CGTX News & Events

Cognition Therapeutics announced that it received written feedback from the FDA following its recent meeting. The FDA agreed that psychosis associated with dementia with Lewy bodies could be an approvable outcome and reached alignment with the company on key aspects of a pivotal trial to support a new drug application, or NDA. The registrational program is expected to begin in mid-2027. As discussed with the FDA, Cognition expects the Phase 3 study will enroll people with DLB who experience psychosis symptoms of hallucinations and delusions. Patients receiving stable background treatment with off-label antipsychotic medications will be eligible. Following screening, participants will be randomized to receive either 100 mg of once-daily oral zervimesine or placebo for nine months. The company will work with the FDA on the analytical and statistical details for the use of the neuropsychiatric inventory as a novel primary endpoint for a pivotal trial in DLB psychosis.

Cognition Therapeutics announced that a notice of allowance has been received from the United States Patent and Trademark Office, or USPTO, for patent application 19/563,468. The allowed patent covers a polymorphic crystalline form of zervimesine. Once issued, the patent will provide protection for this key formulation through 2045 and, if granted a standard five-year extension, could offer protection through 2050.

Cognition Therapeutics conducted a planned meeting with the FDA on May 20. The objective of this meeting was to review results from the Phase 2 study of zervimesine and discuss the design and endpoints of a registrational study in dementia with Lewy bodies patients with psychosis. Lisa Ricciardi, president and CEO of Cognition, stated, "Yesterday we held a productive meeting with the FDA. The agency and we discussed the results from our Phase 2 COG1201 'SHIMMER' Study in DLB and our proposed plan to advance zervimesine into a registrational program. We believe we have a path forward for the development of zervimesine for the treatment of DLB psychosis. We look forward to reviewing the FDA's formal minutes in June."

"We filed a request to meet with the Food and Drug Administration's Division of Psychiatry to discuss our plans for a registrational study in people with dementia with Lewy body psychosis," stated Lisa Ricciardi, Cognition's president and CEO. "We recently received our meeting invitation for May 20, 2026 and we are looking forward to a productive conversation so we can continue to move zervimesine forward in this important indication."