Cognition Therapeutics announced that it has reached the target enrollment of 540 participants in its randomized, placebo‑controlled Phase 2 START Study, a pivotal trial for the company’s lead Alzheimer’s candidate, zervimesine.
The START Study enrolls patients with mild cognitive impairment or early Alzheimer’s disease who are also receiving approved anti‑amyloid antibody therapy. Funded by an $81 million National Institute of Aging grant, the study’s completion of enrollment unlocks the data‑collection phase and positions Cognition to deliver safety and activity results to the FDA in upcoming End‑of‑Phase 2 meetings.
This milestone strengthens Cognition’s dementia portfolio and could accelerate the development of zervimesine, an oral small‑molecule sigma‑2 receptor antagonist that displaces toxic protein oligomers from neurons. By completing enrollment, the company gains a larger evidence base that may support regulatory approvals and attract partnership opportunities, while also demonstrating the ability to execute large‑scale trials in a competitive therapeutic space.
Lisa Ricciardi, Cognition’s president and CEO, said the enrollment numbers were driven by strong interest from patients and investigators, citing presentations of Phase 2 results at international conferences. She added that the company’s alignment with the FDA on a registrational path for zervimesine underscores the strategic importance of the START Study.
Cognition remains a clinical‑stage biopharma with zero revenue and ongoing losses, but it has a robust balance sheet supported by a $30 million registered direct offering completed in November 2025 and remaining grant funds. The company is working to regain Nasdaq compliance and expects the combined funding to provide runway into the second quarter of 2027.
Wall Street Zen upgraded Cognition from “sell” to “hold” on November 9, 2025, after the company beat earnings expectations by $0.06 versus an anticipated loss of $0.07. The upgrade reflects confidence in the company’s financial discipline and the progress of its clinical programs.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.