Assertio Therapeutics Provides Regulatory Update on Long-Acting Cosyntropin
Assertio Holdings, Inc. (ASRT)
Last assertio holdings, inc. earnings: 3/9 04:02 pm
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Source: GlobeNewswire
LAKE FOREST, Ill., Oct. 21, 2019 (GLOBE NEWSWIRE) -- Assertio Therapeutics, Inc. (NASDAQ: ASRT), today announced that its development partner West Therapeutic Development, LLC (West) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for its injectable formulation of long-acting cosyntropin (synthetic adrenocorticotropic hormone, or ACTH). West is seeking approval for use as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency. The primary focus of the CRL relates to the FDA determination that certain pharmacodynamic parameters were not adequately achieved. “West and Assertio will work together to determine how best to address the CRL,” said Arthur Higgins, President and CEO of Assertio. “In the meantime, we continue to focus on driving robust adjusted EBITDA performance and generating strong cash flows.” Long-acting cosyntropin is an alcohol-free formulation of
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News
- Assertio Holdings, Inc. Appoints Mark Reisenauer to Its Board of Directors [Yahoo! Finance]Yahoo! Finance
- Assertio Holdings, Inc. Appoints Mark Reisenauer to Its Board of DirectorsGlobeNewswire
- Assertio Holdings, Inc. (NASDAQ: ASRT) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $4.00 price target on the stock.MarketBeat
- Assertio Announces Results of Rolvedon® (eflapegrastim-xnst) injection Same-Day Dosing Clinical StudyGlobeNewswire
- Assertio Holdings, Inc. Appoints Paul Schwichtenberg to New CTO Role, Mary Pietryga as CCO [Yahoo! Finance]Yahoo! Finance
ASRT
Earnings
- 11/11/24 - Beat
ASRT
Sec Filings
- 12/17/24 - Form 8-K
- 11/19/24 - Form 4
- 11/15/24 - Form 4
- ASRT's page on the SEC website