Brexpiprazole

Intra-Cellular Therapies seeks FDA approval for Caplyta as an adjunct treatment for major depressive disorder (MDD), potentially expanding its market to over $1 billion. Caplyta, already approved for schizophrenia and bipolar disorder, saw Q3 sales of $175 million, with Q4 projections at least $193 million. The MDD submission is based on Phase III trials showing symptom improvement when paired with an antidepressant. Jefferies estimates a 90–95% approval likelihood, predicting a company valuation of $9–12 billion. Intra-Cellular is also exploring Caplyta for autism and developing ITI-214 for Parkinson’s and ITI-333 for opioid use.

New treatments like COMP360, Zuranolone, LY03005, REL-1017, Seltorexant, and ABV-1504 are expected to significantly transform the major depressive disorder (MDD) market. MDD affects 44 million diagnosed cases in the 7MM, with moderate cases being the most prevalent. Treatment approaches include pharmacological interventions, psychotherapy, and lifestyle changes. The market size for MDD is projected to grow from USD 7.1 billion in 2023, driven by disease awareness and new product launches.

Lundbeck aims to deliver four new molecular entities in phase 3 trials by 2026, including an epilepsy drug from its $2.6 billion Longboard Pharma acquisition. Rexulti and Vyepti will drive mid-single-digit revenue growth through 2027, accounting for nearly two-thirds of Lundbeck's revenues. The pipeline includes amlenetug for multiple system atrophy, Lu AG09222 for migraine prevention, Lu AG13909 for Cushing's disease and congenital adrenal hyperplasia, and bexicaserin for rare forms of epilepsy. Lundbeck anticipates peak sales of $1.5 billion to $2 billion for bexicaserin if approved for multiple developmental and epileptic encephalopathies. The company is preparing for the loss of market exclusivity for antidepressant Trintellix/Brintellix in 2026 and targets two to three new product launches before 2030. Lundbeck will write down part of the book value of its 2018 Abide Therapeutics acquisition due to the failure of an early-stage candidate.