http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Tue, 02 Jun 2026 08:01:09 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/Corporate+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html <p>Cingulate Inc. (NASDAQ: CING) received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder, according to a company statement.</p><p>The FDA response identified specific Chemistry, Manufacturing and Controls information requests and did not raise concerns regarding the clinical safety or efficacy of CTx-1301, the company said. CTx-1301 is a once-daily tablet containing dexmethylphenidate HCl that uses Cingulate's Precision Timed Release platform to deliver three timed releases of medication throughout the day.</p><p>"We are encouraged that the FDA's response was limited to specific information requests related to CMC http://www.streetinsider.com/Corporate+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html Tue, 02 Jun 2026 08:01:09 -0400 CING CINGW http://www.streetinsider.com/Corporate+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html <p>Cingulate Inc. (NASDAQ: CING) received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder, according to a company statement.</p><p>The FDA response identified specific Chemistry, Manufacturing and Controls information requests and did not raise concerns regarding the clinical safety or efficacy of CTx-1301, the company said. CTx-1301 is a once-daily tablet containing dexmethylphenidate HCl that uses Cingulate's Precision Timed Release platform to deliver three timed releases of medication throughout the day.</p><p>"We are encouraged that the FDA's response was limited to specific information requests related to CMC http://www.streetinsider.com/Corporate+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html Tue, 02 Jun 2026 08:01:09 -0400 CING CINGW http://www.streetinsider.com/FDA/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html <p>Cingulate Inc. (NASDAQ: CING) received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder, according to a company statement.</p><p>The FDA response identified specific Chemistry, Manufacturing and Controls information requests and did not raise concerns regarding the clinical safety or efficacy of CTx-1301, the company said. CTx-1301 is a once-daily tablet containing dexmethylphenidate HCl that uses Cingulate's Precision Timed Release platform to deliver three timed releases of medication throughout the day.</p><p>"We are encouraged that the FDA's response was limited to specific information requests related to CMC http://www.streetinsider.com/FDA/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html Tue, 02 Jun 2026 08:01:09 -0400 CING CINGW http://www.streetinsider.com/FDA/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html <p>Cingulate Inc. (NASDAQ: CING) received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder, according to a company statement.</p><p>The FDA response identified specific Chemistry, Manufacturing and Controls information requests and did not raise concerns regarding the clinical safety or efficacy of CTx-1301, the company said. CTx-1301 is a once-daily tablet containing dexmethylphenidate HCl that uses Cingulate's Precision Timed Release platform to deliver three timed releases of medication throughout the day.</p><p>"We are encouraged that the FDA's response was limited to specific information requests related to CMC http://www.streetinsider.com/FDA/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html Tue, 02 Jun 2026 08:01:09 -0400 CING CINGW http://www.streetinsider.com/Hot+Corp.+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html <p>Cingulate Inc. (NASDAQ: CING) received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder, according to a company statement.</p><p>The FDA response identified specific Chemistry, Manufacturing and Controls information requests and did not raise concerns regarding the clinical safety or efficacy of CTx-1301, the company said. CTx-1301 is a once-daily tablet containing dexmethylphenidate HCl that uses Cingulate's Precision Timed Release platform to deliver three timed releases of medication throughout the day.</p><p>"We are encouraged that the FDA's response was limited to specific information requests related to CMC http://www.streetinsider.com/Hot+Corp.+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html Tue, 02 Jun 2026 08:01:09 -0400 CING CINGW http://www.streetinsider.com/Hot+Corp.+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html <p>Cingulate Inc. (NASDAQ: CING) received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder, according to a company statement.</p><p>The FDA response identified specific Chemistry, Manufacturing and Controls information requests and did not raise concerns regarding the clinical safety or efficacy of CTx-1301, the company said. CTx-1301 is a once-daily tablet containing dexmethylphenidate HCl that uses Cingulate's Precision Timed Release platform to deliver three timed releases of medication throughout the day.</p><p>"We are encouraged that the FDA's response was limited to specific information requests related to CMC http://www.streetinsider.com/Hot+Corp.+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html Tue, 02 Jun 2026 08:01:09 -0400 CING CINGW http://www.streetinsider.com/Hot+FDA+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html <p>Cingulate Inc. (NASDAQ: CING) received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder, according to a company statement.</p><p>The FDA response identified specific Chemistry, Manufacturing and Controls information requests and did not raise concerns regarding the clinical safety or efficacy of CTx-1301, the company said. CTx-1301 is a once-daily tablet containing dexmethylphenidate HCl that uses Cingulate's Precision Timed Release platform to deliver three timed releases of medication throughout the day.</p><p>"We are encouraged that the FDA's response was limited to specific information requests related to CMC http://www.streetinsider.com/Hot+FDA+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html Tue, 02 Jun 2026 08:01:09 -0400 CING CINGW http://www.streetinsider.com/Hot+FDA+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html <p>Cingulate Inc. (NASDAQ: CING) received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application for CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder, according to a company statement.</p><p>The FDA response identified specific Chemistry, Manufacturing and Controls information requests and did not raise concerns regarding the clinical safety or efficacy of CTx-1301, the company said. CTx-1301 is a once-daily tablet containing dexmethylphenidate HCl that uses Cingulate's Precision Timed Release platform to deliver three timed releases of medication throughout the day.</p><p>"We are encouraged that the FDA's response was limited to specific information requests related to CMC http://www.streetinsider.com/Hot+FDA+News/FDA+issues+complete+response+letter+for+Cingulate%27s+ADHD+drug+CTx-1301/26587805.html Tue, 02 Jun 2026 08:01:09 -0400 CING CINGW http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Press+Releases/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795 http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html <p align="center"><em>No Clinical Safety or Efficacy Concerns Currently Identified </em><br/><em>Agency Feedback Primarily Focused on CMC-Related Requests</em><br/><em>Company Plans Prompt Response and Submission of Requested Information</em><br/><em>Company is Well Capitalized with Nearly $30 Million Cash on Hand</em></p> <p align="left">KANSAS CITY, Kan., June 02, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter for its New Drug Application (“NDA”) for CTx-1301 (dexmethylphenidate HCl) for the treatment of http://www.streetinsider.com/Globe+Newswire/Cingulate+Receives+Complete+Response+Letter+from+FDA+for+CTx-1301/26587673.html Tue, 02 Jun 2026 08:00:00 -0400 A.06822034 A.14320728 A.23650007 CING CINGW O.20026344 O.20250741 O.41161166 O.52480795