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ANI Pharma Shares Take Flight as FDA Approves Return of Cortrophin Gel

By Colin Kellaher

 

Shares of ANI Pharmaceuticals Inc. surged more than 45% on Monday after pharmaceutical company received U.S. Food and Drug Administration approval to reintroduce its Cortrophin Gel to the U.S. market.

The Baudette, Minn., company said the FDA approved the product for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis and rheumatoid arthritis, in addition to excess urinary protein due to nephrotic syndrome.

The FDA first gave the green light to Cortrophin Gel in 1954, and the product, which was last used in patients in the 1980s, has more than 54 indications on its previously approved label.

ANI acquired Cortrophin Gel from Merck & Co. in early 2016 and spent more than $100 million to re-establish the product. The company last year filed for FDA approval to reintroduce it to the U.S. market, but the agency turned the application away, citing concerns related to chemistry, manufacturing and controls section.

ANI, which resubmitted its application to the FDA in June, said it plans full-scale commercial launch of the drug, a potential competitor to Mallinckrodt PLC's Acthar Gel, by early next year.

ANI shares were recently up 46.3% to $54.68 after hitting a 52-week high of $58.14 early in the session.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

November 01, 2021 10:29 ET (14:29 GMT)

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