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Kangio FDA Approval

Key Takeaway: The press release discusses forward-looking statements regarding Kangio's FDA approval and associated risks, emphasizing uncertainties in market acceptance and regulatory compliance.

Market Sentiment Analysis

CONCERNS & RISKS

  • forward-looking statements are subject to risks and uncertainties
  • actual results may differ materially
  • uncertainties regarding FDA approval
  • potential difficulties in market acceptance

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+8%
120-day peak, hindsight
Typical move
10.5%
average across 6 past catalysts

Full Press Release Details

Forward-Looking Statements
This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended and other securities laws. Forward-looking statements are statements that are not historical facts. Words such as “will,” “may,” “intends,” “anticipate(s),” “plan,” “enables,” “potentially,” “entitles,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including, but not limited to: our response to the FDA’s Complete Response Letter on Kangio; any future approval of Kangio by the FDA; any future commercial market acceptance of Kangio; difficulties or delays in manufacturing; the enforceability or defense of intellectual property rights by or against third parties; the outcome of clinical studies; the availability and pricing of third party sourced products and materials, and products licensed to third-parties for promotion and distribution; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; and other factors that are discussed in Eagle’s Annual Report on Form 10-K for the year ended December 31, 2015, and its other filings with the U.S. Securities and Exchange Commission. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to, whether Eagle will adequately evaluate and respond to the FDA’s Complete Response Letter on Kangio; whether the FDA will ultimately approve Kangio; whether the market will accept Kangio, if approved; and other risks described in Eagle’s filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
Investor Relations for Eagle Pharmaceuticals, Inc.:
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
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