Go or no go? Covid-19 upstages US regulatory decisions
A Vantage analysis of FDA decisions expected in the next month and how the ongoing Covid-19 pandemic could affect these.
Upcoming events – Milestone's milestone and Transmedics' panel
Soon Milestone will report pivotal data with etripamil, an intranasal heart arrhythmia therapy, and an FDA adcom approaches for Transmedics' heart preservation…
Upcoming events – Fibroid data for Obseva, as Inventiva turns to Nash
Phase III data for Obseva's uterine fibroid project linzagolix need to prove its safety, while Inventiva tests its pan-PPAR agonist lanifibranor in Nash.
Upcoming events – Soleno has a date with Destiny while Arbutus tries again
Solena is poised to show whether it can sate genetically driven hunger, while the hepatitis B wannabe Arbutus needs to put previous clinical failures behind it.
Go or no go? Ozanimod and Fintepla await FDA verdicts
Big approval decisions pending in March include ozanimod in multiple sclerosis, where Bristol-Myers is likely to win a green light, while the safety of Zogenix's…
Upcoming events – Filgotinib's ulcerative colitis data and serlopitant takes on pruritus
Gilead and Galapagos's filgotinib might not be a match for Rinvoq in ulcerative colitis, while Menlo needs to prove serlopitant works after previous setbacks.
Upcoming events – Avadel takes on Jazz and Axovant awaits early results
Data will soon show whether Avadel’s FT218 is more convenient than Jazz’s Xyrem, while Axovant will be looking for a dose response with its Parkinson’s gene therapy.
Upcoming events – pivotal data for idasanutlin and an interim look at Proqr's exon-skipper
Roche's Mirros study should prove idasanutlin's worth on top of chemotherapy, while Proqr hopes to Usher in a rare disease cure.
Go or no go? Esperion's double whammy and a look to priority reviews
Four assets with previous rejections are due FDA decisions in February, while those with priority review could become the next string of early approvals.
