NEUROCRINE BIOSCIENCES, INC.

Seltorexant, a potent, selective orexin-2 receptor antagonist, improved symptoms of major depressive disorder (MDD) and insomnia in a phase III trial. The study drug, when combined with current antidepressant treatment, showed a significant reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo. Seltorexant is unique as it targets only OX2 receptors, potentially filling an unmet need for new therapies for MDD and insomnia.

AbbVie, a pharmaceutical firm with strong immunology and oncology portfolios, is compared against key competitors in the Biotechnology industry. Analysis reveals AbbVie's PE ratio is low, suggesting potential undervaluation, while its high PB ratio indicates overvaluation based on book value. A low PS ratio implies undervaluation based on sales. AbbVie's high ROE, EBITDA, and gross profit highlight strong profitability and operational efficiency, but low revenue growth indicates challenges in market expansion.

Takeda Pharmaceutical Company Limited (NYSE: TAK), headquartered in Tokyo, is a global leader in pharmaceuticals, focusing on oncology, gastroenterology, neuroscience, rare diseases, and plasma-derived therapies. With a revenue of JPY 4.3 trillion in fiscal 2023, Takeda operates in 80 countries, with 50% of revenue from the US, 20% from Japan, and 20% from Europe and Canada. Notable collaborations include a joint venture with Astellas Pharma Inc. and Sumitomo Mitsui Banking Corporation for early drug discovery, and a partnership with Neurocrine Biosciences to develop NBI-1065845 for major depressive disorder.

Neurocrine Biosciences, Inc. amended and restated Kyle Gano's employment agreement, appointing him as President and CEO effective October 11, 2024. Gano will receive an annual base salary of $900,000 and is eligible for a 100% target bonus. He will also receive equity grants: stock options ($750,000), restricted stock units ($300,000), and performance-vesting restricted stock units ($450,000). Severance benefits include cash payments, continued health coverage, and accelerated vesting of equity awards under certain termination conditions.

Interim data from KINECT-HD2 study shows valbenazine (Ingrezza) is safe and effective for up to 1 year in treating Huntington disease chorea, with improvements in Total Maximal Score (TMC) observed from week 2 to week 50, regardless of antipsychotic use. The study involved 125 HD patients, with 95.2% reporting at least one treatment-emergent adverse event, and 13.6% discontinuing due to adverse events.

Neurocrine Biosciences' crinecerfont, targeting classic congenital adrenal hyperplasia (CAH), receives FDA Priority Review. If approved, it would be the first new CAH treatment in 70 years, offering a novel mechanism. CAH, caused by 21-hydroxylase gene mutations, affects hormone production in adrenal glands, with the US having the highest prevalence. Current treatments focus on managing symptoms, with EFMODY as the only approved drug in Europe. Emerging therapies like crinecerfont aim to normalize hormone levels and address the root cause of CAH.

Bristol Myers Squibb receives FDA approval for Cobenfy, a new antipsychotic drug for schizophrenia, the first in decades. Cobenfy, also known as KarXT, lacks warnings about increased mortality in elderly patients and common side effects like weight gain and movement disorders. Bristol Myers expects $2.5 billion in U.S. sales by 2030 and plans to launch the drug at $1,850 a month. The approval is based on studies showing significant symptom reduction, targeting cholinergic receptors instead of dopamine. Cobenfy's side effects include vomiting and nausea, and it is not recommended for patients with urinary retention or severe kidney/liver disease.

The FDA approved Cobenfy, a new antipsychotic medication for schizophrenia, developed by Karuna Therapeutics. Despite its efficacy in clinical trials, concerns about insurance coverage and high list price ($22,500/year) may limit patient access. Bristol Myers Squibb, which acquired Karuna, plans to expand Cobenfy's use to bipolar disorder and Alzheimer's agitation, with ongoing studies.

FDA approves Cobenfy, a new schizophrenia drug by Bristol-Myers Squibb, causing shares to rise 6% in premarket trade. Cobenfy represents the first new pharmacological approach for schizophrenia in 30 years.

The U.S. FDA approved Bristol Myers Squibb's schizophrenia drug, Cobenfy (KarXT), which reduces symptoms without common side effects, acquired through the $14 billion takeover of Karuna Therapeutics. Expected to generate $2.5 billion in U.S. sales by 2030, it targets cholinergic receptors, unlike traditional dopamine-targeting antipsychotics. Bristol plans to launch the drug in late October at $1,850 per month, with 80% of patients covered by Medicare and Medicaid.