Tag Archive for: Karuna Therapeutics

Recent M&A activity indicates a potential resurgence in the appetites of larger companies for psychiatric drug development, but experts say the space may not offer a sufficient risk-reward proposition for R&D.

Two biotechs, Nvelop Therapeutics and Seaport Therapeutics, emerged from stealth Tuesday with $100 million in financing as they look to target the neuropsychiatric and gene editing spaces, respectively.

Bristol Myers Squibb on Saturday unveiled interim data from the Phase III open-label EMERGENT-4 study, showing that the investigational antipsychotic KarXT (xanomeline and trospium) can elicit significant and sustained symptom improvement in patients with schizophrenia.

The shareholder is seeking to prevent the transaction and is alleging that Karuna’s directors had failed to disclose crucial material information regarding the company’s financial projections and sales processes, according to a case summary from Law.com. The plaintiff also claims that the defendants have conflicts of interests.

The acquisition announced on Friday will give Bristol Myers Squibb ownership of Karuna Therapeutics’ investigational antipsychotic KarXT, which is being tested for schizophrenia and Alzheimer’s disease psychosis.

The regulator accepted Karuna Therapeutics’ NDA and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.

Despite positive results Monday from a Phase III trial of KarXT (xanomeline-trospium) and analysts’ recommendations to buy, Karuna Therapeutics’ stock dropped more than 19% in 48 hours this week.

Among updates from several pharma companies, Sanofi CEO Paul Hudson presented the company’s outlook for the new year, highlighting upcoming milestones and achievements that mark what he called the “new Sanofi.” 

Boston biopharma Karuna Therapeutics appointed Bill Meury as its new president and chief executive officer, succeeding its current head, Steve Paul, the company announced Tuesday. Meury starts on Jan. 3, 2023.

On Monday, Boston biopharma Karuna Therapeutics released results from the Phase III EMERGENT-2 trial showing that KarXT (xanomeline-trospium), its lead candidate, can strongly reduce symptom severity in schizophrenia patients.