Morgan Stanley 2 juli 2019
MANTA Overhang Lifted; US Filgotinib Filing To Occur By YE19
Gilead announced today that an NDA for filgotinib in rheumatoid arthritis (RA) will be submitted to the FDA in 2019, based on pre-NDA discussions with U.S. regulators regarding the PhIII FINCH data in RA as well as the ongoing PhII MANTA studies evaluating the risk of testicular toxicity from filgotinib. Timing for a U.S. launch has been a key investor focus given filgotinib is likely to launch in RA after competing JAK upadacitinib (for which an NDA has been filed), and investors were uncertain how much MANTA safety data the FDA would require to accept a regulatory filing for filgotinib. As we had highlighted in our recent month ahead note (see here), we believe a 2019 filing plan is a bull case scenario and clearly indicates that the FDA is comfortable with interim safety data from the MANTA studies being included in a filing. A requirement for complete MANTA study data would have significantly delayed filing, as primary completion dates for the MANTA studies are in 2021. One lingering concern about the U.S. regulatory filing investors may have is whether a more rapid path to filing may come at the expense of a more restrictive label. While mgt. would not comment on the intended scope of the label, we expect mgt. to pursue a broad label. Overall, we believe this news is a clear positive for Gilead and Galapagos, as a 2019 NDA filing sets up filgotinib for a U.S. RA launch in 2021, one year ahead of consensus expectations. We expect GILD up 1%-2% and GLPG up 5%+.