Another blow for Intra-Cellular

Strike two for Intra-Cellular Therapies’ lead asset, lumateperone. News that the US FDA had cancelled next week’s advisory committee meeting, which had been due to discuss the project in schizophrenia, has raised fears that an outright rejection could follow. It is possible that the agency will still givethe nod after reviewing new preclinical data submitted by Intra-Cellular, but approval by the September 27 PDUFA date now looks unlikely. This was far from a dead cert in any case given mixed phase III results in this disorder. It is also unclear whether the additional data, which were requested by the FDA, relate to toxicity concerns raised in 2017 following findings in a dog study. Leerink analysts contended yesterday that these issues had already been addressed, and the sellside’s firefighting efforts helped Intra-Cellular’s stock rebound 9% this morning after crashing 32% yesterday. Still, yesterday’s announcement came hot on the heels of disappointing data with lumateperone in bipolar depression, and the group’s stock is trading at an all-time low – understandable given the company’s reliance on the project. Intra-Cellular looks unlikely to recover, in the short term at least, unless it gets some good news with lumateperone.

Lumateperone heavy: Intra-Cellular's pipeline
Project Mechanism Indication/status 2024e sales ($m)
Lumateperone Serotonin antagonist & dopamine modulator Schizophrenia (filed) 703
Bipolar depression (phase III reported) 416
Other neurological indications (phase I) 3
ITI-214  PDE1 inhibitor Parkinson’s disease (phase I/II) 90
Heart failure (phase I/II)
ITI-333 Serotonin, dopamine & mu opioid receptor modulator Opioid/substance use disorders, pain & mood disorders (preclinical) 25
Source: EvaluatePharma, company website.

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