Intra-Cellular Looks to Raise $500M in Public Offering Following Phase III MDD Win

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Pictured: Nasdaq headquarters in New York City/iStock, JHVEPhoto

Following a victory in a late-stage major depressive disorder trial, Intra-Cellular Therapies is out to raise capital. The biopharma announced Thursday it is offering over 6.8 million shares at $73 a piece in a $500 million public offering. 

Tuesday, the company reported better-than-expected results from its Phase III trial of its antipsychotic drug Caplyta. Added to existing antidepressant regimens, Caplyta reduced patient’s Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo by 4.9 points at week six for patients suffering from major depressive disorder (MDD). The company had previously projected improvements of two to four points. 

Gross proceeds of $500 million are expected from the stock offering before deducting underwriting discounts and commissions and offering expenses. The announcement did not state what the funds will be used for. Caplyta is in an additional Phase III study for MDD, slated for a readout in the second quarter of 2024. 

MDD is a debilitating and chronic form of depression that seriously impairs a person’s ability to function in everyday life. The NIH estimates 21 million adults in the U.S. experience MDD each year, with nearly two-thirds of patients not experiencing an adequate response to current approved therapies. 

The MDD market is a target for biopharma with projected growth to $9.6 billion in over next five years. Multiple companies are eager to get into the space. 

Biogen and Sage Therapeutics tried to tap into it with its oral treatment. Zurzuvae (zuranolone) received FDA approval for postpartum depression, but the partners’ application for use in MDD was rejected with a complete response letter by the regulator last fall.  

A handful of companies launched Phase II trials this spring, including Arrivo BioVentures, Neurocrine Biosciences and Alto Neuroscience. Axsome Therapeutics initiated a Phase III trial of solriamfetol for MDD, randomizing 300 patients in a 1:1 ratio of treatment versus placebo for six weeks. The primary endpoint is the same as Intra-Cellular's—improvement to patients’ MADRS rating. 

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn. 

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