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- Cingulate Inc filed for an IPO, penciling in a modest $58 million raise, and expects to list on NASDAQ under CING ticker.
- Cingulate has a Phase 3-ready attention deficit hyperactivity disorder (ADHD) program in addition to a follow-up candidate soon to enter human trials and a third program in preclinical development for anxiety.
- The company says in its S-1 filing that most ADHD meds currently approved are stimulants taken in the morning with quick-acting effects, leaving patients needing additional pills in the afternoon after they experience a "crash."
- Cingulate's lead candidate, CTx-1301, is designed to slowly release its active ingredients in three phases throughout the day.
- The first portion is an immediate release, accounting for about 35% of the total medicine contained in the pill, and is delivered over 30 minutes.
- After three to four hours, the second part comprises 45% of the total and is delivered over 90 minutes.
- These first two release schedules are comparable to some meds on the market, such as Focalin, Cingulate says, but CTx-1301 has a third timed-release built-in as a "booster," making up the remaining 20%.
- This booster releases about seven hours after taking the pill and enters the bloodstream over the following 30 minutes.
- The company plans to initiate Phase 3 trials in Q4 of 2021 and file a marketing application to the FDA in 1H of 2023.
- If approved, both CTx-1301 and CTx-1302 will compete against methylphenidate and amphetamine products to treat ADHD.
- The currently available products include Johnson & Johnson (NYSE:JNJ) owned Janssen's Concerta, Novartis AG's (NYSE:NVS) Focalin XR, and Takeda Pharmaceutical Co Ltd's (NYSE:TAK) Adderall XR and Vyvanse, which will lose exclusivity in 2023.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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