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ANI PHARMACEUTICALS, INC.

(ANIP)
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ANI Pharmaceuticals : FDA Accepts Application for Cortrophin Gel Revival

08/31/2021 | 06:53am EST

By Colin Kellaher

ANI Pharmaceuticals Inc. on Tuesday said the U.S. Food and Drug Administration has accepted its application to reintroduce its Cortrophin Gel treatment for patients with chronic auto-immune disorders.

The Baudette, Minn., pharmaceutical company said the agency set a target action date of Oct. 29 for the potential competitor to Mallinckrodt PLC's Acthar Gel.

The FDA originally approved Cortrophin Gel in 1954, but it was last used in patients in the 1980s. The product has more than 54 indications on its previously approved label, including the treatment of acute exacerbations of multiple sclerosis, rheumatoid arthritis and nephrotic syndrome.

ANI, which acquired Cortrophin Gel from Merck in early 2016 and spent more than $100 million to re-establish the product, last year filed for FDA approval to reintroduce it to the U.S. market.

However, the agency turned the application away, citing concerns related to chemistry, manufacturing and controls section. ANI resubmitted the application in June.

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

(END) Dow Jones Newswires

08-31-21 0853ET

Stocks mentioned in the article
ChangeLast1st jan.
ANI PHARMACEUTICALS, INC. 3.68% 42.61 Delayed Quote.41.67%
MALLINCKRODT PLC 0.52% 0.195 Delayed Quote.-22.71%
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Financials (USD)
Sales 2021 212 M - -
Net income 2021 -20,3 M - -
Net Debt 2021 247 M - -
P/E ratio 2021 -47,0x
Yield 2021 -
Capitalization 498 M 498 M -
EV / Sales 2021 3,52x
EV / Sales 2022 2,30x
Nbr of Employees 369
Free-Float 76,9%
Chart ANI PHARMACEUTICALS, INC.
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ANI Pharmaceuticals, Inc. Technical Analysis Chart | ANIP | US00182C1036 | MarketScreener
Technical analysis trends ANI PHARMACEUTICALS, INC.
Short TermMid-TermLong Term
TrendsNeutralBullishBullish
Income Statement Evolution
Consensus
Sell
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Mean consensus OUTPERFORM
Number of Analysts 3
Last Close Price 41,14 $
Average target price 61,67 $
Spread / Average Target 49,9%
EPS Revisions
Managers and Directors
Nikhil Lalwani President, Chief Executive Officer & Director
Stephen P. Carey Chief Financial Officer, Secretary & VP
Patrick D. Walsh Chairman
James G. Marken Senior VP-Operations & Product Development
Robert E. Brown Independent Director
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