Bipolar I disorder

PureTech Founded Entity Karuna Therapeutics to be Acquired by Bristol Myers Squibb for $14 Billion

Retrieved on: 
Friday, December 22, 2023

The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.

Key Points: 
  • The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.
  • ET
    PRINCETON, N.J. & BOSTON -- Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.
  • The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.
  • Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

Bristol Myers Squibb Strengthens Neuroscience Portfolio with Acquisition of Karuna Therapeutics

Retrieved on: 
Friday, December 22, 2023

Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.
  • The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.
  • “There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space.
  • Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

Bristol Myers Squibb Strengthens Neuroscience Portfolio with Acquisition of Karuna Therapeutics

Retrieved on: 
Friday, December 22, 2023

Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.
  • The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.
  • “There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space.
  • Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

First-Ever Psilocybin Clinical Trial for Treatment of Bipolar II Depression Conducted at Sheppard Pratt Reveals Promising Results

Retrieved on: 
Wednesday, December 6, 2023

BALTIMORE, Dec. 6, 2023 /PRNewswire/ -- JAMA Psychiatry recently published a first-of-its-kind clinical trial conducted at Sheppard Pratt studying the efficacy and safety of a single dose of synthetic psilocybin accompanied by psychotherapy in treating individuals with treatment-resistant bipolar type II disorder (bipolar II).

Key Points: 
  • BALTIMORE, Dec. 6, 2023 /PRNewswire/ -- JAMA Psychiatry recently published a first-of-its-kind clinical trial conducted at Sheppard Pratt studying the efficacy and safety of a single dose of synthetic psilocybin accompanied by psychotherapy in treating individuals with treatment-resistant bipolar type II disorder (bipolar II).
  • The study revealed promising results with 80% of participants meeting remission criteria 12 weeks after treatment.
  • The results of this study suggest the efficacy and safety of psilocybin in treatment of bipolar II depression, but cannot be extrapolated to the study of psilocybin to treat bipolar I disorder.
  • Sheppard Pratt's Center of Excellence for Psilocybin Research and Treatment is currently conducting clinical trials on psilocybin with psychotherapy for the treatment of anorexia, treatment-resistant depression and chronic suicidal ideation.

Vanda Pharmaceuticals Announces that U.S. Food and Drug Administration Accepts New Drug Application for Tradipitant for the Treatment of Gastroparesis

Retrieved on: 
Monday, December 4, 2023

WASHINGTON, Dec. 4, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis.

Key Points: 
  • WASHINGTON, Dec. 4, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's New Drug Application (NDA) for tradipitant for the treatment of symptoms of gastroparesis.
  • The FDA has set September 18, 2024 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA).
  • If approved, tradipitant will be the first novel drug to be approved by the FDA for the treatment of gastroparesis in over 40 years and to be accepted for review by the FDA for gastroparesis in over 30 years.
  • "We are very pleased with the FDA's acknowledgment of the completeness of our application and we look forward to a substantive review.

Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

Retrieved on: 
Monday, September 11, 2023

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

Key Points: 
  • — Poster Presentations Highlight Company's Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —
    DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville.
  • This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.
  • "Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases.
  • This year's presentations further reinforce Alkermes' leadership and experience in the field of neuroscience," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

Retrieved on: 
Monday, September 11, 2023

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

Key Points: 
  • — Poster Presentations Highlight Company's Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —
    DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville.
  • This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.
  • "Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases.
  • This year's presentations further reinforce Alkermes' leadership and experience in the field of neuroscience," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Bipolar disorder isn't the same for everyone. So people should have more say in how they're treated

Retrieved on: 
Thursday, August 31, 2023

Around 2% of the adult population have a bipolar disorder.

Key Points: 
  • Around 2% of the adult population have a bipolar disorder.
  • Certain medications may be more beneficial for certain types of bipolar disorder, but how do you know which “type” you or a loved one has?
  • A new approach is needed that places emphasis on “real-world” effectiveness and respects the observations of people with bipolar disorder.

Two types of bipolar disorder

    • Originally called “manic-depressive psychosis”, it is now known as bipolar I disorder.
    • In the mid-1990s, bipolar II disorder was defined.
    • Both bipolar I and bipolar II are marked by pronounced mood swings.
    • The key distinguishing feature between the two bipolar conditions is the presence of psychotic features (delusions and/or hallucinations) in those with bipolar I.

Current treatments

    • Melbourne psychiatrist John Cade discovered the effectiveness of lithium as a treatment for manic depression in 1949.
    • This landmark research ushered in the era of condition-specific psychopharmacology.
    • Practitioners refer to research-based guidelines to determine the best medications to help stabilise a bipolar disorder.

But evidence isn’t everything

    • All were “evidence-based”, but we found minimal agreement between them, thus raising questions about their validity.
    • New guidelines have been published since then but the trend for minimal agreement continues.
    • Assessing a psychiatric evidence base is difficult.

Accounting for side effects

    • However, it has multiple side effects.
    • But 50% of the completers receiving lithium experienced distinctive cognitive impairment – side effects that affected their thinking and reasoning.
    • Many of the antipsychotic drugs nominated in guidelines also have major side effects, including weight gain and diabetes.
    • People who are stable while taking these medications without major side effects should not be alarmed.

We want to hear from people with bipolar disorders


    All these concerns highlight the need for research focused on “real-world” samples to determine the best treatments that consider each person’s responses to any medication. We are conducting such a study now, in collaboration with the Black Dog Institute. If you are interested, you can access the study here. Gordon Parker receives funding from the Australian National Health and Medical Research Council.

Alkermes Highlights Data From Psychiatry Portfolio at Spring 2023 Scientific Conferences

Retrieved on: 
Tuesday, May 16, 2023

DUBLIN, May 16, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of research related to its psychiatry portfolio—which includes LYBALVI® (olanzapine and samidorphan) and ARISTADA® (aripiprazole lauroxil)—at four scientific conferences this spring. Several of these meetings coincide with Mental Health Awareness Month in May, an important moment in the year that provides an opportunity to raise awareness about mental health conditions, support the millions of people living with these complex diseases, and acknowledge the critical work of healthcare providers who deliver care each day. The meetings include:

Key Points: 
  • DUBLIN, May 16, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of research related to its psychiatry portfolio—which includes LYBALVI® (olanzapine and samidorphan) and ARISTADA® (aripiprazole lauroxil)—at four scientific conferences this spring.
  • Highlights of the upcoming presentations include:
    Results from a pooled post hoc analysis evaluating the effect of olanzapine/samidorphan (LYBALVI) versus olanzapine alone on weight change profiles from phase 2 and phase 3 studies where change in body weight was a primary or secondary endpoint.
  • Findings from a cross-sectional health economics and outcomes research online survey assessing patient preferences for characteristics associated with oral antipsychotics and exploring potential tradeoffs that patients may make between efficacy and side effects.
  • Qualitative data from a cross-sectional, noninterventional study of patients, caregivers and providers to better understand perspectives—including benefits and perceived barriers—around the use of long-acting injectable antipsychotics in the context of telepsychiatry services.

Alkermes Highlights Data From Psychiatry Portfolio at Spring 2023 Scientific Conferences

Retrieved on: 
Tuesday, May 16, 2023

DUBLIN, May 16, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of research related to its psychiatry portfolio—which includes LYBALVI® (olanzapine and samidorphan) and ARISTADA® (aripiprazole lauroxil)—at four scientific conferences this spring. Several of these meetings coincide with Mental Health Awareness Month in May, an important moment in the year that provides an opportunity to raise awareness about mental health conditions, support the millions of people living with these complex diseases, and acknowledge the critical work of healthcare providers who deliver care each day. The meetings include:

Key Points: 
  • DUBLIN, May 16, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of research related to its psychiatry portfolio—which includes LYBALVI® (olanzapine and samidorphan) and ARISTADA® (aripiprazole lauroxil)—at four scientific conferences this spring.
  • Highlights of the upcoming presentations include:
    Results from a pooled post hoc analysis evaluating the effect of olanzapine/samidorphan (LYBALVI) versus olanzapine alone on weight change profiles from phase 2 and phase 3 studies where change in body weight was a primary or secondary endpoint.
  • Findings from a cross-sectional health economics and outcomes research online survey assessing patient preferences for characteristics associated with oral antipsychotics and exploring potential tradeoffs that patients may make between efficacy and side effects.
  • Qualitative data from a cross-sectional, noninterventional study of patients, caregivers and providers to better understand perspectives—including benefits and perceived barriers—around the use of long-acting injectable antipsychotics in the context of telepsychiatry services.