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FDA approves Johnson & Johnson's nasal spray for depression as standalone treatment
CNBC· 2025-01-21 13:18
The Food and Drug Administration on Tuesday approved Johnson & Johnson's nasal spray to be used alone in adults with a major depressive disorder that is difficult to treat, as sales of the drug grow. The spray, called Spravato, is now the first-ever standalone therapy for treatment-resistant depression, which is when trying at least two standard treatments does little to nothing to improve depression symptoms in a patient. Previously, Spravato was cleared in the U.S. to use together with an oral antidepress ...
SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression
Prnewswire· 2025-01-21 13:00
Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours1  SPRAVATO® alone showed a rapid and superior improvement vs. placebo in the Montgomery-Asberg Depression Rating Scale (MADRS) total score, with numerical improvements across all 10 MADRS items seen at day 28 in a post-hoc analysis2Monotherapy data adds to well-established clin ...
Should You Buy, Sell or Hold J&J Stock Ahead of Q4 Earnings?
ZACKS· 2025-01-20 21:11
Earnings and Estimates - The Zacks Consensus Estimate for JNJ Q4 sales and earnings is $22.5 billion and $2.01 per share, respectively [1] - The Zacks Consensus Estimate for JNJ's 2024 earnings has risen from $9.93 to $9.95 per share, while the 2025 estimate has declined from $10.54 to $10.50 per share over the past 60 days [2] - JNJ has exceeded earnings expectations in each of the trailing four quarters, with an average four-quarter earnings surprise of 4.15% [5][6] Stock Performance - JNJ stock has declined 9.5% in the past year, compared to a 5.4% decrease for the industry [1][17] - The stock has underperformed the sector and the S&P 500 [17] - JNJ shares currently trade at 13.95 forward earnings, lower than the industry's 15.29 and the stock's 5-year mean of 16.02 [19] Innovative Medicines Segment - Sales are expected to be driven by key products such as Darzalex, Tremfya, and Erleada [8] - The Zacks Consensus Estimate for Darzalex sales is $3.04 billion, while the model estimate is $3.06 billion [8] - The Zacks Consensus Estimate for Tremfya sales is $1.06 billion, while the model estimate is $1.09 billion [8] - The Zacks Consensus Estimate for Erleada sales is $793.8 million, while the model projects $805.0 million [9] - New drugs like Carvykti, Tecvayli, Talvey, and Spravato are likely to have contributed to top-line growth [9] MedTech Segment - Sales in the Asia Pacific region, specifically China, were hurt by the volume-based procurement program and anti-corruption campaign [13] - JNJ does not expect improvement in the Asia Pacific region in Q4 2024, but new product uptake and commercial execution are expected to boost growth in other markets [14] - The Zacks Consensus Estimate for the MedTech segment is $8.28 billion, while the model estimate is $8.23 billion [14] Acquisitions and Pipeline - JNJ completed acquisitions of Shockwave and V-Wave in MedTech, and Ambrx, Proteologix, and NM26 bispecific antibody in Innovative Medicine [23] - JNJ announced a definitive agreement to acquire Intra-Cellular Therapies for $14.6 billion, adding Caplyta and other CNS candidates to its pipeline [24] Challenges - Sales of key drug Stelara declined in Q3 2024 due to unfavorable patient mix and share loss in Europe [10] - Several biosimilar versions of Stelara are expected to be launched in the US in 2025 [11] - Imbruvica sales are likely to have declined due to rising competitive pressure in the US [12] - JNJ faces more than 62,000 lawsuits related to its talc-based products [25] Outlook - JNJ's outlook for 2025 looks positive, with growth expected in the Innovative Medicine segment driven by key products and new drugs [26] - In MedTech, operational sales growth is expected to be at the upper end of the 5-7% long-term guided range, driven by new product launches and acquisitions [26]
Johnson & Johnson (JNJ) Shareholders May Have Been Affected by Fraud- Levi & Korsinsky Investigates
ACCESSWIRE Newsroom· 2025-01-20 16:00
Johnson & Johnson (JNJ) Shareholders May Have Been Affected by Fraud- Levi & Korsinsky Investigates ...
What Analysts Think of Johnson & Johnson Stock Ahead of Earnings
Investopedia· 2025-01-20 15:06
Earnings and Analyst Expectations - Johnson & Johnson (JNJ) is set to report earnings with analysts expecting revenue and profit growth compared to the same period last year [2] - Revenue is expected to rise to $22.51 billion from $21.4 billion, and net income to $4.4 billion from $4.05 billion in Q4 2023 [3] - Analysts are cautiously optimistic, with 6 out of 12 analysts giving a "buy" rating and 6 giving a "hold" rating, with an average price target of $175 implying 19% upside from Friday's close [2] Stock Performance - Johnson & Johnson shares trended lower from mid-October through the end of 2024, ending the year down nearly 8% [3] - The stock has gained close to 2% in January, closing at $147.03 as of Friday [3] Challenges and Risks - The company faces unresolved class action lawsuits related to its talc powder, with hearings scheduled early this year to determine the fate of a subsidiary's bankruptcy plan and a multi-billion dollar settlement [4] - An expiring patent for one of its popular drugs is expected to bring competition [4] - The company's AAA credit rating is at risk due to recent acquisitions, including the $14.6 billion deal to acquire Intra-Cellular Therapies (ITCI), which is expected to be financed with a combination of cash and debt [5] Strategic Moves - Johnson & Johnson made several acquisitions in 2024 and started 2025 with the acquisition of Intra-Cellular Therapies (ITCI) for $14.6 billion, expected to close this year [5]
Shareholders That Lost Money on Johnson & Johnson (JNJ) Should Contact Levi & Korsinsky About Securities Fraud Investigation - JNJ
ACCESSWIRE Newsroom· 2025-01-17 16:15
Shareholders That Lost Money on Johnson & Johnson (JNJ) Should Contact Levi & Korsinsky About Securities Fraud Investigation - JNJ ...
Johnson & Johnson (JNJ) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Shareholders to Contact the Firm to Learn More About the Investigation
ACCESSWIRE Newsroom· 2025-01-17 15:00
Johnson & Johnson (JNJ) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Shareholders to Contact the Firm to Learn More About the Investigation ...
Shareholder Rights Advocates at Levi & Korsinsky Investigate Johnson & Johnson (JNJ) Regarding Possible Securities Fraud Violations
ACCESSWIRE Newsroom· 2025-01-17 14:30
Shareholder Rights Advocates at Levi & Korsinsky Investigate Johnson & Johnson (JNJ) Regarding Possible Securities Fraud Violations ...
Johnson & Johnson: Q4 Earnings May Not Prompt Sustained Directional Moves
Seeking Alpha· 2025-01-16 16:29
Sundry Photography Introduction Johnson & Johnson (NYSE:JNJ), which offers a range of healthcare solutions across the globe, hasn’t done a great deal of good for its shareholders over the past year. Admittedly, even other healthcare stocks from the S&P500 (XLV) have hardly dazzled either, generating positive returns of just low single digits (on average), when the benchmark has surged by +24%. However, JNJ has fared a lot worse, by consistently underperforming XLV through the year, and eventually erodin ...
Insights Into Johnson & Johnson (JNJ) Q4: Wall Street Projections for Key Metrics
ZACKS· 2025-01-16 15:20
Analysts on Wall Street project that Johnson & Johnson (JNJ) will announce quarterly earnings of $2 per share in its forthcoming report, representing a decline of 12.7% year over year. Revenues are projected to reach $22.54 billion, increasing 5.4% from the same quarter last year.Over the past 30 days, the consensus EPS estimate for the quarter has remained unchanged. This demonstrates the covering analysts' collective reassessment of their initial projections during this period.Before a company reveals its ...