Adam Lenkowsky, chief commercial officer for Bristol Myers Squibb Co. (BMS), said his firm plans to launch Karxt (xanomeline-trospium) in the U.S. as soon as it’s approved by the U.S. FDA, and “expect[s] to accumulate sales in early 2025.” BMS tied a bow on the year by disclosing its plan to pay $330 per share to take over Karuna Therapeutics Inc. in a deal valued at $14 billion to bring aboard Karxt, which acts as a dual M1/M4 muscarinic acetylcholine receptor agonist. The FDA has assigned Sept. 26, 2024, as the PDUFA date for Karxt as a new treatment for schizophrenia in adults.
The pivotal phase III study of brilaroxazine from Reviva Pharmaceuticals Holdings Inc. for adults with schizophrenia hit its primary endpoint and two key secondary endpoints, following positive phase II data in 2021. The serotonin-dopamine signaling modulator, the company’s lead candidate, is a once-daily treatment. Results from the study showed brilaroxazine demonstrated reductions in all major symptom domains for the patients and the secondary endpoints at week 4 when comparing the 50-mg dose with placebo.
In a race with Karuna Therapeutics Inc. to get its schizophrenia drug to market, Cerevel Therapeutics Holdings Inc. has priced an underwritten public offering at $22.81 per share. The offering is worth of about $450 million, with the company estimating sales of the 19.7 million shares will yield net proceeds of about $433.6 million.
Just days after Karuna Therapeutics Inc. reported positive data from a third registrational trial of Karxt (xanomeline plus trospium) in schizophrenia, Puretech Health plc sold a portion of its royalty in Karxt in a potential $500 million agreement with Royalty Pharma. Puretech was a founder of Karuna and co-inventor of Karxt, an oral M1/M4-preferring muscarinic agonist.
With phase III data in hand from the Emergent-3 study of Karxt (xanomeline plus trospium) in adults with schizophrenia, Karuna Therapeutics Inc. continues to target mid-2023 for an NDA submission to the U.S. FDA. The 256-subject trial met its primary endpoint, with Karxt turning up a statistically significant and clinically meaningful 8.4-point reduction in Positive and Negative Syndrome Scale total score compared to placebo at the fifth week.
The $60.8 billion collected by biopharma companies throughout 2022 is a sharp drop from each of the two prior years, down by 48.6% from 2021 and 54.8% from 2020. Each were standout years by any measure and a direct result of the investment fervor for the industry brought on by the COVID-19 pandemic. That exuberance diminished in the last year as investors tightened their grips due to economic uncertainties.
Alkermes plc’s recent update on sales of the schizophrenia drug Lybalvi (also indicated for bipolar I disorder) along with positive phase III data from Karuna Therapeutics Inc. from tests of Karxt (xanomeline plus trospium) shone more light on the troublesome indication, where Cerevel Therapeutics Holdings Inc. is advancing emraclidine in what could be a registrational phase II study.
Shares in Karuna Therapeutics Inc. soared Aug. 8 as the biotech moved closer to a breakthrough for schizophrenia therapy after its potential first-in-class drug Karxt (xanomeline + trospium) met its goals in a closely watched phase III trial. Analysts said results from the Emergent-2 trial were at the top end of what was expected, lifting Karuna’s shares (NASDAQ:KRTX) 71.8% to a 52-week high of $241.19.
With phase III data due from Karuna Therapeutics Inc. with its combo Karxt therapy for schizophrenia, interest is rising in the historically difficult space. Karxt pairs xanomeline, a muscarinic receptor agonist that preferentially stimulates M1 and M4 muscarinic receptors, with trospium, an approved muscarinic receptor antagonist that does not measurably cross the blood-brain barrier, confining its effects to peripheral tissues.
Zai Lab Ltd. and Blueprint Medicines Corp. have inked an exclusive collaboration and license agreement for the development and commercialization of two candidates for the potential treatment of patients with EGFR-driven non-small-cell lung cancer (NSCLC) in greater China, where Clarivate forecasts total NSCLC market sales are poised to grow from $3.2 billion in 2020 to $9.5 billion in 2030.