INCORPORATION BY REFERENCE
This report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-203040,333-210810,333-211512,333-213412,333-214843,333-216883,333-228576 and 333-254101) and Form F-3 (Registration Numbers 333-209336,333-211511,333-216882,333-223134,333-225284 and 333-256571) of Ascendis Pharma A/S (the "Company") (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Based on recent discussions with the European Medicines Agency (the "EMA"), the Company believes that it is on track to obtain a positive opinion on TransCon hGH for the treatment of pediatric growth hormone deficiency from EMA's Committee for medicinal products for human use ("CHMP") in the fourth quarter. European Commission approval for TransCon hGH is expected up to 67 days after the positive CHMP opinion, which the Company expects to occur late this year or in early 2022.
This report contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report regarding Ascendis' future plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the Company's belief that it is on track to obtain a positive opinion on TransCon hGH for the treatment of pediatric growth hormone deficiency from EMA's CHMP in the fourth quarter and the Company's expectation that European Commission approval for TransCon hGH is expected up to 67 days after the positive CHMP opinion, which the Company expects to occur late this year or in early 2022. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: delays in the development of its TransCon hGH program related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug; and the effects on its business from the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis' business in general, see Ascendis' Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission ("SEC") on March 10, 2021 and Ascendis' other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.