ANI Announces FDA Acceptance of Supplemental Filing for Cortrophin® Gel 80 U/mL
ANI Pharmaceuticals, Inc. (ANIP)
Last ani pharmaceuticals, inc. earnings: 2/27 08:30 am
Check Earnings Report
US:NASDAQ Investor Relations:
anipharmaceuticals.com/investors_corporate_profile.php
Company Research
Source: PR Newswire
BAUDETTE, Minn., April 13, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that the U.S. Food & Drug Administration ("FDA") has accepted its supplemental new drug application ("sNDA") for Purified Cortrophin® Gel (Repository Corticotropin Injection USP) (80 U/mL). The FDA set a PDUFA goal date of July 23, 2020.Arthur Przybyl, ANI's President and CEO commented, "The acceptance of our filing with a confirmed four-month goal date is an important milestone in our re-commercialization effort for this drug. Notably, in the letter, FDA acknowledged our stated objective of lowering the cost of this drug. We are prepared to immediately launch Cortrophin® Gel in July if FDA approves our filing at that time. We look forward to introducing a new treatment option for patients and physicians and much needed competition into the market."The current annual market for repository corticotropin injection 80 U/ml is $950 million and has only one competitor. Abou
Show less
Read more
Impact Snapshot
Event Time:
ANIP
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
ANIP alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
ANIP alerts
High impacting ANI Pharmaceuticals, Inc. news events
Weekly update
A roundup of the hottest topics
ANIP
News
- ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) is now covered by analysts at HC Wainwright. They set a "buy" rating and a $84.00 price target on the stock.MarketBeat
- ANI Pharmaceuticals to Participate at Leerink Partners Therapeutics Forum: I&I and Metabolism on July 8thGlobeNewswire
- The Top 5 Analyst Questions From ANI Pharmaceuticals's Q1 Earnings Call [Yahoo! Finance]Yahoo! Finance
- ANI Pharmaceuticals Announces Presentation of New Preclinical DataGlobeNewswire
- ANI Pharmaceuticals to Present at the 2025 Jefferies Global Healthcare Conference [Yahoo! Finance]Yahoo! Finance
ANIP
Earnings
- 5/9/25 - Beat
ANIP
Sec Filings
- 7/11/25 - Form S-8
- 7/11/25 - Form S-8
- 6/16/25 - Form 4
- ANIP's page on the SEC website