Aquestive Therapeutics shares slip after FDA rejects Parkinson's drug from licensee Sunovion Pharmaceuticals

Shares of Aquestive Therapeutics Inc (NASDAQ:AQST) took a hit Thursday after the Food and Drug Administration rejected a new drug application (NDA) from its licensee Sunovion Pharmaceuticals for its experimental drug to treat symptoms of Parkinson’s disease.

Upon review of the application, the FDA decided it is unable to approve the NDA for apomorphine sublingual film (APL-130277) in its present form. The agency requested additional information and analyses, but no new clinical studies.

In response, investors sent Aquestive shares down 9.9% to $6.44 in afternoon trading.

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The drug’s rejection prompted Keith Kendall, CEO of Aquestive, to weigh the value of its intellectual property license with Sunovion.

“While APL-130277 is not an Aquestive pipeline program, it remains indicative of the future value in our intellectual property license with Sunovion. We will continue to proactively engage in opportunities to monetize all of our passive assets,” Kendall said in a statement.

For its part, the management at Sunovion said it is still looking to win approval from US regulators for APL-130277.

“Sunovion remains committed to working with the FDA to address its requests so that we can bring apomorphine sublingual film to patients as expeditiously as possible,” said Dr. Antony Loebel, Sunovion’s chief medical officer.

APL-130277, which consists of apomorphine and a dopamine agonist, is being developed for the management of OFF episodes associated with Parkinson’s disease. These episodes occur when tremors, stiffness and other symptoms of Parkinson’s resurface.

Apomorphine, the key drug in APL-130277, has already gotten the green light from the FDA in an injectable form.

Sunovion is based in Marlborough, Massachussetts and is a subsidiary of the Japanese pharmaceutical company Sumitomo Dainippon Pharma Group. Headquartered in Warren, New Jersey, Aquestive Therapeutics specializes in drugs to treat central nervous system conditions.

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors