Vertex should get Orkambi approval by Monday or sooner, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff said he is confident that the FDA will approve Vertex's Orkambi in homozygous F508del cystic fibrosis by its PDUFA date of July 5, meaning a decision should come by either late Thursday or by Monday morning, due to the holiday. Pricing will be key, Tenthoff noted, adding that he expects it to be in-line with Kalydeco's $311,000, except with steeper gross-to-net discounts. Tenthoff expects Vertex to retain its dominance of CF therapy and keeps his Overweight rating and $146 target on its shares, which closed down $4.84 near $122 yesterday.
Galapagos and AbbVie are working together to develop a triple combination therapy for cystic fibrosis patients with the Class II (F508del) mutation. Novel potentiator GLPG1837 is currently in Phase 1 and is expected to enter a Phase 2 study in class III mutation patients before end 2015. Novel corrector GLPG2222 is expected to enter Phase 1 before end 2015. Galapagos and AbbVie expect to nominate a second novel corrector by Q3 2015 and thereby complete the triple combination therapy discovery phase. This second novel corrector is expected to enter Phase 1 in Q2 2016