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Biotech Stocks Facing FDA Decision in January 2018

Sucampo Pharmaceuticals
Sucampo Pharmaceuticals

Sucampo Pharmaceuticals Inc.’s (SCMP) supplemental New Drug Application seeking approval of AMITIZA in children aged 6 to 17 years with pediatric functional constipation is under priority review by the FDA, with a decision expected on January 28, 2018.

If approved, AMITIZA would be the first and only prescription medication specifically for these pediatric patients, who currently have limited options to address their underlying functional constipation, according to the Company.

AMITIZA is already approved for the treatment of chronic idiopathic constipation (CIC) in adults, irritable bowel syndrome with constipation (IBS-C) in adult women and opioid-induced constipation (OIC) in adults suffering from chronic non-cancer related pain.

Sucampo has collaboration and license agreement covering the United States and Canada for AMITIZA with Takeda Pharmaceutical Company Ltd. Mylan has the rights to commercialize AMITIZA in Japan.

On December 26, 2017, the Company inked an agreement to be acquired by Mallinckrodt plc (MNK) for $18.00 per share, or a total value of about $1.2 billion.

SCMP closed Tuesday’s (Dec.26) trading at $18.00, up 5%.