Galapagos N.V. (NASDAQ: GLPG) was crushed on Wednesday after the firm, in conjunction with Gilead Sciences Inc. (NASDAQ: GILD), announced a new commercialization and development agreement for their rheumatoid arthritis (RA) treatment.
Specifically, the firms announced that they have agreed to amend their existing arrangement for the commercialization and development of Jyseleca (filgotinib). This announcement comes after the Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the previously issued Complete Response Letter in regards to the New Drug Application (NDA) for filgotinib.
The FDA has requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. The FDA also has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.
The MANTA and MANTA-RAy studies are fully recruited, with topline results expected in the first half of 2021. Filgotinib is currently under review by regulatory authorities around the world.
According to the feedback received from the FDA during the NDA review process and in the Type A meeting, Gilead will not pursue FDA approval of filgotinib for RA. However, the companies have other options.
Under the new arrangement between the companies, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for the treatment of moderate to severe RA, and in all future indications. Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe, and Gilead will receive royalties from European sales of filgotinib.
Gilead stock traded down fractionally to $59.08 on Wednesday, in a 52-week range of $57.04 to $85.97. The consensus price target is $73.40.
Galapagos stock was down 18%, at $97.82 in a 52-week range of $98.69 to $274.03. The consensus analyst target is $136.41.