYDE?

Infections. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections. Your healthcare provider may check you for infections and tuberculosis (TB) before starting treatment and may treat you for TB before you begin treatment with ICOTYDE if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with ICOTYDE.Tell your healthcare provider right away if you have any infection or have symptoms of an infection, including:

fever, sweat, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal Before taking ICOTYDE, tell your healthcare provider about all of your medical conditions, including if you:

have an infection that does not go away or that keeps coming back. have tuberculosis (TB) or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Avoid receiving live vaccines during treatment with ICOTYDE. have kidney problems.  are pregnant or plan to become pregnant. It is not known if ICOTYDE can harm your unborn baby.
 
Pregnancy Safety Study. There is a pregnancy safety study for women who take ICOTYDE during pregnancy. The purpose of this study is to collect information about the health of you and your baby. If you are pregnant or become pregnant during treatment with ICOTYDE, you can report your pregnancy by calling 1-800-526-7736 or visiting www.ICOTYDE.com. are breastfeeding or plan to breastfeed. It is not known if ICOTYDE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with ICOTYDE. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of ICOTYDE?

ICOTYDE may cause serious side effects. See "What is the most important information I should know about ICOTYDE?"

The most common side effects of ICOTYDE include:

headache nausea cough fungal infection tiredness These are not all the possible side effects of ICOTYDE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

How should I take ICOTYDE?

Take ICOTYDE exactly as your healthcare provider tells you to take it. Take ICOTYDE 1 time a day when you wake up on an empty stomach with water. Wait at least 30 minutes after taking ICOTYDE before eating food. If you have difficulty swallowing tablets, ICOTYDE can be dispersed in water. For more information, please read the Medication Guide. If you miss a dose of ICOTYDE, take the dose as soon as you remember and go back to your regular schedule the next day. Please read the full Prescribing Information, including Medication Guide, for ICOTYDE and discuss any questions that you have with your doctor.

cp-564097v2

About Johnson & Johnson 

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.

Janssen Biotech, Inc. is a Johnson & Johnson company.

Cautions Concerning Forward-Looking Statements 

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding ICOTYDE (icotrokinra). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 

REFERENCES

_____________________________________________
1 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.

2 Richard B, et al. Data presentation. Long-term Durability and Safety of the Targeted Oral Peptide Icotrokinra for High-Impact Site Psoriasis: 2-year Findings From the ICONIC-TOTAL Randomized Controlled Trial. Late-breaking research presentation (Abstract #LB-245) at the European Academy of Dermatology and Venereology Congress. September 2026.

3 Langley RG, Feldman SR, Nyirady J, van de Kerkhof P, Papavassilis C. The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015 Feb;26(1):23-31. doi: 10.3109/09546634.2013.865009. Epub 2013 Dec 20. PMID: 24354461. Accessed October 2026.

4 Merola JF, Bleakman AP, Gottlieb AB, et al. The Static Physician's Global Assessment of Genitalia: a clinical outcome measure for the severity of genital psoriasis. J Drugs Dermatol. 2017;16(8):793-799

5 Goldblum O, et al. Validation of the physician's global assessment of psoriasis of the hands and/or feet as a clinical endpoint. J Am Acad Dermatol. 2013:68(4)Supplement1:AB218.

6 Clinicaltrials.gov. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. https://classic.clinicaltrials.gov/ct2/show/NCT06095115. Accessed October 2026.

7 Clinicaltrials.gov. A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. https://classic.clinicaltrials.gov/ct2/show/NCT06095102. Accessed October 2026.

8 Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate-to-severe Plaque Psoriasis. Identifier NCT06143878. https://clinicaltrials.gov/study/NCT06143878?term=jnj-77242113&rank=10. Accessed October 2026.

9 Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate-to-severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604.

10 Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. https://clinicaltrials.gov/study/NCT06878404. Accessed October 2026.

11 A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. https://clinicaltrials.gov/study/NCT06807424. Accessed October 2026.

12 Clinicaltrials.gov. A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate-to-severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT06934226. https://clinicaltrials.gov/study/NCT06934226. Accessed October 2026.

13 Clinicaltrials.gov. A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis (ICONIC-UC). Identifier NCT07196748. https://clinicaltrials.gov/study/NCT07196748. Accessed October 2026.

14 Clinicaltrials.gov. A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease (ICONIC-CD). Identifier NCT07196722. https://clinicaltrials.gov/study/NCT07196722. Accessed October 2026.

15 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed October 2026.

16 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed October 2026..

17 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/. Accessed October 2026.

18 National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed October 2026..

19 National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed October 2026..

20 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.

21 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.

22 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.

23 ICOTYDE® prescribing information.

24 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html. Accessed October 2026.

25 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html. Accessed October 2026.

26 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html. Accessed October 2026.

Media contact: 
Meg Farina
[email protected]

Investor contact: 
Jessica Margevich
[email protected]

SOURCE Johnson & Johnson

New two-year findings from the Phase 2/3 long-term extension demonstrate sustained disease control through two years, improvement in daily function and muscle strength, and reductions in corticosteroid use in anti-AChR+a adolescents Retrospective survey in adults identified fluctuating symptom control as a top driver for discontinuing prior advanced treatment, with most patient outcomes improving after transitioning to IMAAVY Data among 15 novel abstracts on IMAAVY to be presented at the MGFA Scientific Session during AANEM 2026 , /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new findings on IMAAVY® (nipocalimab-aahu) for the treatment of generalized myasthenia gravis (gMG) across 15 novel abstracts to be presented at the 2026 Myasthenia Gravis Foundation of America (MGFA) Scientific Session and American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. These data include two-year results from the Phase 2/3 study in adolescents which demonstrated sustained disease control while on IMAAVY, with patients maintaining improvements in daily function and muscle strength alongside reductions in corticosteroid use.1 In addition, a retrospective survey of healthcare professionals (HCPs) treating adults with anti-AChRa or anti-MuSKb antibody-positive gMG provides insight into how fluctuating symptoms and the resulting unmet need for more sustained disease control can drive transitions from one advanced therapy to another.2

Long-term data demonstrated sustained disease control in adolescents with gMG

Two-year findings from the Vibrance-MG Phase 2/3 long-term extension study showed sustained disease control in adolescents living with anti-AChR+ gMG alongside continued reductions in corticosteroid use. These findings are consistent with improvements observed in adults in the open-label extension of the Phase 3 Vivacity-MG3 study:1

Daily function and muscle strength improvements were sustained through Week 108: Among participants with available data, mean changes from baseline were −2.88 points in MG-ADLc and −8.25 points in QMGd at Week 108 consistent with findings at Week 4, 24 and at all intervening time points through two years. Corticosteroid reductions were observed: Of the six adolescent patients taking corticosteroids at study entry, three reduced their dose while one discontinued after two years on IMAAVY. No new safety signals were identified through up to two years of treatment: The safety profile of IMAAVY in adolescents was similar to that reported in adults. "For adolescents living with generalized myasthenia gravis, unpredictable muscle weakness and symptoms such as eyelid droop and double vision can affect more than physical health; they can disrupt school, friendships and their growing independence," said Jonathan Strober, M.D., Director, Pediatric Neuromuscular Program and Neuromuscular Clinic Sponsored by the MDA.e "The two-year Vibrance-MG results are encouraging and add to our growing body of evidence of IMAAVY in adolescents with continued improvements in daily function, muscle strength and reductions in corticosteroid use observed over time."

Need for sustained disease control drives treatment transitions

Findings from a retrospective surveyf of HCPs treating adults with anti-AChR+ or anti-MuSK+ gMG highlight how the need for more sustained disease control can shape treatment decisions—from dissatisfaction with fluctuating symptoms on a prior advanced therapy, to seeking improved efficacy and a consistent treatment schedule when initiating IMAAVY:2

Fluctuating symptom control was the most common driver for discontinuing prior therapy: HCPs cited fluctuating symptom control (54.6%) suggesting that a lack of sustained disease control remains an important unmet need shaping treatment decisions. Consistent treatment schedule and hope for improved efficacy were the top drivers for initiating IMAAVY: Among 97 patients who transitioned from prior advanced therapies to IMAAVY, HCPs most frequently cited preference for a consistent treatment schedule (62.9%) and hope for improved efficacy (56.7%) as reasons for initiating IMAAVY. Positive outcomes reported following transition to IMAAVY: HCPs reported that 73.2% of patients were "much improved" or "very much improved," while 76.4% of patients receiving prednisone reduced their dose and 5.5% discontinued use—an important treatment objective for people living with gMG. "People living with generalized myasthenia gravis can experience fluctuating symptoms that make sustained disease control an important treatment goal. The HCP survey findings provide important insight into the factors shaping treatment decisions, with fluctuating symptom control emerging as the leading reason healthcare professionals reported for discontinuing prior therapy," said David M. Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. "The broader clinical evidence for IMAAVY across adolescents and adults, including reductions in corticosteroid use, further informs our understanding of the potential for IMAAVY to deliver sustained disease control across a broad population of people living with gMG."

IMAAVY is an immunoselective treatment designed to substantially reduce pathogenic immunoglobulin G (IgG), a root cause of gMG, while preserving B-cell function. It is currently the only FcRn blocker approved for pediatric patients (12 years of age and older) with anti-AChR or anti-MuSK antibody-positive gMG by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).3,4

Editor's notes:

a. Anti-AChR+ = anti-acetylcholine receptor positive antibody.
b. Anti-MuSK+ = anti-muscle specific tyrosine kinase positive antibody.
c. MG-ADL (Myasthenia Gravis – Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.5
d. QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicate greater disease severity.6
e. Dr. Jonathan Strober has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work.
f. The treatment-switch findings are based on a retrospective, 21-item electronic survey of U.S. neurology HCPs. Eligible HCPs had switched at least one adult with gMG from a prior advanced therapy such as IVIG, an anti-CD19 therapy, complement inhibitor or other FcRn inhibitor; respondents reviewed medical records and reported de-identified data from 97 patients. As findings relied on HCP reporting and retrospective medical record review, they may be subject to information and recall bias. The convenience sample of HCPs may also limit generalizability to broader clinical settings and patient populations, while the cross-sectional design does not allow conclusions about long-term trends or causal relationships.

About generalized myasthenia gravis (gMG)

Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK]), which target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.7,8 The disease impacts an estimated 700,000 people worldwide.9 The disease affects both men and women and occurs across all ages and racial and ethnic groups, but it most frequently starts in young women and older men.10 Roughly 50% of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.10,11,12 Approximately 10 to 15% of new cases of MG are diagnosed in pediatric patients 12-17 years of age.12,13,14,15 Among juvenile MG patients, girls are affected more often than boys, with over 65% of pediatric MG cases in the U.S. diagnosed in girls.16,17,18

Initial disease manifestations are usually eye-related, but approximately 85% of MG patients experience additional advancements to the disease manifestations, referred to as generalized myasthenia gravis (gMG).19,20,21,22,23,24 This is characterized by severe muscle weakness and difficulties in speech and swallowing.20,21,22,23,24 Approximately 100,000 individuals in the U.S. are living with gMG.25 Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.26

About the Phase 2/3 Vibrance-MG study

The Phase 2/3 Vibrance-MG study (NCT05265273) is an ongoing open-label study to determine the effect of nipocalimab in pediatric participants with gMG.27 Seven participants aged 12-17 years with a diagnosis of gMG as reflected by a Myasthenia Gravis Foundation of America (MGFA) Class of II through IV at screening, and an insufficient clinical response to ongoing, stable SOC therapy, have been enrolled in the trial.28 Participants must have a positive blood test for either anti-AChR or anti-MuSK autoantibodies.28 The study consists of a screening period of up to four weeks, a 24-week open-label active-treatment phase during which participants receive nipocalimab intravenously every two weeks, and a long-term extension phase; a safety follow-up assessment will be conducted at eight weeks after last dose.28 The primary endpoint of the study is the effect of nipocalimab on total serum IgG, safety and tolerability, and pharmacokinetics in pediatric participants with gMG at 24 weeks. Secondary endpoints include change in MG-ADL and QMG scores at 24 weeks.28,29

About IMAAVY® (nipocalimab-aahu)

IMAAVY is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving B-cell function based on in vitro and/or in vivo studies.29,30,31 IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.4 IMAAVY is also approved for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.4

Nipocalimab is being investigated across three key segments in the autoantibody space including Rheumatologic diseases, Rare Autoantibody diseases, and Maternal Fetal diseases mediated by maternal alloantibodies, in which blockade of IgG binding to FcRn in the placenta is believed to limit transplacental transfer of maternal alloantibodies to the fetus.32,33,34,35,36,37,38,39,40,41 

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:

EU EMA Orphan medicinal product designation for hemolytic disease of the fetus and newborn (HDFN) in October 2019 and fetal and neonatal alloimmune thrombocytopenia (FNAIT) in April 2025 U.S. FDA Fast Track designation in HDFN, and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, FNAIT in March 2024, Sjögren's disease (SjD) in March 2025, and systemic lupus erythematosus (SLE) in January 2026 U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023 U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for SjD in November 2024  U.S. FDA granted Priority Review in gMG in Q4 2024 and wAIHA in Q2 2026 The legal manufacturer for IMAAVY is Janssen Biotech, Inc.

IMPORTANT SAFETY INFORMATION 

What is the most important information I should know about IMAAVY?

IMAAVY is a prescription medicine that may cause serious side effects, including:

Infections. IMAAVY may increase your risk of infections, including serious infections. If you have an infection, your healthcare provider will treat your infection or delay your infusion until your infection is gone. Tell your healthcare provider right away if you have any of the following infection symptoms: fever chills shivering cough sore throat fever blisters burning when you urinate trouble breathing Allergic (hypersensitivity) reactions can happen during or up to a few weeks after your IMAAVY infusion. Tell your healthcare provider and get emergency medical help right away if you get any of these symptoms during or after your IMAAVY infusion: a swollen face, lips, mouth, tongue, or throat trouble swallowing or breathing hives itchy rash chest pain or tightness Infusion-related reactions. Tell your healthcare provider right away if you get any of these symptoms during or within a few days after your IMAAVY infusion: headache rash nausea fatigue dizziness chills flu-like symptoms redness of skin Do not receive IMAAVY if you have a history of a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY. Reactions have included angioedema and anaphylaxis. Refer to the Patient Information section of the Prescribing Information for a complete list of ingredients in IMAAVY.

Before receiving IMAAVY, tell your healthcare provider about all of your medical conditions, including if you:

have had an allergic reaction to IMAAVY. have or had any recent infections or symptoms of infection. have or had shingles (herpes zoster) or mono (mononucleosis caused by Epstein-Barr virus). have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY should not receive live vaccines. are pregnant or plan to become pregnant. It is not known if IMAAVY will harm your unborn baby. Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY. If IMAAVY is given during pregnancy or you become pregnant while receiving IMAAVY, your healthcare provider should report IMAAVY exposure by contacting Janssen at 1-800-526-7736. are breastfeeding or plan to breastfeed. IMAAVY can pass into your breast milk. It is not known if IMAAVY will harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with IMAAVY.  Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

What are the possible side effects of IMAAVY?

IMAAVY may cause serious side effects. See "What is the most important information I should know about IMAAVY?"

The most common side effects in people with gMG treated with IMAAVY include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.

The most common side effects in people with wAIHA treated with IMAAVY include: peripheral edema (swelling in your hands, ankles, or feet), diarrhea, and pyrexia (fever).

These are not all the possible side effects of IMAAVY. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information and Patient Information for IMAAVY and discuss any questions you have with your doctor.

Dosage Form and Strengths: IMAAVY is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.

About Johnson & Johnson 

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.  

Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com.

Follow us at @JNJInnovMed.  

Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen Global Services, LLC are Johnson & Johnson companies. 

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

REFERENCES

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2 Kutz C, et al. Retrospective Review of Treatment Switches to Nipocalimab in Generalized Myasthenia Gravis: Real-World Healthcare Provider Perspectives. Presented at the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and 2026 Myasthenia Gravis Foundation of America (MGFA) Scientific Session. Poster #55.
3 IMAAVY® U.S. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761430s000lbl.pdf. Last accessed: September 2026.
4 European Medicines Agency. IMAAVY® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/imaavy-epar-product-information_en.pdf. Last accessed: September 2026
5 Wolfe GI. Myasthenia gravis activities of daily living profile. Neurology. 1999;22;52(7):1487-9. 
6 Yin, J et al. A multicenter, randomized, open-label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis. Eur J Neurol. 2024;31(8):e16322.
7 Bacci, ED et al. Understanding side effects of therapy for myasthenia gravis and their impact on daily life. BMC Neurol. 2019;19(1):335.
8 Wiendl, H et al. Guideline for the management of myasthenic syndromes. Ther Adv Neurol Disord. 2023; 16:17562864231213240.
9 Chen J, Tian D-C, Zhang C, et al. Incidence, mortality, and economic burden of myasthenia gravis in China: A nationwide population-based study. The Lancet Regional Health - Western Pacific. 
10 Ye, Yun et al. Epidemiology of myasthenia gravis in the United States. Frontiers in neurology vol. 15 1339167. 16 Feb. 2024.
11 Dresser, Laura et al. Myasthenia Gravis: Epidemiology, Pathophysiology and Clinical Manifestations. Journal of clinical medicine vol. 10,11 2235. 21 May. 2021.
12 J&J. Data on file.
13 Evoli A, et al. Juvenile myasthenia gravis with prepubertal onset. Neuromuscul Disord. 1998 Dec;8(8):561-7.
14 Evoli A. Acquired myasthenia gravis in childhood. Curr Opin Neurol. 2010 Oct;23(5):536-40. 
15 Finnis MF, Jayawant S. Juvenile myasthenia gravis: a paediatric perspective. Autoimmune Dis. 2011; 2011:404101. 
16 Haliloglu G, et al. Gender prevalence in childhood multiple sclerosis and myasthenia gravis. J Child Neurol. 2002 May;17(5):390-2.
17 Parr JR, et al. How common is childhood myasthenia? The UK incidence and prevalence of autoimmune and congenital myasthenia. Arch Dis Child. 2014 Jun;99(6):539-42.
18 Mansukhani SA, et al. Incidence and Ocular Features of Pediatric Myasthenias. Am J Ophthalmol. 2019 Apr; 200:242-249.
19 Law, N et al. The Lived Experience of Myasthenia Gravis: A Patient-Led Analysis. Neurol Ther. 2021;10(2):1103-1125.
20 National Institute of Neurological Disorders and Stroke. Myasthenia Gravis. Available at: https://www.ninds.nih.gov/health-information/disorders/myasthenia-gravis Last accessed: September 2026.
21 Bever, CT et al. (1983), Prognosis of ocular myasthenia. Ann Neurol. 1983;14(5):516-9. 
22 Kupersmith, MJ et al. Development of generalized disease at 2 years in patients with ocular myasthenia gravis. Arch Neurol. 2003;60(2):243-8. 
23 National Institute of Neurological Disorders and Stroke. Myasthenia gravis fact sheet. Available at: https://www.ninds.nih.gov/sites/default/files/migrate-documents/myasthenia_gravis_e_march_2020_508c.pdf. Last accessed: September 2026.
24 Cleveland Clinic. Myasthenia Gravis: Treatment & Symptoms. Available at: https://my.clevelandclinic.org/health/diseases/17252-myasthenia-gravis-mg. Last accessed: September 2026.
25 DRG EPI (2021) & Optum Claims Analysis Jan 2012-December 2020.
26 O'Connell K, Ramdas S, Palace J. Management of Juvenile Myasthenia Gravis. Front Neurol. 2020 Jul 24;11:743. 
27 ClinicalTrials.gov. NCT05265273. Available at: https://clinicaltrials.gov/study/NCT05265273. Last accessed: September 2026.
28 Strober J et al. Safety and effectiveness of nipocalimab in adolescent participants in the open label Phase 2/3 Vibrance-MG clinical study. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
29 Seth, N et al. Nipocalimab, an immunoselective FcRn blocker that lowers IgG and has unique molecular properties. MAbs. 2025;17(1):2461191
30 Zhu, LN et al. FcRn inhibitors: a novel option for the treatment of myasthenia gravis. Neural Regen Res. 2023;18(8):1637-1644.
31 Ling, LE et al. M281, an anti‐fcrn antibody: Pharmacodynamics, pharmacokinetics, and safety across the full range of IGG reduction in a first‐in‐human study. Clinical Pharmacology & Therapeutics. 2018;105(4):1031–1039.
32 ClinicalTrials.gov. Identifier: NCT03842189. Available at: https://clinicaltrials.gov/ct2/show/NCT03842189. Last accessed: September 2026.
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35 ClinicalTrials.gov Identifier: NCT05379634. Available at: https://clinicaltrials.gov/study/NCT05379634. Last accessed: September 2026.
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SOURCE Johnson & Johnson Innovative Medicine

New results suggest earlier treatment may increase the likelihood of long-term remission Study adds to Johnson & Johnson's overwhelming body of evidence supporting its innovative multiple myeloma therapies in second line, where earlier intervention may increase long-term remission and disease control , /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, announced today new long-term follow-up data from the initial subgroup of cohort A in the Phase 2 CARTITUDE-2 study (N=20) showing that 50% of patients (10/20) in early line relapsed or refractory multiple myeloma (RRMM) who were treated with a single infusion of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) remained alive and progression-free for at least five years without maintenance therapy.1 These results build on the durable, treatment-free remissions observed in the CARTITUDE-1 study, which evaluated patients in later lines of therapy, and reinforce that earlier treatment with CARVYKTI® may increase long-term remission and disease control. Together, these findings add to the emerging evidence suggesting that CARVYKTI® may have curative potential in some patients. 

Findings were presented at the International Myeloma Society (IMS) Annual Meeting (Abstract #PA-288).

Expert and company perspectives on earlier treatment-free remissions with CARVYKTI®
"Five years ago, treatment-free remissions of this duration were difficult to imagine for many patients with relapsed or refractory multiple myeloma," said Niels van de Donk, M.D., Ph.D., Professor of Hematology, University Medical Center, Amsterdam, the Netherlands.* "These new CARVYKTI findings provide additional evidence that when highly effective, established therapies are used earlier in the disease course, more patients may have the opportunity to achieve deep, durable remissions and long-term disease control without maintenance."

"These results add to the growing body of evidence suggesting that CARVYKTI may have curative potential for some patients, and reinforce the value of bringing highly effective therapies to patients earlier in their treatment journey," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "As we continue to advance a portfolio of complementary and combinable therapies, these findings reinforce our commitment to pursuing curative approaches and redefining what patients can expect from multiple myeloma treatment."

Phase 2 CARTITUDE-2 study build on previous findings
CARTITUDE-2 cohort A (N=20) enrolled patients with RRMM who had received one to three prior lines of therapy, were exposed to a proteasome inhibitor, and were refractory to lenalidomide.1 The primary endpoint was minimal residual disease (MRD) negativity.1 Patients from initial cohort A were followed to assess long-term outcomes following a single CARVYKTI® infusion without maintenance therapy.1

At a median follow-up of 60.7 months:

Half of the patients (n=10, 50%) remained alive and progression-free at five years The five-year overall survival rate was 69.2% Median progression-free survival was 60.5 months Patients received a single CARVYKTI® infusion without maintenance therapy At five years, MRD was assessed by bone marrow in three patients and was not required per protocol.1 All three patients were MRD-negative at the deepest level tested (10-6), indicating no detectable disease using highly sensitive testing methods.1

Long-term remissions were observed even among patients with high-risk disease features.1 Of the 10 patients who remained alive and progression-free at five years, five had at least one high-risk cytogenetic abnormality, including four patients with two or more high-risk features.1

The safety profile observed with longer follow-up was consistent with the known safety profile of CARVYKTI®, with no new CAR T-cell-related neurotoxicity reported.1 Since the previous analysis, one patient developed a new hematologic malignancy (acute myeloid leukemia) and two deaths occurred due to progressive disease and new cancer.1

About CARTITUDE-2
CARTITUDE-2 (NCT04133636) is an ongoing, multicohort Phase 2 study evaluating the efficacy and safety of ciltacabtagene autoleucel (CARVYKTI®) in patients in different clinical settings, including patients with one to three prior lines of therapy, and continues to generate long-term follow-up data on depth and durability of response. CARTITUDE-2 findings have been presented at major medical congresses, including the International Myeloma Society (IMS) Annual Meeting, and contribute to the growing body of evidence supporting earlier use of CARVYKTI® in multiple myeloma.

About multiple myeloma 
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.2 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.3 Multiple myeloma is the third most common blood cancer worldwide.4 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.5 People living with multiple myeloma have a 5-year survival rate of 59.8%.6 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.7,8 In recent years, potential overall survival has improved from years to decades for some patients, with effective treatment options now available across every stage and line of therapy.9

About Johnson & Johnson's multiple myeloma portfolio 
Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies. 

Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses. 

Through ongoing research and a robust clinical program, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured. 

About CARVYKTI®
CARVYKTI® (cilta-cel) received U.S. Food and Drug Administration approval in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.10

In April 2024, CARVYKTI® was approved in the U.S. for treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and who are refractory to lenalidomide, following a unanimous (11 to 0) FDA Oncologic Drugs Advisory Committee (ODAC) recommendation in support of this new indication. In April 2024, the European Medicines Agency (EMA) approved a Type II variation for CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. In September 2022, Japan's Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma in patients that have no history of CAR-positive T cell infusion therapy targeting BCMA and who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. In July 2026, CARVYKTI® obtained a label expansion in Japan, allowing its use in patients with relapsed or refractory multiple myeloma who have received at least on prior therapy.

CARVYKTI® is a BCMA-directed, autologous T-cell immunotherapy, which involves reprogramming a patient's own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T cells to eliminate cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. The CARVYKTI® CAR protein features two BCMA-targeting single domains designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells. CARVYKTI® is available in 17 markets worldwide and has been used to treat more than 13,000 patients globally.

In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialize CARVYKTI®. 

For more information, visit www.CARVYKTI.com. 

CARVYKTI® Important Safety Information

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI®. Do not administer CARVYKTI® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI®. Provide supportive care and/or corticosteroids as needed. Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI®. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®. HLH/MAS can occur with CRS or neurologic toxicities. Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI®. Immune Effector Cell-associated Enterocolitis (IEC-EC), including fatal or life threatening reactions, occurred following treatment with CARVYKTI®. Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI®. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®.

WARNINGS AND PRECAUTIONS 

Increased early mortality. In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm. Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events. Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12).

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & -4 studies (N=285), CRS occurred in 84% (238/285), including ≥ Grade 3 CRS (ASTCT 2019) in 4% (11/285) of patients. Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%). Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4).

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Confirm that a minimum of 2 doses of tocilizumab are available prior to infusion of CARVYKTI®.

Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least 1 dose of corticosteroids for treatment of CRS.

Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic toxicities, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of Parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.

Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥ Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544). Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients.

Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.

Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients, with a median time to resolution of 3 days (range: 1 to 143 days). Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients, respectively.

Immune Effector Cell-associated Neurotoxicity Syndrome occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent (≥2%) manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%). Monitor patients at least daily for 7 days following CARVYKTI® infusion for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms.

Monitor patients for signs or symptoms of ICANS for at least 2 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Advise patients to avoid driving for at least 2 weeks following infusion.

Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days). Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients.

Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).

Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson's disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment.

Guillain-Barré syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis.

Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.

Immune mediated myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.

Peripheral neuropathy occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days). Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients including those with ongoing neurologic events at the time of death or data cutoff.

Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS.

Cranial nerve palsies occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days). Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients, including those with ongoing neurologic events at the time of death or data cutoff. Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4).

The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.

Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI®, with a median onset of 10 days (range: 8 to 99 days), and all occurred in the setting of ongoing or worsening CRS. The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure.

Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI®.

HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.

Prolonged and Recurrent Cytopenias: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion.

Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, Grade 3 or higher cytopenias not resolved by Day 30 following CARVYKTI® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285), and anemia 2% (6/285). After Day 60 following CARVYKTI® infusion, 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia. Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death.

Monitor blood counts prior to and after CARVYKTI® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.

Infections: CARVYKTI® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after CARVYKTI® infusion.

Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, infections occurred in 57% (163/285), including Grade ≥3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients. Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm.

Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19.

Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.

Reactivation of John Cunningham (JC) virus, leading to progressive multifocal leukoencephalopathy (PML), including cases with fatal outcomes, have been reported following treatment. Perform appropriate diagnostic evaluations in patients with neurological adverse events.

Hypogammaglobulinemia can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 93% (265/285) of patients. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis. Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI® treatment, and until immune recovery following treatment with CARVYKTI®.

Hypersensitivity Reactions occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤2 Grade. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia.

Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction.

Immune effector cell-associated enterocolitis (IEC-EC) has occurred in patients treated with CARVYKTI®. Manifestations include severe or prolonged diarrhea, abdominal pain, and weight loss requiring parenteral nutrition. IEC-EC has been associated with fatal outcome from perforation or sepsis. Manage according to institutional guidelines, including referral to gastroenterology and infectious disease specialists.

In cases of refractory IEC-EC, consider additional workup to exclude alternative etiologies, including T-cell lymphoma of the GI tract, which has been reported in the post marketing setting.

Secondary Malignancies: Patients treated with CARVYKTI® may develop secondary malignancies. Among patients receiving CARVYKTI® in the CARTITUDE-1 & -4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia). The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post marketing setting. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. Mature T-cell malignancies, including CAR positive tumors, may present as soon as weeks following infusions, and may include fatal outcomes.

Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.

ADVERSE REACTIONS

The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia.

Please read full Prescribing Information, including Boxed Warning, for CARVYKTI®.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.jnj.com/innovativemedicine/ Follow us at @JNJInnovMed. Janssen Research & Development, LLC, and Janssen Biotech, Inc., are both Johnson & Johnson companies.

Caution Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory actions; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Footnote
* Niels van de Donk, MD, PhD, Professor of Hematology, University Medical Center, Amsterdam, Netherlands, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

1 Cohen A, et al. Long-Term (≥5-Year) Remission and Survival With Ciltacabtagene Autoleucel (Cilta-Cel) in Relapsed/Refractory Multiple Myeloma (RRMM) With 1 to 3 Prior Lines of Therapy: CARTITUDE-2 Cohort A. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 25, 2026; Glasgow, Sweden.
2 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-567.
3 National Cancer Institute. Plasma cell neoplasms. Accessed September 2026. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq
4 City of Hope. Multiple myeloma: Causes, symptoms & treatments. 2022. Accessed September 2026. https://www.cancercenter.com/cancer-types/multiple-myeloma
5 International Agency for Research on Cancer (World Health Organization). Multiple myeloma fact sheet. 2024. Accessed September 2026. https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf
6 SEER Explorer: An interactive website for SEER cancer statistics. Surveillance Research Program, National Cancer Institute. Accessed September 2026. https://seer.cancer.gov/explorer/
7 American Cancer Society. What is multiple myeloma? Accessed September 2026. https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html
8 American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. Accessed September 2026. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html
9 Kazandjian D. Multiple myeloma epidemiology and survival: a unique malignancy. J Clin Oncol. 2018;36(15):1479-1487. https://pmc.ncbi.nlm.nih.gov/articles/PMC6119139/
10 CARVYKTI® U.S. Prescribing Information. 2025. Horsham, PA: Janssen Biotech, Inc.

SOURCE Johnson & Johnson

Analysis shows ~87% of patients treated with TECVAYLI® plus DARZALEX FASPRO® as early as second line were estimated to have comparable mortality risk to the general population A separate analysis shows the survival benefit was driven by a 90% reduction in the risk of multiple myeloma progression versus standard of care, with no significant difference in rates of non-relapse mortality  Johnson & Johnson is advancing a differentiated multiple myeloma portfolio designed to deliver deeper, more durable disease control and improve long-term outcomes for patients  , /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced new data from the Phase 3 MajesTEC-3 study showing sustained disease control and survival with TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma (RRMM) who had received 1-3 prior lines of therapy.1,2

Using a relative survival mixture cure model (MCM) and actual progression-free survival (PFS) and overall survival (OS) data from the trial, statistical modeling estimated that ~87% of patients treated with TECVAYLI® plus DARZALEX FASPRO® (Tec-Dara) may experience a mortality risk and projected life expectancy similar to an age-matched general population.1 Modeling further predicted that median overall survival with Tec-Dara would be nearly four-fold longer than with the standard of care (SOC) comparator in the study, dexamethasone with pomalidomide or bortezomib (DPd/DVd). These data help to illustrate to what extent treatment with TECVAYLI® plus DARZALEX FASPRO® as early as second line may reshape survival expectations in multiple myeloma.1

In the MajesTEC-3 study, TECVAYLI® plus DARZALEX FASPRO® significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years.3 A post hoc analysis showed that Tec-Dara reduced the risk of cumulative incidence of disease progression by 90% versus SOC, with no significant difference in non-relapse mortality over time between the treatment arms.2 These data (Abstract #OA-58 and Abstract #OA-49) will be presented in two oral sessions at the International Myeloma Society (IMS) Annual Meeting.

Expert and company perspectives emphasize the potential for durable, long-term disease control

"These findings underscore how consequential treatment choice at first relapse can be in shaping a patient's long-term trajectory," said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham.* "The sustained disease control observed with TECVAYLI plus DARZALEX FASPRO is changing expectations for what treatment can achieve in relapsed or refractory multiple myeloma, moving beyond just delaying the next relapse toward the possibility of durable long-term disease control." 

"The continued analyses of the unprecedented MajesTEC-3 trial challenge long-held expectations of what may be possible in multiple myeloma," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "Our ambition is to build on this progress by fundamentally changing the long-term trajectory of multiple myeloma and, ultimately, creating a future in which this disease is no longer defined as incurable." 

Model-based analysis projects potential long-term survival outcomes

The MajesTEC-3 study evaluated TECVAYLI® plus DARZALEX FASPRO® versus investigator's choice of daratumumab SC plus DPd/DVd in patients with RRMM who had received one to three prior lines of therapy.3 In this analysis, a relative survival mixture cure model was applied to patients treated with TECVAYLI® plus DARZALEX FASPRO® (n=291) and DPd/DVd (n=296) to assess whether long-term disease control could translate into outcomes approaching those of the general population.1 Best-fit models estimated cure fractions of 86.6% (95% confidence interval [CI], 81–91) for OS with the combination, compared with 0% (95% CI, 0–53) with DPd/DVd, with substantially greater uncertainty in the DPd/DVd estimates.1 Model projected remaining life expectancy was 18.5 years with the combination, nearly four times the 4.9 years projected with DPd/DVd and approaching 21.1 years for the matched general population.1

Reduced disease progression drives survival benefit

A separate post hoc analysis provided further insight into the survival benefit observed in MajesTEC-3.2 At 36 months, the cumulative incidence of disease progression was 8.7% with TECVAYLI® plus DARZALEX FASPRO®, versus 62.1% with DPd/DVd, representing a 90% reduction in the risk of disease progression (subdistribution hazard ratio [sHR]=0.10; 95% CI, 0.07–0.16; P<0.0001).2 The 36-month OS rate was 83.3% versus 65.0%, respectively (hazard ratio [HR]=0.46; 95% CI, 0.32–0.65; P<0.0001).2 There was no significant difference in non-relapse mortality between treatment groups, with 36-month rates of 10.2% with TECVAYLI® plus DARZALEX FASPRO® and 9.0% with DPd/DVd (sHR=1.16; 95% CI, 0.69–1.98; P=0.5668).2

There was no difference in OS through 10 months (HR=1.08; 95% CI, 0.64–1.81).2 Beyond 10 months, OS favored TECVAYLI® plus DARZALEX FASPRO®, with a 78% reduction in the risk of death versus DPd/DVd (HR=0.22; 95% CI, 0.13–0.38).2 A prespecified restricted mean survival time analysis also confirmed a significant OS benefit, with a difference of 2.15 months (P=0.0088).2

Together, these analyses provide complementary evidence supporting the long-term benefit observed with TECVAYLI® plus DARZALEX FASPRO®. While the MCM analysis suggests the potential for highly durable disease control to extend overall survival for patients with multiple myeloma relative to the general population, the competing risk analysis helps explain these outcomes by demonstrating a profound reduction in disease progression without a significant increase in non-relapse mortality. MajesTEC-3 is ongoing, and continued follow-up will assess whether observed outcomes confirm these model-based predictions.

About the MajecTEC-3 study

MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab SC versus investigator's choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients with relapsed/refractory multiple myeloma who have received 1–3 prior lines of therapy. The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD)-negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety. The MajesTEC-3 study is a part of the MajesTEC clinical program, which includes exploring the potential of teclistamab as a combination regimen.

About multiple myeloma

Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.4 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.5 Multiple myeloma is the second most common blood cancer worldwide.6 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.7 People living with multiple myeloma have a 5-year survival rate of 59.8%.8 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.9,10 In recent years, overall survival has improved from years to decades, with effective treatment options now available across every stage and line of therapy.11

About Johnson & Johnson's multiple myeloma portfolio

Johnson & Johnson is a global leader in multiple myeloma therapies, with a broad and differentiated portfolio designed to address the complexity and heterogeneity of the disease. Our portfolio spans multiple mechanisms of action, targets and treatment modalities, including CD38-directed therapies, BCMA- and GPRC5D-targeting bispecific antibodies, and cellular therapies.

Over the past decade, Johnson & Johnson therapies have helped extend survival for patients with multiple myeloma from just a few years to a decade or more. With the right medicines, used as early as possible, combined and sequenced for the best results, Johnson & Johnson is expanding treatment options to match the right therapy to the right patient at the right stage of disease and drive deeper and more durable responses.

In August 2026, the EC approved an indication extension for TECVAYLI® in combination with daratumumab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The approval introduces a new treatment option as early as second line for patients living with RRMM. 

Through ongoing research and a robust clinical program, Johnson & Johnson is committed to transforming multiple myeloma into a more manageable condition that is no longer treated to progression but has the potential to, ultimately, be cured.

About TECVAYLI®

TECVAYLI® (teclistamab-cqyv) is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. TECVAYLI® received accelerated approval from the U.S. Food and Drug Administration (FDA) in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.12

In March 2026, the U.S. FDA approved TECVAYLI® in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. The supplemental Biologics License Application was proactively selected for the Commissioner's National Priority Voucher Pilot Program and also granted the application Breakthrough Therapy Designation and Real-Time Oncology Review. This approval expanded the use of TECVAYLI® into earlier lines of therapy and is the first bispecific antibody-based combination regimen in this setting.

To date, more than 30,000 patients have been treated worldwide with TECVAYLI®. 

The European Commission (EC) granted TECVAYLI® conditional marketing authorization in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023, the EC approved a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response or better for a minimum of six months.

In August 2026, the EC approved an indication extension for TECVAYLI® in combination with daratumumab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The approval introduces a new treatment option as early as second line for patients living with RRMM.

For more information, visit www.TECVAYLI.com.

About DARZALEX FASPRO® and DARZALEX® 

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for 11 indications in multiple myeloma, fiveof which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.13 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.

DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant-eligible and ineligible.14 In 2025, DARZALEX FASPRO® was approved by the U.S. FDA and EMA as the first and only treatment for patients with high-risk smoldering multiple myeloma.

DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma. DARZALEX®-based regimens have been used in the treatment of more than 830,000 patients worldwide and more than 68,000 patients in the U.S. alone.

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.

For more information, visit www.DARZALEX.com.

TECVAYLI® INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

TECVAYLI® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma:

in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TECVAYLI. Initiate treatment with TECVAYLI step-up dosing schedule to reduce risk of CRS. Withhold TECVAYLI until CRS resolves or permanently discontinue based on severity.

Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious, life-threatening, or fatal reactions, can occur in patients receiving TECVAYLI. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold TECVAYLI until neurologic toxicity resolves or permanently discontinue based on severity.

TECVAYLI is available only through a restricted program called the TECVAYLI and TALVEY® Risk Evaluation and Mitigation Strategy (REMS).

WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome - TECVAYLI can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions.

In the clinical trials (monotherapy and combination therapy; N=448), CRS occurred in 64% of patients who received TECVAYLI at the recommended dosage, with Grade 1 CRS occurring in 46% of patients, Grade 2 in 18%, and Grade 3 in 0.2%. Recurrent CRS occurred in 27% of patients. Most patients experienced CRS during the initial step-up dosing schedule (step-up dose 1 [37%], step-up dose 2 [32%], or the initial treatment dose [20%]). CRS first occurred following subsequent doses of TECVAYLI in 2.5% of patients. The median time to onset of CRS was 2 (range: 1 to 9) days after the most recent dose and the median duration of CRS was 2 (range: 1 to 22) days.

Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation).

Initiate therapy according to TECVAYLI step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI accordingly.

At the first sign of CRS, immediately evaluate the patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines. Withhold until CRS resolves or permanently discontinue TECVAYLI based on severity.

TECVAYLI is available only through a restricted program under a REMS.

Neurologic Toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome - TECVAYLI can cause serious, life-threatening, or fatal neurologic toxicity, including immune effector cell associated neurotoxicity syndrome (ICANS).

In the clinical trials (monotherapy and combination therapy trials; N=448), neurologic toxicity occurred in 60% of patients who received TECVAYLI at the recommended dosage, with Grade 3 or 4 neurologic toxicity in 6%. Neurologic toxicities reported in ≥5% of patients included headache (27%), sensory neuropathy (16%), motor dysfunction (15%), insomnia (12%), encephalopathy (11%), and dizziness (8%). Fatal neurologic toxicity occurred in 0.4% of patients, including Guillain-Barré syndrome and status epilepticus (one patient each).

In MajesTEC-1, ICANS was reported in 6% of patients who received TECVAYLI as monotherapy at the recommended dosage. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent TECVAYLI doses. The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia.

In MajesTEC-3, ICANS was reported in 1.1% of patients who received the recommended TECVAYLI dosage in combination with daratumumab and hyaluronidase-fihj, including Grade 4 ICANS in 1 patient. All events of ICANS occurred during the step-up dosing schedule. The median time to onset of ICANS was 2 (range: 1 to 3) days after the most recent dose and the median duration of ICANS was 2 (range: 1 to 2) days. The clinical manifestations of ICANS reported were amnesia, encephalopathy and delirium.

The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.

Monitor patients for signs and symptoms of neurologic toxicity, including ICANS during TECVAYLI treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate patient and provide supportive therapy based on severity. Withhold until neurologic toxicity resolves or permanently discontinue TECVAYLI based on severity per recommendations and consider further management per current practice guidelines.

Due to the potential for neurologic toxicity, patients receiving TECVAYLI are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during and for 48 hours after completion of TECVAYLI step-up dosing schedule and in the event of new onset of any neurologic toxicity symptoms until neurologic toxicity resolves.

TECVAYLI is available only through a restricted program under a REMS.

TECVAYLI and TALVEY REMS - TECVAYLI is available only through a restricted program under a REMS called the TECVAYLI and TALVEY REMS because of the risks of CRS and neurologic toxicity, including ICANS.

Hepatotoxicity - TECVAYLI can cause hepatotoxicity, including fatalities. There was one fatal case of hepatic failure in MajesTEC-1. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448) elevated aspartate aminotransferase (AST) occurred in 47% of patients, with Grade 3 or 4 elevations in 2.9%. Elevated alanine aminotransferase (ALT) occurred in 48% of patients, with Grade 3 or 4 elevations in 3.8%. Elevated total bilirubin occurred in 10% of patients with Grade 3 or 4 elevations in 0.7%. Liver enzyme elevation can occur with or without concurrent CRS.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.

Infections - TECVAYLI can cause severe, life-threatening, or fatal infections. In MajesTEC-1 (N=165), in patients who received the recommended TECVAYLI dosage, serious infections, including opportunistic infections, occurred in 30% of patients, Grade 3 or 4 infections in 35% of patients, and fatal infections in 4.2% of patients.

In MajesTEC-3 (N=283), in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj at the recommended dosage, serious infections, including opportunistic infections, occurred in 54% of patients, Grade 3 or Grade 4 infections in 54% of patients, and fatal infections in 4.6% of patients.

Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI and treat appropriately. Administer prophylactic antimicrobials according to current practice guidelines.

Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.

Monitor immunoglobulin levels prior to and during treatment with TECVAYLI and administer subcutaneous or intravenous immunoglobulin (IVIG) to maintain the serum levels >400 mg/dL.

Neutropenia - TECVAYLI can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), decreased neutrophils occurred in 88% of patients, with Grade 3 or 4 decreased neutrophils in 70%. Febrile neutropenia occurred in 6% of patients.

Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines.

Monitor patients with neutropenia for signs of infection.

Withhold TECVAYLI based on severity.

Hypersensitivity and Other Administration Reactions - TECVAYLI can cause both systemic administration-related and local injection-site reactions.

Systemic Reactions - In patients who received the recommended TECVAYLI dosage in the clinical trials (monotherapy and combination therapy trials; N=448), 2.5% of patients experienced systemic administration reactions, which included recurrent pyrexia and rash.

Local Reactions - In patients who received TECVAYLI at the recommended dosage in the clinical trials (monotherapy and combination therapy trials; N=448), injection-site reactions occurred in 37% of patients, with Grade 1 injection-site reactions in 29% and Grade 2 in 9%.

Withhold TECVAYLI or consider permanent discontinuation of TECVAYLI based on severity.

Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI may cause fetal harm when administered to a pregnant patient. Advise pregnant patients of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TECVAYLI and for 5 months after the last dose.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) in patients who received TECVAYLI monotherapy were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common adverse reactions (≥20%) in patients who received TECVAYLI in combination with daratumumab and hyaluronidase-fihj were hypogammaglobulinemia, upper respiratory tract infection, CRS, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis, and weight decreased.

The most common Grade 3 to 4 laboratory abnormalities (≥20%) with TECVAYLI (as monotherapy or in combination with daratumumab and hyaluronidase-fihj) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.

Please read full Prescribing Information, including Boxed WARNING, for TECVAYLI.

DARZALEX FASPRO® INDICATIONS AND IMPORTANT SAFETY INFORMATION 

INDICATIONS

DARZALEX® (daratumumab) is indicated for the treatment of adult patients with multiple myeloma:

In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) is indicated for the treatment of adult patients with multiple myeloma:

In combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor (PI) In combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy As monotherapy in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent IMPORTANT SAFETY INFORMATION

DARZALEX® ANDDARZALEX FASPRO®: CONTRAINDICATIONS
DARZALEX® and DARZALEX FASPRO® are contraindicated in patients with a history of severe hypersensitivity to daratumumab, hyaluronidase (for DARZALEX FASPRO®), or any of the components of the formulations.

WARNINGS AND PRECAUTIONS
DARZALEX®: Infusion-Related Reactions
DARZALEX® can cause severe and/or serious infusion-related reactions including anaphylactic reactions. These reactions can be life-threatening, and fatal outcomes have been reported. In clinical trials (monotherapy and combination: N=2066), infusion-related reactions occurred in 37% of patients with the Week 1 (16 mg/kg) infusion, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions. Less than 1% of patients had a Grade 3/4 infusion-related reaction at Week 2 or subsequent infusions. The median time to onset was 1.5 hours (range: 0 to 73 hours). Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX®. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma.

Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision.

When DARZALEX® dosing was interrupted in the setting of autologous stem cell transplant (ASCT) (CASSIOPEIA) for a median of 3.75 months (range: 2.4 to 6.9 months), upon re-initiation of DARZALEX®, the incidence of infusion-related reactions was 11% for the first infusion following ASCT. Infusion-related reactions occurring at re-initiation of DARZALEX® following ASCT were consistent in terms of symptoms and severity (Grade 3 or 4: <1%) with those reported in previous studies at Week 2 or subsequent infusions. In EQUULEUS, patients receiving combination treatment (n=97) were administered the first 16 mg/kg dose at Week 1 split over two days, ie, 8 mg/kg on Day 1 and Day 2, respectively. The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt DARZALEX® infusion for reactions of any severity and institute medical management as needed. Permanently discontinue DARZALEX® therapy if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.

To reduce the risk of delayed infusion-related reactions, administer oral corticosteroids to all patients following DARZALEX® infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short- and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®.

DARZALEX FASPRO®: Hypersensitivity and Other Administration Reactions
Both systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®.

Systemic Reactions
In a pooled safety population of 1446 patients with multiple myeloma (N=1235) or light chain (AL) amyloidosis (N=193) who received DARZALEX FASPRO® as monotherapy or as part of a combination therapy, 7% of patients experienced a systemic administration-related reaction (Grade 2: 3%, Grade 3: 0.8%, Grade 4: 0.1%).

In all patients (N=1639), systemic administration-related reactions occurred in 7% of patients with the first injection, 0.5% with the second injection, and cumulatively 1% with subsequent injections. The median time to onset was 3.2 hours (range: 4 minutes to 3.5 days). Of the 283 systemic administration-related reactions that occurred in 135 patients, 240 (85%) occurred on the day of DARZALEX FASPRO® administration. Delayed systemic administration-related reactions have occurred in 1% of the patients.

Severe reactions included hypoxia, dyspnea, hypertension, tachycardia, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Other signs and symptoms of systemic administration-related reactions may include respiratory symptoms, such as bronchospasm, nasal congestion, cough, throat irritation, allergic rhinitis, and wheezing, as well as anaphylactic reaction, pyrexia, chest pain, pruritus, chills, vomiting, nausea, hypotension, and blurred vision.

Pre-medicate patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids. Monitor patients for systemic administration-related reactions, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) administration-related reactions, immediately and permanently discontinue DARZALEX FASPRO®. Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions.

Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®.

Local Reactions
In this pooled safety population of 1446 patients with multiple myeloma (N=1253) or light chain amyloidosis (N=193), injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 1.1%. The most frequent (>1%) injection-site reactions were injection site erythema and injection site rash. In patients with high-risk smoldering multiple myeloma (N=193), injection-site reactions occurred in 28% of patients, including Grade 2 reactions in 3%. These local reactions occurred a median of 6 minutes (range: 0 minutes to 6.5 days) after starting administration of DARZALEX FASPRO®. Monitor for local reactions and consider symptomatic management.

DARZALEX® and DARZALEX FASPRO®: Infections
DARZALEX® and DARZALEX FASPRO® can cause serious, life-threatening, or fatal infections. In patients who received DARZALEX® in a pooled safety population (N=2066), serious infections, including opportunistic infections, occurred in 22.6% of patients, Grade 3 or 4 infections occurred in 24.3%, and fatal infections occurred in 1.2%. The most common (≥2%) types of serious infection reported were pneumonia (11%), upper respiratory tract infection (4%), sepsis (3%), and bronchitis (2%). In patients who received DARZALEX FASPRO® in a pooled safety population including patients with smoldering multiple myeloma and light chain (AL) amyloidosis (N=1639), serious infections, including opportunistic infections, occurred in 24% of patients, Grade 3 or 4 infections occurred in 22%, and fatal infections occurred in 2.5%. The most common type of serious infection reported was pneumonia (8.5%).

Monitor patients for signs and symptoms of infection prior to and during treatment with DARZALEX® or DARZALEX FASPRO® and treat appropriately. Administer prophylactic antimicrobials according to guidelines.

DARZALEX® and DARZALEX FASPRO®: Neutropenia and Thrombocytopenia
DARZALEX® and DARZALEX FASPRO® may increase neutropenia and thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. Consider withholding DARZALEX® or DARZALEX FASPRO® until recovery of neutrophils or for recovery of platelets.

In lower body weight patients receiving DARZALEX FASPRO®, higher rates of Grade 3-4 neutropenia were observed.

DARZALEX® and DARZALEX FASPRO®: Interference With Serological Testing
Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive indirect antiglobulin test (indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab administration. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX® and DARZALEX FASPRO®. Type and screen patients prior to starting DARZALEX® and DARZALEX FASPRO®.

DARZALEX® and DARZALEX FASPRO®: Interference With Determination of Complete Response
Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

DARZALEX® and DARZALEX FASPRO®: Embryo-Fetal Toxicity
Based on the mechanism of action, DARZALEX® and DARZALEX FASPRO® can cause fetal harm when administered to a pregnant woman. DARZALEX® and DARZALEX FASPRO® may cause depletion of fetal immune cells and decreased bone density. Advise pregnant women of the potential risk to a fetus. Advise females with reproductive potential to use effective contraception during treatment with DARZALEX® or DARZALEX FASPRO® and for 3 months after the last dose.

The combination of DARZALEX® or DARZALEX FASPRO® with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. Refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy.

DARZALEX®: ADVERSE REACTIONS
The most frequently reported adverse reactions (incidence ≥20%) with DARZALEX® were upper respiratory infection, neutropenia, infusion-related reactions, thrombocytopenia, diarrhea, constipation, anemia, peripheral sensory neuropathy, fatigue, peripheral edema, nausea, cough, pyrexia, dyspnea, and asthenia. The most common hematologic laboratory abnormalities (≥40%) with DARZALEX® are neutropenia, lymphopenia, thrombocytopenia, leukopenia, and anemia.

DARZALEX FASPRO®: ADVERSE REACTIONS
In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, sleep disorder, headache, rash, renal impairment, motor dysfunction, pyrexia, cough, muscle spasms, back pain, vomiting, hypertension, musculoskeletal pain, decreased appetite, urinary tract infection, abdominal pain, upper respiratory tract infection, peripheral neuropathy, peripheral sensory neuropathy, constipation, pneumonia, edema, dizziness, bruising, and COVID-19.

The most common hematologic laboratory abnormalities (≥40%) with DARZALEX FASPRO® are decreased leukocytes, decreased lymphocytes, decreased neutrophils, decreased platelets, and decreased hemoglobin.

Please click here to read full Prescribing Information for DARZALEX®.
Please click here to read full Prescribing Information for DARZALEX FASPRO®.

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. 

Caution Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to TECVAYLI® (teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 

Footnote

*Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

1 Effelterre T, et al. Projecting Functional Cure in Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM) in the MajesTEC-3 Study of Teclistamab-Daratumumab (Tec-Dara) Using a Mixture Cure Model. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 23, 2026; Glasgow, Sweden.

2 Costa L, et al. Overall Survival, Progression and Non-Relapse Mortality With Teclistamab Plus Daratumumab (Tec-Dara) vs Dara-Based Triplets in Relapsed/Refractory Multiple Myeloma (RRMM): MajesTEC-3 Post Hoc Analysis. Presented at: The 2026 International Myeloma Society (IMS) Annual Meeting; September 24, 2026; Glasgow, Sweden.

3 MajesTEC-3, NCT05083169. A Phase 3 Randomized Study Comparing Teclistamab + Subcutaneous Daratumumab (Tec-Dara) Versus Daratumumab SC + Pomalidomide + Dexamethasone (DPd) or Daratumumab SC + Bortezomib + Dexamethasone (DVd). https://clinicaltrials.gov/study/NCT05083169. Accessed September 2026

4 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. Am J Hematol. 2020;95(5):548-567.

5 National Cancer Institute. Plasma cell neoplasms. Accessed September 2026. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq

6 City of Hope. Multiple myeloma: Causes, symptoms & treatments. 2022. Accessed September 2026. https://www.cancercenter.com/cancer-types/multiple-myeloma

7 International Agency for Research on Cancer (World Health Organization). Multiple myeloma fact sheet. 2024. Accessed September 2026. https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf

8 SEER Explorer: An interactive website for SEER cancer statistics. Surveillance Research Program, National Cancer Institute. Accessed September 2026. https://seer.cancer.gov/explorer/ 

9 American Cancer Society. What is multiple myeloma? Accessed September 2026. https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html 

10 American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. Accessed September 2026. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html

11 Kazandjian D. Multiple myeloma epidemiology and survival: a unique malignancy. J Clin Oncol. 2018;36(15):1479-1487. https://pmc.ncbi.nlm.nih.gov/articles/PMC6119139/

12 Johnson & Johnson. U.S. FDA approves TECVAYLI® (teclistamab-cqyv), the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma. Accessed September 2026. https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma

13 DARZALEX FASPRO® U.S. Prescribing Information. 2025. Horsham, PA: Janssen Biotech, Inc.

14 DARZALEX® U.S. Prescribing Information. 2022. Horsham, PA: Janssen Biotech, Inc.

SOURCE Johnson & Johnson

Johnson & Johnson (JNJ.N) said on Monday its experimental use of Caplyta for bipolar mania met the main goal ​of a late-stage study, bringing the drug a step ‌closer to expanding beyond its currently approved uses.

J&J gained Caplyta through its $14.6 billion acquisition of Intra-Cellular Therapies last year to bolster ​its neuroscience business.

Caplyta significantly reduced symptoms of bipolar mania ​compared with placebo in the late-stage trial, meeting ⁠the study's main goal, J&J said.

Symptoms of mania can ​include grandiosity, decreased need for sleep, racing thoughts, distractibility, and ​risk-taking behavior.

Patients showed improvement as early as three days after starting treatment with the drug, with benefits maintained through the study's three-week ​duration, according to the company.

The study also met a ​key secondary goal measuring overall severity of illness, J&J said.

About 46% of ‌patients ⁠treated with Caplyta achieved a clinical response, compared with about 21% of patients who received placebo, the company said.

The trial evaluated a once-daily 42-milligram dose of Caplyta in adults ​experiencing manic ​episodes associated with ⁠bipolar I disorder.

J&J's Caplyta is already approved in the United States for depressive episodes ​associated with bipolar I and bipolar II ​disorder and ⁠schizophrenia.

Bipolar disorder affects an estimated 37 million people worldwide. Mania, a defining feature of bipolar I disorder, is marked by ⁠unusually ​elevated or irritable mood and increased ​energy or activity levels that often occur alongside depressive episodes, according to ​J&J.

Johnson & Johnson (JNJ - Free Report) ended the recent trading session at $270.22, demonstrating a +1.1% change from the preceding day's closing price. The stock's change was less than the S&P 500's daily gain of 1.14%. Meanwhile, the Dow gained 0.61%, and the Nasdaq, a tech-heavy index, added 1.69%.

Prior to today's trading, shares of the world's biggest maker of health care products had lost 2.24% lagged the Medical sector's loss of 0.26% and was narrower than the S&P 500's loss of 2.85%.

Analysts and investors alike will be keeping a close eye on the performance of Johnson & Johnson in its upcoming earnings disclosure. The company's earnings report is set to go public on October 13, 2026. It is anticipated that the company will report an EPS of $2.96, marking a 5.71% rise compared to the same quarter of the previous year. Our most recent consensus estimate is calling for quarterly revenue of $25.36 billion, up 5.71% from the year-ago period.

For the full year, the Zacks Consensus Estimates project earnings of $11.61 per share and a revenue of $101.13 billion, demonstrating changes of +7.6% and +7.37%, respectively, from the preceding year.

Investors might also notice recent changes to analyst estimates for Johnson & Johnson. Recent revisions tend to reflect the latest near-term business trends. As a result, we can interpret positive estimate revisions as a good sign for the business outlook.

Empirical research indicates that these revisions in estimates have a direct correlation with impending stock price performance. To utilize this, we have created the Zacks Rank, a proprietary model that integrates these estimate changes and provides a functional rating system.

Ranging from #1 (Strong Buy) to #5 (Strong Sell), the Zacks Rank system has a proven, outside-audited track record of outperformance, with #1 stocks returning an average of +25% annually since 1988. Over the past month, there's been a 0.04% fall in the Zacks Consensus EPS estimate. Right now, Johnson & Johnson possesses a Zacks Rank of #3 (Hold).

From a valuation perspective, Johnson & Johnson is currently exchanging hands at a Forward P/E ratio of 23.05. This denotes a premium relative to the industry average Forward P/E of 15.67.

We can additionally observe that JNJ currently boasts a PEG ratio of 2.55. The PEG ratio is akin to the commonly utilized P/E ratio, but this measure also incorporates the company's anticipated earnings growth rate. Large Cap Pharmaceuticals stocks are, on average, holding a PEG ratio of 1.98 based on yesterday's closing prices.

The Large Cap Pharmaceuticals industry is part of the Medical sector. This industry, currently bearing a Zacks Industry Rank of 103, finds itself in the top 42% echelons of all 250+ industries.

The Zacks Industry Rank is ordered from best to worst in terms of the average Zacks Rank of the individual companies within each of these sectors. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.

To follow JNJ in the coming trading sessions, be sure to utilize Zacks.com.

Core Capital Management & Research inc. bought a new position in Johnson & Johnson (NYSE:JNJ – Free Report) during the 2nd quarter, according to its most recent Form 13F filing with the Securities and Exchange Commission (SEC). The firm bought 4,002 shares of the company’s stock, valued at approximately $1,087,000.

A number of other hedge funds have also modified their holdings of JNJ. Silver Coast Investments LLC boosted its stake in shares of Johnson & Johnson by 3.8% in the second quarter. Silver Coast Investments LLC now owns 1,066 shares of the company’s stock worth $271,000 after acquiring an additional 39 shares during the period. Townsend Asset Management Corp NC ADV lifted its holdings in Johnson & Johnson by 0.6% in the 2nd quarter. Townsend Asset Management Corp NC ADV now owns 6,418 shares of the company’s stock worth $1,630,000 after purchasing an additional 39 shares in the last quarter. Triumph Capital Management boosted its stake in Johnson & Johnson by 1.6% in the 2nd quarter. Triumph Capital Management now owns 2,531 shares of the company’s stock worth $643,000 after purchasing an additional 39 shares during the period. Denali Advisors LLC grew its holdings in Johnson & Johnson by 1.2% during the 2nd quarter. Denali Advisors LLC now owns 3,305 shares of the company’s stock valued at $839,000 after buying an additional 40 shares in the last quarter. Finally, Beaird Harris Wealth Management LLC grew its holdings in Johnson & Johnson by 1.8% during the 4th quarter. Beaird Harris Wealth Management LLC now owns 2,422 shares of the company’s stock valued at $501,000 after buying an additional 42 shares in the last quarter. 69.55% of the stock is currently owned by institutional investors.

Wall Street Analysts Forecast Growth JNJ has been the subject of a number of research reports. TD Cowen raised their target price on shares of Johnson & Johnson from $250.00 to $300.00 and gave the company a “buy” rating in a research note on Monday, July 13th. Guggenheim raised their price objective on Johnson & Johnson from $270.00 to $287.00 and gave the company a “buy” rating in a research report on Thursday, August 6th. Johnson Rice reiterated a “buy” rating on shares of Johnson & Johnson in a research report on Monday, August 3rd. Freedom Capital upgraded Johnson & Johnson from a “hold” rating to a “strong-buy” rating in a report on Thursday, July 16th. Finally, Raymond James Financial set a $280.00 price objective on shares of Johnson & Johnson in a research report on Monday, August 3rd. One equities research analyst has rated the stock with a Strong Buy rating, eighteen have issued a Buy rating and six have assigned a Hold rating to the company’s stock. Based on data from MarketBeat.com, the company presently has a consensus rating of “Moderate Buy” and an average price target of $274.13.

View Our Latest Analysis on JNJ Insider Transactions at Johnson & Johnson In related news, EVP Timothy Schmid sold 33,597 shares of the company’s stock in a transaction that occurred on Wednesday, September 2nd. The stock was sold at an average price of $274.74, for a total value of $9,230,439.78. Following the sale, the executive vice president owned 25,447 shares in the company, valued at $6,991,308.78. This represents a 56.90% decrease in their ownership of the stock. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available at this hyperlink. Also, EVP Vanessa Broadhurst sold 23,054 shares of the firm’s stock in a transaction that occurred on Monday, July 20th. The stock was sold at an average price of $251.27, for a total transaction of $5,792,778.58. Following the transaction, the executive vice president directly owned 23,003 shares of the company’s stock, valued at $5,779,963.81. This represents a 50.06% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. In the last ninety days, insiders have sold 87,569 shares of company stock valued at $23,064,544. 0.16% of the stock is owned by company insiders.

More Johnson & Johnson News Here are the key news stories impacting Johnson & Johnson this week:

Positive Sentiment: Promising lung-cancer results strengthen J&J’s growth outlook. New Phase 2b and Phase 3 data showed that RYBREVANT-based combinations for EGFR-mutated non-small-cell lung cancer delivered improved tolerability, fewer treatment-related adverse events and longer reported overall survival. The results could support adoption of RYBREVANT and LAZCLUZE in first-line treatment. Johnson & Johnson Reports Stronger Survival Data in EGFR-Mutated Lung Cancer Positive Sentiment: Underlying business momentum remains resilient despite STELARA pressure. Management said sales increased 5.6% excluding the roughly 460-basis-point drag from STELARA, encouraging investors to focus on growth from the broader pharmaceutical and MedTech portfolios. The company previously reported quarterly revenue of $25.31 billion, up 6.6% year over year, and adjusted EPS above consensus. Should You Judge JNJ Stock Without STELARA? Positive Sentiment: Potential value creation from a DePuy Synthes sale is attracting investor interest. Apollo Global Management is reportedly considering acquiring J&J’s orthopedics business for close to $20 billion. A transaction could unlock value, sharpen J&J’s portfolio focus and provide capital for acquisitions or shareholder returns, although no deal has been announced. Apollo and J&J Face a High-Stakes Orthopedics Deal Neutral Sentiment: J&J remains viewed as a defensive, dividend-oriented healthcare holding. Its roughly 2% yield, recent outperformance and FY 2026 EPS guidance of $11.60–$11.75 support the investment case, but a valuation near 31 times earnings leaves less room for execution disappointments. Negative Sentiment: A partnered depression drug failed a key Phase 2 endpoint. Contineum Therapeutics said the MOONLIGHT-1 trial of JNJ-5120/PIPE-307 did not meet its primary efficacy goal in major depressive disorder. J&J is reviewing additional data, but the setback weakens the near-term pipeline contribution from the program. Johnson & Johnson-Partnered Contineum Depression Drug Fails Mid-Stage Trial Negative Sentiment: Reported insider activity shows executives have sold shares without any purchases during the past six months, a potentially cautionary sentiment signal, though such transactions may reflect diversification or scheduled sales rather than a fundamental view of JNJ. Johnson & Johnson Price Performance Shares of JNJ stock opened at $267.35 on Thursday. Johnson & Johnson has a fifty-two week low of $173.33 and a fifty-two week high of $281.07. The company has a debt-to-equity ratio of 0.44, a quick ratio of 0.81 and a current ratio of 1.09. The firm has a market capitalization of $644.28 billion, a price-to-earnings ratio of 30.98, a PEG ratio of 2.55 and a beta of 0.24. The stock’s 50-day simple moving average is $263.25 and its 200-day simple moving average is $246.40.

Johnson & Johnson (NYSE:JNJ – Get Free Report) last issued its quarterly earnings results on Wednesday, July 15th. The company reported $2.90 earnings per share (EPS) for the quarter, beating analysts’ consensus estimates of $2.84 by $0.06. The business had revenue of $25.31 billion for the quarter, compared to analyst estimates of $25.06 billion. Johnson & Johnson had a net margin of 21.48% and a return on equity of 32.42%. Johnson & Johnson’s revenue for the quarter was up 6.6% compared to the same quarter last year. During the same quarter in the prior year, the business posted $2.77 EPS. Johnson & Johnson has set its FY 2026 guidance at 11.600-11.750 EPS. As a group, equities analysts forecast that Johnson & Johnson will post 11.61 earnings per share for the current fiscal year.

Johnson & Johnson Announces Dividend The company also recently disclosed a quarterly dividend, which was paid on Tuesday, September 8th. Stockholders of record on Tuesday, August 25th were issued a $1.34 dividend. The ex-dividend date of this dividend was Tuesday, August 25th. This represents a $5.36 dividend on an annualized basis and a dividend yield of 2.0%. Johnson & Johnson’s dividend payout ratio is currently 62.11%.

Johnson & Johnson Profile (Free Report)

Johnson & Johnson (NYSE: JNJ) is a global healthcare company that develops, manufactures and markets pharmaceutical and medical device products. Founded in 1886 and headquartered in New Brunswick, New Jersey, the company serves patients, healthcare professionals and institutions in markets around the world.

Johnson & Johnson operates through two primary business segments: Innovative Medicine and MedTech. Innovative Medicine focuses on prescription treatments in areas including immunology, oncology, neuroscience, cardiovascular and metabolic disease, infectious diseases, and pulmonary hypertension.

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The Manufacturers Life Insurance Company lifted its stake in shares of Johnson & Johnson (NYSE:JNJ – Free Report) by 5.1% during the second quarter, according to its most recent filing with the Securities and Exchange Commission (SEC). The institutional investor owned 3,746,452 shares of the company’s stock after purchasing an additional 180,724 shares during the quarter. The Manufacturers Life Insurance Company owned about 0.16% of Johnson & Johnson worth $951,486,000 at the end of the most recent reporting period.

Several other large investors also recently made changes to their positions in JNJ. Blueline Advisors LLC bought a new position in Johnson & Johnson in the fourth quarter worth approximately $25,000. Outlook Capital Management LLC bought a new stake in shares of Johnson & Johnson during the second quarter valued at approximately $28,000. MidAtlantic Capital Management Inc. bought a new stake in shares of Johnson & Johnson during the fourth quarter valued at approximately $37,000. Matrix Trust Co raised its position in shares of Johnson & Johnson by 56.2% during the second quarter. Matrix Trust Co now owns 150 shares of the company’s stock worth $38,000 after purchasing an additional 54 shares during the period. Finally, Hyposwiss Advisors SA bought a new position in shares of Johnson & Johnson in the 4th quarter worth $42,000. 69.55% of the stock is currently owned by institutional investors and hedge funds.

JNJ stock opened at $267.35 on Thursday. The stock has a market cap of $644.28 billion, a P/E ratio of 30.98, a P/E/G ratio of 2.55 and a beta of 0.24. The company has a current ratio of 1.09, a quick ratio of 0.81 and a debt-to-equity ratio of 0.44. The stock’s fifty day simple moving average is $263.25 and its two-hundred day simple moving average is $246.40. Johnson & Johnson has a 1-year low of $173.33 and a 1-year high of $281.07.

Johnson & Johnson (NYSE:JNJ – Get Free Report) last released its earnings results on Wednesday, July 15th. The company reported $2.90 EPS for the quarter, topping analysts’ consensus estimates of $2.84 by $0.06. The company had revenue of $25.31 billion for the quarter, compared to analysts’ expectations of $25.06 billion. Johnson & Johnson had a return on equity of 32.42% and a net margin of 21.48%.The business’s revenue for the quarter was up 6.6% compared to the same quarter last year. During the same period in the previous year, the business posted $2.77 EPS. Johnson & Johnson has set its FY 2026 guidance at 11.600-11.750 EPS. Analysts expect that Johnson & Johnson will post 11.61 EPS for the current year. Johnson & Johnson Announces Dividend The business also recently disclosed a quarterly dividend, which was paid on Tuesday, September 8th. Shareholders of record on Tuesday, August 25th were given a $1.34 dividend. The ex-dividend date of this dividend was Tuesday, August 25th. This represents a $5.36 annualized dividend and a yield of 2.0%. Johnson & Johnson’s payout ratio is currently 62.11%.

Analyst Upgrades and Downgrades Several analysts recently issued reports on JNJ shares. Royal Bank Of Canada boosted their price target on shares of Johnson & Johnson from $265.00 to $287.00 and gave the company an “outperform” rating in a research note on Monday, July 13th. Wells Fargo & Company raised their price objective on shares of Johnson & Johnson from $272.00 to $282.00 and gave the company an “overweight” rating in a research note on Monday, August 3rd. Wall Street Zen cut shares of Johnson & Johnson from a “buy” rating to a “hold” rating in a report on Saturday, August 1st. UBS Group began coverage on shares of Johnson & Johnson in a report on Wednesday, September 2nd. They issued a “buy” rating and a $320.00 target price on the stock. Finally, Bank of America raised their price target on shares of Johnson & Johnson from $254.00 to $263.00 and gave the company a “neutral” rating in a research report on Friday, July 10th. One analyst has rated the stock with a Strong Buy rating, eighteen have issued a Buy rating and six have issued a Hold rating to the company. According to MarketBeat.com, Johnson & Johnson has an average rating of “Moderate Buy” and an average price target of $274.13.

Get Our Latest Research Report on Johnson & Johnson

Insider Activity at Johnson & Johnson In related news, EVP Jennifer L. Taubert sold 15,000 shares of Johnson & Johnson stock in a transaction that occurred on Monday, August 17th. The shares were sold at an average price of $263.36, for a total value of $3,950,400.00. Following the sale, the executive vice president owned 194,451 shares of the company’s stock, valued at approximately $51,210,615.36. The trade was a 7.16% decrease in their position. The transaction was disclosed in a document filed with the SEC, which can be accessed through this hyperlink. Also, EVP Vanessa Broadhurst sold 23,054 shares of the company’s stock in a transaction that occurred on Monday, July 20th. The shares were sold at an average price of $251.27, for a total value of $5,792,778.58. Following the completion of the transaction, the executive vice president owned 23,003 shares in the company, valued at approximately $5,779,963.81. The trade was a 50.06% decrease in their position. Additional details regarding this sale are available in the official SEC disclosure. Insiders have sold 87,569 shares of company stock valued at $23,064,544 in the last three months. Insiders own 0.16% of the company’s stock.

Key Headlines Impacting Johnson & Johnson Here are the key news stories impacting Johnson & Johnson this week:

Positive Sentiment: Promising lung-cancer results strengthen J&J’s growth outlook. New Phase 2b and Phase 3 data showed that RYBREVANT-based combinations for EGFR-mutated non-small-cell lung cancer delivered improved tolerability, fewer treatment-related adverse events and longer reported overall survival. The results could support adoption of RYBREVANT and LAZCLUZE in first-line treatment. Johnson & Johnson Reports Stronger Survival Data in EGFR-Mutated Lung Cancer Positive Sentiment: Underlying business momentum remains resilient despite STELARA pressure. Management said sales increased 5.6% excluding the roughly 460-basis-point drag from STELARA, encouraging investors to focus on growth from the broader pharmaceutical and MedTech portfolios. The company previously reported quarterly revenue of $25.31 billion, up 6.6% year over year, and adjusted EPS above consensus. Should You Judge JNJ Stock Without STELARA? Positive Sentiment: Potential value creation from a DePuy Synthes sale is attracting investor interest. Apollo Global Management is reportedly considering acquiring J&J’s orthopedics business for close to $20 billion. A transaction could unlock value, sharpen J&J’s portfolio focus and provide capital for acquisitions or shareholder returns, although no deal has been announced. Apollo and J&J Face a High-Stakes Orthopedics Deal Neutral Sentiment: J&J remains viewed as a defensive, dividend-oriented healthcare holding. Its roughly 2% yield, recent outperformance and FY 2026 EPS guidance of $11.60–$11.75 support the investment case, but a valuation near 31 times earnings leaves less room for execution disappointments. Negative Sentiment: A partnered depression drug failed a key Phase 2 endpoint. Contineum Therapeutics said the MOONLIGHT-1 trial of JNJ-5120/PIPE-307 did not meet its primary efficacy goal in major depressive disorder. J&J is reviewing additional data, but the setback weakens the near-term pipeline contribution from the program. Johnson & Johnson-Partnered Contineum Depression Drug Fails Mid-Stage Trial Negative Sentiment: Reported insider activity shows executives have sold shares without any purchases during the past six months, a potentially cautionary sentiment signal, though such transactions may reflect diversification or scheduled sales rather than a fundamental view of JNJ. About Johnson & Johnson (Free Report)

Johnson & Johnson (NYSE: JNJ) is a global healthcare company that develops, manufactures and markets pharmaceutical and medical device products. Founded in 1886 and headquartered in New Brunswick, New Jersey, the company serves patients, healthcare professionals and institutions in markets around the world.

Johnson & Johnson operates through two primary business segments: Innovative Medicine and MedTech. Innovative Medicine focuses on prescription treatments in areas including immunology, oncology, neuroscience, cardiovascular and metabolic disease, infectious diseases, and pulmonary hypertension.

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Receive News & Ratings for Johnson & Johnson Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for Johnson & Johnson and related companies with MarketBeat.com's FREE daily email newsletter.

Improved sexual functioning could support adherence, expanding the strategic value of J&J's $14.6 billion acquisition. Summary

Caplyta’s differentiation may extend beyond symptom control.

Johnson & Johnson JNJ, the pharmaceutical and medical-technology giant, added another potentially important commercial argument for Caplyta, with new late-stage data showing improved sexual functioning among depression patients, Reuters reported Wednesday. J&J shares were roughly flat, slipping about 0.1% to $266.965. The valuation picture is much hotter than the stock move: the shares trade 38.04% above the $193.40 GF Value estimate.

More than 80% of the study's 480 participants entered the trial reporting sexual dysfunction, a common problem that can complicate antidepressant treatment. Patients receiving 42 milligrams of Caplyta alongside their existing antidepressants recorded statistically significant improvements versus placebo across measures including desire, arousal, orgasm and pleasure. Caplyta already carries approvals for schizophrenia, bipolar depression and adjunctive treatment of major depressive disorder, so better tolerability could give J&J another lever to differentiate the drug in a crowded psychiatric market.

J&J picked up Caplyta through its $14.6 billion acquisition of Intra-Cellular Therapies, a sizable bet equal to roughly 57.7% of the company's latest $25.3 billion in quarterly sales. The new data strengthen Caplyta's clinical story, but the stock's 38.04% premium to GF Value raises the bar: investors now need better patient retention and stronger sales growth to translate that clinical advantage into returns that justify both the acquisition price and J&J's current valuation.

Disclosures I/we have no positions in any stocks mentioned, and have no plans to buy any new positions in the stocks mentioned within the next 72 hours.

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