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Cingulate Inc. Receives Buy Rating: PDUFA Fee Waiver and Competitive Edge of CTx-1301 Boost Market Prospects

Cingulate Inc. Receives Buy Rating: PDUFA Fee Waiver and Competitive Edge of CTx-1301 Boost Market Prospects

Cingulate Inc, the Healthcare sector company, was revisited by a Wall Street analyst yesterday. Analyst Naz Rahman from Maxim Group reiterated a Buy rating on the stock and has a $8.00 price target.

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Naz Rahman has given his Buy rating due to a combination of factors that highlight Cingulate Inc.’s promising prospects. A significant factor is the recent PDUFA fee waiver from the FDA, valued at approximately $4.3 million, which facilitates the company’s first NDA filing for its lead asset, CTx-1301, aimed at treating ADHD. This waiver not only reduces financial burdens but also accelerates the pathway to potential market entry.
Another critical aspect influencing the Buy rating is the competitive edge demonstrated by CTx-1301 in clinical studies, showcasing best-in-class onset and duration for ADHD treatment. The drug’s ability to be administered once daily without the need for boosters, coupled with its compatibility with food, enhances its commercial appeal, especially amid current stimulant shortages. Additionally, the FDA’s indication that existing data is sufficient for NDA filing further strengthens the company’s position, as it allows Cingulate to leverage existing data packages, expediting the approval process without extensive additional trials.

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