Galapagos announces that Gilead received a complete response letter for filgotinib for the treatment of moderately to severely active rheumatoid arthritis - Seite 4

Galapagos Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent uncertainties associated with competitive developments, clinical trial and product development activities, and regulatory approval requirements (including that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development of filgotinib due to safety, efficacy or other reasons), whether or when regulatory authorities would approve marketing authorization for filgotinib after receipt of data from MANTA and MANTA RAy studies or whether regulatory authorities will require additional studies, Galapagos’ reliance on collaborations with third parties (including its collaboration partner for filgotinib, Gilead), the uncertainty regarding estimating the commercial potential of filgotinib, that Galapagos’ expectations regarding its operational cash burn for financial year 2020 may be incorrect, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended December 31, 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

 

¹ Gilead & Galapagos Filgotinib Clinical Program Trial Details: FINCH 1 (NCT02889796); FINCH 2 (NCT02873936); FINCH 3 (NCT02886728); SELECTION (NCT02914522); DIVERSITY (NCT02914561); PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839)

 

Attachment

• PDF version