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Cinclus Pharma Holding AB ( (SE:CINPHA) ) just unveiled an update.
Cinclus Pharma has received a positive assessment from the US Food and Drug Administration on its nonclinical development plan for linaprazan glurate, its lead candidate for treating gastric acid-related diseases. The FDA stated that, based on current information, no additional toxicology studies are required ahead of a future New Drug Application.
The outcome streamlines Cinclus Pharma’s path toward completing the remaining clinical trials for linaprazan glurate and could accelerate timelines and reduce development costs. The company plans to continue its Phase III program and maintain close dialogue with the regulator, reinforcing its positioning as a late-stage contender in the treatment of severe gastroesophageal reflux disease.
The most recent analyst rating on (SE:CINPHA) stock is a Buy with a SEK60.00 price target. To see the full list of analyst forecasts on Cinclus Pharma Holding AB stock, see the SE:CINPHA Stock Forecast page.
More about Cinclus Pharma Holding AB
Cinclus Pharma Holding AB is a late-stage clinical pharmaceutical company focused on developing drugs for acid-related diseases and disorders of the upper gastrointestinal tract. Its lead candidate, linaprazan glurate, a prodrug of the P-CAB linaprazan originally developed by AstraZeneca, aims to treat severe gastroesophageal reflux disease more effectively than current proton pump inhibitors in a market affecting over 100 million adults in the US and EU.
Average Trading Volume: 43,939
Technical Sentiment Signal: Sell
Current Market Cap: SEK801.4M
For detailed information about CINPHA stock, go to TipRanks’ Stock Analysis page.