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FDA Issues Complete Response Letter to Otsuka and Lundbeck for PTSD Treatment

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FDA Issues Complete Response Letter to Otsuka and Lundbeck for PTSD Treatment

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Otsuka Holdings Co ( (JP:4578) ) has provided an update.

Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S have received a Complete Response Letter from the U.S. FDA for their supplemental New Drug Application for REXULTI in combination with sertraline for treating PTSD in adults. The FDA’s decision indicates that the application lacks substantial evidence of effectiveness, impacting Otsuka’s efforts to expand its product offerings in the mental health sector.

The most recent analyst rating on (JP:4578) stock is a Buy with a Yen8975.00 price target. To see the full list of analyst forecasts on Otsuka Holdings Co stock, see the JP:4578 Stock Forecast page.

More about Otsuka Holdings Co

Otsuka Holdings Co., Ltd. operates in the pharmaceutical industry, focusing on the development and sale of innovative medical products. The company is known for its work in mental health, with a particular emphasis on psychiatric and neurological disorders.

YTD Price Performance: -4.53%

Average Trading Volume: 1,289,403

Technical Sentiment Signal: Strong Buy

Current Market Cap: Yen4294.8B

See more insights into 4578 stock on TipRanks’ Stock Analysis page.

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