Acorda Therapeutics craters 24% premarket as FDA rejects Parkinson's application [MarketWatch]
Acorda Therapeutics, Inc. (ACOR)
Last acorda therapeutics, inc. earnings: 2/13 07:00 am
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Source: MarketWatch
UPDATE: Acorda Therapeutics shares crater 26% premarket after FDA rejects application for Parkinson's treatment Acorda Therapeutics Inc. shares ACOR, +2.19% slid 26% premarket Tuesday, after the company said it has received a Refusal to File letter from the U.S. Food and Drug Administration regarding its new drug application for inbrija, an investigational treatment for symptoms of Parkinson's disease. The FDA said the NDA was not complete enough to permit a substantive review. Specifically, it questioned the date by which the manufacturing site would be ready for inspection, as well as the submission of the drug master production record. The company said it will seek a meeting with the FDA and that it believes the issues can be addressed. "We will work with the FDA as quickly as possible to address the open issues and to clarify the path to successfully re-file our application," Chief Executive Ron Cohen said in a statement. "We remain confident in INBRIJA's data package and its p
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ACOR
News
- Acorda Therapeutics, Inc. (NASDAQ: ACOR) is now covered by analysts at StockNews.com. They set a "buy" rating on the stock.MarketBeat
- Acorda Therapeutics, Inc. (NASDAQ: ACOR) is now covered by analysts at StockNews.com. They set a "buy" rating on the stock.MarketBeat
- Acorda Therapeutics Announces Nasdaq Delisting Notification [Yahoo! Finance]Yahoo! Finance
- Acorda Therapeutics Announces Nasdaq Delisting NotificationBusiness Wire
- CALM,PLAY and VNDA are among after hour movers [Seeking Alpha]Seeking Alpha
ACOR
Sec Filings
- 4/4/24 - Form 8-K
- 3/13/24 - Form 8-K
- ACOR's page on the SEC website