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Biotech Stocks Facing FDA Decision In May 2019

Acacia Pharma Group
Acacia Pharma Group

Acacia Pharma Group plc’s BARHEMSYS is at the FDA altar, with a decision expected on May 5, 2019.

BARHEMSYS, proposed for post-operative nausea & vomiting, was turned down by the U.S. regulatory agency last October due to deficiencies relating to the pre-approval inspection of the contract facility employed to manufacture amisulpride, the active pharmaceutical ingredient in BARHEMSYS.

Addressing the FDA’s concerns, the Company resubmitted the New Drug Application for BARHEMSYS in November 2018, and now awaits the decision.

The Company’s shares are listed on Euronext Brussels.

ACPH.BR closed Thursday’s trading at EUR 3.53, up 3.07%.