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Johnson & Johnson (JNJ - Free Report) announced positive topline results from the pivotal late-stage MDD3001 study, which evaluated its investigational oral drug seltorexant in patients with major depressive disorder (MDD) with insomnia symptoms.
The MDD3001 study evaluated the drug as an adjunctive treatment to baseline antidepressants in adult and elderly patients who did not benefit from antidepressants alone. The study met all its primary and secondary endpoints.
Treatment with seltorexant achieved statistically significant and clinically meaningful improvement in depressive symptoms at day 43 when compared with placebo. Patients treated with the drug also reported improvements in sleep disturbance outcomes.
MDD is one of the most common psychiatric disorders and the leading cause of disability worldwide. The disorder is often accompanied by sleep disturbances such as insomnia or hypersomnia, which can even increase the risk of depressive relapse and suicide. Per management, nearly 60% of MDD patients experience insomnia despite being on an SSRI/SNRI antidepressant. Currently, there are no therapies to treat MDD with insomnia symptoms.
Seltorexant is designed to target the human orexin-2 receptor, which has shown the potential to improve mood and sleep symptoms associated with depression. If approved, the J&J drug will offer a novel mechanism of action to treat MDD patients.
Year to date, J&J’s shares have lost 7.9% against the industry’s 14.7% growth.
Image Source: Zacks Investment Research
Alongside these results, management also provided additional data from the phase IV TRD4005 study, which evaluated its depression nasal spray Spravato as a monotherapy in patients with treatment-resistant depression (TRD). This study also met its primary and secondary endpoints, demonstrating that treatment with the spray provided rapid and sustained efficacy in TRD.
Spravato is currently approved by the FDA, in combination with an oral antidepressant, to treat adults with TRD and depressive symptoms in adults with MDD with suicidal thoughts or behaviors.
J&J presented results from both the above studies at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.
In the past 60 days, estimates for Arcutis Biotherapeutics’ 2024 loss per share have narrowed from $2.49 to $1.60. During the same period, the loss estimates per share for 2025 have improved from $1.77 to $1.14. Year to date, shares of Arcutis have surged 165.9%.
Earnings of Arcutis Biotherapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. Arcutis delivered a four-quarter average earnings surprise of 14.93%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have improved from $2.43 to $1.87. During the same period, loss estimates for 2025 have narrowed from $1.97 to 90 cents.
Earnings of Marinus Pharmaceuticals beat estimates in two of the last four quarters and met the mark on one occasion while missing the mark on another. Marinus registered a four-quarter average earnings surprise of 3.27%.
In the past 60 days, estimates for Heron Therapeutics’ 2024 loss per sharehave improved from 22 cents to 10 cents. During the same period, estimates for 2025 have improved from a loss of 9 cents to earnings of 1 cent. Year to date, HRTX’s shares have appreciated 92.4%.
Earnings of Heron Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. HRTX delivered a four-quarter average earnings surprise of 30.33%.
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J&J's (JNJ) Oral Pill Improves Depression & Insomnia Symptoms
Johnson & Johnson (JNJ - Free Report) announced positive topline results from the pivotal late-stage MDD3001 study, which evaluated its investigational oral drug seltorexant in patients with major depressive disorder (MDD) with insomnia symptoms.
The MDD3001 study evaluated the drug as an adjunctive treatment to baseline antidepressants in adult and elderly patients who did not benefit from antidepressants alone. The study met all its primary and secondary endpoints.
Treatment with seltorexant achieved statistically significant and clinically meaningful improvement in depressive symptoms at day 43 when compared with placebo. Patients treated with the drug also reported improvements in sleep disturbance outcomes.
MDD is one of the most common psychiatric disorders and the leading cause of disability worldwide. The disorder is often accompanied by sleep disturbances such as insomnia or hypersomnia, which can even increase the risk of depressive relapse and suicide. Per management, nearly 60% of MDD patients experience insomnia despite being on an SSRI/SNRI antidepressant. Currently, there are no therapies to treat MDD with insomnia symptoms.
Seltorexant is designed to target the human orexin-2 receptor, which has shown the potential to improve mood and sleep symptoms associated with depression. If approved, the J&J drug will offer a novel mechanism of action to treat MDD patients.
Year to date, J&J’s shares have lost 7.9% against the industry’s 14.7% growth.
Image Source: Zacks Investment Research
Alongside these results, management also provided additional data from the phase IV TRD4005 study, which evaluated its depression nasal spray Spravato as a monotherapy in patients with treatment-resistant depression (TRD). This study also met its primary and secondary endpoints, demonstrating that treatment with the spray provided rapid and sustained efficacy in TRD.
Spravato is currently approved by the FDA, in combination with an oral antidepressant, to treat adults with TRD and depressive symptoms in adults with MDD with suicidal thoughts or behaviors.
J&J presented results from both the above studies at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.
Johnson & Johnson Price
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Zacks Rank & Key Picks
J&J currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Arcutis Biotherapeutics (ARQT - Free Report) , Marinus Pharmaceuticals (MRNS - Free Report) and Heron Therapeutics (HRTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Arcutis Biotherapeutics’ 2024 loss per share have narrowed from $2.49 to $1.60. During the same period, the loss estimates per share for 2025 have improved from $1.77 to $1.14. Year to date, shares of Arcutis have surged 165.9%.
Earnings of Arcutis Biotherapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. Arcutis delivered a four-quarter average earnings surprise of 14.93%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have improved from $2.43 to $1.87. During the same period, loss estimates for 2025 have narrowed from $1.97 to 90 cents.
Earnings of Marinus Pharmaceuticals beat estimates in two of the last four quarters and met the mark on one occasion while missing the mark on another. Marinus registered a four-quarter average earnings surprise of 3.27%.
In the past 60 days, estimates for Heron Therapeutics’ 2024 loss per sharehave improved from 22 cents to 10 cents. During the same period, estimates for 2025 have improved from a loss of 9 cents to earnings of 1 cent. Year to date, HRTX’s shares have appreciated 92.4%.
Earnings of Heron Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. HRTX delivered a four-quarter average earnings surprise of 30.33%.