Morgan Stanley (en nog andere analisten) heeft een poging gedaan met een aantal scenario’s:
What are the potential outcomes for this event?
Scenario 1: Filgotinib is approved in RA with a clean label (no black box) at both dose levels: FDA determines there is a significant positive risk-benefit for filgotinib in RA at both 100mg and 200mg dose levels, based on the FINCH program, interim data from MANTA and long-term safety data. Infrequent cases of DVT/PE, serious infections, and MACE justify the drug's approval without black box, and no class label.
Scenario 2: Filgotinib is approved in RA with a class label (warning for serious infections) at both dose levels: FDA determines there is a positive risk-benefit for filgotinib in RA at both 100mg and 200mg dose levels, based on the FINCH program and long-term safety data. Despite differentiation data on safety, FDA sees the risk as a class effect. The scenario may include a warning about male toxicity pending full readout of the MANTA data.
Scenario 3: Filgotinib is approved in RA with a class label at 100mg only: FDA sees positive risk-benefit for filgotinib in RA at 100mg only, rejects 200mg dose level pending the full outcome of the MANTA study, and approval includes a class label warning for serious infections. Rejection of high dose filgotinib is based on the lack of data from the MANTA and MANTA-RAy trials.
Scenario 4: FDA issues a Complete Response Letter (CRL): Due to lack of clarity on testicular toxicity, FDA issues a CRL and thereby rejects the application for filgotinib at both 100mg and 200mg dose levels. We would expect management to need to refile in 1H21, likely delaying the launch by 1-1.5 years.
What are the potential stock implications from these outcomes?
Scenario 1: We see GLPG up 10-15%+ and GILD up 3-5%+ on a clean label with both doses approved.
Scenario 2: We see approval of both doses with a class label as the most likely scenario. In this case, GLPG may rise ~5%, and GILD may rise by ~2-3%.
Scenario 3: We see GLPG flat to down ~5% and GILD flat to down ~2-3% on rejection of the high dose and approval of the low dose with a class label.
Scenario 4: We see GLPG down 15-20%+ and GILD down 3-5% in the event of a Complete Response Letter (rejection requiring the company to provide more information and then resubmit for approval again) from the FDA.
What is our base case expectation for this event?
Our base case expectation is class labeling with approval of both doses, including a potential warning about male reproductive toxicity pending the results of the MANTA studies:
Het lijkt erop dat alleen scenario 1 de beleggers hier tevredenheid kan geven. Verwacht zelf toch wel een redelijk bodem op 152. 80% van m’n aandelenporto in Gala. Korte termijn verkeerd gegokt, lange termijn veilige haven.
Succes iedereen vandaag!