Karuna Therapeutics reports Q3 EPS ($3.16), consensus ($2.74)

Reports no Q3 revenue, consensus $1.25M. The company expects that current cash, cash equivalents, and available-for-sale investment securities of $1.3B as of September 30, 2023, will enable the Company to fund its operating expenses and capital expenditure requirements through 2026. “Q3 was highlighted by our NDA submission to the FDA for KarXT for the treatment of schizophrenia, a significant milestone for Karuna, as well as for patients living with this serious mental illness,” said CEO Bill Meury. “There remains an unmet need for new treatment options and, if approved, KarXT would represent the first novel pharmacological approach to treating schizophrenia in decades. In parallel to our submission, we continue to advance our commercialization plans ahead of the potential approval and launch of KarXT in the U.S. in the second half of next year. Additionally, we have made important progress across our ongoing KarXT Phase 3 programs, highlighted by the initiation of the ADEPT-2 and ADEPT-3 trials in psychosis in Alzheimer’s disease. Beyond our primary indications in schizophrenia and Alzheimer’s disease, we’re also focused on building our pipeline with potential new opportunities for KarXT, as well as advancing other early-stage compounds across a broad range of neuropsychiatric conditions.”