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Cingulate nears NDA resubmission for ADHD drug CTx-1301, expects FDA review by early 2027

Company Fundamentals
13 Nov 2026, 23:45 WIB
GlobeNewsWire
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Neutral
Cingulate nears NDA resubmission for ADHD drug CTx-1301, expects FDA review by early 2027

Cingulate Inc. has substantially completed manufacturing work to address FDA requests for its ADHD drug CTx-1301 and plans to resubmit the new drug application between December 2026 and January 2027. The FDA previously issued a Complete Response Letter requesting additional manufacturing information but raised no safety or efficacy concerns. The company reported a net loss of $7.7 million for Q3 2026 and has $23.2 million in cash, expecting to fund operations into mid-2027. The resubmission could lead to FDA review within two to six months, advancing Cingulate's goal to bring a next-generation ADHD treatment to market.

Cingulate Inc.'s Q3 2026 financial results and regulatory update provide context for health sector trends. For readers following health stocks, here is Pluang's market snapshot as of Nov 14, 2026 04:11 WIB: out of 150 priced US health-sector stocks, 71 rose and 75 fell. Notable movers include Alnylam Pharmaceuticals at USD 165.74 with a 5.80% increase and Canopy Growth Corp at USD 0.57 down 5.79%.

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