ANI Pharmaceuticals Shares Rise After Earnings Report and FDA Approval

Nov 1, 2021 By MarketDepth

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FDA Approved

ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) stock jumped more than 40% on Monday after the pharma Company announced business highlights and financial results for the three months ended September 30, 2021. 

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According to the Company has accomplished important major milestone including FDA’s approval of the Company’s supplemental new drug application (sNDA) for Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) (Cortrophin Gel) 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 approval of Cortrophin Gel marks a critical milestone for ANI. During the past five years, we have made a significant investment in establishing and updating manufacturing processes and ensuring a sustainable, U.S.-based supply chain for this important product. Physicians now have a much-needed treatment option for patients with acute exacerbations of multiple sclerosis and rheumatoid arthritis, as well as nephrotic syndrome, who can benefit from a repository corticotropin. We have built an experienced rare disease leadership team to drive a full-scale commercial launch early in the first quarter of 2022.”

Nikhil Lalwani, President and CEO of ANI

ANI Pharmaceuticals, Inc., a specialty pharmaceutical company, develops, manufactures, and markets branded and generic prescription pharmaceuticals in the United States and Canada. It focuses on producing controlled substances, oncology products, hormones and steroids, and other formulations. The company manufactures oral solid dose products; semi-solids, liquids, and topicals; and potent products, as well as performs contract manufacturing for other pharmaceutical companies. 

“ANI is at an inflection point, having achieved critical milestones against key strategic pillars which we believe will deliver sustainable growth. Approval of the Cortrophin Gel sNDA enables ANI to serve patients in need and build new capabilities. In addition, we have delivered a strong third quarter in our base business, and the Novitium acquisition investment thesis is well on track, achieving ten new product approvals since March of 2021.”

Nikhil Lalwani, President and CEO of ANI