SEC Filings

8-K
AVEXIS, INC. filed this Form 8-K on 06/14/2017
Entire Document
 

 

Forward-Looking Statements

This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, AveXis’ research, development and regulatory plans for AVXS-101, including the Company’s commercial manufacturing process, the Company’s potency assay development and the expected timing of the submission of data regarding the potency assay to the FDA, the expected timing of the initiation of the Company’s planned future clinical trials, the expected timing of future meetings with the FDA, the Company’s ability to meet future commercial demand for AVXS-101 through its manufacturing facility and the possibility that the Company may be able to utilize data from its Phase 1 clinical trial in the regulatory pathway of AVXS-101. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, the results of the Company’s ongoing potency assay development efforts are unpredictable, uncertainties regarding the FDA’s agreement that the data generated from such efforts will be sufficient to permit the Company to progress in clinical trials with AVXS-101 drug product from its new manufacturing process, potential timing delays in the Company’s recruitment and enrollment of patients for its planned future clinical trials, uncertainty regarding the potential regulatory approval of AVXS-101 and regulatory developments in the U.S. and EU, as well as other factors discussed in the “Risk Factors” and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of AveXis’ Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 16, 2017. In addition to the risks described above and in the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect AveXis’ results. There can be no assurance that the actual results or developments anticipated by AveXis will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, AveXis. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

 

All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. AveXis cautions investors not to rely too heavily on the forward-looking statements AveXis makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). AveXis undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

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